Authored by Ammu Brigit

One of the licences that is issued under the Drugs and Cosmetics Act 1940 (DCA) for manufacturing of drugs is given to a licence applicant who does not have a manufacturing facility and intends to get the drug manufactured through a person with such facility and a manufacturing licence. Under the DCA such licences are referred to as loan licences, and commonly known as contract manufacturing.

Prior to March 2021, the responsibility of maintaining the quality of drugs lied solely with the contract manufacturer and only the name and address of the contract manufacturer of the drug was required to be printed on the label or container of the drug.

In M/s Glaxo Smithkline Pharmaceuticals Limited vs. State of Bihar & Anr 2011, the writ petitioner, Glaxo Smithkline Pharmaceuticals (GSK) through a third-party manufacturing agreement engaged Emcure Pharmaceuticals Ltd (Emcure) to manufacture certain drugs. The Inspector of Drugs found certain drugs in the premises of the agents with names of GSK also printed along with the name of the manufacturer, Emcure. According to Rule 96 and 97 of the Drugs and Cosmetics Rules 1945 (