India Takes a Stand: New Drug Manufacturing Standards Implemented for Industry Overhaul

In a bid to address concerns over drug quality and safety, the Indian government has instituted stringent rules for drug manufacturing, as outlined in a notice issued on Saturday. This move comes in the wake of incidents involving deaths linked to Indian-made drugs abroad since 2022, prompting Prime Minister Narendra Modi’s government to closely monitor pharmaceutical factories and elevate industry standards.

The notification, dated December 28, emphasizes the manufacturer’s responsibility for ensuring the quality of pharmaceutical products, certifying their suitability for intended use, compliance with license requirements, and preventing patient risks due to inadequate safety, quality, or efficacy.

According to the new regulations, companies must only market finished products after obtaining “satisfactory results” from ingredient tests. Additionally, they are required to retain a sufficient quantity of samples of intermediate and final products, allowing for repeated testing or verification of a batch.

In August, the health ministry reported findings from inspections of 162 drug factories since December 2022, revealing an “absence of testing of incoming raw materials.” It noted that less than a quarter of India’s 8,500 small drug factories met the international drug manufacturing standards set by the World Health Organization (WHO).

The notification specifies that large drugmakers must address these concerns within six months, while small manufacturers have a 12-month deadline. Smaller companies, citing financial challenges, have requested an extension, warning that meeting the standards could lead to the closure of nearly half of them, as they are already heavily indebted.

The World Health Organization (WHO) and other health authorities have previously linked Indian cough syrups to the deaths of at least 141 children overseas, underscoring the urgency of addressing manufacturing standards.

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