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Chapter- 5

Chapter- 5 Quality Standard of Drugs

12. Drugs to be safe for public consumption, efficacious and of quality
standard:

Each drug shall be safe for public consumption, efficacious and of quality  standard in such a manner as to keep on maintaining its prescribed quality standard.

13. Prohibition on manufacture, sale, distribution, export, import, storage
or consumption of drug not conforming to prescribed standard :

No person shall manufacture, sell, distribute, export, import, store, or cause to do same or cause the consumption of, a drug which is not safe for public consumption, efficacious and of quality standard.

14. Return of drug which is not safe for public consumption, efficacious and
of quality standard :

(1) If a drug which has already been marketed for sale and distribution is not safe for public consumption, efficacious and of quality standard pursuant to Section 12, the manufacturer or his/her agent shall get back such drug from the seller or distributor.
(2) If it comes to the knowledge of the Administrator in any manner that a drug which is not safe for public consumption, efficacious and of quality standard has been marketed for sale and distribution, he/she may cause the seller or distributor of the drug to return the drug to its manufacturer.

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♦ Inserted by the Second Amendment.
Amended by the Second Amendment.
♦ Inserted by the Second Amendment.

15. Provision of compensation:

If a drug manufactured in such a manner that it is not safe for public consumption, efficacious and of quality standard results in the death of, or causes injury to the health of any person, the drug manufacturer shall be responsible for it and provide compensation, as prescribed, to the successor to the deceased for such death and to that person in the event of such injury.

16. Submission of letter of guarantee to Department:

A drug manufacturer him/herself or his/her authorized agent or exporter or importer shall submit to the Department a certified copy of the document issued by the manufacturer guaranteeing that the drug registered pursuant to Section 8A is safe for public consumption, efficacious and of quality standard.

17. Categorization of drugs:

( 1) The drugs may be classified into categories or sub- categories, as prescribed.
(2) No person shall sell or distribute such drugs without prescription of a doctor as categorized not to be sold or distributed without such prescription      pursuant to Sub-section (1). The pharmacist or pharmacy assistant ♦ or professional person himself shall sell or distribute such drugs on prescription of a doctor; and the presence of a pharmacist or pharmacy assistant ♦ or professional
person shall be compulsory where a person other than the doctor, pharmacy assistant ♦ or professional person sells or distributes such drugs.
(3) The drugs categorized as to be sold or distributed only in presence of a pharmacist or pharmacy assistant ♦ or professional person or any of them while making categorization pursuant to Sub-section (2) may be sold or distributed only by them or in their presence.
(4) Any seller may, based on the experience, sell in a reasonable quantity

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? Amended by the Second Amendment.
♦ Inserted by the Second Amendment.
♦ Inserted by the Second Amendment.
♦ Inserted by the Second Amendment.
♦ Inserted by the Second Amendment.

the drugs other than those categorized pursuant to subsections (2) and (3).
Explanation: “Pharmacist” means a person who has done graduation in pharmacy ? or graduation in pharmaceutics or and been recognized by the Drugs Advisory Committee, “pharmacy assistant” means a person who has passed certificate level or equivalent in pharmacy ♦ and “professional person” means a person who has possessed the prescribed qualifications and been recognized by the Drugs Advisory Committee.

18. Prohibition on misuse or abuse of drugs:

(1) No person shall misuse or abuse drugs.
(2) Sale and distribution of any drug in contravention of the provisions contained in Sub-sections (2) and (3) of Section 17 shall be deemed to have misused or abused such drug.

19. Prohibition on false or misleading advertisement of drugs:

(1) No person shall make a false or misleading publicity or advertisement about the use, utility
or efficacy of any drug.
(2) Any person who intends to make publicity or advertisement of any drug shall obtain the license, as prescribed, from the Department, by paying the fees prescribed for the same.

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