Revised Drugs, Medical Devices and Cosmetics Bill Faces Industry Opposition

The Union Government's ongoing initiative to overhaul India's decades-old drug regulation architecture encountered resistance as pharmaceutical and medical device sector representatives submitted critical feedback on the proposed Drugs, Medical Devices and Cosmetics Bill. Industry stakeholders argued that crucial recommendations had been overlooked, leaving core provisions similar to previously deferred drafts.

India's pharmaceutical regulatory framework currently relies on the historical Drugs and Cosmetics Act of 1940. Given the expansion of modern bio-pharmaceuticals, clinical trial frameworks, medical technology, and e-pharmacies, a comprehensive updating of legislation has been under drafting since 2022 to replace archaic regulatory clauses.

The proposed legislation seeks to create a dedicated Central Licensing and Surveying Authority, separate regulatory provisions for medical devices versus traditional pharmaceuticals, and strict criminal penalties for spurus or adulterated drugs.

This update touches upon Public Health, Intellectual Property Rights, and Regulatory Governance in GS Paper II and Paper III. Students should study the regulatory role of CDSCO, Central Drugs Standard Control Organization, and challenges in maintaining global quality compliance.