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Indian pharma grapples with new standards post overseas drug-related deaths

Triggered by several fatalities abroad associated with Indian-manufactured drugs since 2022, the central government has intensified its scrutiny of pharmaceutical factories, aiming to refurbish the reputation of the $50 billion industry.

Indian pharma grapples with new standards post overseas drug-related deaths AJR
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First Published Jan 6, 2024, 2:40 PM IST

Amid concerns over drug quality and safety, Indian pharmaceutical companies face new manufacturing standards mandated by a recent central government notification. The announcement, issued on Saturday, has ignited debates, particularly among smaller companies seeking a delay due to their existing debt burdens.

Triggered by several fatalities abroad associated with Indian-manufactured drugs since 2022, the central government has intensified its scrutiny of pharmaceutical factories, aiming to refurbish the reputation of the $50 billion industry.

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Stating that manufacturers are accountable for ensuring the quality and suitability of pharmaceutical products, the notification, dated December 28, underscores the need to meet licensing requirements without compromising patient safety or product efficacy.

It outlines stringent regulations mandating companies to market finished products only after obtaining satisfactory test results for ingredients. Additionally, the directive emphasizes the retention of adequate samples for repeated testing or batch verification.

The health ministry's scrutiny of 162 drug factories since December 2022 raised red flags over several issues, including the absence of incoming raw material testing. Alarmingly, it revealed that fewer than a quarter of India's 8,500 small drug factories complied with the international drug manufacturing standards endorsed by the World Health Organization (WHO).

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The notification sets a timeline, demanding compliance within six months for large drug manufacturers and 12 months for smaller counterparts. However, smaller entities have requested an extension, highlighting that the necessary investments to meet these standards might cripple nearly half of them due to their existing heavy debts.

The concerns stretch beyond regulatory compliance. Organizations like the WHO and other health authorities have linked Indian-manufactured cough syrups to the tragic deaths of at least 141 children in Gambia, Uzbekistan, and Cameroon, underscoring the urgency for stringent measures and quality assurance in pharmaceutical manufacturing.

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