Mint Explainer: Why India revised good manufacturing practices for MSME drug cos

livemint.com:

₹250 crore will have to compulsorily follow GMP within six months, while those with a turnover of less than ₹250 crore will have to do so in a 12-month period. The government amending schedule M of the Drugs and Cosmetics Rules, 1945 to upgrade and tighten the GMP norms for pharma firms. This compulsory compliance comes after the government inspection found serious lapses in the maintenance by these drug firms.

Mint takes a closer look at it. Good Manufacturing Practices (GMP) are mandatory standards that aim to bring quality into product by way of control on materials, methods, machines, processes, personnel, facility and environment etc. 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.

Existing schedule M under the Drugs Rules, 1945 prescribes details of requirements of facilities and their maintenance, personnel, manufacture, control and safety testing, storage and transport of material, written procedures, written records, traceability, etc. India is major exporter of medicines to Low-Middle-Income-Countries (LMIC) which require WHO GMP certification. There are around 10,500 manufacturing units in the country out of which around 8500 fall under MSME category.

We have around 2,000 units in the MSME category in the country having WHO GMP certification. Pharmaceutical manufacturing and quality domain has developed significantly in the last 15-20 years. The linkage between good manufacturing practice and product quality is interdependent.