The Author, Janani N. is a student of School of Excellence in Law (SOEL), Dr. Ambedkar Law University, Chennai. She is currently interning with LatestLaws.com.
Q1: What is the main aim of this Act?
Ans: This Act wants to regulate the following:
- Manufacture DRUGS & COSMETICS THROUGH LICENSING
The above mentioned 4 points could be done only by qualified persons; to prevent substandard in drugs; to regulate sidhha and ayurvedic, and unani drugs; and to establish Drug Technical Advisory Board (DTAB) and Drug consultative committees (DCC) for allopathic and allied drugs & cosmetic.
Q2: What is the history of its Act?
Ans: During the British era, there was no proper medication system and there exist poor heal care to the Indian Citizens. So the Drug enquiry committee and Indian medication association observed the issue and submitted a report in Indian Medical Gazette during the years 1920-30. This in turn introduced this Act long with the Rules.
Q3: What is the definition of Drug under this Act?
Ans: section 2(b) of this Act defines Drug, it means:
- All medicines for internal and external use of human beings or animals
- and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes
- such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of 6 [vermin] or insects which cause disease in human beings or animals
- all substances intended for use as components of a drug including empty gelatin capsules
- such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board.
Q4: Definition of cosmetic?
Ans: Section 2[(aaa)] “cosmetic” means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic.
Q5: What does the term Misbranded drug mean?
Ans: Section. 9 of the Act defines it,
- it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is;
- if it is not labelled in the prescribed manner;
- if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.
Q6: What are the provisions under this Act deals with adulterated drugs and spurious cosmetics/drugs?
- adulterated drugs are dealt under section 9A
- Spurious cosmetics under section 9D and IN CASE OF IMPORT OF DRUGS
- Spurious drugs under section 9B & COSMETICS.
- adulterated drugs are dealt under section 17A
- Spurious cosmetics under section 17C and IN CASE OF MANUFACTURE,
- Spurious drugs under section 17B SALE & DISTRIBUTION
Q7: What is the jurisdiction prevailing for this Act?
Ans: No court which is inferior to MM (metropolitan magistrate) or I-JM (Judicial magistrate of first class) shall try offences that are punishable under section 13 of this Act.
Q8: What are the powers that are conferred to Inspector under this Act?
- Inspect any premises where any drug/cosmetic is being manufactured
- Standardizing and testing the drugs
- Take sample of the drugs/cosmetics which is:
- Offered for sale
- Search any person
- Enter and search any place
- Stop and search any vehicle
- Examine records, register, document or any other material
- Require any person to produce records, register, document or any other material
- The Cr.P.C provision shall apply for search and seizure
- Punishment: imprisonment upto 3 years or with fine or both.
Q9: What are administrating this Act?
- Drug technical advisory board —– ADVISORY
- Drug consultative committee
- Central drug lab —— ANALYTICAL
- Drug control lab in state
- Government analysis
- Licensing authorities
- Controlling authorities —– EXECUTIVES
- Drug inspector
Q10. What are the Conditions for importing of biological drugs (c/c1)-licensee should possess?
- Facility for storage
- Sale record
- They must allow the inspect
- Furnishing the sample
- He should recall the batch from market
Q11. What are the Necessary qualifications for importing drug for personal use?
- Only upto 100 doses as average may be imported without permit
- In case more than 100 doses with permit- then form no.12 –A , 12-B will apply
- It should be of bonafide use
- Drugs must be declared to custom collector.