Centre sets new standards for pharma firms after overseas deaths
The Central government has issued new manufacturing standards for pharmaceutical companies in India, an official notification said, per Reuters. The decision comes after several overseas deaths since 2022 were linked to Indian-made drugs. This is also aimed at increasing scrutiny of the pharma sector and enhancing the 3.2 lakh crore industry's reputation. Large drug makers have six months to address these concerns, while smaller manufacturers have 12 months. The latter requested more time due to their debt burden.
Why does this story matter?
The cough syrups of three Indian companies were linked to the deaths of at least 141 children in Cameroon, Gambia, and Uzbekistan. The World Health Organization (WHO) had also flagged the issue, saying the syrups contained contaminants such as diethylene and ethylene glycol at levels over the permitted limit. The WHO's probe flagged a total of 20 toxic medicines, including seven from India, whose consumption led to the deaths of more than 200 people across the world.
Ensuring quality, safety, and efficacy of pharmaceuticals
The notification, dated December 28, states that manufacturers must take responsibility for the quality of their pharmaceutical products. The companies must ensure that their products are suitable for their intended use, comply with licensing requirements, and do not put patients at risk due to insufficient safety, quality, or effectiveness, it said. Companies can only market finished products after obtaining "satisfactory results" from ingredient tests and must keep enough samples of intermediate and final products for additional testing or verification.
Inspections reveal absence of testing and subpar standards
In August, the Ministry of Health and Family Welfare disclosed that inspections of 162 drug factories since December 2022 found an "absence of testing of incoming raw materials." It was also reported that less than a quarter of India's 8,500 small drug factories met international drug manufacturing standards set by the WHO. Moreover, only 2,000 of the country's 10,500 manufacturing units were found to be in compliance with the WHO-Good Manufacturing Practices (GMP) standards.
Global influence of Indian pharma industry
The Indian pharmaceutical industry is a significant manufacturer and exporter of medical products in the global market. It produces over 60,000 generic drugs in different 60 therapeutic categories, the official data revealed. India is also ranked third in the world in terms of pharmaceutical production by volume and 13th in terms of its global valuation, according to The Economic Times.
