USFDA lens slow down Indian pharma exports, says CII official

By: |
Published: November 18, 2019 5:36:24 PM

"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.

USFDA, Dr Reddys Laboratories Ltd, National Committee on Pharmaceuticals, active pharmaceutical ingredients, FDAChina 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.

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 slow Down 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.

He suggested 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.

Get live Stock Prices from BSE and NSE and latest NAV, portfolio of Mutual Funds, calculate your tax by Income Tax Calculator, know market’s Top Gainers, Top Losers & Best Equity Funds. Like us on Facebook and follow us on Twitter.

Next Stories
1Why cloud computing is the gateway to industry 4.0 for Indian small businesses
2Bill Gates is now world’s richest man; beats Amazon’s Jeff Bezos again for top spot
3Indra Nooyi inducted into Smithsonian’s Portrait Gallery along with Amazon CEO Jeff Bezos