A little over a month ago, industry veteran Sudarshan Jain was appointed Secretary General of the Indian Pharmaceutical Alliance, a platform largely representing domestic drugmakers.

The appointment was significant as the IPA recently lost its public face in the untimely passing of spokesperson DG Shah. And the IPA plays a mighty vocal role not just in taking industry concerns to Government, but in also stating India’s position on intellectual property (IP) on a global stage, besides countering generic-drug-bashing oft witnessed in some quarters.

Jain took charge even as the domestic drug industry faced all of the above situations. The United States Trade Representative’s Special 301 report came out, retaining India on its “Priority Watch List”. (This report is a US scorecard on its trading partners and their handling of IP.) And later, an ongoing investigation in the US put a clutch of Indian drugmakers under the scanner for price collusion.

Jain having worked with the Piramals and Abbott, I ask him if this is his third innings or an entirely new and busy one at that? Jain’s response is sanguine. It’s a journey, he says, through the Indian pharma industry’s days of struggle to holding pride of place today in expanding affordable healthcare across the world.

So, when critics of Indian generic drugmakers allege that medicines are of “flea-market” quality, as a recent book also alleges, is there cause for concern? Do Indian companies follow dual standards for local and overseas markets? Do they short-cut processes to sell bad quality drugs?

No dilution of quality

“I have been with this industry for 40 years... I joined Lupin in 1977 with DB Gupta. When he said, ‘we will be the largest producer of TB drugs in the world,’ I couldn’t imagine at that time that it would happen,” he recalls, adding that today the industry has built its manufacturing capabilities. “It is also a fact that every third tablet in the US is from India. The market in 1990, which was 33 per cent generic drugs, is today 90 per cent generic drugs. So Indian companies have played a very vital role of improving the reach of affordable healthcare around the world and I am proud of that journey and I have seen that journey,” says Jain.

Healthcare is about patients, and the industry will have to stay focussed on improving the life of patients, he says. On quality concerns, he says, Indian companies have evolved over a period of time and their standards are comparable to the best in the world. “With the evolution of every industry it happens, it happens in the US, it happens in India,”he says, adding that such scrutiny comes with keeping businesses accountable.

Jain points to statements by former USFDA Commissioner Scott Gottlieb and Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research.

“They are supporting the quality systems they have set from themselves,” he says, indicating that if companies are selling in these markets, they do because they have the requisite quality and approvals. On the price collusion allegations in the US, he clarifies that the IPA was leaving it to the companies to defend themselves.

Looking ahead, Jain says healthcare is poised at an exciting phase in time. The effort is to get more conversations going between industry and academics in terms of policy discussions and improving course content for students who may enter the pharmaceutical industry, he says. Jain wears many hats, including being on the board of multiple academic institutions and companies, from med-tech company Healthium, API (active pharmaceutical ingredients) maker Zandu Chemicals to e-pharma startup Pharmeasy.

With the NDA-led government set for another five years, Jain expects more traction on issues involving quality, including upgradation support for smaller manufacturing companies, a long pending look to build bulk drugs manufacturing capacities and greater clarity on laws involving med-tech and online pharmacies.

That said, he adds that the pharma industry will have to live with the fact that they will always be regulated, as it has to do with the health of patients. And that’s a role none other can match.

“We have imprints in more than 200 countries. According to me, compared to even (the) IT industry, the imprint of pharma is more. And it has done more to alleviate suffering,” he says, in a gently assertive manner.

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