USFDA objections hurting exports, says Dr Reddy's Labs

India's drug major, Dr Reddy's Laboratories has said that regular interventions from the U.S-based drug regulator, the U.S. Food and Drug Administration (USFDA), is hurting exports of India's pharma industry.

Dr Reddy's Chairman Satish Reddy, Wednesday said at the Board of Trade meeting in New Delhi that a dialogue between the government and the USFDA is much needed, the Press Trust of India reported.

Reddy said the Indian pharma exports grew by 9.7 percent but the figure is disappointing since they were in double digits in the past. "Even though we are growing, we are not growing according to the potential," he said.

Dr. Reddy's Labs was served a warning letter from the U.S-based drug regulator Wednesday, after which the company recalled 3,342 vials of anti-osteoporosis injection, on account of lack of assurance of sterility, the Press Trust of India reported.

According to the data released last month by the Ministry of Commerce, the export of drugs and pharmaceuticals commodities stood at $1,264.65 million in February. However, in comparison to the previous month, the export of these commodities has decreased by 11.69 percent.

The USFDA recently cracked whip on India's leading pharma companies, Sun Pharmaceuticals and Lupin, for substandard facilities at its manufacturing plants. Lupin plunged more than 13 percent to a new 52-week low on the Bombay Stock Exchange after USFDA audit team inspected its facilities at Madhya Pradesh and Goa, and made three observations. Dr Reddy's also received a warning letter from the USFDA last year, related to its two manufacturing plants in Andhra Pradesh and Telangana.

The U.S. is regarded as one of the world's biggest markets for generic medicines.

"When it comes to the issue of exports to the U.S., it has to do more with regulatory actions which the USFDA has had on leading Indian companies which has affected exports," Reddy said. He added that a dialogue being carried out by both the pharma industry as well as the Commerce Ministry with the USFDA officials needs to be sustained.

"I am not expecting more but just to keep that sustenance of that dialogue. That is critical," he added.

According to Indian Pharmaceutical Industry Analysis, India supplies about 20 percent of global generic medicines, making the country the largest provider of generic medicines globally.