New Delhi: The Drug Controller General of India (DCGI) is considering issuing and renewing licences only to those pharmaceutical companies that can prove they follow good manufacturing practices.
The move – the first of its kind – assumes significance given the growing size of India’s pharmaceutical industry, which currently stands at $65 billion, and the crisis of confidence it faces.
Pharmaceutical standards
Good Manufacturing Practices, or GMP, prescribed in Schedule M of the Drugs and Cosmetics Rules, 1945, set standards for pharmaceutical companies on the quality of raw materials, methods, machines, processes, personnel, facilities and the environment, among other things.
The Ministry of Health made good manufacturing practices mandatory in December last year. However, pharmaceutical companies have been slow to follow the rule and some are said to still be adapting to compliance requirements.
The issue was discussed at a meeting of the Drugs Advisory Committee (DCC) in June, which recommended that all states follow the rules notified last December.
Following the recommendation, the apex drug regulator, which is the central licensing authority, and state licensing authorities will verify compliance with GMP and make a decision on issuing or renewing licenses based on the GMP reports.
As per the December 2023 notification, pharmaceutical companies with annual revenue of Rs 250 crore or more were required to mandatorily follow GMP within six months, while those with revenue of less than Rs 250 crore were given 12 months to do so.
Increased compliance with GMP norms would bring India’s drug manufacturing capacity at par with global standards, especially those issued by the WHO. This would also ensure production of drugs of globally acceptable quality.
This exercise comes against a backdrop of links between contaminated Indian cough syrups and deaths of children in developing countries, including 66 in Gambia and 68 in Uzbekistan in 2022.
More than 10,000 pharmaceutical companies in India
India is the largest supplier of medicines to low and middle income countries, medicines that require WHO GMP certification.
However, of the 10,500 drug manufacturing units in India, 8,500 are small firms that do not have GMP certification. According to government figures, the remaining 2,000 firms are GMP certified.
The Central Drugs Standard Control Organisation (CDSCO), DCGI and state drug controllers (SDC) have been conducting inspections of pharmaceutical companies since last year. Around 400 facilities, including SMEs, have been inspected so far.
During the inspection, several drug samples were taken and analysed. Some of them were found to be “not of standard quality”.
On August 2, the Union Health Ministry said that state licensing authorities had taken over 300 measures such as show-cause notices, stop production orders, suspension, cancellation of licences, etc.
Industry welcomes initiative
Sudarshan Jain, Secretary General of the Indian Pharmaceutical Alliance (IPA), said, “As far as quality of medicines is concerned, we welcome all the initiatives of the drug regulator. They are in line with the revised Annexure M, which mandates pharmaceutical companies to follow GMP norms in accordance with international standards, making quality critical.”
Daara Patel, secretary general of the Indian Drug Manufacturers Association, said all member companies are following good manufacturing practices. The IDMA is conducting webinars to sensitize companies to comply with government norms.
Questions sent to the spokesperson of the Ministry of Health remained unanswered by the time this edition went to press.
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