Opinion In framing new clinical trial rules, government must balance pace with prudence

In the past seven years, the government has taken several measures to streamline the drug approval process. The New Drugs and Clinical Trials (NDCT) Rules, notified in 2019, reduced timelines for ratifying therapies and clarified safety-related procedures. Last year, the Drugs Controller allowed novel products to enter the Indian market without local clinical trials if they had been approved in the US, UK, Australia, Japan, Canada, and the EU. The Union Ministry of Health and Family Welfare has now proposed amendments to the NDCT rules, including waiving the local clinical trial requirement for more formulations. Nimble regulation could fast-track research in cutting-edge medicine and enable doctors in the country to deploy novel therapies for TB, cancer, autoimmune disorders, and Alzheimer’s. However, in its quest to spur innovation, the government would do well to be scrupulous about another fundamental requisite of the medical sciences — the safety of clinical trial participants and the welfare of patients.

A hub of out-of-patent therapies and affordable vaccines, India has been lagging in the development of new medicine molecules. Drug discovery is a long, expensive, and often complicated procedure. In the last 15 years, the Council for Scientific and Industrial Research has tried to bring together academia and business bodies to circumvent this challenge. However, regulatory processes continue to be the Achilles’ heel of pharma innovation in the country. Despite the recent attempts at simplifying research requirements, the country continues to follow complex documentation, clinical trial, and inspection processes. As a Deloitte and Assocham report pointed out last year: “Several policy challenges continue to hinder the growth of India’s pharmaceutical R&D sector, such as inadequate capacity for drug regulation, the need for advanced testing facilities, and the lack of a strong framework for monitoring quality compliance in manufacturing units.” Developing synergies between laboratories in the country and outside its shores could help address some of these problems.

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At the same time, medical policymakers should heed the caveats of abbreviating trials. Some of the new formulations that manipulate genetic material or modify immune cells carry long-term risks that are not yet fully understood. Even drugs that promise significant therapeutic advancements need careful scrutiny when used in a genetically diverse population. That’s why a section of experts caution that skipping local trials could compromise safety. Other scientists reason that regulatory authorities should strengthen the monitoring of drugs exempt from local trials — like in the US and EU, for example. The government has invited public comments on the amendments to the NDCT rules. It must patiently parse criticisms and observations, and not act in haste.