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  • 13 March 2015
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India needs Biotech Product Trials Authority

After seven months of deliberations, the Modi government has replaced the erstwhile Planning Commission in New Delhi with NITI Aayog or National Institution for Transforming India which will be a commission with widened set of stakeholders

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Essentially, it has been done to change the way government resources are allocated among states for major projects.

Now will the Modi government turn its attention to similarly transform India's fledgling biotech sector which is hurtling towards disaster due to policies that stymie its growth? There are two key segments that require immediate policy attention. The industry's future growth has been stalled due to the near total ban on conducting field trials of new crops that use genetically modified (GM) technologies and clinical trials of new biotech drugs.

In both the cases, the general distrust of the existing regulatory mechanisms by some of the key stakeholders in the society is the culprit.

This is how it has happened. Take the case of clinical trials of newly developed medical products. Some of the new cures are the only hope of many patients who enroll in these trials. Without trial data, regulators cannot approve new products. Few dozen deaths of patients, not necessarily due to the side effects of new drugs, in recent years have been played up so much that the Supreme Court of India has put a stop to trials of new drugs. Without trial data and regulatory approval, no new drugs can be introduced in the country in the near future.

There are many unscrupulous companies which are manipulating clinical trial data but to stop the entire process, approved by the relevant regulator, belies logic. It is clear that the society mistrusts the trial data generate by private companies. One way to get around this is for the government to set up an independent Authority that will conduct the clinical trials of all new medical products for an appropriate fee. It may reassure the public and restore confidence in the clinical trials process.

Similarly, the GM crops trials have also come to a halt. Without the introduction of new technologies, the challenges of increase demand for food in the future cannot be met.

Here again, the government could set up a separate Authority to conduct field trials of all GM crops that are planned to be introduced in the country by public and private companies. There is a vast network of agricultural universities and research institution with abundance of experts and land for experimental field trials. In an interview to BioSpectrum, eminent Agricultural Scientist and Father of India's Green Revolution, Dr MS Swaminathan too has suggested the need for such an independent Field Trials mechanism.

Prime Minister Mr Narendra Modi has demonstrated his penchant for tackling many of India's insurmountable problems through a fresh approach such as Make in India campaign, Clean India Campaign, Teach India and many more.

Mr Modi will do the biotech industry and the people of India a great service if his government helps this promising sector to remove the crutches that are holding back the promise of a new technology that has done wonders around the world.

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