India’s 86-Year-Old Drug Law Is Finally Being Rewritten

Imagine buying a medicine for a child and assuming one thing: the system has already checked it. Recent cough-syrup tragedies showed why that assumption cannot always be taken for granted. India’s 1940 Drugs and Cosmetics Act is now 86 years old, while the pharmaceutical industry has become far more complex. The proposed Draft Drugs, Medical Devices & Cosmetics Bill, 2026 attempts to modernise this framework. The core problem is fragmented regulation. Drug approvals sit largely with the Centre, while manufacturing licences are handled by state regulators. This creates gaps in coordination and enforcement. India has already conducted hundreds of risk-based inspections, with regulatory action against a large number of high-risk facilities. The proposed framework could bring: • Greater centralisation of manufacturing licensing • Stronger quality-control mechanisms • Clearer rules for e-pharmacies • A modern framework for medical devices • More proportionate treatment of minor procedural violations But there is a catch. States are reluctant to surrender regulatory powers, while medical-device companies argue that devices require a separate regulatory framework because engineering products cannot simply be regulated like medicines. Stocks to watch If implementation improves quality standards and favours manufacturers with strong compliance infrastructure, established Nifty 500 healthcare names could potentially be better positioned. Sun Pharma $SUNPHARMA | Cipla | Dr. Reddy’s Laboratories | Lupin | Divi’s Laboratories | Torrent Pharma | Zydus Lifesciences | Aurobindo Pharma | Alkem Laboratories | Poly Medicure These are stocks to study, not buy recommendations. Nifty 500 includes major healthcare companies, while Poly Medicure provides exposure to the medical-device side of the story. Regulatory reform can reshape competitive advantages, but investors should evaluate compliance strength, valuations, earnings quality and execution before investing.