Modi Government Set To Remove Compensation Clause From New Clinical Trial Rules

The Bharatiya Janata Party-led NDA government is reportedly set to remove a clause from the final version of the draft clinical trial rules that mandates compensation in case of death or injury from a clinical trial. 

In February this year, the draft version of the New Drugs and Clinical Trials Rules, 2018 was released. 

It included a provision that if a human subject participating in a clinical trial or a ‘bioavailability study’ or ‘bioequivalence study’ died or suffered permanent disability during the course of the trial or study, then the sponsor of the clinical trial shall pay upfront an interim compensation, amounting to 60% of the compensation payable within 15 days of the opinion of an ‘Ethics Committee’, which was proposed be set up.

After the Ethics Committee gave its opinion, the Central Licensing Authority (CLA) would have passed its order. The remaining 40% of the compensation was to be paid within 30 days of the order by the C. The interim compensation shall not be reimbursable regardless of the CLA order.  

The compensation is to be calculated through a formula specified in the Seventh Schedule of the draft rules.

According to the draft rules, any institution or organisation that intends to conduct biomedical and health research shall be required to have an Ethics Committee in place to oversee the conduct of such research. 

The Ethics Committee would have consisted of seven members, including medical scientists, non-medical scientists, non-scientific experts, legal experts, one lay person from community, and a woman member. The committee’s task would have been ensuring that medical research and experiments on human beings are carried out in compliance with ethical concerns and requirements, reviewing and according approval to a clinical trial protocol, etc.

“Every member of the Ethics Committee shall be required to undergo such training and development programmes as may be specified by the Central Licencing Authority from time to time,” say the rules.

While it is expected that the pharmaceutical companies and lobbies would oppose such a clause, the World Health Organisation (WHO) also lobbied on behalf of the pharma industry.

On June 19, WHO deputy director general Soumya Swaminathan wrote to Union health secretary Preeti Sudan asking the Indian government to “reconsider” the compensation clause as it would not only drive away drug companies which would find the clause “unacceptable” but also “hamper” the WHO’s work with India. 

“I fear that if the rules are finalised as they currently stand, there is a possibility that sponsors will not conduct clinical trials in India and go elsewhere,” Swaminathan wrote in her letter, as reported by Mint.

“It will also hamper WHO’s work with India where we consider that it is a public health priority to conduct clinical trials on a particular condition in India, WHO ourselves may not wish to act as sponsor and other partners may be similarly discouraged.” 

“Our major concern is the reaction sponsors are likely to have to the scenario, whereby the ethics committee determines a death or permanent disability is related to the product, but the sponsor disagrees,” she said. 

Swaminathan said ethics committees lack expertise and internationally it was not the usual practice for ethics committees to make such decisions. 

Even the Indian Council of Medical Research (ICMR) agreed with these objections, as ICMR’s director general Balram Bhargava wrote to the Health Ministry stating that some of the provisions in the draft rules would adversely impact the future of clinical trials in India. 

The Mint report quoted him as saying, “At present most ethics committees in India are not appropriately trained with variations in quality and efficiency to review to deal with the issue of compensation.”

The Indian Express quoted a senior government official on the condition of anonymity, “There is a serious opposition to this provision of clinical trial rules by industry and even the WHO (World Health Organisation). In the final version, we may remove this clause as it can prove to be too onerous for companies and sponsor organisations that run various clinical trials in India.”

It is not surprising that the Modi government is once again kowtowing to the diktats of corporates — in this case the powerful global pharma industry — without caring about the well-being of its own people.

But it is also one of those occasions when the WHO has revealed its neoliberal moorings, making explicit how much value it attaches to human lives in the Global South in the face of global capital.

Telling Indians that if they ask for more, drug companies would go elsewhere where the compensation laws are not strict and more compliant to the pharma industry’s interests amounts to making the case that cheaper human bodies can be found in the rest of the developing world.