The National Human Rights Commission (NHRC) has underlined the urgent need for coordinated institutional action, stronger regulatory oversight, and a centralized databank to curb the menace of spurious and substandard medicines in the country, warning that lapses in drug regulation can directly threaten the right to life and health.
In a country as vast and diverse as India, even isolated regulatory failures can escalate into large-scale human distress if not addressed decisively and systematically, warned NHRC Member Justice (Dr.) Bidyut Ranjan Sarangi. He was speaking at a meeting themed “Measures to Curb Spurious Medicines in India,” held in hybrid mode recently.
The deliberation brought together senior government officials from the Centre and states, drug regulators, law enforcement authorities, medical experts, and representatives of the pharmaceutical industry to deliberate on legal, regulatory, and technological solutions to the problem.
Justice Sarangi observed that the increasing circulation of spurious, substandard, and falsified medicines has serious human rights implications. “The right to life and health is directly impacted when citizens unknowingly consume unsafe medicines,” he said, calling for a coordinated, multi-sectoral approach to tackle what he described as a grave rights violation.
NHRC Member Vijaya Bharathi Sayani emphasized the human cost of regulatory lapses, recounting how a member of her own family suffered permanent vision loss due to improper treatment and poor-quality medicines. She stressed the need for strengthened oversight and accountability mechanisms across the pharmaceutical ecosystem to prevent similar tragedies.
Setting the context, NHRC Secretary General Bharat Lal drew a clear distinction between “spurious drugs,” as defined under Section 17-B of the Drugs and Cosmetics Act, 1940, and “substandard drugs,” which are authorized products that fail to meet prescribed quality standards. While spurious drugs are often manufactured and distributed as part of organized criminal activity and lack traceable origins, substandard drugs can be linked to identifiable manufacturers.
Citing findings from the National Survey on Drugs, Lal noted that nearly 10% of government drug samples tested were found to be substandard. He warned that citizens consume medicines in good faith, trusting the state’s obligation to safeguard their health, and any breach of that trust amounts to a violation of human rights. He reiterated that “medicines must heal, not harm.”
He also referred to recent suo motu cognizance taken by the Commission in cases involving alleged deaths of children following consumption of contaminated cough syrups. In October 2025, the NHRC issued notices to the governments of Madhya Pradesh, Rajasthan, and Uttar Pradesh, as well as Union health authorities, directing comprehensive supply-chain investigations and submission of laboratory test reports.
Former NHRC Member Rajiv Jain proposed the establishment of special drug courts for expeditious trials, real-time drug testing mechanisms, and mandatory QR codes with track-and-trace systems, including blockchain-based authentication. He also suggested compulsory testing through NABL-accredited laboratories, AI-based anomaly detection in distribution networks, strengthened whistleblower protection, digital case tracking, and the creation of a centralized national database of spurious drug cases.
Dr. Keshav Kumar, Special Rapporteur, NHRC, highlighted low conviction rates, delays in investigation and adjudication, and higher prevalence of substandard samples in certain procurement channels. He called for central and state-level task forces, better inter-agency coordination, structured training for law enforcement and judicial officers, and victim compensation mechanisms.
Nishtha Tiwari, Joint Secretary, MHA, highlighted key interventions by the Ministry to combat the scourge of spurious drugs, while Chandrashekhar Ranga, Joint Drugs Controller (DCGI), highlighted measures including coordinated inspections, strengthening of surveillance systems, and enhanced training of drug inspectors.
Experts also flagged regulatory and bioequivalence concerns in generic medicines, emphasizing transparency and rigorous quality assurance.
Among key recommendations emerging from the deliberations was the creation of a comprehensive, centralized databank integrating inputs from enforcement agencies, regulators, and states. Participants also called for predictive analytics, supply-chain mapping, intelligence-driven vigilance, inter-state coordination, and transfer of pending cases to Sessions Courts from Judicial Magistrate First Class (JMFC) courts or other subordinate courts in line with Supreme Court rulings.
Before finalizing the recommendations, the NHRC has sought views from stakeholders, particularly citizens, to ensure the strengthening of India’s drug regulatory framework and the safeguarding of citizens’ right to safe medicines.
