Protecting patients from fake medicines

A public interest litigation filed before the Supreme Court seeking directions to the central and state governments to ensure time-bound investigation and trial in cases involving adulterated and spurious medicines, injections, and vaccines has placed this important public health issue under judicial scrutiny, as persistent administrative gaps in quality control have allowed illegal circulation of such medicines. The recent busting of a fake cancer and other critical medicines and injection supply racket in Karnataka, where initial investigation findings revealed that a licensed pharmacist supplied counterfeit medicines and critical-care injections to over 90 hospitals in the state, is merely the beginning of a larger issue of counterfeit medicines and critical-care injections supplied by licensed pharmacists to more than 90 hospitals in the state. This situation is only the beginning of a much larger problem. The recovery of expired and spurious medicines worth Rs 5 crore during the crackdown, along with links to other states, highlights the significant gap in inspection and enforcement. The sale of spurious and adulterated medicines poses serious health hazards, and deterrent actions are needed to prevent recurrence and protect patients from dangerous exposure to unsafe pharmaceutical products. Official data indicating that over 3,000 drug samples were declared “not of standard quality” and 283 samples were classified as “spurious/adulterated” across various states in 2025-26 highlights the ongoing issue of spurious and adulterated medicines in circulation. The central government has been reiterating on the floor of parliament that manufacture/sales/distribution of spurious/adulterated/not of standard quality drugs, etc., is a punishable offence under the Drugs & Cosmetics Act, 1940, and the Drugs Rules, 1945, and concerned licensing authorities are empowered to take action in such cases. Section 17 B of the Act states that a drug is considered spurious if it is manufactured under the name of another drug, is an imitation intended to deceive, bears a false manufacturer’s name, claims to be produced by a non-existent manufacturer, or has been wholly or partly substituted with another substance. According to provisions of the Act, if the spurious drug causes death or grievous hurt, the offender may face imprisonment of not less than 10 years, which may extend to life imprisonment, along with a fine of at least Rs. 10 lakh or three times the value of the drugs confiscated. In other cases, the punishment includes imprisonment of not less than 7 years, which may extend to life imprisonment, along with a minimum fine of Rs. 3 lakh or three times the value of the drugs. Poor conviction rates have failed to create a deterrent impact, despite the provisions for stringent punishments. The Parliamentary Standing Committee on Health and Family Welfare sounded the caution that regulatory approval alone is insufficient to guarantee drug quality unless it is matched by robust oversight of the distribution chain through which medicines reach patients. The Committee’s report reveals that gaps in traceability create vulnerabilities for the entry of substandard or spurious drugs into the supply chain, highlighting persistent systemic issues in quality control. Its recommendation for enforcing end-to-end traceability of pharmaceutical products and mandating strict compliance with Good Distribution Practices across manufacturers, distributors, and retailers is pragmatic guidance to curb spurious/adulterated medicines. The central government acting on the Committee’s recommendations for the creation of a unified Digital Drug Regulatory System that seamlessly connects central and state drug regulators on a common technology platform, with an inbuilt Risk Management System to enable real-time monitoring, early identification of quality risks, and coordinated enforcement action, is an urgent necessity. An Open House Discussion on “Measures to Curb Spurious Medicines in India” organised by the National Human Rights Commission (NHRC) in February this year highlighted how circulation of spurious, substandard and falsified medicines also needs to be considered a serious issue of human rights violation. NHRC member Justice (Dr) Bidyut Ranjan Sarangi, who chaired the discussion, insisted that the growing threat posed by spurious, substandard and falsified medicines and its direct implications on the right to life and health demand coordinated, multi-sectoral action to address this grave issue of human rights violation. Some of the key suggestions which were made in the discussion, according to an official release, included the establishment of a comprehensive, centralised databank on spurious and sub-standard medicines, integrating inputs from enforcement agencies, regulators and states; technological interventions to facilitate predictive analytics, pattern recognition, supply-chain mapping and early risk detection; institutionalising capacity-building of drug inspectors through structured and periodic training programmes; preventive surveillance, market sampling and coordinated inspections should be strengthened, with emphasis on identifying repeat offenders and vulnerable supply-chain nodes; and taking appropriate steps to ensure that pending cases currently before judicial magistrates First-class courts or other subordinate courts are transferred to the competent Sessions Courts in light of the Supreme Court’s judgement that offences under the Drugs and Cosmetics Act are triable exclusively by Sessions Courts. Medicine quality must be guaranteed through rigorous laboratory testing and full compliance with regulatory standards throughout the supply chain, thereby assuring patients that the medicines they purchase are safe and unadulterated.