Is Drotin banned in India?

Drotin is drotaverine, an antispasmodic used for abdominal and menstrual cramps, and Drotin-M pairs it with the painkiller mefenamic acid. Neither is banned in India.

Drotaverine has never been named in a Section 26A notification. It is not in the CDSCO's list of banned single-ingredient drugs and does not appear in the FDC waves of 2016, 2018, 2023, 2024 or 2026. The two-drug drotaverine + mefenamic acid combination is likewise absent from those lists.

The action that started the question was the CDSCO's direction of 11 April 2025, in which it told state licensing authorities to halt 35 fixed-dose combinations that had been licensed at state level without the central approval required for new drugs. One of the 35 was drotaverine + mefenamic acid + paracetamol, a three-drug product sold by several small manufacturers. Coverage described it as a "drotaverine-mefenamic acid combination", and Drotin-M inherited the description. The plan we work from also flags the legal nature of that April 2025 action, a direction to licensing authorities rather than a Gazette ban, for verification.

For patients, the check is the ingredient list. Drotaverine alone is Drotin; drotaverine with mefenamic acid is Drotin-M; both are fine. Drotaverine with mefenamic acid and paracetamol is the halted product, and a pharmacist can supply the two-drug version and, if needed, paracetamol separately.