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FDA To Intensify Inspections At Indian Drug Units Amid Quality Concerns

Updated: Feb 28, 2024 02:30:38pm

FDA To Intensify Inspections At Indian Drug Units Amid Quality Concerns

New Delhi, Feb 28 (KNN) In response to mounting worries over drug quality, the U.S. Food and Drug Administration (FDA) is gearing up to enhance inspections at Indian pharmaceutical manufacturing units in the coming year.

Following a hiatus in unannounced inspections during the pandemic, the FDA conducted over 200 inspections in India during 2023, as disclosed by a senior FDA official to Reuters.

Sarah McMullen, FDA Country Director (India), emphasised the agency's commitment to intensify inspections and expressed the need for additional drug investigators to be deployed.

This move comes at a crucial juncture as India's pharmaceutical industry, valued at USD 42 billion, strives to expand its global footprint. With the government advocating for the adoption of good manufacturing practices to align with international standards, ensuring drug quality remains a top priority.

Highlighting the gravity of the situation, the World Health Organisation previously linked the deaths of numerous children in Gambia to drugs manufactured in India. Notably, the United States constitutes 30 per cent of India's total pharmaceutical exports.

McMullen underscored the imperative for the Indian pharmaceutical sector to invest more in automation to enhance compliance. Additionally, she stressed the necessity for bolstering the resources of the country's drug regulatory body to fortify industry oversight.

As regulatory scrutiny intensifies, stakeholders in India's pharmaceutical realm face a pressing need to prioritise quality assurance measures to uphold global standards and ensure public health safety.

(KNN Bureau)


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