India to Require Warning Display on High Risk Drugs

Beginning November 1, 2018, high-risk medicines sold in India will be required to carry warnings on the packaging, part of a series of moves by the country’s Ministry of Health and Family Welfare to toughen labeling norms on pharmaceuticals.

Under the new rules, the warnings must be printed in black ink within a red, rectangular box on the innermost container of high-risk or sensitive drugs.

The new restrictions are aimed at boosting consumer awareness, preventing the sale of prescription drugs over the counter, and ramping up pharmaceutical company accountability in a vast drug market that has been notoriously underregulated in the past.

The labelling rules apply to a broad array of drugs designed to be used under medical supervision or that have a high risk of side effects. They include some cancer drugs, analgesics, sedatives, narcotics, tranquilizers, antidepressants, and steroids. Warnings will also be required on some antimicrobials and anticoagulants.

India’s domestic pharmaceuticals market, already one of the largest in the world, is projected to exceed $100 billion by 2025.