24October2017

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Drugs Can't be Packed in Unlicensed Premises of Others

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Query: “Can Packing of drugs be outsourced? Can manufactured drugs be packed in some other facility?”

Answer: According to the Drugs & Cosmetics Act, 1940, and Drugs & Cosmetics Rules, 1945, the packing of drugs cannot be outsourced. According to Sec. 3(f) of the Drugs & Cosmetics Act, 1940, manufacture in relation to any drug includes any process or part of a process for making, altering, ornamenting, finishing, packing, labeling, breaking up or otherwise treating or adopting any drug with a view to its sale or distribution but does not include the compounding or dispensing in the ordinary course of retail business.

The manufacture of drug should only be completed in the licensed premises of the Person, Proprietorship, Firm or Company to whom the license to manufacture the drug is granted by the Drug Licensing Authority. One has no right to manufacture the drug partly in his licensed premises and complete the process of manufacture in others' manufacturing premises.

The packing of the drug is a part of manufacture, so it should be completed in the premises of the Company/Firm to whom the license for manufacturing the drug is granted.

As per Rule 68 of Drugs & Cosmetics Rules, 1945, if drugs are manufactured in more than one set of premises, a separate license is required for each set of premises, where the process of manufacture is completed. If anyone has a license to manufacture a drug in his own licensed premises, then he has to complete the manufacture process in his own licensed premises.

He cannot used the other's premises to complete the manufacture process as per Drugs & Cosmetics Act, 1940, and as per Drugs & Cosmetics Rules 1945.

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