CHENNAI: Indian pharma major Dr Reddy’s Laboratories Chairman Satish Reddy on Wednesday asserted that recent regulatory action by the US Food and Drug Administration (USFDA) on leading Indian firms has impacted exports from the country.
Reddy went on to add that a dialogue between the Indian government and US health regulator was essential in solving the issue.
Reddy, who was among the industry leaders who attended the Board of Trade meeting in New Delhi, said that while exports of pharma products grew by 9.7 per cent, the normal trend had been in double digits before the USFDA crackdown.
“Even though we are growing, we are not growing according to the potential,” pointed out Reddy, adding that there were several factors that have impacted exports to the US market.
“When it comes to the issue of exports to the US, it has to do more with regulatory actions, which the USFDA has had on leading Indian companies which has affected exports. A sustained dialogue is being carried out by the industry as well as the Commerce Ministry. I am not expecting more but just to keep that sustenance of that dialogue. That is critical,” he asserted.
In the recent times various leading drug makers including Sun Pharma, Lupin, Wockhard, have come under the USFDA scanner for lapses in manufacturing norms. Including, Dr Reddy’s which had received a
warning letter from the USFDA in November last year relating to two of its API manufacturing plants and a formulation plant in Andhra Pradesh and Telangana.
In response to that letter, the drug maker’s CEO G V Prasad had said the company was in the process of shifting some products from these plants to other facilities and considering third party assessment for its plants.
The US agency had also asked the drug maker to provide a comprehensive evaluation of the extent of inaccuracies in recorded and reported data, while also including a detailed action plan to fully investigate the scale and root causes of “deficient documentation and data management practices.”