Schedule M likely to be revised to bring it closer to WHO standards

The draft rules, still under consideration, include provisions to strengthen quality control and the safety of drugs manufactured in India

A notification for revising Schedule M (of the Drugs and Cosmetics Rules, 1945) may be released soon to help Indian pharma companies adopt good manufacturing practices (GMP) as prescribed by the World Health Organization (WHO), a senior government official said.

The Drugs Controller General of India (DCGI), Rajiv Singh Raghuvanshi, said at a conference revised Schedule M would bring the industry on a par with global standards.

The move has come after the WHO raised concern when cough syrups exported by some Indian companies were allegedly responsible for the deaths of children abroad.

Adopting GMP in accordance with revised Schedule