Citation : 2015 Latest Caselaw 8386 Del
Judgement Date : 5 November, 2015
$~40
* IN THE HIGH COURT OF DELHI AT NEW DELHI
+ W.P.(C) NO.10280/2015 & CM No.25532/2015 (for stay)
HARI OM GUPTA ..... Petitioner
Through: Mr. Gurmit Singh Hans with Mr.
Vihsal Soni, Mr. Kunal Bhardwaj and
Ms. Aarti Manchanda, Advs.
Versus
GOVT. OF NCT OF DELHI ..... Respondent
Through: Ms. Jyoti Taneja, Adv. for GNCTD
with Mr. K.C. Aggarwal, Assistant
Drug Controller and Mr. B. Sahu,
Drugs Inspector.
CORAM:
HON'BLE MR. JUSTICE RAJIV SAHAI ENDLAW
ORDER
% 05.11.2015
1. The petition impugns, (i) the order dated 7 th September, 2015 of the
Assistant Drugs Controller of the respondent Govt. of NCT of Delhi
(GNCTD) acting as the Licensing Authority under the Drugs and Cosmetics
Act, 1940 of cancellation / revocation of the licence of the petitioner valid
till 1st April, 2019 to run and operate a chemist shop; and, (ii) the order dated
21st October, 2015 of the Lt. Governor, Delhi exercising powers as an
Appellate Authority, of dismissal of the appeal preferred by the petitioner
against the order of cancelation of his licence.
2. The petition had come up before this Court first on 2 nd November,
2015, when the counsel for the respondent GNCTD appearing on advance
notice was asked to obtain instructions and to ensure presence of the
concerned official along with records in the Court today. In compliance
therewith Mr. K.C. Aggarwal, Assistant Drug Controller and Mr. B. Sahu,
Drugs Inspector are present in Court. The counsels have been heard.
3. The premises of the petitioner at Shops No.3&4, 15A Mahindra Park,
Sanjay Nagar, Delhi were inspected by the Drugs Inspectors of the
respondent GNCTD on 13th May, 2015 in the presence of Mr. Shriniwas
Gupta person in charge. It was inter alia found, (i) that the original licences
were not displayed; (ii) that the records for Schedule H-1 drugs were not
found maintained; (iii) that the records of purchase and sale of ten drugs
found stocked for sale/distribution in the premises were not produced; (iv)
another drug found to have been purchased but no sale invoices / records of
sale were found; and, (v) Form 35 was not found maintained. A
memorandum dated 15th May, 2015 was issued to the petitioner of the
discrepancies aforesaid found during the said inspection. The petitioner was
asked to show cause as to why his licence should not be suspended /
cancelled under Rule 66 of the Drugs and Cosmetics Rules, 1945 for the
contraventions aforesaid of Rules 65(3), (4) & (16) of the said Rules.
4. The petitioner submitted a reply and also availed of an opportunity of
hearing.
5. The Assistant Drugs Controller vide impugned order aforesaid
cancelled the licences of the petitioner with immediate effect and gave time
of 30 days to the petitioner to dispose of his current stocks in accordance
with the provisions of Rule 66A of the Rules. It is recorded in the said order
that the petitioner in reply to the show cause notice and in the hearing had
admitted to the discrepancies aforesaid and had assured not to repeat the
same in future but which was not found satisfactory. It is further recorded in
the said order that the petitioner had on earlier occasion also been warned
vide memorandum dated 3rd November, 2008 and the licence of the
petitioner had also been suspended on an earlier occasion for a period of two
days vide order dated 30th January, 2012 for similar offences.
6. The Lt. Governor has dismissed the appeal preferred by the petitioner
accepting the arguments of the respondent that the petitioner had been found
dealing in 'habit forming drugs' and the respondent had been receiving a
large number of complaints in which the main allegation is of the medical
stores in Mahendra Park indulging in the sale of 'habit forming drugs' and
thereby affecting the public and innocent people are becoming the victim.
The petitioner was reasoned to be part of same, since the petitioner was
found not maintaining the requisite records and could not produce the
documents at the time of inspection. It was further reasoned that the licence
for a medical store is given to make available drugs / medicines to the public
in their neighbourhood and not for the purpose which affects their health
adversely.
7. The counsel for the petitioner during the hearing on 2nd November,
2015 and today has not controverted that the documents were not produced /
shown as the time inspection. His contention was that all the said documents
were produced along with reply to the show cause notice and thus the
petitioner could not be said to be not maintaining the same as was required.
However, it was clarified that register of Schedule H-1 drugs was not being
maintained and thus could not be produced but the same is labeled as an
inadvertent / innocent mistake on the part of the petitioner.
8. The matter on 2nd November, 2015 was adjourned to enable the
counsel for the respondent GNCTD to show that the documents aforesaid are
required to be maintained at the premises and to be offered for inspection
whenever demanded. The argument of the counsel for the petitioner then
was that the documents could not be shown because the petitioner was
personally not present at the time of inspection and his employees could not
show the documents demanded. It was as such also enquired from the
counsel for the respondent GNCTD, whether it is mandatory for the licensee
to be personally present in the shop at all times when it is open for sale.
9. The counsel for the respondent GNCTD today has stated that Mr.
Srinivas Gupta who was admittedly present at the time of inspection is the
registered Pharmacist and brother of the petitioner and thus it cannot be said
that absence of the petitioner at the time of inspection was the cause for non-
production of any document. Attention is also invited to Rule 65(3)(i) and
65(6) requiring maintenance of a register with the particulars as specified
therein and to be offered for inspection 'whenever demanded'. The counsel
for the respondent GNCTD in Court has also handed over photocopies of the
complaints of the Residents Welfare Association (RWA) of the Chemists in
the said locality selling Schedule H-1 drugs required to be sold by the
Chemists only on prescription of registered medical practitioners, without
any such prescription, leading to the residents of the locality forming a habit.
The counsel on instructions from the officials present also states that in fact
the premises of the petitioner were found to be stocking mostly the said
drugs, with the proportion of the other drugs being very small; though it is
fairly admitted that the same is not recorded in the inspection report or in the
show cause notice or in the order--but the official concerned was the
Inspector who had carried out the inspection.
10. From the aforesaid provisions it is clear that the entries in the register
to be maintained have to be made at the time of each sale and the records of
sale / purchase of drugs are required to be maintained and offered for
inspection.
11. In the light thereof, the explanation of the counsel for the petitioner
that the documents could not be produced and were produced along with the
reply to the show cause notice cannot be a ground for non-compliance with
the statutory provisions. Experience of life has shown that upon time being
available, it is not difficult at all to prepare registers and / or to procure and
manufacture the bills of sale / purchase. The Supreme Court in the context
of the inspections under the Indian Medical Council Act, 1956 in Manohar
Lal Sharma Vs. Medical Council of India (2013) 10 SCC 60 has held that
the inspection always has to have an element of surprise inasmuch as
inspection after notice loses its purpose. The same is the position here.
Once the rule requires a Chemist to maintain the records and to make entries
therein at the time of each transaction, the non-availability of the said records
at the time of surprise inspection is a clear indication of the said rule having
been violated. Once the rule, subject to compliance with which the licence
was given to the petitioner, has admittedly been violated, I do not see any
ground on which the petitioner can be heard to say that the consequence
thereof of cancellation of licence should not follow.
12. The counsel for the petitioner has however drawn attention to the
Proviso to Rule 66 which provides for such cancelation. To appreciate the
contention, it is deemed appropriate to set out herein below the entire Rule
66 of the Rules:
"66. Cancellation and suspension of licences.--(1) the licensing authority may, after giving the licensee an opportunity to show cause why such an order should not be passed by an order in writing stating the reasons therefore, cancel a licence issued under this Part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates, if in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or rules thereunder:
Provided that, where such failure or contravention is the consequence of an Act or omission on the part of an agent or employee, the licence shall not be cancelled or suspended if the licensee proves to the satisfaction of the licensing authority--
(a) that the act or omission was not instigated or connived at by him or if the licensee is a firm or company, by a partner of the firm or a director of the company, or
(b) that he or his agent or employee had not been
guilty of any similar act or omission within twelve months before the date on which the act or omission in question took place, or where his agent or employee had been guilty of any such act or omission, the licensee had not or could not reasonably have had, knowledge of that previous act or omission, or
(c) if the act or omission was a continuing act or omission, he had not or could not reasonably have had knowledge of that previous act or omission, or
(d) that he had used due diligence to ensure that the conditions of the licence or the provisions of the Act or the rules thereunder were observed. (2) A licensee whose licence has been suspended or cancelled may, within three months of the date of order under sub-rule (1), prefer an appeal against that order to the State Government, which shall decide the same."
(emphasis added)
13. The counsel for the petitioner has argued that under the Proviso
aforesaid, even though the petitioner was guilty of contravention of the Rules
leading to cancellation under Rule 66(1), since the allegation against the
petitioner was that he had committed similar violence in the years 2008 and
2012 and not one year prior to the issuance of the show cause notice, the
petitioner is entitled to the benefit of Clause (b) of the Proviso.
14. I am unable to agree. The Proviso is applicable only where the
contravention is the consequence of act or omission of an agent or employee
and not otherwise. In the present case, the petitioner is admittedly in
violation of the requirement to maintain register of sale of Schedule H-1
drugs. The said violation cannot be attributed to any agent or employee of
the petitioner. The petitioner himself as the licensee was required to ensure
maintenance of the said register. The reason for maintenance of the said
register is not difficult to fathom. Since Schedule H-1 drugs mentioned in
the show cause notice are habit forming, the provision for maintenance of
register is intended to prevent sale thereof, without the same being
prescribed. The petitioner admittedly was not maintaining the said register.
15. The argument, that the same was a mistake, also cannot be accepted.
The petitioner was carrying on business in articles affecting health and
cannot afford to make such mistakes which have the impact on the human
life. If the petitioner is susceptible to make such mistakes, it is all the more
reason for the petitioner being not entitled to the licence to sell medicines /
drugs, which cannot be claimed as a fundamental right.
16. The counsel for the petitioner has in this regard relied on the judgment
dated 21st March, 1976 of High Court of Guwahati titled Mst. Saleha
Khatun Bewa Vs. The State of Assam but in view of the Proviso itself
having not to be attracted, the question of applicability thereof does not arise.
17. The counsel for the petitioner has lastly contended that the petitioner
holds licence besides for Schedule H-1 drugs, also for Ayurvedic drugs and
for the violations with respect to Allopathic drugs, the licence with respect to
the Ayurvedic drugs has also been cancelled.
18. Mr. K.C. Aggarwal, Assistant Drug Controller present in Court states
that the Licensing Authority under the Drugs Act is not the Licensing
Authority for Ayurvedic medicines and the cancellation of the licence on
Forms 20 & 21 is with reference to the cancellation of licence for sale of
biological and Schedule H-1 drugs.
19. There is no merit in the petition; dismissed.
No costs.
RAJIV SAHAI ENDLAW, J.
NOVEMBER 05, 2015 bs
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