Govt enforces new drug manufacturing standards; check details

PTC Web Desk: Indian pharmaceutical companies face new drug manufacturing standards this year, mandated by a recent Central Government notification. However, smaller firms are requesting a delay due to their existing financial burdens, as per the notification.

The Central Government's intensified scrutiny follows a series of overseas deaths associated with drugs manufactured in India since 2022. Aimed at revitalising the reputation of Indian pharmaceutical companies, the government's notification says "manufacturers must ensure the quality, safety, and efficacy of pharmaceutical products, assuming full responsibility for their suitability and compliance".

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As per the notification, companies are required to conduct tests on ingredients and maintain adequate samples of intermediate and final products before marketing the finished product. The objective is to enable repeated testing or verification of a batch.

Highlighting findings from the health ministry inspections conducted since December 2022, it was noted that 162 drug factories lacked testing of incoming raw materials. Shockingly, less than a quarter of India's 8,500 small drug factories met international drug manufacturing standards stipulated by the World Health Organization (WHO).

Deadline established

The notification sets a deadline for addressing these concerns—large drugmakers must comply within six months, while small manufacturers have a 12-month timeline. However, small companies, already burdened by heavy debts, have appealed for an extended deadline, fearing that meeting these standards would financially cripple nearly half of them.

The WHO and various health authorities have connected Indian cough syrups to the tragic deaths of at least 141 children across Gambia, Uzbekistan, and Cameroon.

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The enforcement of these new standards represents a critical juncture for the Indian pharmaceutical industry, demanding adherence to elevate the overall quality and safety of drug manufacturing.