Govt notifies Schedule M guidelines for pharma manufacturing units

NEW DELHI: The Union Health Ministry has notified the Revised Schedule M guidelines under which pharmaceutical companies will have to intimate the licensing authority about recalling a drug and also report product defects, deterioration or faulty production.

Till now there was no provision for informing the licensing authority about drug recall.

Schedule M part of Drugs and Cosmetics Act 1940 deals with ‘Good Manufacturing Practices’ to be followed by pharmaceutical manufacturing units in the country.

The new guidelines issued on December 28 state the manufacturer must be responsible for quality of products so that “they are fit for their intended use, comply with requirements of licence and do not place patients at risk due to inadequate safety, quality or efficacy”.

These guidelines come against the backdrop of complaints of sub-standard Indian drugs and deaths abroad reportedly due to it since 2022.

The amended guidelines stress the need for stability testing of drug substances in accordance with recommended climate conditions with an aim to upgrade MSMEs at par with global standards, especially to those of WHO, and ensure production of globally acceptable quality of drug.