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

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.

Pharma standards

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.

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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.

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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. Moreover, this would ensure the production of globally acceptable quality of drugs.

This exercise comes in the backdrop of contaminated Indian cough syrups being linked to the deaths of children in developing countries, including 66 in Gambia and 68 in Uzbekistan in 2022.

Over 10,000 drug firms in India

India is the largest supplier of medicines to low- and middle-income countries – drugs that require a WHO GMP certification.

However, of the 10,500 drug manufacturing units in India, 8,500 are small businesses that do not have GMP certification. According to government figures, the remaining 2,000 firms have GMP certification.

The Central Drugs Standard Control Organization (CDSCO), the DCGI and state drugs controllers (SDCs) have been conducting the inspections of pharma companies since last year. Around 400 premises including MSMEs have been inspected so far.

During the inspection a number of drug samples were drawn and tested. Certain samples were found to be “not of standard quality".

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On 2 August, the union health ministry stated that more than 300 actions—like show cause notices, stop production orders, suspension, cancellation of licences, etc.—were taken by state licensing authorities.

Industry welcomes the initiative

Sudarshan Jain, Secretary-General of the Indian Pharmaceutical Alliance (IPA), said, “As far as quality of drugs are concerned, we welcome all initiatives by the drug regulator. It is in line with revised Schedule M which makes it mandatory for drug firms to follow GMP standards as per international standards and thus quality becomes fundamental."

Daara Patel, Secretary General at Indian Drugs Manufacturing Association said that GMP are being followed by all member companies. IDMA is going webinars to sensitize the companies to meet the government compliance.

Queries sent to the ministry of health spokesperson remained unanswered till press time.