India issues urgent public health notice for all GLP-1 drugs including semaglutide

The Indian Pharmacopoeia Commission (IPC), the health and family welfare ministry’s apex body responsible for setting drug standards, issued a public notice on 14 May calling for monitoring the safety of glucagon-like peptide-1 (GLP-1) drugs including the blockbuster semaglutide and dulaglutide, liraglutide and tirzepatide.

Given their rapid clinical adoption, regulatory authorities including IPC, the Central Drugs Standard Control Organisation (CDSCO) and the health ministry are emphasizing the critical importance of post-marketing surveillance to ensure patient safety and identify any previously undocumented side-effects. Recognizing that risks may extend across this entire class of medications, the IPC has expanded its safety net.

“Apart from semaglutide, any adverse event caused by other GLP-1 receptor agonists (such as dulaglutide, liraglutide, tirzepatide) should also be reported to the PvPI – Pharmacovigilance Programme of India,” the IPC said in the document.

Adverse events (AE) and adverse drug reactions (ADRs) can be reported to ARD monitoring centres, ADR forms on the IPC website, tollfree number 1800-180-3024, mobile app ADR PvPI 2.0 available on the Google Play Store and ADRMS software.

The document noted that the drug is approved in India for three primary therapeutic indications—type 2 diabetes mellitus, chronic weight management and cardiovascular risk reduction.

“This comprehensive approach ensures that all major modern metabolic and weight-management therapies undergo the same rigorous safety scrutiny,” one of the officials said.

Mint reported earlier about semaglutide being placed under the scanner over suspected complications. The IPC is evaluating reported side-effects including gastrointestinal distress—severe nausea and persistent vomiting—and major dermatological issues. The review could lead to tighter norms, label changes, safety warnings and stricter prescription rules.

Experts said irrational usage of these drugs has led to increasing self-medication, without proper medical consultation, often considering them a shortcut for rapid weight loss.

“The government move is a progressive and much-needed public safety step,” said Dr. Aashish Chaudhry, managing director of Aakash Healthcare, a super speciality hospital in Delhi. “GLP-1 drugs undoubtedly hold immense promise, especially for patients struggling with obesity linked to diabetes and metabolic disorders, but every powerful therapy must also be backed by responsible usage and scientific monitoring.”

Dr. Chaudhry said even minor symptoms or trivial reactions should be reported because these reports collectively help create a robust pharmacovigilance database that can identify patterns, rare complications, and overall safety outcomes associated with the drug.

According to Dr Soumya Swaminathan, former chief scientist of the World Health Organization, these drugs reduce cravings and appetite and may help with other addictions. However, an extreme side-effect is that it can significantly reduce desire, potentially causing depression and a loss of interest in life.

Mankind Pharma Ltd, one of the generic manufacturers of semaglutide in India, said the drug is a prescription-only therapy and acknowledged that safety, oversight and responsible use remain central to how it is introduced and adopted.

“Our pharmacovigilance framework includes post-marketing surveillance, continuous safety monitoring and close alignment with national regulatory requirements. We work closely with the medical community to support early identification and effective management of any adverse events,” said Sheetal Arora, promoter and chief executive officer of Mankind Pharma.

Novo Nordisk and Cipla, which sell the drug in India, declined to comment. Queries emailed to the spokespersons of the health and family welfare ministry, the Drugs Controller General of India, Sun Pharmaceutical Industries, Zydus Lifesciences and Dr Reddy’s Laboratories on 23 May remained unanswered.