Frequent FDA inspections slow down Indian pharma exports

Hyderabad: Frequent inspections of Indian plants by the US FDA and subsequent observations slow down the growth of pharma exports even as US-China trade war presents huge opportunities for the drug industry, GV Prasad, Chairman, CII National Committee on Pharmaceuticals and Co-Chairman and MD of Dr Reddys Laboratories Ltd said on Monday.

"It (effect of frequent inspections) is quite significant (on India pharma exports). Part of the slowdown is that. Lot of companies' approvals have stalled because of warning letters. That has affected the new product introductions and growth," he said.

"Everybody should up their game in terms of quality, systems, discipline, integrity of data. All there are important things for the industry," Prasad said when asked about the effect of frequent inspections of Indian pharma manufacturing plants by the FDA and measures to be taken to reduce the impact.

According to him, China is a major source of active pharmaceutical ingredients (API) and chemical intermediaries for the global pharmaceutical industry, including that of India, due to their competitive pricing.

He, however, said, the trade war with the USA has prompted western companies to start 're-looking' into their dependence on Asia's largest economy as the situation impacted the duty structures, among others.

"That (the situation) opens up an opportunity for India. China as a nation is moving towards more innovation and getting out of what they perceive as low value-added business.

That is the opportunity which is opening up for India. And China itself is a great market," he said.

Prasad said there was a need for the government to focus on and invest more in primary healthcare.

He further said though drug prices in India are cheaper when compared to other nations, the affordability by the public is becoming an issue as there is no 'national healthcare system' in place in the country.