Pulse 1st Anniversary Edition. Drug makers seek to shed their old skin

It was literally baptism by fire for Satish Reddy after he was appointed President of the Indian Pharmaceutical Alliance, representing the biggest boys of the domestic pharmaceutical industry. A revised regime on price control had just been introduced, casting its net over all 348 medicines on the Government’s list of essential medicines. And the implementation of this Drug Prices Control Order (2013) had industry in a tizzy.

“It literally became a one sided game – everybody else against the industry,” says Reddy, recalling the intense discussions then between Government and civil society groups. On a parallel track, the Supreme Court had called for the re-examination of over 150 clinical trials (involving the testing of medicines on humans).

Close to two years on, both issues continue to simmer between industry and Government. But what worries Satish and fellow industry chiefs today is the Government’s approach to intellectual property.

“The stance needs to be spelt out more clearly. That’s what we are struggling with,” says Reddy, referring to indications that the Government may take a softer approach on “patent linkages” and “data exclusivity.”

Both options result in delaying the entry of inexpensive generic medicines (drugs chemically similar to the original) in the market.

The disastrous affects of this on the Indian industry has to be recognized, talked about more explicitly and a position stated clearly, he says, adding “Industry has concerns with that. And me as the head of IPA have big concerns with that.”

“Although we hear the right voices coming in from government in some quarters, I don’t hear that consistently,” he says, explaining their discomfort with statements from representatives in the US on commitments from India, following the Obama visit. Reddy is Chairman Dr Reddy’s Laboratories, and the IPA includes drug-majors Sun Pharma, Lupin, Cipla, etc.

Outlining the landscape in which domestic drug makers operate, Reddy hopes the nature of the dialogue changes to a more progressive tone, with solutions for industry and the people.

At present though, he says, “what’s giving us sleepless nights” is the negativity being heaped on drug companies. “Whether it is regulations or special interest groups, activists - the industry does not get the credit it deserves,” he points out.

The industry’s “angst” stems from being made targets when in fact they have made drugs affordable in the first place, amply aided by policy, says Reddy. “The entire pharmaceutical policy aided companies, even our founding of our company was because of that kind of a policy of 1970,”he adds.

But present day debates on health don’t see the big picture and health insurance or health outcomes are not even discussed, he says. And these prevailing policy uncertainties have led companies to take their clinical trials out of the country, pushing up their cost by five times, if not more, for instance.

The generic story is about being on to time, that’s the target, says Reddy. “We cannot be battling with uncertainties of what if something else happens. And then we incur a high cost and it affects our margin. But we have to be in the market – so that’s a concern,” he says, on an issue that’s still in Court.

Discussing why drug majors get rapped by foreign regulators, sometimes on basic hygiene issues, Reddy agrees that a “quality culture” needs to percolate through companies to the last person. Industry is working towards addressing this collectively, he says, confident that local drug makers will be able to meet these challenges in overseas markets.

“The real problem is we would like to do more in the home country,” he says, recalling people like his father, late Dr Anji Reddy, who ventured into drug discovery.

“While we address the basics how do we even get to that (drug discovery) stage – because that’s the Holy Grail for any pharma firm and we are not even scratching the surface even now. That’s the angst that companies like us feel,” he says. Research requires a scientific ecosystem, he says, calling for more interactions with academic institutions, meaningful funding from Government etc.

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