Delhi Narcotic Drugs Rules, 1985

Delhi Narcotic Drugs Rules,1985

Published vide Notification No. Delhi Gazette (Extraordinary), Part 4, dated 14.11.1985 at pages 30 to 64 (w.e.f. 14.11.1985)

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Notification F.10, 76/85-Fin. (G) dated, 14th November, 1985. - In exercise of the powers conferred by Section 10, read with sub-sections (1) and (2) of Section 78 of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) read with the Government of India Ministry of Home Affairs Notification No. S.O. 818(E), dated 8.11.1985 the Administrator or the Union Territory of Delhi is pleased to make the following rules, namely-

CHAPTER I

Preliminary

1. Short title, extent and commencement. - (1) These rules may be called the Delhi Narcotic Drugs Rules, 1985.(2) They shall extend to the whole of the Union Territory of Delhi,(3) They shall come into force with immediate effect.2. Definition. - In these rules, unless.there is anything repugnant in the subject or context:

(i) "Act" means the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985);

(ii) "Administrator" means the Administrator of the Union Territory of Delhi appointed by the President under Article 239 of the Constitution;

(iii) "Approved Practitioner" means-

(a) a medical practitioner registered under any medical Act for the time being in force in India;

(b) a medical officer of the Military, Naval or Air Force Services on the active lists, or

(c) any qualified veterinary surgeon, provided that the Excise Commissioner may declare any approved practitioner to be deprived of the privilege of an approved practitioner by reason of unprofessional conduct in respect of the import, export, transport, possession, use or prescription of the manufactured drugs other than prepared opium.or by reason of conviction of an offence under any of the following Acts, namely:-

1. The Punjab Excise Act, 1914 (Punjab Act 171) as extended to the Union Territory of Delhi.

2. The Opium Act, 1957 (Act No. 13 of 1957);

3. The Dangerous Drug Act, 1930 (Act No. 2 of 1930);

4. The Opium Act, 1878 (Act No. 1 of 1878).

(iv) "Chemical Examiner" means the Chemical Examiner, Delhi Administration and includes the Chemical Examiner of the Central Revenue Control Laboratory, or any Chemical Examiner of a local body in Delhi or any other Territory or State as may be approved by the Excise Commissioner for the purpose of these rules;

(v) "Collector" means the Collector of Excise, Delhi and includes any other officer specially empowered by the Administrator to perform all or any of the functions of the Collector under these rules;

(vi) "Delhi" means the Union Territory of Delhi;

(vii) "Drug" means manufactured drug or any preparation containing manufactured drug;

(viii) "Excise Commissioner" means the Excise Commissioner of Delhi and includes any other officer specifically empowered by the Administrator to perform all or any of the functions of the Excise Commissioner under these rules;

(ix) "Export" means to take out of Delhi to any other State or Union Territory in India;

(x) "Import" means to bring into Delhi from any other State or Union Territory of India;

(xi) "Licensed Chemist" means a person licensed under these rules for the possession and sale, on prescription, of the manufactured drugs or preparations containing the manufactured drug specified in his license for medical purpose;

(xii) "Licensed Dealer" means a person who has obtained a licence under these rules-

(a) for the manufacture of any preparation containing medicinal opium, morphine, codeine, thebaine and their salts, cocaine and its salts any other manufactured drug notified under sub-clause (b) of Clause (xi) of Section 2 of the Act from the materials which he is lawfully entitled to possess under this licence; and/or

(b) for the possession and the sale, otherwise than on prescription, of such manufactured drugs or preparations containing the manufactured drug as referred to in (a) above, for medical purposes;

(xiii) "Manufactured drug" means a manufactured drug as defined in Clause (ix) of Section 2 of the Act;

(xiv) "Narcotic Drugs" means narcotic drugs as defined in Clause (xiv) of Section 2 of the Act;

(xv) "Preparation" in relation to narcotic drugs means any one or more such drugs in dosage form, or any solution, or mixture in whatever physical state, containing one or more such drug;

(xvi) "Prescription" means a prescription given by an approved practitioner for supply of any narcotic drug to a patient for his medical use or to a person for the medical use of his animal.

3. Prohibition. - (1) No person shall manufacture, possess, sell, purchase, transport, warehouse, use, consume, import or export any narcotic drugs except for medical or scientific purposes and in the manner and to the extent provided by the provisions of these rules:Provided that the Government Opium and Alkaloid Works, Ghazipur/Neemuch may engage in the aforesaid operations in accordance with the provisions of the Narcotice Drugs and Psychotropic Substances Rules, 1985.(2) Notwithstanding anything contained in these rules no person shall possess, transport, import, export, sell, purchase, use or consume coca leaf; or cannabis, that is ganja, charas, hashish oil or liquid hashish or any mixture with or without any neutral material or drink prepared therefrom, or property straw concentrate; or medical cannabis, or Desomorphine; or ketobemidone and their salts and preparations, or diacetyl/morphine that is, the alkaloid of opium, also known as diamorphine or heroin and its salts and preparations except for the purposes of scientific research and in the manner and to the extent provided by the provisions of these rules.(3) No person shall cultivate any cannabis plant, or manufacture, or produce cannabis in Delhi.(4) No addict, registered with the Delhi Administration, shall manufacture and possess prepared opium from opium lawfully possessed by him for personal consumption against the licence issued to him on medical advice.

CHAPTER II

Manufacture

4. Manufacture of Medicinal Opium etc. - Manufacture of medicinal opium from the material which the maker is lawfully entitled to possess or medicinal Hemp (Medicinal cannabis) is prohibited in Delhi.5. Manufacturer of preparation. - A licensed dealer may, subject to the payment of such fees as may be prescribed under these rules, manufacture preparations containing any manufactured drug from the material which the maker is lawfully entitled to possess for medicinal purposes under the licence granted in accordance with the provisions of these rules.

CHAPTER III

Possession and Sale

6. (1) Any-

(a) approved practitioner desiring to possess manufactured drugs or preparations containing manufactured drugs, other than medicinal opium and opium alkaloid derivatives for the purpose of use in his practice shall make an application to the Collector for the grant of the licence of Form D.D.5;

(b) dealer desiring to possess manufactured drugs for the manufacture or preparations containing these manufactured drugs and to manufacture and sell the preparations so manufactured, shall make an application to the Excise Commissioner for the grant of licence in Form D.D. 9;

(c) dealer desiring to possess manufactured drugs or preparations containing manufactured drugs and such drugs or preparations, otherwise than on prescription, shall make an application to the Commissioner of Excise for the grant of licence in form D.D. 10;

(d) chemist desiring to possess manufactured drugs or preparations containing manufactured drugs and sell such drugs or preparations on prescription, shall make an application to the Collector for the grant of licence in Form D.D. 11.

(2) On receipt of such application, the licensing authority shall make such inquiries and/or demand the submission of such documents/ recommendations as deemed necessary, and if he is satisfied that there is no abjection to grant a licence applied for, he may grant the applicant a licence an payment of the fees prescribed in these rules for the grant of such licence.7. No licensed chemist or approved practitioner shall dispense manufactured drugs or preparations containing manufactured drugs except an prescription and in accordance with the conditions of his licence.8. No person shall possess any manufactured drug or preparations containing these drugs except in such quantity as has been at one time, dispensed or sold to him for his medical use in accordance with the provisions of Rule 7 or of any corresponding rules, for the time being in force, in any part of India, the import wherefrom into or export whereto from Delhi is permitted.9. (1) An approved practitioner may possess for the purpose of "use in his practice" and not for sales, the following manufactured drugs or preparations containing these drugs/not exceeding the quantities specified below against each without obtaining a licence in this behalf, namely:-

(i)

Medicinal opium 2.0 grams.

(ii)

Opium Alkaloid Derivatives (excluding prepared opium, diacetyl morphine). 0.2 grams of each variety.

Provided that the collector may, with the previous sanction of the Excise Commissioner by general or special order, authorise any approved practitioner to possess any large quantity.(2) (a) An approved practitioner may be authorised by the Collector or any other officer duly authorised by the Excise Commissioner in this behalf, to possess, for the purpose of "use in his practice" and not for sales, the following manufactured drugs or preparations containing these manufactured drugs, not exceeding the quantities specified below against each-

(i)

Morphine and Appropine.  
  (a) Ampules

2.5 grams.

  (b) Tablets

5.0 grams.

(ii)

Pethidine-  
  (a) Ampules

2.5 grams.

  (b) Tablets

5.0 grams.

(iii)

Any other drug declared to be manufactured drug under Section 2, (xi)(b) of the Act. Such quantity as may be recommended by the Drug Controller or the Director of Health Services.

Provided that the Collector may, with the previous sanction of the Excise Commissioner by general or special order, authorise any approved practitioner to possess for "use in his practice" any preparation containing not more than 0.3 gramme of cocaine in aggregate.

(b) No approved practitioner shall possess any manufactured drug or any preparation containing any manufactured drug] except as provided in this rule.

(3) No approved practitioner shall, for the purpose of sale, posses any quantity of any manufactured drug or preparation containing any manufactured drug.(4) An approved practitioner shall maintain a register in Form D.D. 15, showing the receipt and disposal of each drug or preparation containing manufactured drug.(5) A separate page of the register shall be assigned to each of the following classes of drugs or preparations containing such drugs:

(a) Medical opium and preparations containing medicinal opium;

(b) Morphine and preparations containing morphine;

(c) Dihyropydroxy condeinone (that is derivative of morphine and commonly known as Ducodal) and its preparations;

(d) Dihydrocodinone (that is, derivative of morphine and commonly known as Disodide) and its preparations;

(e) Pethidine and its preparations; and

(f) Dihydromorphine (that is, derivatives of morphine commonly known as Dilaoddide) and its preparations.

(6) Entries in the register shall be made on the day on which the manufactured drugs or preparation thereof, are received or disposed of. It is not necessary that the approved practitioner shall himself enter in the register the particulars of the drugs administered by him or under his supervisions but entries shall be verified by him on the date of entry. Where approved practitioner practices at more I Iran one premises, a separate accounts of drugs kept at each premises shall be maintained.Explanation.-(1) Expression "use in his practice" in this rule means only the actual direct administration of the drugs by or in the presence of the approved practitioner. All other issues of the drugs by an approved practitioner shall amount to sale.(2) Quantity of manufactured drug in respect of preparations containing the manufactured drug means quantity of manufactured drug contained in such preparation.10. The, Collector may, with the previous sanction of the Excise Commissioner, by general or special order, authorise, on his application showing, annual requirements duly recommended by the Drugs Controller or the Assistant Drugs Controller or the Director/Dy. Director, Health Services, Delhi:

(i) a Government Medical Officer in-charge of Government Medical Institution, or of a Government grant-in aided Medical Institution, to possess, for use in such Institution, or

(ii) an approved practitioner in-charge of a local board or Municipal Dispensary belonging to missions and other corporate bodies, to posses, for use in such dispensary and hospital, or

(iii) a Government Medical Officer in-charge of a hospital or dispensary, belonging to Railways, to possess for use in such hospital or dispensary, to possess such quantities of the manufactured drugs (other than prepared opium) or preparations containing manufactured drugs as may be specified in the order/authorisation, and subject to such conditions and in such manner as may be specified therein:

Provided that the recommendations of the said authority will not be necessary in case of Government hospital/dispensaries:Provided further that the Collector may dispense with the requirements of the recommendations of the said authority, if in his opinion, the applicant is a man of good repute.11. A medical officer or an approved practitioner possessing manufactured drugs under Rule 10 shall:

(a) keep accounts of the manufactured drugs received, used and held in the stock by him, from time to time, in form D.D. 6. The accounts shall be clearly and correctly written up daily in books, bound, paged, and sealed with the seal of an Excise Officer, not below the rank of Sub-Inspector, and shall show in each case of purchase, the date of purchase and the name and address of the person or firm or, corporate body from whom the purchase was made. A separate page of the register shall be assigned to each manufactured drug or preparation containing such drugs;

(b) preserve the accounts, for not less than two years, from the date of the last entry in the accounts book and shall produce them, together with any manufactured drugs or preparations containing manufactured drug, that may be in his possession at the time, for inspection on demand by an Excise Officer not below the rank of Sub-Inspector;

(c) furnish to the Collector or any other officer duly authorised by him in his behalf, a week after the end of each calendar year, information regarding the purchase and consumption of the manufactured drugs or preparations containing manufactured drugs during the preceding year, the stocks held by him on the last day of the year in form D.D. 6-A.

12. Subject to the provisions of Rule 8, no person unless he is authorised in this behalf by the Collector by an order, shall possess any manufactured drugs or any preparation containing any manufactured drug. The order shall specify the maximum quantity of such drugs that may be possessed and condition subject to which the same may be possessed.13. (1) (a) No licensed dealers all possess manufactured drugs or any preparations containing any manufactured drug except in such quantity and in such manner as may be specified in his licence.

(b) The licensing authority shall not authorise and dealer requiring manufactured drugs for manufacture of medicinal preparation containing manufactured drugs, to possess any manufactured drug, not recommended by the Drugs Controller/Assistant Drugs Controller, Delhi Administration.

(c) The Drugs Controller/Assistant Drugs Controller, may, on the application of a dealer requiring these drugs for manufacturing of medical preparations, recommended the following manufactured drugs, if he is satisfied about the genuineness of the formulations of the medicinal preparations for the manufacture of which the manufactured drugs are required-

(i) Medicinal opium;

(ii) Opium Alkaloid derivatives-

(a) Morphine and its salts;

(b) Codeine and its salts;

(c) Thebaine and its salts;

(d) All preparations containing more than 0.2 per cent of morphine;

(iii) Pethidine and its salts;

(iv) Cocaine and its salts.

(v) Any other drug declared by the Government of India to be manufactured drug under Section 2 (xi) (b) of the Act.

(2) (a) The licensing authority shall not authorise any dealer requiring the licence not for the manufacture of any medicinal preparation containing these drugs, but for possession and sale of the manufactured drugs or preparations containing any manufactured drug, to possess any manufactured drug or preparations containing any manufactured drug unless it has been duly recommended by the Drugs Controller/Assistant Drugs Controller, Delhi Administration.

(b) The Drugs Controller/Assistant Drugs Controller may recommend on the application of the dealer, to possess such manufactured drugs or preparation containing any manufactured drug, as he may think to be genuinely required for medical purposes.

(c) The licensing authority may dispense with the requirement of the recommendations of the said authority if the dealer has applied for the grant of the licence for the possession and sale of Morphine and Atrophine or Pethidine Ampules only and the applicant is, in his opinion, a man of good repute.

(3) (a) No licensed chemist shall possess manufactured drugs or preparation containing any manufactured drug except in such quantities and in such manner as may be specified in his licence.

(b) The licensing authority may authorise a licensed chemist to possess the following manufactured drugs or the preparation containing these manufactured drugs-

(i) Medicinal opium (excluding the extract or Tincture of medicinal opium) or preparation containing Medicinal opium;

(ii) Opium Alkaloid derivatives-

(a) Morphine and their salts; or preparations thereof;

(b) Codeine and their salts; or preparations thereof;

(c) Thebaine and their salts; or preparations thereof;

(d) All preparations containing more than 0.2% of morphine.

(iii) Pethidine or any other drug declared under Section 2 (xi) (b) of the Act and on the recommendations of the Drugs Controller:

Provided that the Excise Commissioner may be special order, authorise a licensed chemist to possess, extracts or tincture of Medicinal opium or any preparation containing more than 0.1 per cent of cocaine :Provided further that except with the special sanction of the Excise Commissioner, such a licence shall not authorise the chemistal to possess a greater quantity than 125 grammes of opium alkaloid derivatives, 125 grammes of cocaine or 125 grammes of pethidine, in aggregate.14. (1) (a) A licensed dealer in manufactured drugs may sell, otherwise than on prescription, manufactured drugs or preparation thereof specified in his license to-

(i) an approved practitioner who is either known to the licensee or is introduced by some one known to him either sings the register in person or sends a written or signed order stating his name, address and name and quantity of drugs required. An entry of each such sales shall be made by the licence in the D.D. 5 licence or the approved practitioner :

Provided that making of entry is not necessary in case of sale of Medicinal Opium Alkaloid Derivatives specified in Rule 9(i) on the basis of the Registration Certificate in Form D.D. 8;

(ii) a chemist/dealer licensed under these rules;

(iii) an approved practitioner or a Government Medical Officer in-charge of hospital/dispensary and holding authorisation/order under Rule 10;

(iv) a person holding appropriate licence in any other State/Union Territory of India under the rules, for the time being in force, in that State/Union Territory.

(v) an approved practitioner engaged in veterinary practice and holding licence in Form D.D. 5 or Registration Certificate in Form D.D. 8.

(b) Each such sale to the persons mentioned in sub- Clauses (it) and (iii) of Clause (a) above, shall be made against the Transport Passes in Form D.D.4, issued by the competent authority under these rules and duplicate copies of the Transport Passes shall be kept by the licensed dealer as a token of such sale having been made.

(c) Each such sale to the persons mentioned in sub- Clause (iv) of Clause (a) above, shall be made after obtaining an Export pass in Form D.D. 3, issued by the competent authority under these rules and original copy of the Export pass shall be kept by the licensed dealer as token of such sale having been made.

(2) The licence shall maintain, in register in Form D.D. 13, a correct and written account/record of all transactions of manufactured drugs. Such account shall show:

(a) In respect of receipts, the source of supply the quantity of each individual drug received, the number and date of the Transport/Import Permit on the basis of which supplies have been received.

(b) In respect of the manufacture, the quantity of the manufactured drugs used in manufacturing medical preparations, the quantity Of the finished preparations, the number of bottles, containers, or packages in which finished preparations have been packaged alongwith the quantity of drugs contained in such containers, bottles, packings.

(c) In respect of sale, the name and address of the persons to whom the preparations containing these drugs have been sold, the quantity of drugs in such preparations so sold, the number and date of the Transport-Export pass.

(3) Such account/record shall be preserved for a period of not less than two years from the date of [he entry last therein.(4) The licensee shall, on the first day of every quarter, submit a correct quarterly statement, showing the quantity of drugs received by him during the previous quarter, the quantity used in manufacturing of medicinal preparations, the quantity sold by him and the quantity remaining in his possession, to the Collector and the Drugs Controller, Delhi:Provided that if the licensee has been authorised to possess Extracts or Tinctures of Medicinal Opium, or any preparation containing Coacine, such statement of receipt and disposal thereof shall be submitted by the seventh day of each month to the authorities mentioned in this rule.(5) The bottles, phials packages or other containers of the preparations containing manufactured drugs possessed by the licensee for sale, or the labels affixed to them, shall either plainly show the actual quantity of the drugs present in each container or give sufficient particulars to submit of the ready calculation of such quantity.(6) A preparation, admixture, extract or any other substance containing any manufactured drugs, shall be sold only in package or bottle plainly marked:

(a) in case of powders, solution or ointment, with the total quantity of the drugs in the packages or bottle and the percentage of the manufactured drugs in the powder of ointment, and

(b) in case of tablets or other similar forms of preparations, with the quantity of the manufactured drugs in each tablet or other similar form of preparation, and the number of tablets or other forms of preparations in the packages or bottle.

15. (1) (a) No licensed chemist shall sell manufactured drugs otherwise than on the prescription in Form D.D. 12 and subject to the conditions of his licence.

(b) He shall sell the manufactured drugs or preparations containing manufactured drugs, in such quantity and for the use of such person only as may be specified in the prescriptions.

(c) If the prescription does not bear a superscription by an approved practitioner stating that it is to be repealed and at what interval of time it is to be repealed, he shall sell the manufactured drugs or preparations containing manufactured drugs once only on such prescription and shall retain the prescription:

Provided that he shall forewarn the person presenting the prescription that unless it bears such superscription as aforesaid, it shall be retained.

(d) If the prescription bears the superscription as aforesaid, he shall enter in the prescription the date of sale and shall sign and seal the prescription:

Provided that if it appears that manufactured drugs or preparations containing manufactured drugs have already been sold on the prescription six times of for such number of times as the prescription is required to be repealed, or that the interval specified in the prescription has not elapsed since the prescription was last dispensed, he shall not sell the manufactured drugs or preparations containing manufactured drugs on such prescription unless it has further been superscribed by the approved practitioner.(2) The licensee shall keep an account of the receipt and disposal of the manufactured drugs in the register in Form D.D. 14. Such account shall be kept by the licensee for a period of not less than two years from date of the last entry entered in the register.(3) The provisions of sub-rules (2), (3), (4), (5) and (6) of Rule 14 shall apply in case of the licensed chemists also.16. Notwithstanding anything contained in these rules, the holder of a licence shall, whenever required to do so, sell any manufactured drug or preparations containing manufactured drugs to any Government Officer who is duly authorised by the Administrator in this behalf to purchase and possess such drug on behalf of the Government:Provided that a receipt is obtained by the holder of the licence form such officer for the same and kept on his record.17. No prescription for the supply of manufactured drugs (other than prepared opium) shall be given by an approved practitioner otherwise than in accordance with the following conditions:

(a) the prescription shall be in writing and shall be dated and signed by the approved practitioner with his full name and address and qualifications and shall specify the name, address of the person to whom, and the nature of ailment for which the prescription is given, the directions for use and the total amount of the drug to be supplied on the prescription provided that where the medicine to be supplied on the prescription is a proprietary medicine, it shall be sufficient to state the amount of medicine to be supplied, when a dose in excess of the usual dosage of any such manufactured drug, is prescribed, the amount of the does shall be emphasised by being underlined and the initials of the practitioner set in the margin opposite;

(b) the prescription shall not be given for the use of the prescriber himself;

(c) a registered dentist shall give a prescription only for the purpose of dental treatment and shall mark it "For local treatment only";

(d) a registered veterinary surgeon shall give a prescription only for the purpose of treatment of animals and shall mark it "For animals treatment only"; and

(e) an approved practitioner of indigenous system of medicine may prescribe only those drugs which are included in that system.

CHAPTER IV

Accounts

18. Notwithstanding any other provisions relating to the maintenance of accounts contained in these rules, the Excise Commissioner may prescribes, from time to time, the maintenance of such records in such form and submission of such returns as Ire may consider necessary for the purpose of these rules.

CHAPTER V

Approval, Authorisation, Licenses and Permits

19. (1) The Excise Commissioner may, for the purpose of these rules, approve any person engaged in veterinary practice.(2) The Collector or any other officer duly authorised by the Excise Commissioner in this behalf, may authorise an approved practitioner to possess and transport manufactured drugs as specified in Rule 9 (2) for use in his practice by grant of a licence in Form D.D. 5 A fee of rupees five only per annum in the form of court-fee stamp shall be levied on every such licence.(3) An approved practitioner who desires to possess Medicinal Opium and Opium Alkaloid derivatives, or preparations containing Medicinal Opium or Opium Alkaloid derivatives, or desires to write prescriptions, shall get himself registered with the Collector. Full particulars of such registration shall be maintained by the Collector in register in Form D.D. 7 No fee shall be charged for such registration. The Collector shall immediately after the registration of the approved practitioner, issue him a Registration Certificate in Form D.D. 8 which shall be produced by him on demand by an officer of the Excise and/or the Drugs Control Department, not below the rank of Sub-Inspector, for inspection.20. The Collector may, with the sanction of the Excise Commissioner, by special order, authorise,-

(i) any approved practitioner, in managing or supervision charge of a hospital or dispensary, not being a Government, local board or municipal hospital or dispensary, to possess, import or transport manufactured drugs or preparations containing manufactured drugs in such manner as may be specified by him in that order/authorisation and a fee of Rs. 50 (rupees fifty) only per annum shall be levied on every such licence.

(ii) any person in-charge of an Educational Institution or engaged in scientific research to possess, import or transport, for educational and scientific purposes only manufactured drugs in such quantity and in such manner as may be specified by him in that order.

21. The Excise Commissioner may, by special order authorise any person to export manufactured drugs subject to such conditions, if any, as may be specified that order.22. (1) The Excise Commissioner may grant to any person a dealer's licence in Form D.D. 9, appended to these rules, permitting him to manufacture preparations containing Medicinal Opium, Morphine, Condeine, Thebaine and their salts, Cocaine and its salts and any other manufactured drugs notified under Section 2 (xi) (b) of the Act and to possess and sell, otherwise than on prescription, such manufactured drugs referred to above, for medical purposes, subject to the provisions of these rules and to the conditions of the licence:Provided that no such licence shall be granted unless the applicant is holding an appropriate manufacturing and sale licence under the Drugs and Cosmetics Rules, 1945 made under the Drugs and Cosmetic Act, 1940, for manufacture and sale of the medicinal preparations approved by the Drugs Controller/Assistant Drugs Controller, Delhi Administration.(2) The Excise Commissioner may grant to any person a dealer's licence in Form D.D. 10 appended to these rules, permitting him to possess and sell such manufactured drugs or preparations containing manufactured drugs as referred to in sub-rule (1) subject to the provisions of these rules and to the condition of the licence:Provided that no such licence shall be granted unless the applicant is holding an inappropriate licence in Forms 20-B and 21-B under Drugs and Cosmetics Rules, 1945 made under the Drugs and Cosmetics Act, 1940.(3) The Collector may grant to any person a chemist's licence in From D.D. 11 appended to these rules permitting him to possess and sell manufactured drugs or preparations containing manufactured drugs subject to the provisions of these rules and to the conditions of the licence:Provided that no such licence shall be granted unless the applicant is holding an appropriate licence in Forms 20 and 21 under the Drugs and Cosmetics Rules, 1945 made under the Drugs and Cosmetics Act, 1940.(4) A fee of Rs. 300 (rupees three hundred), Rs. 200 (rupees two hundred), Rs. 100 (rupees one hundred) only per annum shall be levied on every licence granted under sub-rule (1) of sub-rule (2) of sub-rule (3), respectively.23. The Excise Commissioner may grant to any licensed dealer or licensed chemist an authorisation in Form D.D. 2 for the import of manufactured drugs not exceeding the quantity which such dealer or chemist may lawfully possess.24. When an authorisation has been granted, under the rules for the time being in force in any part of India outside Delhi, to any person to import manufactured drugs or preparations containing manufactured drugs from Delhi into such part of India, such person shall present authorisation to the Excise Commissioner who shall enter therein, the period for which the authorisation is to remain in force and the route which and the person, (if any,) in whose charge the consignment is to be conveyed and the number and description of the packages and shall countersign the authorisation.25. The Collector may grant to any licensed dealer or licensed chemist, a permit in from D.D. 4 appended to these rules, for the transport of manufactured drugs or preparations containing manufactured drugs not exceeding the quantity which such dealer or chemist may lawfully possess.26. (1) The officer who has granted a licence to, or has by order, approved or authorised any person under these rules, may after giving such person an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons thereof, cancel such licence or order, or suspend it for such period as he thinks fit either wholly or in a respect of some of the drugs to which it relates; if in his opinion such person has-

(a) failed to pay duty a fee payable by him; or

(b) by himself or by any servant or person acting on his behalf committed any breach of conditions of such licence or order or of these rules; or

(c) been convicted of any offence under the Act or under the law for the time being in force, a relating to excise, revenue or prohibition or of any criminal offence; or any other case not falling under this clause.

(2) The officer who has granted a licence to or has by order approved or authorised any person under these rules, shall cancel such licence or order within fifteen days of the receipt of a notice from such person that he desired to surrender the same.(3) When such licence or order is cancelled or suspended, such person shall forthwith make over to the Collector all manufactured drugs or preparations containing manufactured drugs then in his possession and he shall not be entitled to any compensation in this behalf.(4) When any manufactured drugs or preparations containing manufactured drugs in possession of any person licensed or authorised under these rules is found by him or by the chemical examiner, to be unfit for use, such person shall forthwith deliver up such drug to the Collector.

CHAPTER VI

Poppy Straw

27. Every cultivator licensed to cultivate opium poppy for the producing of opium under the Narcotic Drugs and Psychotropic Substances Rules, 1985, after each harvesting of opium, dispose of, subject to the provisions of Rule 4, the poppy straw obtained from such cultivation in the following manner-

(i) he shall not keep with him such poppy straw in any year beyond the 31st July of the same year;

(ii) he may dispose of such poppy straw before the expiry of the aforesaid date by-

(a) warehousing the same for export or export out of India;

(b) exporting the same for warehousing;

(c) exporting the same out of India;

(d) using the same as manure in his field; or

(e) destroying the same.

28. (1) The Administrator may declare any place to be a warehouse wherein it shall be the duty of the owner to deposit all such poppy straw as is legally imported inter-State and is intended for export inter-State or export from India. The order declaring a place to be a warehouse shall specify the arrangement for safe custody of such poppy straw warehouse and the conditions for the removal of the same for export inter-State or export from India.(2) The Administrator may prescribe the rate of fees to be levied for such warehousing and the manner in which and the period after which the poppy straw warehouse shall be disposed of in the default of payment of fees.29. (1) Subject to the provisions of these rules, no person shall, purchase, sell/possess, transport, use, consume, ware house, import or export poppy straw except under a licence or permit granted under these rules and subject to such conditions and payment of such fee as may be prescribed in these rules.(2) The Excise Commissioner may grant to any person a licence in Form D.D. 9 permitting him to possess such quantity of poppy straw as may be specified in the licence for the manufacture of any preparation in the manufacture of which poppy straw is required to be used as an ingredient:Provided that no such licence shall be granted under this sub-rule unless the applicant is holding an appropriate licence granted by the Drugs Controller/Assistant Drugs Controller under the Drugs and Cosmetics Rules, 1945 for the manufacture of such preparation for which the poppy straw is required and the said authority has recommended the quantity required for such purpose.(3) A fee of Rs. 200 (rupees two hundred) only per annum shall be levied on every licence granted under sub-rule (2).(4) A person who has been granted a licence under sub-rule (2) may import, after obtaining permit in Form D.D. 2, such a quantities of poppy straw and in such manner as may be specified in the permit.

CHAPTER VII

Import, Export and Transport

30. (1) No person shall import, export or transport any manufactured drugs except in such quantity, as he may lawfully possess under these rules.(2) All applications for grant of permits to import and transport manufactured drugs shall be in Form D.D. 2.31. No approved practitioner shall import, export or transport any manufactured drug except such drugs and in such quantities as he may lawfully possess under these rules with or without a licence in this behalf.32. Any person authorised in this behalf may import manufactured drugs in such quantity and in such manner as may be specified in import permit in Form D.D. 2.33. A licensed dealer may, subject to the conditions of his licence, export after obtaining export pass in Form D.D. 3, manufactured drugs to any parts of India, outside Delhi Territory, subject to the terms of import authorisations granted under the rules, for the time being in force, in such part of India and countersigned by the Excise Commissioner.An indent of manufactured drugs countersigned by the Chief Medical Officer or Civil Surgeon or Superintendent of the Civil Veterinary Department shall, for the purpose of this rule, be deemed to be an authorisation and shall not require further counter-signature.34. A person authorised in this behalf by the Excise Commissioner, by a special order made under these rules, may export manufactured drugs, in such quantity and in such manner as may be specified in the export pass in Form D.D. 3.35. A person to whom a pass or authorisation has been granted under these rules for the transport of manufactured drugs may transport the drugs in such quantity and in such manner as may be specified in the pass or authorisation granted to him in Form D.D. 4.36. Every person importing, exporting or transporting manufactured drugs shall comply with the general or special directions as may be given by the Excise Commissioner.37. Nothing in these rules shall be deemed to permit import of manufactured drugs from any part of India outside Delhi, unless the rules, for the time being in force in such part of India, relating to the export of such drugs, have complied with.38. Except as provided in these rules, no one shall import, export, or transport, by post manufactured drugs.39. The transmission of manufactured drugs by inland post by licensed chemist and licensed dealers for medical purpose is permitted subject to the following conditions-

(i) only the parcel post shall be used;

(ii) the parcels shall be insured;

(iii) the parcels shall be covered by permits issued by the proper authorities in the State to which the parcels are addressed;

(iv) the parcels shall be accompanied by a declaration stating the names of the consignee and the consignor, the contents of the parcels in details, the number and date of the permit covering the transmission and the number of licence held by the licensee; and

(v) the consignee shall show distinctly in his account books the name of the consignor and the quantity of drugs sent to him, time to time, by post.

Explanation.-The expression "manufactured drugs" means manufactured drugs as defined in Clause (xii) of Rule 3 of these rules and includes any preparation containing manufactured drug for the purposes of this chapter.

CHAPTER VIII

Opium

40. (1) Notwithstanding anything contained in Rule 4, Opium may be purchased by the Excise Commissioner or any other authority specially authorised by the Administration in this behalf, from the Government Opium Factory, Ghazipur for use by the addicts registered with the Delhi Administration.(2) The opium received in accordance with sub-rule (1) may be kept in District Treasury with proper security arrangement.41. (1) The Collector or any other officer, specially authorised by the Excise Commissioner in this behalf, may grant any authorisation to an addict in Form OP for possession of opium supplied to such addict under these rules, for personal consumption and subject to such conditions as may be specified in the authorisation. A fee of Rs. 10/- (rupees ten only) per annum shall be levied on every such authorisation :Provided that no such authorisation shall be granted to an addict not registered with the Excise Department as an addict and holding a permit in Form OP-4 granted under the Delhi Opium Rules, 1959 made under the Opium Act, 1878, on the day immediately prior to the date on which these rules come into force.(2) The authorisation Form OP shall be granted in respect of such quantity of opium as may be fixed by the licensing authority but not exceeding the quantity which he was entitled to purchase in a month under his OP-4 permit immediately prior to the date on which these rules come into force:Provided that the aggregate quantity that can be purchased in a month by the addict shall not exceed 60 grammes and the quantity that can be possessed at any one time shall not exceed 6 grammes.(3) The opium received in accordance with the provisions of sub-rule (1) of Rule 40, shall be sold to the addicts from the Depots established by the Excise Commissioner for this purpose and at such price as may be fixed by him from time to time.(4) An addict holding a permit or any authorisation granted by a competent authority of any other State/Union Territory in India and visiting Delhi, may import, without any permit or authorisation from the competent authority in Delhi, opium obtained and possessed under the said permit or authorisation for personal consumption upto the extent authorised in it.(5) An addict holding authorisation under sub-rule (1), may export such quantity of opium as has been purchased and possessed by him under his authorisation to any other State or Union Territory, for his personal consumption only:Provided that the information of the same shall be given by the holder of authorisation to the Collector.

CHAPTER IX

Renewal and Cancellation of Licences

42. (1) Any authority empowered to grant any authorisation or a licence, permit or pass under any of these rules, may, in his discretion, either grant such authorisation, licence, permit or pass, as the case may be, applied for or by an order, in writing, refuse to grant such authorisation, licence, permit or pass.(2) A person whose application for any authorisation, licence, permit or pass has been refused, shall be entitled to be informed of the reasons upon which such refusal is based.(3) (a) An authorisation or licence, except the licence in Form D.D. 5, shall remain in force from the date of issue till the 31 March, next following on which date it shall expire unless renewed.

(b) The licence in Form D.D. 5 shall remain in force from the date of issue till the 31st March of the 3rd year following on which date, it shall expire unless renewed.

(c) The said licence may be renewed for a similar period on the application of the licence holder if the licensing authority is satisfied that the licensee has not violated any terms and conditions of the licence or any provision of Act or these rules.

(d) All applications of renewal of the said licence in Form D.D. 5 shall be accompanied by a fee deposit receipt of Rs. 15/- (rupees fifteen only) or court fee stamp of Rs. 15/- (rupees fifteen only).

(4) Every application for the renewal of the authorisation or licence, shall be submitted to the licensing authority at least two months before the commencement of the year of which renewal is required and shall be accompanied by a treasury challan showing payment of fee, if any, prescribed for the grant of the authorisation or the licence.(5) The authority empowered to grant a licence or authorisation, may renew it or refuse to renew it, on sufficient grounds after giving him a reasonable opportunity of being heard.(6) Every authorisation, licence, permit or pass granted under these rules, shall be held to have been granted personally to the person named therein.(7) It any holder of authorisation, licence, permit or pass dies before or during the currency of his authorisation, licence,permit or pass, it shall determine forthwith.

CHAPTER X

Appeals

43. (1) An appeal shall lie from an original or appellate order as follows-

(a) to the Excise Commissioner, when the order is made by the Commissioner:

Provided that-

(a) when an original order is confirmed on first appeal, a further appeal shall not lie;

(b) when an original order is modified or reversed on first appeal by the Excise Commissioner, the order on second appeal, if any, made by the Administrator shall be final.

(2) Every memorandum of appeal shall be presented within one month from the date of the order appealed from.(3) Every memorandum of appeal shall be accompanied by the order appealed from in original, or by a certified copy of such order unless the omission to produce such order or copy is explained to the satisfaction of the appellate authority.(4) In computing the period of limitation prescribed under sub-rule (2), the time requisite for obtaining a certified copy of such order shall be excluded.

CHAPTER XI

Exemptions

44. Nothing in these rules shall apply to the possession, by a cultivator, licensed to cultivate opium poppy for the production of opium, under the Narcotic Drugs and Psychotropic Substances Rules, 1985 of opium produce, until such time as such produce is required to be delivered by him to the officer of the Narcotic Department, authorised to receive such opium on account of the Central Government.45. Nothing in these rules shall apply to the transport of opium by a licensed opium poppy cultivator, of his opium produce from the field from which it is produced to his residence, to the opium weighment centre, set up by the Narcotic Department, for the collection of such opium.46. Nothing in these rules shall apply to the transport of opium from the opium weighment centre to the Government Opium and Alkaloid Works at Ghazipur and Neemuch on account of the Central Government.47. Nothing in these rules shall apply to the transport, export or import of opium or any manufactured drug from or to the Government Opium and Alkaloid Works at Ghazipur/Neemuch for or on behalf of the Government.48. (1) The following rules made under the Opium Act, 1878 and the Dangerous Drugs Act, 1930, are hereby repealed-

(i) The Delhi Opium Rules, 1957;

(ii) The Delhi Opium (Restriction on Oral Consumption) Rules,, 1958;

(iii) The Delhi Poppy Head Rules, 1961;

(iv) The Delhi Poppy Head Auction Rules, 1968; and

(v) The Delhi Manufactured Drugs Rules, 1962.

(2) Notwithstanding any such repeal, anything done or any action taken or purported to have been done or taken or any licence granted, under any of the rules repealed by sub-rule (1), shall, in so far as these are not inconsistent with these rules or the Narcotic Drugs and Psychotropic Substances Act, 1985, be deemed to have been done, taken or granted under the corresponding provision of these rules.

Form D.D. 1

[See Rule 30(2)]

Application for permit to Import/Transport manufactured drugs other than prepared Opium in the Union Territory of Delhi

1. Name and Address of applicant..................................2. The above-name being

Licensed Dealer

(a) A................in the Union Territory of Delhi.

Licensed Chemist

Licensed to possess  
  Medicinal Opium Opium Alkaloid Derivatives Coca Derivatives. Pethidine Other Drugs

(b) A Government servant requiring the manufactured drugs other than prepared opium in his official capacity.

3. And having in hand manufactured drugs as follows-

1. Medicinal Opium..............................................................................................

2. Opium Alkaoid Derivatives...................................................................................

3. Coca Derivatives.:..........................................................................................

4. Pethidine...................................................................................................

5. Other drugs.................................................................................................

4. Desires to import/transport by land from M/s.......................licensed to sell such drugs at ................. in the ............... district or State or .................. manufactured drugs other than prepared opium as follows-

1. Medicinal Opium.............................................................................................

2. Opium Alkaloid Derivatives..................................................................................

3. Pethidine ........................................................................................................................................................

4. Other drugs.................................................................................................

The..............................200............ Signed........................................................

Note.-This application should be submitted to the Excise Inspector/Excise Sub-Inspector of the Zone concerned. The Excise Inspector/Excise Sub-Inspector verifying paragraph 2 and if he thinks necessary paragraph 3 also should sign the endorsement and forward it to the Excise Officer.

Forwarded to the District Excise Officer, Delhi with the recommendation that....................

Excise Inspector/Excise Sub-Inspector

Form D.D. 2

(See Rule 32)

(Foil)

(To be retained, in the office of issue)

Permit and Pass (on the reverse) for the Import/Transport of manufactured drug other than prepared Opium into the Union Territory of Delhi.Before the drug covered by the permit are exported from any State the permit must be presented to the Collector of the District of Export and the

 

 

Permit No.

For the transport of/import

Coca derivatives/Medicinal Opium/Opium Alkaloid Derivatives/Pethidine/Other Drugs

 

 

 

 

Permit granted to (a)...................To transport/import by land Form (b).................

 

  Medicinal Opium Opium Alkaloid Derivatives Coca Derivatives. Pethidine Other Drugs

to the extent specified below, viz


Description of each class of drug. Weight or quantity

 


Kgms Gms Mgms

The permit must be used within two months of its issueOne copy of the permit and the pass on the reverse shall be delivered on arrival of the consignment of

  Medicinal Opium Opium Alkaloid Derivatives Coca Derivatives. Pethidine Other Drugs

(C) at its destination to(................) The bulk consignment shall not be broken in transit.Date ....................... 200.............

Collector

(a) Here state the name and designation of the consignee.

(b) Here state the locality and district.

(c) Here state the official designation of the person to whom pass to be delivered.

Form D.D. 2

(See Rule 32)

Duplicate

(To be given to the importer)

Permit and Pass (on the reverse) for the Import/Transport of manufactured drugs other than prepared Opium in the Union Territory of Delhi.Before the drugs covered by the permit are exported from any State the permit must be presented to the Collector of the District of Import/Export and the export pass on the reverse must be completed and signed by such officer.

 

 

Permit No.

For the transport of/import

Coca derivatives/Medicinal Opium/Opium Alkaloid Derivatives/Pethidine/Other Drugs

 

 

 

 

Permit granted to (a)..................To transport/import by land Form (b).

 

  Medicinal Opium Opium Alkaloid Derivatives Coca Derivatives. Pethidine Other Drugs

to the extent specified below, viz

Description of each class of drug. Weight or quantity

 


Kgms Gms Mgms


The permit must be used within two months of its issueOne copy of the permit and the pass on the reverse shall be delivered on arrival of the consignment of

  Medicinal Opium Opium Alkaloid Derivatives Coca Derivatives. Pethidine Other Drugs

(C) at its destination to( )The bulk consignment shall not be broken in transit.Date.......................200.................................... Collector

(a) Here state the name and designation of the consignee.

(b) Here state the locality and district.

(c) Here state the official designation of the person to whom pass is to be delivered.

Form D.D. 2

(See Rule 32)

Triplicate

(To be sent to the Collector or the exporting District)

Permit and Pass (on the reverse) for the import/transport of manufactured drugs other than prepared Opium into the Union Territory of Delhi.Before the drugs covered by the permit are exported from any State the permit must be presented to the Collector of the District of Export and the export pass on the reverse must be completed and signed by such officer.

 

 

Permit No.

For the transport of/import

Coca derivatives/Medicinal Opium/Opium Alkaloid Derivatives/Pethidine/Other Drugs

 

 

 

 

Permit granted to (a)..................To transport/import by land Form (b).

 

  Medicinal Opium Opium Alkaloid Derivatives Coca Derivatives. Pethidine Other Drugs

to the extent specified below, viz


Description of each class of drug. Weight or quantity

 


Kgms Gms Mgms

The permit must be used within two months of its issueOne copy of the permit and the pass on the reverse shall be delivered on arrival of the consignment of

  Medicinal Opium Opium Alkaloid Derivatives Coca Derivatives. Pethidine Other Drugs

(C) as its destination to(........................)The bulk consignment shall not be broken in transit.Date.......................200......................................... Collector

(a) Here state the name and designation of the consignee.

(b) Here state the locality and district.

(c) Here state the official designation of the person to whom pass is to be delivered.

Form D.D. 2

(Reverse)

Pass for the export of Medicinal Opium Opium Alkaloid Derivatives Coca Derivatives. Pethidine Other Drugs

(Foil) This pass is to remain in force.............................................from (a)........................ to (a)......................................

  Medicinal Opium Opium Alkaloid Derivatives Coca Derivatives. Pethidine Other Drugs

covered by

theit shall be conveyed by (b)..................................................in charge of (c).............................................................and (d)......................................................................Dated...........................200..................

.....................Collector of Customs .....................Collector ....................District

(a) Here specify date and hour.(b) Here state route and mode of conveyance.(c) Here given name of person, if any.(d) Here state number and description of packages.

Form D.D.2

(Reverse)

Pass for the export of Medicinal Opium Opium Alkaloid Derivatives Coca Derivatives. Pethidine Other Drugs

(Duplicate)

This pass is to remain in force........... form (a)............................to (a)..........

Medicinal Opium Medicinal Opium Opium Alkaloid Derivatives Coca Derivatives. Pethidine Other Drugs covered by

theit shall be conveyed by (b)...............................................in charge of (c)................................................................................and (d)...........................................................................Dated.........................200...................

.......................Collector of Customs ........................Collector ......................District

(a) Here specify date and hour.

(b) Here state route and mode of conveyance.

(c) Here give name of person, if any.

(d) Here state number and description of packages.

Form D.D.2

(Reverse)

Pass for the export of Medicinal Opium Opium Alkaloid Derivatives Coca Derivatives. Pethidine Other Drugs

(Duplicate)

This pass is to remain in force.........................................from (a)...........................to..........................(a).....................

  Medicinal Opium Opium Alkaloid Derivatives Coca Derivatives. Pethidine Other Drugs

covered by

theit shall be conveyed by (b).................................................................in charge of (c).........................................................................and (d)............................................................................Dated......................200..............................

................... Collector of Customs .....................Collector ......................District

(a) Here specify date and hour.

(b) Here state route and mode of conveyance.

(c) Here give name of person, if any.

(d) Here state number and description of packages.

Form D.D. 3

(See Rule 33)

(Foil)

(To be retained in the office of issue)

Pass for the export of manufactured drugs other than prepared opium.No........................................dated............................Licensed Dealer

at

Licensed Chemist

 

upto

authorised to possess Medicinal Opium............. Coca Derivatives. Opium Alkaloid Derivatives................ Pethidine Other Drugs

is hereby authorised to export......................................................(2)............................................................................ from the licensed premises at.................................................................To the licensed premises of..................................................................at...........................................................................................This pass shall be carried with the consignment of the drugs the export of which it is intended to cover, and it is current uptill.......(3) One copy of this pass must be kept in the licensed premises.

(Signature and full official designation of the officer granting the pass)

(1) Here enter the name of licensee.(2) Here enter the name of the drug and the quantity allowed to be exported.(3) Omit in the case of export to a Government of State Official.

Form D.D. 3

(See Rule 33)

Duplicate

(To be given to the exporter)

Pass for the export of manufactured drugs other than prepared opium.No....................dated..................(1) ......................................................Licensed Dealer

at

Licensed Chemist

 

upto

authorised to possess Medicinal Opium............. Coca Derivatives. Opium Alkaloid Derivatives................ Pethidine Other Drugs

is hereby authorised to export.........................................................(2) ........................................from the licensed premises at................................................To the licensed premises of........................................... .....at...........................................................................This pass shall be carried with the consignment of the drugs the export of which it is intended to cover, and it is current uptill..........................(3) One copy of this pass must he kept in the licensed premises.(Signature and full official designation of the officer granting the pass)

(1) Here enter the name of licensee.

(2) Here enter the name of the drug and the quantity allowed to be exported.

(3) Omit in the case of export to a Government of State Official.

Form D.D. 3

(See Rule 33)

Triplicate

(To be sent to the Collector of the District of destination)

Pass for the export of manufactured drugs other than prepared opium.No...........................dated.......................(1)......................................................Licensed Dealer

at

Licensed Chemist

 

upto

authorised to possess Medicinal Opium............. Coca Derivatives. Opium Alkaloid Derivatives................ Pethidine Other Drugs

is hereby authorised to export.......................................................(2) ................................................................................from the licensed premises at...............................................................To the licensed premises of ..............................................at................................This pass shall be carried with the consignment of the drugs the export of which it is intended to cover, and it is current uptill..............(3) One copy of this pass must be kept in the licensed premises.

(Signature and full official designation of the officer granting the pass)

(1) Here enter the name of licensee.(2) Here enter the name of the drug and the quantity allowed to be exported.(3) Omit in the case of export to a Government of State Official.

Form D.D. 4

(See Rule 35)

(Foil)

(To be retained in the office of issue)

Pass for the Transport of manufactured drugs other than prepared opium.No.......................Dated.........................(1) ...................................................Licensed Dealer

at

Licensed Chemist

 

upto

authorised to possess Medicinal Opium............. Coca Derivatives. Opium Alkaloid Derivatives................ Pethidine Other Drugs

is hereby authorised to transport...............(2) ............................................................................from his licensed premises at to the licensed premises of.... at.............................One copy of this pass shall be carried with the consignment of the drugs transport of which it is intended to cover. It is current uptill........One copy of this pass must be kept in the licensed premises.

(Signature and full official designation of the officer granting the pass)

(1) Here enter the name of the licensee.(2) Here enter the name of the drug and the quantity allowed to be transported.

Form D.D.4

(See Rule 35)

(Duplicate)

(To be given to the Transport)

Pass for the Transport of manufactured drugs other than prepared opium.No................Dated................(1) .....................................................Licensed Dealer:

at.......................

Licensed Dealer

at

Licensed Chemist

 

upto

authorised to possess Medicinal Opium............. Coca Derivatives. Opium Alkaloid Derivatives................ Pethidine Other Drugs

is hereby authorised to transport......(2) ...............................................................from his licensed premises at ..................................to the licensed premises of...................................at............................................................One copy of this pass shall be carried with the consignment of the drugs transport of which it is intended to cover. It is current uptill.......One copy of this pass must be kept in the licensed premises.

(Signature and full official designation of the officer granting the pass)

(1) Here enter the name of the licensee.(2) Here enter the name of the drug and the quantity allowed to be transported.

Form D.D. 5

[See Rule 19 (2)]

Licence for the possession and transport of manufactured drugs by an approved practitioner for "use in his practice"

1. Licence Holder's Name

2. Father/Husband's Name

3. Address in full (Residence)

4. Address of the Clinic

5. Address of the premises where the manufactured drugs shall be kept for use in his practice.

6. Name of the manufactured drugs Quantity

1. Morphine and Atropine

(a) Ampoules

(b) Tablets

2. Pethidine

(a) Ampoules

(b) Tablets

3. Preparations containing cocaine.

4. Other drug declared to be manufactured drug under the Act and specified herein.

Note : For the cocaine, special authorisation of Excise Commissioner is necessary. Quantity of manufactured drug i.r.o. the preparation means the quantity of manufactured drug contained in such preparation.

This licence is granted under and subject to the provisions of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) and the Delhi Narcotic Drugs Rules, 1985 on payment of Rs. 15/- authorising him to possess and transport above mentioned manufactured drugs subject to the following conditions-

1. This card shall remain in force from to 31st March (both days inclusive).

2. These manufactured drugs shall be possessed/transported only in the form of medicinal preparation containing these drugs.

3. The licence-holder shall not obtain during any one quarter manufactured drugs exceeding the quantities mentioned in Column 5 provided that the quantities remaining unconsumed with the card- holder at the end of a quarter shall be counted towards the quantities of the following quarter.

4. The licence-holder shall keep an account of purchase and consumption of the drug in the prescribed register in Form D.D. 15 which shall be open for inspection by the officer of the Excise and Drugs Control Department not below the rank of a Sub-Inspector. A separate page of the register shall be assigned to each drug or preparation and entries of receipt and disposal shall be made on the same day.

5. The licence-holder shall not obtain his supplies of the manufactured drugs from any place except from a licensed dealer.

6. The licence-holder shall get details of the purchase entered on the reverse of the card by the licensee before he removes the drugs purchased by him from the licensed dealer.

7. The manufactured drugs other than those obtained under this licence shall be transported by the holder except under a transport pass granted by the competent Excise Officer.

8. The manufactured drugs obtained under this licence shall be for use only in the practice of the card-holder.

Explanation-(a) The term "use in his practice" covers only the actual direct administration of the drugs in injection, during operations or other emergent cases by or in the presence of the Approved Practitioner.

(b) All other uses of the drugs by the card-holder from his dispensary will amount to sale.

9. The licence shall be non-transferable and may be suspended or cancelled at any time, by the officer granting it-

(a) for non-payment of fee, if any, payable by the licensee.

(b) for default or violation by the licence-holder of any of the conditions specified in the licence or any order framed or directions issued, under the Narcotic Drugs and Psychotropic Substances Act, 1985 or rules made thereunder.

(c) If the licence-holder is convicted of an offence against any law relating to excise, opium, revenue and liquor, opium, manufactured drugs.

10. In case the licence is surrendered, suspended or cancelled during the currency or is not renewed on its expiry whole of the unconsumed stock of the drugs shall forthwith be surrendered to the officer granting the licence granted this....................day of...................20..................

(Signature and designation of authority granting the licence)

Space for renewal:

(i) Renewed for the year ending 31st March, 20........

(ii)

(iii)

(iv)

(Signature of the Authority renewing the licence)

Reverse

(See condition No. 6)

 

 

Name of the manufactured drug

Date

Quantity

Name and signature of the dealer

Remarks

1.

       

2.

       

3.

       

4.

       

5.

       

 

 

Form D.D. 6

(See Rule 11)

Form of the Register to be maintained by the Medical Officer/Approved Practitioner holding authorisation under Rule 10Name of the manufactured drug or preparations containing manufactured drug.

 

 

Sl. No.

Date

Opening Balance

Quantity received the name of the Licensed Dealer from whom received and No. and date of Transport/ Import Permit No.

Quantity consumed

Closing Balance

1. 2. 3. 4. 5.

         

 

 

Form D.D. 6-A

(See Rule 11)

(Form of statement to be submitted by such person within a week after the end of each calendar year)

 

 

Name of the manufactured drug preparations

Opening balance as on 1st January of the last calendar year

Total Quantity received during that year

Total Quantity consumed during the year

The balance of the stock as on 1st January of the current year

1. 2. 3. 4. 5.

       

 

 

Registration Register

Form D.D. 7

(See Rule 19(3)]

 

 

Reg. No.

Name of the Approved Practitioner

Qualification

Residential and clinical Address

1

2

3

4

1. 2. 3. 4. 5.

     

 

 

Registration Certificate

Form D.D. 8

(See Rule 19(3))

Registration No.

Allotted

Certificate that

(1) Shri...............................................................

(2) Son of.............................................................

(3) Resident of........................................................

(4) Having clinical....................................................

(5) Having Medical Registration No..................... has been registered in this office in accordance with the provisions of the Delhi Narcotic Drugs

Rules, 1985 and his Registration No. is in the prescribed Register in Form D.D. 7.Seal

Collector of Excise, Delhi

Note-Holder of this Registration Certificate may prescribe medicines containing manufactured drugs to a patient on prescription and possess the following manufactured drugs or preparations containing these manufactured drugs for use in his practice and not for sale.

1. Medicinal Opium upto 283 grammes.2. Opium Alkaloid Derivatives upto 0.2 grammes of each variety. (Excluding Prepared Opium, Diacetyl Morphine and Morphine and Atropine).The approved practitioner shall maintain an account register in Form D.D. 15 showing the receipts and disposal of each drugs or preparations thereof. A separate page of the register shall be assigned to each of the drugs or preparations. Entries of the receipts and disposal shall be made on the same day. The accounts and the stock of the drugs shall be open for inspection by the Officers of the Excise and Drug Control Department not below the rank of Sub-Inspectors and Inspectors respectively.

Form D.D. 9

[See Rules 14(1), 22(10)]

(Dealer licence granted on payment of Rs for possession of manufactured drugs for manufactured of the medicinal preparations containing manufactured drugs and for sale of such preparations).

(i) No. of licence

(ii) Name of the licensee

(iii) Name of firm/company in which the licensee is an active Partner/Managing Director

(iv) Status of the licensee in such firm/company                    Proprietary/Active Partner/Managing Director

(v) Residential address of the licensee

(vi) Address of the licensed premises.

The person named above and hereinafter called "the Licensee" is authorised by the Excise Commissioner to possess the following manufactured drugs-

(a) Medicinal Opium

(b) Opium Alkaloid Derivatives-

(i) Morphine and its salts.

(ii) Codeine and its salts.

(iii) Thebaine and its salts.

(iv) Preparation containing more than 0.2% of Morphine.

(c) Pethidine and its salts.

(d) Any other substance or preparation declared to be manufactured drug under Section 2(xi)(b) of the Act.

(i) ............

(ii)............

(iii)..........

And to manufacture the following medicinal preparations containing manufactured drugs duly approved by Drug Controller/Assistant Drug Controller from the manufactured drugs specified above-

 

 

Name of the preparation

The name of the drug to be used as such

Formula of the Medicinal Preparations

(a) (b) (c) (d)

   

 

And to sell, otherwise than on prescription, the preparations so manufactured by him; from the date of the grant of this licence to 31st March of 19......And subject to the following conditions-(1) The licensee shall comply with the provisions of the Narcotic Drugs and Psychotropic Substances Act, 1985, the Narcotic Drugs Rules, 1985, and any other rules which may from time to time be made under the Act.(2) The licensee shall be responsible for the acts and omissions of every person employed by him and carrying on his business and of all his servants, as if the said acts and omissions were his own.(3) Any loss of any drug and preparations containing drug or any records kept under these rules shall be immediately reported to the Police and Excise Officer.(4) The licensee shall not have at any time in his possession any of these drugs in greater quantities than the following:

 

(a) Medicinal Opium.

(b) Opium Alkaloid Derivatives.

(i) Morphine and its salts.

(ii) Codeine and its salts.

(iii) Thebaine and salts.

(iv) Preparation containing more than 0.2% or morphine.

(c) Pethidine and its salts.

(d) Any other drug.

(5) The licensee shall not keep the manufactured drug in any place except in the premises specified in the licence.(6) The licensee shall procure his supplies either from a licensed vendor in Delhi, if any, or by importation from a licensed vendor outside Delhi after obtaining from the Collector of Excise an import permit in Form D.D. The importation of his supplies by post is absolutely prohibited.(7) The licensee shall maintain in a Register in Form D.D., a correct account of all transactions. Such account shall show in respect of receipts the source of supply, the number and date of import/transport permit and quantity of drug used in of manufacturing, the quantity of the finished product, the number of containers, bottles or packages in which such finished preparations has been packed alongwith the quantity'' of drug contained in each such container, bottle or packages and in respect of issues the name and address of the person whom the preparations containing the drugs have been issued the quantity issued in each case, the date and number of transport or quantity issued export permit/pass. Such accounts shall be preserved for not less than two years from the date of the last entry in the account register and shall be signed by an Excise Officer who inspects the licensed premises.(8) Any package or bottle containing drugs manufactured by the licensee shall, before sale, be marked with the quantity of the drugs contained therein.(9) Any preparation so manufactured shall be sold only in a package or bottle plainly marked;

(a) in case of a powder, solution or ointment, with the total quantity of drugs in the package or bottle and the percentage of drugs in the powder, solution or ointment, and;

(b) in case of tablets or other articles, with the quantity of drugs in each article and the number of articles in the package or bottle.

(10) All stocks of the drugs and the preparations manufactured from such drugs by the licensee and all account of the transactions under the licence, shall be open to inspection by any officer of the Excise Department not below the rank of Sub-Inspector and any officer of the Drug Department not below the rank of a Drug Inspector or any other officer empowered to do so under any provisions of the Act and Rules, order made thereunder.(11) The licensee shall on requisition by the Collector or any officer of the Excise Department not below the rank of Sub-Inspector, deliver the licence for amendment or issue of fresh licence.(12) The licensee on the first day of every quarter submit a correct quarterly statement showing the quantity of the drugs received, quantity of drugs used in manufacturing of preparations, balance of the unused drug in his possession, the quantity of the drugs contained in the preparations so manufactured, the quantity of drugs contained in preparations sold and in the preparations in his possession.(13) If on the expiry of cancellation of the licence, any stock of the drugs or preparations containing the drugs is in the possession of the licensee, he shall at once surrender these stocks to Collector who may order for its destruction or disposal in the manner he thinks reasonable. The licensee shall not be entitled for any compensation for any loss on account of such destruction or disposal.(14) The licensee shall sell the preparations containing manufactured drugs, otherwise than on prescription, to the following class of persons-

(a) Any approved practitioner holding a licence in Form D.D. 5 or Registration Certificate in Form D.D. 8 who is either known to him or is introduced by some one known to him and either signs the register in person or sends a written or signed order stating the name address and the name and quantity of the drugs required. An entry of each such sale of the drugs specified in Rule 10(2) shall be made by the licensee on the reverse of D.D. 5 Licence of the Approved Practitioner.

(b) A Chemist Dealer licensed under these rules.

(c) An approved practitioner or a Government Medical Officer-in-Charge of a hospital/dispensary and holding authorisation under Rule 11.

(d) An approved practitioner engaged in the veterinary practice and holding licence in Form D.D. 5 or Registration Certificate in Form D.D. 8 :

Provided that each such sale to I he person mentioned in (b) and (c) above shall be made against the Transport Passes in Form D.D., and to the persons mentioned in (d) above, the licensee shall obtain Export Pass in Form issued by the competent authority under these rules and he shall keep a copy of the Transport Permit or Export Pass, as the case may be, as token of such sale having been made. No such Transport Permit shall be necessary if the drug is sold to the Approved Practitioner on the basis on D.D. 5 licence or Registration Certificate in Form D.D. 8. However, no manufactured drug except Medicinal Opium and Opium Alkaloid Derivatives as specified in Rule 10(1) shall be sold on the basis of R.C. in Form D.D. 8.(15) The licensee shall not import, export or transport any manufactured drug or preparations thereof by post.(16) The licensee shall comply with the orders, directions issued from time to time by the Collector or any Excise Alkaloid Officer subordinate to him not below the rank of Sub-Inspector.(17) The licensee shall not, in any circumstances, sell or dispose of any manufactured drug or preparation thereof except for the medical purposes and in the manner provided in this licence and the Narcotic Drugs Rules, 1985.(18) In any matter not provided in this licence or the Narcotic Drugs Rules,1985, the licensee shall comply with the orders of Excise Commissioner or any officer duly authorised by him on this behalf.

Excise Commissioner

Delhi.

Place................Date... ............

Form D.D. 10

[See Rules 13(2), 13(3), 22(2)]

(Dealer Licence granted on payment of Rs for possession and sale of manufactured drugs or preparatioxas containing manufactured drugs otherwise than on prescription).

(i) No. of Licence........

(ii) Name of the Licence ..........

(iii) Name of the firm/company in which the licensee is Proprietor/Active Partner/Managing Director

(iv) Status of the licensee in such finn/company Proprietor/Active Partner/Managing Director

(v) Residential address of the licensee

(vi) Address of the licensed premises.........

The person named above and hereinafter called the licensee is authorised by the Excise Commissioner to possess and sell, otherwise than on prescription, the following manufactured drugs or preparations containing the manufactured drugs for medical purposes :

(i) Medicinal Opium or preparations containing Medicinal-Opium or Tinctures of Medicinal-Opium.

(ii) Opium Alkaloid Derivatives-

(a) Morphine and its salts or preparations containing Morphine or its salts.

(b) Codeine and its salts or preparations containing codeine or its salts.

(c) Thebaine and its salts or preparations containing thebaine or its salts.

(d) Other preparations containing more than 0.2% of morphine (names to be specified by licensing authority)

(iii) Cocaine or preparations containing cocaine.

(iv) Pethidine and its salts.

(v) Any other drug declared to be manufactured drug under Section 2(xi)(b) of the Act-

(name to be specified)

(a)

(b)

(c)

And hereinafter referred to as the drugs.From the date of the grant of this licence to 31st March of 19 and subject to the following conditions-(1) The licensee shall comply with the provisions of the Narcotic Drugs and Psychotropic Substances Act, 1985, the Narcotic Drugs Rules, 1985 and any other rules which may from time to time be made under the Act.(2) The licensee shall be responsible for the acts and omissions of every person employed by him in carrying on his business and of all his servants as if the said acts and omissions were his own.(3) Any loss of any drug and preparations containing drug or any records kept under these rules shall be immediately reported to the Police and Excise Officer.(4) The licensee shall not have at any time in his possession any of these drugs in greater quantities than the following-

(i) Medicinal opium/preparations containing Medicinal.

Opium.................................                       Quantity.

(ii) Opium Alkaloid Derivatives-

(a) Morphine/Morphine Atropine/Salts of Morphine/preparations containing Morphine or salts.

(b) Codeine/salts of codeine/preparations containing condeine or its salts.

(c) Thebaine/salts of the thebaine/preparations containing thebaine/or salts.

(d) Any other preparation containing more than 0.1% of morphine.

(iii) Pethidine.

(iv) Cocaine/salts of cocaine/preparations containing cocaine.

(v) Any other drug.

(a)

(b)

(c)

(5) The license shall not keep the manufactured drug in any place except in the premises specified in the licence.(6) The licensee shall procure his supplies either from a licensed vendor in Delhi, if any, or by importation from a licensed vendor outside Delhi after obtaining from the Collector an import permit in Form D.D. 2. The importation of his supplies by post is absolutely prohibited.(7) The licensee shall maintain in a Register in Form D.D. 13 a correct account of all transactions. Such account shall show in respect of receipts, the source of supply, the number and date of import/Transport Permit and quantity of each individual drug received, in respect of manufacture the quantity of the drug used in the manufacturing, the quantity of the finished product, the number of containers, bottles or packages in which such finished preparations has been packed alongwith the quantity of drug contained in each such container, bottle, or packages, and in respect of issues the name and address of the person whom the preparations containing the drugs have been issued the quantity issued in each case, the date and number of transport or export permit/passes. Such accounts shall be preserved for not less than two years from the date of the last entry in the accounts register and shall be signed by an Excise Officer who inspects the licensed premises.(8) Any package or bottle containing drugs manufactured by the licensee shall, before sale, be marked with the quantity of the drugs contained therein.(9) Any preparations so manufactured shall be sold only in a package or bottle plainly marked-

(a) in case of a powder, solution or ointment, with the total quantity of drugs in the packages or bottles and the percentage of drugs in the powder, solution or ointment; and

(b) in a case of tablets or other articles, with the quantity of drugs in each article and the number of articles in the package or bottle.

(10) All stocks of the drugs and the preparations manufactured from such drugs by the licensee and all accounts of the transactions under the licence, shall be open to inspection by any officer of the Excise Deptt. not •below the rank of Drugs Inspector or any other officer empowered to do so under any provisions of the Act or rules, orders made thereunder.(11) The licensee shall on requisition by the Collector or any officer of the Excise Deptt. not below the rank of Sub-Inspector, deliver the licence for amendment or for issue of fresh license.(12) The licensee shall on the first day of every quarter submit a correct quarterly statement showing the quantity of the drugs received, quantity of drugs used in manufacturing of preparations, balance of the unused drug in his possession, the quantity of drugs contained in the preparations so manufactured, the quantity of drugs contained in preparations sold and in the preparations in his possession.(13) If on the expiry or cancellation of the licence, any stock of the drugs or preparations containing the drugs is in the possession of the licensee, he shall at once surrender these stocks to Collector who may order for its destruction, disposal or in the manner he thinks reasonable. The licensee shall not be entitled for any compensation for any loss on account of such destruction or disposal.(14) The licensee shall sell the preparations containing manufactured drugs, otherwise than on prescription to the following class of persons:-

(a) an Approved Practitioner holding a licence in Form D.D. 5 or Registration Certificate in Form D.D. 8 who is either known to him or introduced by someone known to him and either signs the register in person or sends a written or signed order stating the name, address and the name and the quantity of drugs required. An entry of each such sales shall be made by the licensee on the Reserve of the D.D. 5 licence of the Approved Practitioner. Provided that making of entry is not necessary in case of sale of Medicinal Opium and Opium Alkaloid destruction.

(b) A Chemist/Dealer Licensed under these rules.

(c) An Approved Practitioner or a Government Medical Officer-in-Charge of a Hospital/Dispensary and holding authorisation under Rule 11.

(d) A person holding appropriate licence in any other State/Union Territory of India under the rules for the time being in force in such State/Union Territory.

(e) An Approved Practitioner engaged in the veterinary practices (and holding licence in Form D.D. 5 Registration Certificate in Form D.D. 8 :

Provided that each sale to the persons mentioned in (b) and (c) above shall be made against the Transport Pass in Form D.D. 4 and to the persons mentioned in (b) above the licensee shall obtain the Export pass in Form D.D. 3 issued by the competent authority under these rules and he shall keep a copy of the Transport Permit or Export Pass, as the case may be, as a token of such sale having been made. No such Transport Permit shall be necessary if the drug is sold to the approved Practitioners (on the basis of D.D. 5 licence) or Registration Certificate in Form D.D. 8. However no drug except the Medicinal Opium and Opium Alkaloid Derivatives as specified in Rule 9(1) shall be sold on the basis of the Registration Certificate in Form D.D. 8(15) The licensee shall not import, export or transport any manufactured drug or preparations thereof by post.(16) The licensee shall comply with the orders/directions issued from time to time by the Collector or any Excise Officer subordinate to him not below the rank of Sub-Inspector.(17) The licensee shall not, in any circumstances, sell or dispose of any manufactured drug or preparation thereof except for the medical purposes and in the manner provided in this licence and the Narcotic Drugs Pules, 1985.(18) [n any matter not provided in this licence or the Narcotic Drugs Rules, 1985 the licensee shall comply with the orders of Excise Commissioner or any officer duly authorised by him on this behalf.Place

Excise Commissioner, Delhi.

Date :

Form D.D. 11

[See Rule 22(2)]

Chemist licence granted on payment of Rs for sale, on prescriptions of Manufactured Drugs or Preparations containing the Manufactured Drugs for medical purposes.

(i) No. of licensee............................................... .....

(ii) Name of the licensee.............................................

(iii) Name of the firm/company in which the licensee is an active partner/Managing Director...............................................

(iv) Address of the licensed premises..................................

The person named above, and hereinafter called "the licensee" is authorised by the Collector to possess and sell, on prescriptions, the following manufactured drugs and/or preparations containing these manufactured drugs.

(i) Medicinal opium and/or preparations thereof.

(ii) Opium Alkaloid derivatives-

(a) Morphine and their salts and/or preparations thereof.

(b) Codeine and their salts and/or preparations thereof.'

(c) Thebaine and their salts and/or preparations thereof.

(d) Preparations containing more than 0.2% of morphine.

(iii) Preparations containing more than 0.1% of cocaine.

(iv) Pethidine and/or preparations thereof.

(v) Other drugs declared to be manufactured drugs by Government of India under Section 2(xi)(b) of the Act.

hereinafter referred to as "The drugs from the date of the grant of this licence to the 31st March, 19 "Subject to the following conditions-(1) The licensee shall be bound by provisions of "The Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985)." "The Delhi Narcotic Drugs Rules, 1985" and any other rules which may from time to time be made under the Act.(2) The licensee shall be responsible for the acts and omission of every person employed by him in carrying on his business and of all his servants, as and if the said acts and omissions were his own.(3) The licensee shall not permit any drugs, which he is authorised to sell, to be dispensed by any person other than a medical practitioner or a dispenser, registered under the Pharmacy Act, 1948 (Act No. 7 of 1948).(4) Cocaine or Extracts and Tinctures of the Medicinal Opium and Medicinal Cannabis shall not be possessed and sold without the previous authorisation of the Excise Commissioner.(5) The licensee shall be authorised to sell the drugs only against a prescription issued by an Approved Practitioner and the drugs shall not be delivered to any person not holding a prescriptions appropriately signed by the medical practitioner.(6) The licensee shall not at any one time keep or sell the drugs in any place except in their premises described in the licence.(7) The licensee shall not at any time have in his possession the drugs in greater quantities than the following:

(i) Medicinal opium Quantity

(ii) Medicinal cannabis........

(iii) Opium and Alkaloid derivatives-

(a) Morphine and their salts........

(b) Codeine and their salts.......

(c) Thebaine and their salts......

(d) Preparations containing 0.2% of Morphine.........

(iv) Preparations containing more than 0.1% of cocaine........

(v) Pethidine..........

(vi) Other manufactured drugs (the name of the drug to be specified).

Explanation-Quantity in relation to the preparations containing manufactured drug means the quantity of manufactured drug contained in preparations.(8) The license shall obtain his supplies either by direct importation from any other State/Union territory or any other licensed dealer after obtaining the permit in form D.D and D.D...................respectively.(9) The licensee is authorised to compound any preparations containing any manufactured drug from the materials which he is lawfully entitled to possess.(10) The name of person, firm or body corporate dispensing prescriptions, the address of the premises at which and date on which it is dispensed must be entered in the prescription.(11) All prescriptions for the dispensing of such drugs shall be written out by the approved practitioner in Form D.D. 12 and the licensee shall be responsible that the prescription on the authority of which such drugs are to be sold, are made out in this Form.(2) (i) The licensee shall sell the drugs in such conditions and for use of such persons only as may be specified in prescription.

(ii) If the prescription does not bear a superscription by any medical practitioner stating that it is to be repealed and at what interval of time it is to be repealed and how many times it is to be repeated, he shall sell the drugs once only on such prescription and shall retain the prescription:

Provided that he shall first warn the person presenting the prescription, that, unless it bears the requisite superscription it will be retained.

(iii) If the prescription bears the requisite superscription he shall enter in the prescription the date of sale, and shall sign and seal the subscription, giving particulars as laid down in cdndition 11:

Provided that if it appears that the drugs have already been sold on the prescription six times, or such number of times as the prescription is required to be repeated, or that the interval specified in the prescription, had not elapsed since the prescription was last dispensed, he shall not sell the drugs on such prescription, unless it has further been superscribed by the medical practitioner.(13) The licensee shall maintain correct accounts of transactions in Form D.D Such accounts shall show in respect of each receipt, the source of supply and the quantity received, and in respect of each issue the quantity issued and the name and address of the person to whom it is issued. He shall file in support of his accounts of receipt the import or transport passes, and in respect of his account of issues, the original prescription on which have been issued. Such accounts and documents shall be preserved for a period of not less than two years from date of the last entry in account register.(14) (a) The bottles, phials, packages, or other containers of the preparations or in the labels affixed to them shall either plainly show the actual quantity of the drugs present in each container or give sufficient particular to admit of the ready calculations of such quantity.

(b) A package or bottle containing the drugs shall before the sale be marked with the quantity of the drugs in the package or bottle plainly marked:

(i) in the case of powder, solution or ointment with the total quantity thereof in the package or bottle and the percentage of the drugs in the powder, solution or ointment;

(ii) in the case of tablet or other similar forms of preparation with the quantity of the drugs in each tablet or the similar forms of preparation, and the package or bottle.

(15) All stocks of drugs and all accounts and records of transaction in the licence shall be open to inspection by any officer of the Excise Department not below the rank of Sub-Inspector and any officer of the Drug Control Department not below the rank of a Drug Inspector.(16) The licensee shall on requisition by the Excise Commissioner or by any Officer duly authorised by him in this behalf deliver up his licence for amendment or for the issue of fresh licence.(17) The licensee shall in the first day of every quarter submit correct quarterly statement showing the quantity of drugs received by him during the previous quarter, the quantity sold by him and the quantity remaining in his possession to the District Excise Officer and Drugs Inspector of the Drug Control Department, Delhi:Provided that in case of Tinctures Extracts of opium and cannabis, such statements shall be submitted every month.(18) If on expiry or cancellation of this licence, any quantity of the drug remain in the possession of the licensee he shall surrender the stock to the Collector in the manner specified in the order, licensee shall not be entitled to claim any compensation for loss resulting from such destruction or disposal of any stock declared by the Chemical Examiner to be unfit for human consumption, it shall be disposed of only by destruction.(19) The licensee shall not sell or dispense any manufactured drug or the preparation containing these drugs except for the medical purposes.Place :

Collector of Excise

Date :

Delhi

Notes.: Before issue of the licence, strike out the name of the drugs which the licensee has not been authorised to possess and sell.

Special Order of the Excise Commissioner

The above-named licensee is authorised to possess and sell on prescription, the following manufactured drugs for medical purposes:

(a) (i) Extract of medicinal opium

(ii) Tincture of medicinal opium.

(b) preparations containing more than 0.1.% of cocaine. Subject to the conditions specified in this licence.

Place:

Collector of Excise

Date:

Delhi

Form D.D. 12

[See Rule 15(1)]

Official Form of prescription to be used when preparations containing manufactured drugs are prescribed

Not to be repeated.(To be repeated at the interval of days).

(Note-Cross out one of the two alternatives)

1. Name, address and description of the person to whom the prescription is issued.2. Nature of the ailment..........3. Directions for use..........4. Dose (if in excess of usual doses)........5. Amount of drug to be supplied at one time..............6. No. of Registration certificate in Form D.D. 8. or Form D.D. 5 Licence of Approved Practitioner...............Address:..................Date:.....................

..................

..................

Full name, qualifications and signature of the Approved Practitioner

1. Name of the Licensed Chemist who dispenses the prescription.2. Address of premises3. Date.

Conditions

(a) The prescription can be prescribed only by those approved practitioners who are either registered with Collector of Excise on this behalf and have obtained Registration Certificate in Form D.D. 8 or holding a licence in Form D.D. 5.

(b) On the authority of this prescription, the drug must not be supplied to the holder more than 6 times.

(c) The prescription shall not be given for the use of prescriber himself.

(d) A registered dentist shall give a prescription only for the purpose of dental treatment and shall make it "for animal treatment only".

(e) A registered veterinary surgeon shall give prescription only for the purpose of treatment of animals and shall make it for local dental treatment only.

(f) An approved practitioner of indigenous system of medicine may prescribe only those drugs which are included in the indigenous system of medicine.

Form D.D. 12

[See Rule 15(1)]

Official Form of prescription to be used when preparations containing manufactured drugs are prescribed

Not to be repeated. ,(To be repeated at the interval of days).

(Note-Cross out one of the two alternatives)

1. Name, address and description of the person to whom the prescription is issued.............2. Nature of the ailment...........3. Directions for use........4. Dose (if in excess of usual doses.)..........5. Amount of drug to be supplied at one time..............6. No. of Registration certificate in Form D.D. 8 or Form D.D. 5 Licence of Approved Practitioner...............Address :.............Date:.................

..................

..................

Full name, qualifications and signature of the Approved Practitioner

1. Name of the Licensed Chemist who dispenses the prescription.2. Address of premises.3. Date.

Conditions

(a) The prescription can be prescribed only by those approved practitioners who are either registered with Collector of Excise on this behalf and have obtained Registration Certificate in Form D.D. 8 or holding a licence in Form D.D. 5.

(b) On the authority of this prescription, the drug must not be supplied to the holder more than 6 times.

(c) The prescription shall not be given for the use of prescriber himself.

(d) A registered dentist shall give a prescription only for the purpose of dental treatment and shall make it "for animal treatment only".

(e) A registered veterinary surgeon shall give prescription only for the purpose of treatment of animals and shall make it for local dental treatment only.

(f) An approved practitioner of indigenous system of medicine may prescribe only those drugs which are included in the indigenous system of medicine.

Form D.D. 13

[See Rule 14(2)-For Selling Dealers]

(Form of Register to be maintained by Dealer Licensed to sell the manufactured drugs/preparations thereof. A separate page of the Register

 

 

Sl. No.

Date

Opening Balance of the drug

Receipts alongwith No. and date of import/ Transport Permit

Total

Quantity sold

1

2

3

4

5

6

1. 2. 3. 4. 5.

         

 

 

Balance

Name and address of the person to whom sold

No. and date of the Transport/Export Permit or No. of the Licence of the Approved Practitioner

Remarks, if any

7

8

9

10

1. 2. 3. 4. 5.

     

 

 

Form D.D. 13

[See Rule 14(2)-For Manufacturing Dealers]

Form of Register of accounts to be maintained by Licensed Dealer. A separate page of the Register be assigned to each Drug

(a) Receipts

 

 

Sl. No.

Date

Opening Balance of unused manufactured drugs

Quantity of Manufactured drugs reed, for manufacturing of medical preparations

Balance of stock of manufactured drugs kept for manufacturing

Remarks No. and date of import permit against which drugs received and source of supply

1

2

3

4

5

6

1. 2. 3. 4. 5.

         

 

 

Quantity of the drugs used in manufacturing

Balance stock

Quantity of preparations manufactured from the drugs shown to be used in Col. 7

Drugs Content in such preparations shown in Col. 9

7

8

9

10

1. 2. 3. 4. 5.

     

 

 

(c) Sale

 

 

Quantity of preparations sold

Drug content in the preparation sold

Transport/ Export permit No. of Licence No. of the Approved Practitioner

Names and address of the persons to whom sold

Balance of the stock of the preparations

Drugs content in such preparations shown in Col. (15)

11

12

13

14

15

16

1. 2. 3. 4. 5.

         

 

 

Form D.D. 14

[See Rule 15(2)]

(Form of Register to be maintained by the Licensed Chemists. One page of register be assigned to each drug)

 

 

Sl. No.

Date

Opening Balance

Receipts

Total

Issue of the day

1

2

3

4

5

6

1. 2. 3. 4. 5.

         

 

 

Name and address of the patients

Name and address of the Approved Practitioner prescribing with Regd. No. or D.D. 5 Licence No.

Balance

Remarks/ Import / Transport Permit No. against which received

7

8

9

10

1. 2. 3. 4. 5.

     

 

 

Form D.D. 15

(See Rule 9)

(Form of Register to be maintained by the Approved Practitioner holding Licence in Form D.D. 5)

 

 

Sl. No.

Date

Opening Balance

Quantity received

Quantity consumed

Name and address of patients to whom administered

Closing Balance

1

2

3

4

5

6

7

1. 2. 3. 4. 5.

           

 

 

Form O.P.

(See Rule 41)

Permit No..............

Authorisation/permit for the possession of opium for personal oral consumption by Registered Addicts(A) (1) Permit-holder's name................................................

(2) Father's name/Husband's name in case of married woman..............

(3) Religion or caste..................................................

(4) Apparent age.......................................................

(5) Address in full....................................................

(6) Occupation.........................................................

(B) (1) Name and address of the Medical Board which granted the certificate...........................................................................................

(2) Date of certificate................................................

(3) Quantity of opium recommended per month............................

(4) Personal identification marks of the permit-holder as verified by the Medical Board.

This permit is granted under and subject to the provisions of the Narcotic Drugs and Psychotropic Substances Act, 1985 and the rules made thereunder to................. of.............(hereinafter referred to as "thePermit-holder"), on payment of a fee of Rs authorising him to possess and transport opium subject to the following conditions:

Conditions

1. This permit shall remain in force from to (both days inclusive).2. The permit-holder shall as soon as possible submit this before the local Inspector or Sub-Inspector of Excise Department for his counter-signature and in any case not later than one month from the receipt of this permit.3. (1) The permit-holder shall not obtain during one month opium exceeding grammes:Provided that this quantity may be reduced during the currency of the permit according to the orders of the Excise Commissioner.

(2) The permit-holder shall not possess at any one time more than 6 grammes of opium.

4. (1) The permit-holder shall not obtain his supplies of opium from any place except from a depot established under the Delhi Narcotic Drugs Rules, 1985.

(2) The permit-holder shall get the detail of the purchases entered on the reverse of the permit by the officer-in-charge of the depot before he removes from the depot the opium purchased by him.

(3) No opium other than opium obtained under this permit shall be transported or possessed by the permit-holder.

5. The opium obtained under this permit shall neither be used by any person other than the permit-holder nor shall it be used for any purpose other than the purpose for which this permit is granted.6. The privilege of transport and possession of opium granted under this permit shall extend only so far as they are incidental to its consumption in accordance with this permit.7. The permit shall be non-transferable and may be suspended or cancelled at any time by the officer granting it:

(a) for non-payment of any fee payable by the permit- holder;

(b) for default or violation by the permit-holder of any of the conditions specified in the permit;

(c) if the holder thereof be convicted of any offence against any law relating to excise, revenue, liquor, opium or intoxicating drugs;

(d) if the permit-holder infringes any of the provisions of the Narcotic Drugs and Psychotropic Substances Act, 1985 or of the rules in force thereunder;

(e) if the purpose for which the permit was granted ceases to exist.

8. In case the permit is surrendered, suspended or cancelled during its currency or is not renewed on its expiry, the whole of the consumed stock of opium shall forthwith be surrendered to the officer granting the permit.Granted this...............day of..................

 

 

Signature or left hand thumb impression of the permit-holder Signature and designation of authority granting the permit Countersigned
Dated............................. Inspector/Sub-Inspector of the Excise Department.