Drugs licence approval only if you show good manufacturing practices: DCGI

livemint.com:

New Delhi: The Drugs Controller General of India (DCGI) is considering issuing and renewing licences only to those pharmaceutical firms that can prove they follow good manufacturing practices. The move—the first such—assumes significance given the growing size of the Indian pharmaceutical industry, currently at $65 billion, and the crisis of confidence faced by it. Good Manufacturing Practices, or GMP, prescribed in Schedule M of the Drugs and Cosmetics Rules, 1945, set the standards for pharma companies on the quality of raw materials, methods, machines, processes, personnel, facility and environment, among other things.

The health ministry made GMP mandatory in December last year. However, drugmakers have been slow in following the rule, with some said to be still adapting to the compliance requirements. The matter was discussed in a Drugs Consultative Committee (DCC) meeting in June which recommended that all states shall follow the rules notified last December.

Following the recommendation, the apex drug regulator who is the central licensing authority and state licensing authorities will be checking on GMP compliance, and taking a call on licence issuance or renewal on the basis of GMP reports. According to the December 2023 notification, pharma companies with annual revenues of Rs250 crore and above were to compulsorily follow GMP within six months, while those with revenues of less than Rs250 crore had 12 months to do so. The increased compliance with GMP standards would bring India’s drug manufacturing capability at par with global standards, especially those issued by the WHO.