Pulse

Vocal about local, but for the right scientific reasons

PT Jyothi Datta | Updated on August 14, 2020 Published on August 14, 2020

Local research and data must match global standards and stand up to scientific scrutiny   -  sanjeri

Be it for Covid or other challenges, Indian pharma must generate local data and research

If there’s one thing Covid-19 has exposed across geographies, it is the lack of preparedness of countries to meet their emergency needs for medicines, vaccines and medical technology.

And the fallout of this desperate need is what’s being labelled as “vaccine nationalism”, where countries scramble to get the medicine or vaccine for their own people. And everyone’s culpable.

In the early days of the pandemic, the US reportedly wooed a German company to take its Covid-19 vaccine-related research to the US. Countries have been putting big money to support companies that have started “at risk” manufacturing of Covid vaccine candidates, to be able to vaccinate their own people as soon as a workable vaccine is developed.

And earlier this week, Russia stirred a hornet’s nest when it said it had a Covid vaccine ready to be given to people, even as late-stage trials were under way.

India too had its moments, when an official letter went out to researchers urging them to get the Covid-19 vaccine candidate they were testing ready by August 15. The unstated but ostensible reason of being a possible Independence Day announcement of a vaccine for the country was not lost on industry watchers.

But away from the political overtones of these scientific developments, members of the medical and research community stress that it is important to generate local data and research. Not just for Covid and other emergencies, but even on a good day, for the right scientific reasons.

It is important to generate local data and research from a scientific point of view, because people have ethnic, genetic, environmental, dietary and other type of differences that could have a bearing on the effectiveness of a medicine, says Dr Monika Tandon, Glenmark Pharma‘s Vice-President and Head (Clinical Development), and a researcher for about two decades.

The dosage of a medicine used in an Asian population may differ from that used in a Caucasian population, which is why many human trials are multi-country studies to encompass all geographies, she points out. Countries may require local studies in their population, but there are others that rely on data generated in another country provided it is done in line with Good Clinical Practice norms. Besides, it also depended on the medical product and data generated to show if local studies were required.

Against the pandemic backdrop, researchers across the world are keen to get involved and come out with a meaningful development that is useful to the country and people. Researchers have been doing interesting work in the past as well, in India, she says. “The difference now is that it is more visible as local people recognise it and grasp its importance.” The pandemic, in that sense, has given the right push to spur companies to invest in research for unmet needs, she acknowledges.

Glenmark’s version of Covid-19 drug Favipiravir, for instance, was the first to launch in India and the company has been continuing with research on different dosages and combinations of the drug to treat the virus.

Self-sufficiency

The need to pay attention to strengthening local scientific research and manufacturing capabilities had been raised with the Centre close to a decade ago, says Dr K Srinath Reddy, President, Public Health Foundation of India, referring to long-standing recommendations on building bulk drug capabilities, among other things.

Even if the Government wants to issue a compulsory licence (CL) on a critical drug for public health reasons, it will need to have local capabilities to make the drug, he says. (A compulsory licence allows a third party to make an original drug, on payment of royalty.) “It does not mean retracting from global cooperation, it’s about becoming self-sufficient,” he points out.

Geo-political reasons and changes in diplomatic relations will have an impact on industry.

But on the scientific side, Dr Reddy says, generating Indian data is important also to streamline effective treatment by knowing the risk in the population.

Members of the research community are unanimous on the importance of building local research and data. And, it needs to be done not just to meet local unmet needs but also in a manner that matches global standards, besides standing up to scientific scrutiny, points out regulatory expert in clinical research, Dr Arun Bhatt. Only then will the benefits of “going local” pass on to patients in India and overseas, a reputation that Indian drug companies have always had.

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Published on August 14, 2020
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