With all major US export-oriented drug manufacturing plants in the country up for inspection in 2022, some estimates peg that at least 20-30 per cent of the new product launches lined up for the US will be subject to on-site inspection by the US Food and Drug Administration (USFDA). The last two years saw limited physical inspections due to travel restrictions during the pandemic. "Pre-Covid, the frequency and number of inspections of manufacturing plants in India by USFDA had increased significantly," analysts from ICICI Securities Research noted. "With growing ANDA filings, especially for complex products. "We expect this trend to return with the environment normalising," analysts from ICICI Securities Research noted.
Recently, Ranbaxy and Wockhardt too were hauled up.
In March, the FDA had issued an import alert, banning formulations and active pharmaceutical ingredients from the factory.
The FDA has been tightening its monitoring of Indian pharma majors over compliance issues. Surprise plant inspections and import alerts have been frequent outcomes
Under terms of the agreed deal, Ranbaxy shareholders will get 0.8 of a Sun Pharmaceutical share for each Ranbaxy share they own.
The Competition Commission of India and the US Federal Trade Commission are yet to give their nod to the biggest pharma merger and acquisition deal this year in the Asia-Pacific region.
Since 2013, the FDA has banned around 30 Indian drug manufacturing units for various violations
Details on prices sought as 10 generic drugs become up to 83 times costlier in 6 months
In a surprise announcement in April, Sun and Ranbaxy -- at that time owned by Japan's Daiichi -- declared an all-stock deal to create India's largest and world's fifth-largest drugmaker in an over $4 billion deal.
My goal is to implement the Sevak project all over India and make the villages true Gandhian villages -- self sustainable in every way, including health, says Dr Thakor Patel, head of the American Association of Physician of Indian Origin's Public Health Committee. Aziz Haniffa reports
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