USFDA lens slow down Indian pharma exports, says CII official

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, chairman of CII national committee on pharmaceuticals, GV Prasad said on Monday.

Prasad, also co-chairman and managing director of Dr Reddys Laboratories, said, it (effect of frequent inspections) is quite significant (on India pharma exports). Part of the slow-down is because of that."

Lots of companies approvals have stalled owing to warning letters. That has affected the introduction and growth of new products, he said.

Everybody should up their game in terms of quality, systems, discipline, integrity of data. All these are important things for the industry, he said when asked about the effect of frequent inspections of Indian pharma manufacturing plans 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 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 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. He suggested that the Indian drug manufacturers need to go for digitisation of systems and use those tools various verticals of the organisation including marketing. Prasad, however, said though there would be some job losses due to the 'increased efficiency,' new sources of employment would be created.