Here’s Why Prosfora’s Amit Ranjan Believes Indian Drugmakers Fall Short Of U.S. FDA Standards
An employee checks a vaccine vial moving along a vaccine vial monitor labeling machine at the Serum Institute of India’s pharmaceutical plant in Pune, Maharashtra, India. (Photographer: Sanjit Das/Bloomberg)

Here’s Why Prosfora’s Amit Ranjan Believes Indian Drugmakers Fall Short Of U.S. FDA Standards

Indian drugmakers specialising in sterile products have a long way to go before meeting specifications of the U.S. Food and Drug Administration.

That’s according to Amit Ranjan, managing director of Prosfora Technologies Pvt. Ltd., which works on good manufacturing practices in the sector. “It’s a given that we’re lacking in injectable manufacturing,” Ranjan told BloombergQuint in an interview. “Our expertise in sterile products needs to be improved. Basic lapses exist in (current) accepted practices.”

The scrutiny on Indian firms has worsened compared with the rest of the world in the past year. Indian pharma firms accounted for nearly a third of the total foreign inspections by the U.S. FDA between October 2018 and June 2019, according to data collated by Jefferies India Pvt. Ltd.

In the past four years, India’s share in the total number of foreign inspections by the U.S. FDA was about one-fifth of the total. That, according to Ranjan, meant that the “honesty level also has to improve”.

Watch | Prosfora Technologies’ Amit Ranjan On Indian pharma firms’ manufacturing practices

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