Context:

• India, known as the “pharmacy of the world,” faces a grave crisis from the proliferation of counterfeit and substandard medicines, threatening both public health and national credibility.
• Recent deaths caused by adulterated cough syrups expose deep systemic failures in India’s drug regulation and law enforcement systems. 

The Counterfeit Drug Crisis in India:

• The counterfeit medicines or fake drugs are increasingly infiltrating the pharmaceutical supply chain.
• The conviction rate for counterfeit drug cases in India is a mere 5.9%, and after procedural adjustments, the effective conviction rate rarely exceeds 3%.
• Weak enforcement under the Drugs and Cosmetics Act (D&C Act), 1940, which lacks provisions suited to handle modern transnational pharmaceutical crimes.
• Absence of data analytics, forensic mapping, and inter-agency coordination enables counterfeiters to operate with impunity.

Legal and Procedural Challenges:

• Impact of Supreme Court’s Ashok Kumar (2020) verdict:
  • It limited the registration of offences under the D&C Act exclusively to Drug Control Officers.
  • While this decision aimed to prevent misuse of police powers, it inadvertently paralysed law-enforcement capability.
  • Excluding the police from directly registering cases under the Act created an enforcement vacuum that is exploited by counterfeiters.
• Indian Pharmaceutical Alliance (IPA) PIL:
  • IPA has filed a Public Interest Litigation (PIL) in the SC challenging this restriction.
  • It argues for allowing police participation in investigations to ensure operational effectiveness.

Leveraging the Bharatiya Nyaya Sanhita (BNS), 2023:

• The BNS provides avenues for police investigation under general criminal laws -
  • Section 318 – Cheating
  • Sections 336–338 – Forgery and falsification of records
• These can be invoked in counterfeit drug cases involving consumer deception and fake documentation.
• Successful examples include Meerut, Agra, Delhi, and Dehradun, where police-IPA collaboration led to dual investigations.
• The Delhi High Court upheld this dual approach, recognising concurrent application of regulatory and criminal laws.

Integrating Regulatory and Criminal Enforcement:

• The “Best of Both Worlds” model: It combines the Drug Control Department’s scientific expertise with the police’s investigative and prosecutorial powers.
• Enables simultaneous enforcement of:
  • D&C Act (1940) – Regulatory compliance
  • BNS (2023) and Prevention of Money Laundering Act (PMLA 2002) – Criminal and financial investigation
• Enhances: Evidence credibility and court admissibility through multi-agency validation.

Expanding the Enforcement Framework:

• Economic and organised crime dimensions: Counterfeit medicine rackets involve money laundering, tax evasion, and organised syndicates.
• Enforcement framework:
  • Agencies like the Enforcement Directorate (ED), Income Tax Department, and GST authorities must target the financial networks sustaining counterfeit operations.
  • The PMLA can be invoked to track and freeze assets derived from counterfeit drug trade.

Forensic Science as a Pillar of Prosecution:

• Transition from mere seizures to scientific evidence collection is essential.
• Use of chemical analysis, toxicology, packaging forensics, ink and digital footprint analysis, and Call Detail Records (CDR) enhances the evidence chain.
• Strengthening Forensic Science Laboratories (FSLs) and the National Forensic Sciences University (NFSU) will boost capacity, certification, and expert testimony.

Institutional Mechanisms and Legal Provisions:

• Section 111 of BNS: It allows declaring large-scale counterfeit drug operations as organised criminal enterprises.
• Formation of Special Investigation Teams (SITs): It involves police, Drug Control Department, ED, and forensic experts who can ensure a coordinated response.

Way Forward:

• Amend the D&C Act (1940): To allow joint jurisdiction of Drug Control Officers and police.
• Establish national and state-level SITs: For counterfeit drug investigations.
• Mandate forensic analysis: In all major counterfeit drug cases.
• Empower financial probes: Through ED, Income Tax, and GST departments.
• Institutionalise inter-agency training: And build forensic awareness among investigators.

Conclusion:

• India’s counterfeit drug problem is both a law enforcement challenge and a legislative gap.
• The way forward lies in integrating regulatory precision with criminal investigative strength.
• A multi-agency, forensic-led, and financially integrated framework will convert reactive raids into proactive public health protection.
• When science meets justice and data meets deterrence, India can restore its global reputation as a trusted “pharmacy of the world” and ensure the safety of its citizens.