Inspections by FDA hurting Indian drug exports, says Dr. Reddy's chairman
- Satish Reddy, Chairman of Dr. Reddy's, blamed regulatory oversight from the U.S. FDA for lower pharmaceutical exports to the U.S. from India, the Economic Times reports.
- Speaking at a Board of Trade meeting in New Delhi, Reddy advocated for greater dialogue with FDA officials.
- Reddy's comments come as the FDA has stepped up enforcement of Indian manufacturing sites. The regulator has sent over a dozen warning letters to firms with facilities in India over the past year.
"Even though we are growing, we are not growing according to the potential," Reddy said, in commets reported by the Economic Times. He cited lowered pharma export growth compared to past double digit increases.
This year the FDA has sent letters to lesser-known Wockhardt and Ipca Labs for manufacturing and data violations, but notices in the past have gone out to larger firms like Sun Pharma, Dr. Reddy's, and Cipla.
Forty-two Indian firms are currently on the FDA's import ban list, prohibiting products from those firms entering the U.S.
In addition the FDA, however, the Indian government also appears to be taking quality control issues more seriously. Last month, the Health Ministry banned nearly 350 fixed dose combination drugs because of potential risk to patients. However, many of the pharmaceutical companies involved have received a stay on the ban from Indian courts.
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