NHRC Calls for Joint Action to Curb Spurious Drugs

Justice Sarangi warned that in a country as vast and diverse as India, even isolated regulatory lapses can translate into large-scale human distress.

The National Human Rights Commission (NHRC), India, has called for coordinated, multi-sectoral action to combat the growing menace of spurious and substandard medicines, terming it a direct violation of the right to life and health.

At an Open House Discussion (OHD) held in hybrid mode in New Delhi on the theme “Measures to Curb Spurious Medicines in India,” senior regulators, law enforcement officials, pharmaceutical industry representatives, and public health experts deliberated on systemic reforms needed to address the issue.

The discussion was chaired by NHRC Member Justice (Dr.) Bidyut Ranjan Sarangi and attended by NHRC Member Smt. Vijaya Bharathi Sayani, Secretary General Shri Bharat Lal, Director General (Investigation) Smt. Anupama Nilekar Chandra, and several senior officials from central and state agencies.

Human Rights at the Core of Drug Safety

Justice Sarangi warned that in a country as vast and diverse as India, even isolated regulatory lapses can translate into large-scale human distress.

“The growing threat posed by spurious, substandard and falsified medicines, and its direct implications on the right to life and health, demands coordinated, multi-sectoral action,” he said.

Smt. Vijaya Bharathi Sayani highlighted the human cost of poor-quality medicines, sharing a personal account of permanent vision loss suffered by a family member due to improper treatment and inferior drugs. She stressed the need for stronger oversight and accountability within the pharmaceutical ecosystem.

Clear Distinction: Spurious vs Substandard Drugs

Setting the tone for deliberations, NHRC Secretary General Shri Bharat Lal drew attention to the legal distinction under the Drugs and Cosmetics Act, 1940:

• Spurious drugs: counterfeit, fake or deliberately mislabelled products, often linked to organised criminal activity with no identifiable manufacturer.

• Substandard drugs: authorised products that fail to meet prescribed quality standards or specifications.

Citing the National Survey on Drugs, he noted that nearly 10 percent of government samples were found substandard — a statistic that underscores the scale of the challenge.

He also referred to the Commission’s recent suo motu notice issued in October 2025 to the Governments of Madhya Pradesh, Rajasthan and Uttar Pradesh, along with Union health authorities, following media reports of children allegedly dying after consuming contaminated cough syrups. The NHRC had directed a comprehensive supply-chain probe and mandatory laboratory testing reports.

Stronger Enforcement and Technology Solutions

Former NHRC Member Shri Rajiv Jain proposed a series of enforcement and regulatory reforms, including:

• Establishment of special drug courts for expeditious trials

• Real-time drug testing mechanisms

• Mandatory QR codes and track-and-trace systems

• Blockchain-based supply chain authentication

• AI-based anomaly detection in distribution patterns

• Compulsory use of NABL-accredited laboratories

• Strengthened whistle-blower protection

• Digital case tracking and centralised national database on spurious drug cases

He also called for examination of regulatory safeguards concerning e-prescriptions and improved public helplines.

Low Conviction Rates and Delays a Concern

Dr. Keshav Kumar, NHRC Special Rapporteur, presented findings from his research highlighting low conviction rates in spurious drug cases, prolonged delays in investigation and adjudication, and higher prevalence of substandard samples in certain procurement channels.

He recommended:

• Creation of central and state-level task forces

• Enhanced regulatory compliance and inter-agency coordination

• Training of law enforcement and judicial officers

• Victim compensation mechanisms

• Collaboration with international bodies

Regulatory and Enforcement Perspectives

Officials from the Ministry of Home Affairs, Central Drugs Standard Control Organisation (CDSCO), National Pharmaceutical Pricing Authority (NPPA), National Investigation Agency (NIA), and state Food and Drug Administrations outlined ongoing efforts such as:

• Coordinated inspections and surveillance

• Inter-state investigations

• Invocation of organised crime provisions in counterfeit drug cases

• Capacity-building of drug inspectors

• Strengthening laboratory infrastructure

Joint Drugs Controller (DCGI) Shri Chandrashekhar Ranga stressed the need for sustained capacity building to address emerging challenges, while author Shri Prashant Reddy T. highlighted concerns around regulatory transparency and bioequivalence standards.

Comprehensive Reform Recommendations

Among the key suggestions emerging from the discussion were:

• Establishing a centralised databank integrating inputs from regulators, enforcement agencies and states

• Leveraging predictive analytics, supply-chain mapping and early risk detection

• Institutionalising structured training programmes for Drug Inspectors

• Creating a centre–state joint enforcement mechanism

• Documenting and replicating best practices from high-performing states

• Strengthening intelligence-driven vigilance frameworks

• Transferring pending cases to Sessions Courts in line with Supreme Court rulings

Medicines Must Heal, Not Harm

Participants reiterated that citizens consume medicines in good faith, trusting the state to safeguard their health and dignity. Any breach, they noted, amounts to a violation of fundamental human rights.

The NHRC invited stakeholders to submit written recommendations to assist in finalising its advisory framework.

The discussion concluded with a shared consensus: tackling spurious and substandard medicines requires not just regulatory vigilance but systemic reform, technological innovation and coordinated national action.