From Fixing Drug Recalls to New Work Structures, Govt Coaches Pharma Industry on Revised Drug Laws

by Aditya Kumar

The Union government of India is taking steps to upgrade manufacturing practices in the pharmaceutical industry through a series of workshops aimed at small and medium-sized enterprises (SMEs) in the sector. These workshops, conducted in partnership with India’s drug quality regulator, CDSCO, under the Health Ministry, are designed to help drug manufacturers navigate regulatory requirements and enhance good manufacturing practices.

The pharmaceutical industry in India has faced increasing scrutiny from global regulators due to compliance issues faced by SMEs. To address these concerns, the Ministry of Commerce and Industry’s pharmaceutical export wing, Pharmexcil, proposed the capacity-building workshops to help MSME drugmakers improve their manufacturing practices.

One of the major objectives of these workshops is to provide insights to manufacturers about good manufacturing practices. The workshops aim to educate drug manufacturers on the importance of adhering to regulations and standards, such as the implementation of Schedule M, which tightens manufacturing practices across all pharmaceutical companies in India.

According to government data, there are approximately 10,500 manufacturing units in India, of which around 8,500 are classified as MSMEs. However, only 2,000 of these are approved by the World Health Organization and certified as WHO-GMP compliant. This means that the majority of manufacturing units in the sector must comply with Schedule M to improve their manufacturing practices.

The workshops use a 43-slide presentation to educate manufacturers on the differences between the current regulations and the changes that will occur after the implementation of Schedule M. The presentation covers various topics, including product recall, sanitation practices, compliance and adverse reactions, and the pharmacovigilance system.

The new regulations will require manufacturers to inform the licensing authority in the event of a product recall, and a comprehensive system will be specified for prompt and effective recall. Sanitation practices will also be expanded to cover personnel, premises, equipment, apparatus, production materials, and containers.

Under the new laws, reporting adverse reactions will be extended to cover faulty manufacture, product deterioration, and serious quality problems. Additionally, the new regulations will require the establishment of a pharmacovigilance system to detect, assess, understand, and prevent adverse effects related to medicines or vaccines.

Furthermore, the frequency of self-inspection, quality audits, and supplier audits will be regulated, with a minimum requirement of once a year.

These workshops and the implementation of stricter regulations are essential for enhancing the manufacturing practices of pharmaceutical companies in India. By improving compliance and adhering to global standards, Indian drug manufacturers can build trust and confidence among global regulators and consumers. This will not only help boost exports but also ensure the production of safe and high-quality medicines for both domestic and international markets.

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