India's Drug Consultative Committee orders safety reviews of GLP-1 weight‑loss drugs
→State and UT drug controllers must enforce labelling, marketing and surveillance for GLP‑1 drugs
Change
India's Drug Consultative Committee tasked the Indian Pharmacopoeia Commission (IPC) to compile monthly or bi‑monthly adverse‑event reports on GLP‑1 weight‑loss drugs and directed state and union territory drug controllers to strengthen enforcement of marketing, labelling and risk‑management obligations.
Why it matters
Marketing authorisation holders for GLP‑1 and similar drugs are required to adhere to approved indications, labelling requirements, ethical marketing practices and applicable risk‑management plans. State and union territory drug controllers have been authorised to take enforcement action for significant violations and must intimate any such enforcement to the Central Drugs Standard Control Organisation (CDSCO).
Implications
- — Compliance teams at pharmaceutical marketing authorisation holders for GLP‑1 drugs must immediately update and certify product labelling, approved indications, promotional materials, and risk‑management plan filings — failure risks enforcement action and penalties under the Drugs and Cosmetics Act, 1940.
- — State and union territory drug controllers must immediately escalate surveillance, investigate suspected surrogate advertising or off‑label promotion, initiate enforcement where breaches are found, and notify the Central Drugs Standard Control Organisation (CDSCO) of any enforcement actions — failure to act or report contravenes the Drug Consultative Committee directive.
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Source
View on Economic Times