‘USFDA hurting India’s exports, our Govt should intervene’
Asserting that regulatory action by the US Food and Drug Administration (USFDA) on leading Indian firms has impacted exports from the country, Dr Reddy’s Laboratories Chairman Satish Reddy on Wednesday asked for a dialogue between government and US health regulator. Reddy, who was among the industry leaders who attended the Board of Trade meeting here, said exports have been hit due to USFDA actions.
Exports of pharma although grew by 9.7 per cent but it used to be in double digits in the past so it has come down slightly, Reddy said. “Even though we are growing, we are not growing according to the potential,” Reddy said.
He added that there were several factors that have impacted the exports to the US market, which is the world’s largest marketplace for medicines. “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 that’s being carried out by the industry as well as the Commerce Ministry...industry is also continuing the dialogue (with the FDA officials). I am not expecting more but just to keep that sustenance of that dialogue. That is critical,” he added.
In the recent times various leading drug makers including Sun Pharma, Lupin, Wockhard, have come under the scanner of USFDA for lapses in manufacturing norms. In November last year, Dr Reddy’s had received a warning letter from the USFDA relating to two of its API manufacturing plants and a formulation plant in Andhra Pradesh and Telangana.
In response to the letter, the country’s second-largest drug maker’s CEO G V Prasad had said the company is in the process of shifting some of the products from these plants to other facilities and considering third party assessment for its plants. The US agency had asked the drug maker to provide a comprehensive evaluation of the extent of inaccuracies in recorded and reported data and include a detailed action plan to fully investigate the scale and root causes of “deficient documentation and data management practices”.
On Venezuela, which has banned drug imports from India, Reddy said: “I would like to point out Venezuela...here also we see an opportunity because we are looking at $350 million of exports potential going down to zero if we don’t act on it.”