WHO audit, India hopes, will restore shine to its ‘pharmacy of the world’ image

Subscribe to enjoy similar stories. India plans to get its drug regulatory system audited and rated by the World Health Organization (WHO) to detect specific strengths and weaknesses that will help to make it fool proof, according to four officials and a document reviewed by Mint. The move comes after multiple instances of drug safety related incidents in the country as well as export markets raised serious questions on the quality of medicines made in India, often referred to as ‘pharmacy of the world’.

India faces multiple challenges in drug quality given the sheer scale of the industry, comprising thousands of manufacturers regulated by varying state-level standards. Under the proposed assessment, WHO will evaluate India’s regulatory system to assure the quality, safety, and efficacy of medicines and rate the overall ‘maturity’ of a regulatory system on a scale of 1 to 4. The assessment by WHO is treated worldwide as a gold standard for medicine quality and is often used in global tenders to purchase drugs.

“The WHO has been insisting on this quality control assessment for medicines for a very long time. While this benchmarking is conducted globally, in India, it is currently limited to vaccines," said one of the four officials, all of whom did not want to be identified in this story. “Under this framework, the WHO rigorously assesses core regulatory functions—such as inspections, approvals and enforcement actions—to rank the national system against standard parameters and suggest improvements.