India to rewrite drug quality rules to match US, EU, Japan

India is setting up new standards for 123 drugs, updating them for another 200 medicines

- Priyanka Sharma

India’s $50-billion pharmaceutical industry is set for a quality overhaul, as the government is preparing to unveil new safety and quality standards to reinforce the country’s reputation as a global leader in drug manufacturing and bolster trust in medicines made by domestic companies.

India is setting up new standards for 123 drugs, and updating them for another 200 medicines, as it aims to align with the benchmarks in the US, Japan and the European Union (EU), according to three government officials familiar with the matter and documents reviewed by Mint.

To be released shortly, these legally enforceable standards, known as Indian Pharmacopoeia (IP) monographs, are detailed blueprints outlining a drug’s identity, purity and strength. They were last updated in 2022.