India's drug regulator won't release GLP-1 trial data. A fitness CEO is taking them to court.
Jitendra Chouksey, the founder of fitness platform FITTR, has been asking one question since 2025: did the companies selling generic GLP-1 drugs in India actually run proper clinical trials before getting approval?
His team reviewed publicly available documents for several Indian pharma companies that launched generic semaglutide. Two companies had no Clinical Trial Registration on record. One had started trials only in China, not in India. A fourth company completed trials but never published results.
The RTI rejection
Chouksey's team filed an RTI request with CDSCO, India's drug regulator, asking for the clinical trial data these companies submitted to win approval. CDSCO turned them down, citing Section 8(1)(d) (confidentiality) and Section 8(1)(e) (competitive position of the companies).
Chouksey's argument is straightforward: clinical trial data affects public health. It shouldn't be hidden behind commercial confidentiality. Trial data isn't a trade secret. It's evidence that a drug is safe.
From RTI to the courtroom
In 2025, Chouksey filed a Public Interest Litigation in the Delhi High Court challenging the approval process for GLP-1 drugs used off-label for weight loss. The court directed CDSCO to review the matter within three months.
When CDSCO didn't comply, a contempt of court petition was filed in March 2026. The Delhi High Court issued notice and directed the DCGI and Union of India to respond.
Why this matters for patients
Injectable GLP-1 agonist sales in India jumped 177% between February 2025 and February 2026, from Rs 571 crore to Rs 1,446 crore. Over 40 generic manufacturers entered the market when semaglutide's patent expired. The question Chouksey keeps raising is whether patients can trust what's inside those pens when the trial data behind the approvals isn't public.
CDSCO did issue an advisory in March 2026 warning manufacturers against promotional activities for GLP-1 drugs. Chouksey's take: the advisory came 10 months after his first complaint, and only after a contempt petition forced their hand. He's said he plans to take the case to the Supreme Court.
Sources: Bar and Bench · YourStory · Business Standard · Medical Dialogues