NHRC Issues Strong Warning: 10% Drug Samples Found Substandard, Urgent Crackdown on Fake Medicines

New Delhi: The National Human Rights Commission (NHRC), India, has underscored the urgent need for coordinated, multi-sectoral action to tackle the growing menace of spurious and substandard medicines, terming it a serious threat to the right to life and health. At an Open House Discussion held in hybrid mode at its New Delhi premises, senior officials, regulators, law enforcement agencies and pharmaceutical stakeholders deliberated on regulatory gaps, enforcement challenges and systemic reforms required to curb the proliferation of fake and poor-quality drugs.

‘Regulatory gaps can cause large-scale human distress’NHRC

Chairing the discussion, NHRC Member Justice (Dr.) Bidyut Ranjan Sarangi cautioned that in a country as vast and diverse as India, even isolated regulatory failures can translate into widespread human suffering if not addressed decisively. He observed that the rising threat posed by spurious, substandard and falsified medicines directly impacts the constitutional right to life and health and requires coordinated institutional intervention.

NHRC Member Vijaya Bharathi Sayani reflected on the human cost of regulatory lapses, recounting a personal family tragedy involving permanent loss of eyesight due to improper treatment and poor-quality medicines. She stressed the need for strengthened oversight and accountability across the pharmaceutical ecosystem.

Clear distinction between ‘spurious’ and ‘substandard’ drugs

Setting the tone for deliberations, NHRC Secretary General Bharat Lal emphasised that while the discussion focused on spurious drugs, both spurious and substandard medicines undermine human rights.

He clarified that under Section 17-B of the Drugs and Cosmetics Act, 1940, spurious drugs refer to counterfeit or falsely labelled products often linked to criminal activity, whereas substandard drugs are authorised products that fail to meet prescribed quality standards.

Citing the National Survey on Drugs, he noted that nearly 10% of government samples were found to be substandard. He further highlighted that spurious drugs often lack identifiable manufacturers and require criminal investigation, while substandard drug manufacturers can be traced and held accountable.

Reference to recent NHRC intervention

Bharat Lal also referred to a recent notice issued by the NHRC 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 Commission directed a comprehensive supply-chain probe and mandated laboratory reports, reinforcing the urgency of coordinated regulatory action.

Proposal for special drug courts, real-time testing

Former NHRC Member Rajiv Jain proposed a series of structural reforms to strengthen enforcement and deterrence, including:

Establishment of special drug courts for speedy trials
Real-time drug testing mechanisms
Mandatory QR codes and track-and-trace systems, including blockchain-based authentication
Compulsory use of NABL-accredited laboratories
AI-based anomaly detection in distribution patterns
Surprise inspections and digital case tracking
Creation of a centralised national database on spurious drug cases
Strengthened whistle-blower protection
Examination of safeguards relating to e-prescriptions

Strengthening investigation, training and coordination

Dr. Keshav Kumar, Special Rapporteur, NHRC, who has conducted extensive research on the subject, highlighted systemic concerns such as low conviction rates, delays in investigation and adjudication, and higher prevalence of substandard samples in certain procurement channels.

He recommended enhanced monitoring, formation of central and state-level task forces, structured training for law enforcement and judicial officers, improved regulatory compliance, victim compensation mechanisms and collaboration with international bodies.

Officials from the Ministry of Home Affairs and drug regulatory authorities detailed steps already taken, including coordinated inspections, strengthened surveillance systems and enhanced training of drug inspectors. Continued capacity building was emphasised to address emerging challenges.

Enforcement trends and judicial developments

The discussion also examined recent enforcement trends, including coordinated inter-state investigations, invocation of organised crime provisions in counterfeit drug cases, and evolving jurisprudence of the Supreme Court and High Courts relating to prosecution, police jurisdiction and victim rights.

Participants suggested that pending cases before Judicial Magistrate First Class (JMFC) courts be transferred to competent Sessions Courts in light of the Supreme Court’s ruling that offences under the Drugs and Cosmetics Act are triable exclusively by Sessions Courts.

Key recommendations from the discussion

Among the major suggestions that emerged were:

Creation of a comprehensive, centralised databank integrating inputs from regulators, enforcement agencies and states

Use of predictive analytics, pattern recognition and supply-chain mapping for early risk detection

Institutionalised and periodic training programmes for Drug Inspectors

Documentation of best practices across states for nationwide replication

Establishment of a coordinated Centre–State joint enforcement mechanism

Strengthening preventive surveillance, market sampling and intelligence-driven vigilance frameworks

‘Medicines must heal, not harm’

Emphasising that citizens consume medicines in good faith, trusting the State’s obligation to safeguard life and dignity, the NHRC reiterated that any regulatory failure resulting in harm amounts to a violation of human rights.

The Commission has invited stakeholders to submit detailed written suggestions to enable it to finalise comprehensive recommendations aimed at ensuring that medicines in India truly heal and do not harm.