Government set a deadline for the pharma industry to adopt good manufacturing practices.

Government set a deadline for the pharma industry to adopt good manufacturing practices.: Ministry of Health announced that all pharma industries with an annual turnover of over Rs 250 crore will have to mandatorily adopt good manufacturing practices (GMP) within six months.

Pharma companies with less than Rs 250 crore in revenue would have to adopt good manufacturing practices within a year. The timeline for adopting Schedule M of the Drugs and Cosmetics Act will start from 1 August. It has not been implemented by most of the drugmakers.

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Schedule M of the Drugs and Cosmetics Act of 1940 deals with Good Manufacturing Practices (GMP) for pharmaceutical manufacturing units. GMP includes specific requirements pertaining to premises, plant and equipment. GMP are mandatory standards to bring quality in products by controlling materials, methods, machines, processes, environment, etc. GMP was first incorporated in Schedule M in 1988. The norms of GMP were last amended in 2018.

In India, there are around 10,500 pharma manufacturing units. Out of the total, 8500 are MSMEs. Around 2000 manufacturing units in India have WHO GMP certification.