Good manufacturing norms may be mandatory for all drug firms

Good manufacturing norms may be mandatory for all drug firms

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  • September 17, 2023
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NEW DELHI : The union health ministry may shortly notify proposed amendments to rules in order to make good manufacturing practice (GMP) mandatory for all pharmaceutical firms after a spate of scandals linking Indian-made drugs to children’s deaths abroad.

With the Indian drugs failing quality checks in other countries, the government recently made GMP mandatory for micro, small and medium enterprises manufacturing drugs. India is the largest supplier of medicines to low-middle-income-countries (LMIC), which requires the World Health Organization’s GMP certification.

Only 2,000 of the 10,500 manufacturing units in the country have the certification.

GMP, as mandated by the WHO, prescribes essential standards to enhance product quality through control measures related to materials, methods, machinery, processes, personnel, facilities, as well as the environment.

A meeting was recently called by the Drugs Controller General of India (DCGI) Rajeev Raghuvanshi with industry stakeholders and drug firms. Meetings or workshop have also being held with state drug controllers to sensitize them about the enforcement of the new GMP regime.

“Revision in schedule M of the Drugs and Cosmetics Rules is the new legislation and hence there are several doubts and queries with the pharma companies about its implementation. In the past, DCGI held several meetings with the state drugs controllers to discuss the subject matter and now it’s the turn of pharma companies and associations,” said one of the state drug controllers.

“GMP under schedule M is under revision and it under active consideration of the health ministry to publish final notification on revised schedule M,” said Raghuvanshi to all pharma stakeholders in a communication seen by Mint.

“In this regard, it is decided to conduct one-day regional workshops across India for dissemination of revised schedule M requirement to all stakeholders,” he said.

The first such meetings were held in New Delhi, Baddi and Hyderabad last week while other will be organized in Kolkata, Mumbai and Ahmedabad in the coming days.

Daara B Patel, Secretary General at the Indian Drugs Manufacturing Association (IDMA) said, “We have disseminated the information to all our member companies to participate in meeting with DCGI on 30 September and are hopeful for a fruitful discussion.”

Under the proposed amendment in Schedule M of the Drugs and Cosmetics Rules, 1945, the Centre has given six months to large companies (with a turnover exceeding 250 crore) and 12 months to MSMEs (below 250 crore) to implement the upgraded GMP standards.

Queries sent to the health ministry remained unanswered.

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Updated: 17 Sep 2023, 10:43 PM IST

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