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India’s clinical-trial rules to speed up drug approvals

Drugs that have been approved in some countries will no longer require trials in India.

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A pharmaceutical research laboratory in Mumbai, India.

India's drug regulator has introduced new clinical-trial regulations.Credit: Frédéric Soltan/Corbis via Getty

India has announced new rules for clinical trials that will speed up drug approvals and remove the requirement for large studies to test the efficacy of drugs that have already been approved in other nations. The country will also introduce regulations for universities undertaking research involving people.

The government hopes the rules, effective immediately, will increase and improve clinical research in India, which hosts only 1.2% of the world’s clinical trials despite having a high burden of disease.

India tightened its clinical-trial regulations in 2013 after a series of scandals involving allegations of unethical practices. The government relaxed some of these rules in 2015, following a drop in clinical research. But the regulations became fragmented and difficult to understand, says Chirag Trivedi, head of the Indian Society for Clinical Research, an association for pharmaceutical companies and clinical-research organizations in Mumbai.

The new rules are cohesive and comprehensive, says Trivedi. They outline how all clinical research should proceed, he says.

The rules stipulate deadlines for the drug-approval regulator, the Central Drugs Standard Control Organisation (CDSCO), to make decisions on trials. The regulator will now have 90 days to decide whether to approve global clinical-trial applications and 30 days for domestic trials. Previously, such decisions could take up to six months.

Pharmaceutical companies that want to sell a new drug will no longer have to conduct a phase III clinical trial that tests for efficacy and safety of the drug in the Indian population, if it has been approved for sale in the European Union, the United Kingdom, Australia, Canada, Japan or the United States. But companies will need to conduct a trial after the drug has been marketed to evaluate long-term effects, known as a phase IV clinical trial.

The regulator will also have the authority to exempt medicines known as orphan drugs, which treat conditions affecting less than 500,000 Indians, from both phase III and IV clinical trials. Physicians think that this policy will improve people’s access to drugs. But the efficacy of some drugs, such as oral vaccines, can vary between populations in high-income nations and those in low- and middle-income countries. Without trials in India, physicians worry they won't know if the drugs are working well in the local population or not.

Commercial ethics boards

Clinical trials will now be able to use commercial ethics review boards to oversee drug development, says Anant Bhan, a health-policy researcher at Yenepoya University in Mangalore. Regulators had earlier restricted the use of commercial review boards to oversee only bioequivalence studies, which explore whether a patented drug and its generic version work in the same way. Bhan worries that commercial boards will be focused on making profits and might not provide strict oversight of trials, a situation that occurred in the United States.

The policy also regulates research involving people conducted at universities and other research institutes. Until now, only guidelines for such studies existed.

From 15 September, trials at universities will need to be reviewed by an ethics committee registered with the Department of Health Research. Previously, researchers had escaped oversight, and the duties of university ethics committees were typically to rubberstamp projects, says Roli Mathur, head of the Indian Council of Medical Research bioethics unit. The new rules will ensure the rights, safety and welfare of participants, Mathur says. “The quality of research is going to grow, which means the participants are going to be benefited,” she says.

doi: 10.1038/d41586-019-01054-4

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