• 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.

• Good Manufacturing Practices (GMPs) are mandatory standards which build and bring quality into product by way of control on materials, methods, machines, processes, personnel and facility/environment, etc.

• The GMP was first incorporated in Schedule M of the Drugs and Cosmetics Rules, 1945 in the year 1988 and the last amendment was done in June, 2005.

• The new guidelines state that the manufacturer must be responsible for the quality of the products so that “they are fit for their intended use, comply with the requirements of the 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.

• It also specifies that release of the finished product is conditional upon satisfactory results of these tests.

• There are around 10,500 manufacturing units in the country out of which around 8,500 fall under the MSME (Micro, Small & Medium Enterprises) category. 

• India is a major exporter of medicines to low/middle-income countries (LMICs) which require WHO GMP certification.

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