24October2017

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Whole seller, Retailer of drugs to face action from Authority if Rule 65 violated

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 “We are interested to know your legal opinion on Drug Rule 65 (19) and Rule 61 of Drug and Cosmetics Act 1940, Rules 1945. On rule 61, my opinion is all licenses form 20 21 20a 21a and 20b 21b are restricted category. Please give your valuable opinion on these rules.”

According to Drugs & Cosmetics Act 1940 & Drugs & Cosmetics Rules 1945, Rule 65 (19) is related to retail sales license, which needs qualified person (Registered Pharmacist).

The qualified person shall pack the drug in envelope or small containers as the case may be, by indicating name of drug, quantity sold, name and address of the dealer from whom he has acquired the drug as per rule 65(19) of Drugs & Cosmetics Act 1940 & Rules 1945.

Wholesale licensee (Form 20B & 21B) has no right to sell the drug in retail sale.

Rule 61 is related regarding Forms of licensees to sell drugs.

In licensee on Form 20 & 21, qualified person (Registered Pharmacist) is essential for retail sale

In licensee 20B & 21B--it is for wholesale purpose. It needs no services of registered pharmacist, but any person who holds a graduate degree with one year sales of drugs experience or a person with high school or intermediate qualifications with four years sales experience.

In licensee 20A and 21A, it is for restricted license. It needs no registered pharmacist because they sell only OTC drugs. They have no right to sell Prescription Drugs. The drugs which need the prescription of R.M.P. are Prescription Drugs.

If any whole seller and retailer violates the provisions of rule 65 (Conditions of licensees), the Drug Licensing Authority has right to take action against whole seller and retailer as the case may be according to Rules 66(1) of Drugs & Cosmetics Rules 1945.

RAMESH CHAND, ADVOCATE
Nationally acclaimed  expert on Drugs
and Cosmetics Act (1940)