Prashant Reddy: The regulatory mess in Indian science

Last Updated: Sat, Jan 12, 2013 18:41 hrs

India’s first Prime Minister Pandit Nehru and India’s current Prime Minister Manmohan Singh may not have much in common apart from their honesty and their infatuation with the wonders of modern sciences. Nehru lay down the foundations of modern science in India, contributing to a nuclear programme, a space programme and fancy scientific labs even when the rest of India was living “ship to mouth”, as the old line had it. For his part, Manmohan Singh has tried to push forward the future of Indian science by kick-starting several policy initiatives such as the National Innovation Council and the National Knowledge Commission to reform and ignite the genius of the country’s scientists. And yet, despite the PM’s well-meaning efforts, public faith in cutting edge new-age technologies is probably at its lowest since independence.

From nuclear power plants to genetically modified foods to clinical trials of new pharmaceuticals, almost every issue has ended up in the Supreme Court — an institution which is far from prepared to handle the regulation of science. While one may be tempted to blame this on the increasing activism of the Supreme Court, it is also true that the safety regulators in these sectors inspire little public confidence.

Consider nuclear energy and biotechnology, to pick just two examples currently in the news. The Atomic Energy Regulatory Board (AERB) is directly subordinate to the Department of Atomic Energy (DAE) and the Genetic Engineering Approval Committee (GEAC) is pretty much under the influence of the Department of Biotechnology (DBT). The problem with these cosy relationships is that they represent a blatant conflict of interest between the supposedly independent regulators and the government bodies such as the DBT and the DAE which are tasked with promoting the biotechnology and nuclear technology industries in India. This is like asking the Securities and Exchange Board of India (Sebi) to report to the Bombay Stock Exchange (BSE).

As for the country’s drug regulator, a parliamentary standing committee itself has commented on how the regulator seems to be more interested in serving industry interests rather than upholding safety standards for the citizenry. And let’s not forget the regulator under whose watch the ghastly Bhopal Gas Tragedy happened — the Central Insecticides Board of the Department of Agriculture, which is set up under the Insecticides Act, 1968. This legislation is set to be replaced by the pending Pesticide Management Bill, 2008. When the Parliamentary Standing Committee scrutinised this Bill and submitted its report, it did not even make a cursory mention of the Bhopal Gas Tragedy.

To the credit of the prime minister, he announced the creation of a new autonomous regulator for the nuclear industry immediately in the aftermath of the Fukushima crisis. However, the proposed Nuclear Safety Regulatory Authority of India Bill has been languishing in Parliament since 2011. As for the biotech sector, the government has drafted a Biotechnology Regulatory Authority of India (BRAI) Bill, which has not even been introduced in Parliament despite being on the anvil for a very long period now. This bill, and the biotech regulator it will bring in, is crucial not only to establish public confidence in genetically modified food but also pave the way for the crucial biotech drug industry which has the potential to revolutionise treatment for several life-threatening diseases such as cancer, etc.

The charge, by activists, against these proposed regulators, which are supposed to be independent, is once again that they lack independence from the government. The activist community may have gone overboard in its demands for unrealistic levels of independence for regulators — but it is also absolutely clear that things cannot continue as they are.

The prime minister has only one year left in office. He’s unlikely to accomplish much on the scientific front in this short period but at the very least, he should make some effort to sort out this regulatory mess in Indian science. He can start by asking the Law Commission to define the meaning of regulatory independence’ and then push his party and Parliament to implement these changes across safety regulators in India. It will not be an easy job — both industry and civil society are sure to find a thousand faults with his effort. But somebody has to make a start, and who better than the economist prime minister who best understands the need for enlightened regulation.

The writer is at Stanford Law School  

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