India Proposes to Align GMP with WHO Standards, End License Renewals

India’s drug regulator is looking to align the country’s GMP requirements with WHO standards and eliminate the need for license renewals.

In a notice, the Central Drugs Standard Control Organization said its proposals are intended to improve drug quality and make it easier for industry to do business in the country. 

The agency’s proposal to harmonize its GMP standards with WHO guidelines would involve gap analysis, the Drugs Controller General of India G.N. Singh said, providing no other details on how the measure would be implemented. Gap analyses would help manufacturers determine what steps need to be taken to successfully meet WHO guidelines.