Should India approve weight loss drugs without local data?

The Delhi High Court has asked the Drugs Controller General of India (DCGI) to review the regulatory basis for approving certain weight-loss drug combinations currently being sold in the country.

The direction came in response to a writ petition filed by Jitendra Chouksey, who challenged the approvals of these drugs on the grounds that they were granted without India-specific clinical trials or efficacy data. Argued by senior advocate Diya Kapur, the petition also raised concerns about the broader legal and ethical framework governing such approvals.

According to the petitioner, licences for these weight-loss drug combinations were issued “without conducting India-specific trials and studies” and “not based on adequate data.”

Taking note of earlier representations made to the DCGI and the Ministry of Health and Family Welfare in April 2025, a division bench comprising Chief Justice Devendra Kumar Upadhyaya and Justice Tushar Rao Gedela permitted the petitioner to file a fresh, comprehensive representation. This additional submission is to include documents already placed before the court.

“We find it appropriate to permit the petitioner to approach the Drugs Controller General of India by way of making an additional representation, bringing to his notice the materials and documents submitted to the Court,” the bench noted.

The High Court has directed the DCGI to consider this supplementary representation within three months, and to consult relevant clinical experts and stakeholders as part of the review process. “The Drugs Controller General of India shall accordingly take an appropriate decision in the matter and shall address the concerns raised in the writ petition by the petitioner appropriately,” the order stated.

Weight-Loss Medications Face Regulatory Heat

The court’s directive comes at a time when interest in weight-loss medications—particularly GLP-1 receptor agonists and fixed-dose combinations (FDCs)—is on the rise. Several of these combinations are already being marketed, but their safety has come under scrutiny due to the absence of India-specific clinical evidence.

This isn’t the first time the regulatory framework for FDCs in India has faced questions. In the past, the Ministry of Health banned hundreds of such combinations—ranging from painkillers to cold medications—following expert reviews that deemed them irrational or poorly supported by data. Some of these bans, including those on combinations like paracetamol with nimesulide and ibuprofen with phenylephrine, were upheld by the courts.

Although the High Court has not commented on the legality of existing drug approvals, it has placed the responsibility on the DCGI to conduct a thorough review. The petitioner must submit the supplementary representation within two weeks, after which the DCGI has three months to examine the matter, seek expert input, and take an informed decision.

The petition has now been disposed of, leaving the door open for a regulatory reassessment.

Experts Weigh In: ‘One Size Doesn’t Fit All’

The High Court’s directive has reignited debate on whether India should fast-track approvals of globally popular weight-loss drugs without robust local clinical trials.

Dr Sukhvinder Singh Saggu, Director, Minimal Access, GI & Bariatric Surgery at the CK Birla Hospital®, Delhi, said the concern is both timely and valid. “The directive highlights an important issue—the need for India-specific clinical data when approving weight-loss drugs. Given the genetic, dietary, and lifestyle diversity in India, relying solely on international studies is not adequate,” he told Business Today.

He noted that Indian patients often exhibit central obesity and accumulate more visceral fat compared to Western populations. “At a BMI of 27.5, Indian patients already face high risks of diabetes, hypertension, and cardiovascular disease,” Dr Saggu said. “Genetic variability across Indian states can also influence drug efficacy and side effects.”

While drugs like semaglutide and tirzepatide are transforming global obesity care, experts caution against bypassing domestic trials. “Approving drugs based on local evidence will not only improve outcomes but also increase public confidence and regulatory transparency,” Dr Saggu added.

Obesity, he said, is a complex and multifactorial disease. “It cannot be treated with a one-size-fits-all approach. A multi-modal strategy—combining dietary changes, physical activity, behavioural counselling, and, in select cases, medication—is essential.”

Weight-loss drugs, he emphasised, can be valuable for patients who do not respond to lifestyle interventions. “But they must be prescribed with care, and always alongside medical supervision and structured behavioural support. These are not standalone solutions.”