Editorial 1: Need More Than the Regulator
Context:
India, often hailed as the “pharmacy of the world,” faces a deepening crisis of counterfeit and substandard drugs that threatens both public health and the nation’s credibility. The repeated incidents of deaths caused by adulterated cough syrups across different states are not isolated accidents, but signs of a systemic failure in regulation, investigation, and prosecution.
Outdated Legal Framework and Enforcement Gaps:
- India’s current regulatory and law enforcement framework—particularly under the Drugs and Cosmetics Act (D&C Act) of 1940—is outdated and inadequate to address modern, transnational counterfeit drug crimes.
- The Drugs and Cosmetics Act, enacted in 1940, was designed for a very different pharmaceutical landscape.
- Today’s counterfeit drug operations are complex, organized, and often transnational in nature, but the D&C Act lacks the mechanisms to address such sophistication.
- The Act’s enforcement relies heavily on Drug Control Officers, who are experts in regulatory compliance but not equipped for criminal investigation.
- Compounding this weakness, the law excludes the police from directly registering cases under the Act, creating an enforcement vacuum exploited by counterfeiters.
- The Indian Pharmaceutical Alliance (IPA) has challenged this exclusion through a Public Interest Litigation (PIL) in the Supreme Court, arguing that restricting the police from initiating cases under the D&C Act weakens enforcement.
- As a result, counterfeit medicine crimes often remain uninvestigated or end with mere seizures rather than full criminal prosecutions.
Bharatiya Nyaya Sanhita (BNS):
- While the D&C Act restricts police jurisdiction, the Bharatiya Nyaya Sanhita (BNS)—India’s new criminal code—offers scope for police intervention under provisions relating to cheating, forgery, and fabrication of spurious medicines.
- Police forces in Meerut, Agra, Delhi, and Dehradun have successfully used these provisions alongside the D&C Act to prosecute counterfeiters.
- These dual investigations, combining regulatory and criminal laws, have proven effective because they merge field intelligence with legal expertise.
- There should be joint investigations by the Drug Control Department and police, enabling simultaneous enforcement of both the D&C Act and general criminal laws like the BNS, Prevention of Corruption Act, and the Indian Penal Code (now BNS equivalent).
- Such collaboration not only widens investigative scope but also improves the admissibility and credibility of evidence in court, as it is corroborated across agencies.
Fight to Financial and Organized Crimes:
- Counterfeit drug rackets are deeply intertwined with money laundering, tax evasion, and organized criminal networks.
- Thus, enforcement cannot be limited to drug inspectors alone. There is involvement of financial and investigative bodies like the Enforcement Directorate (ED), Income Tax Department, and GST authorities.
- Under the Prevention of Money Laundering Act (PMLA), the ED can trace and freeze assets derived from counterfeit drug operations, dismantling the financial backbone of these syndicates.
- Similarly, the tax and GST departments can track shell companies and fake billing structures used to legitimize illegal profits.
- Targeting the financial infrastructure ensures that counterfeiters are permanently neutralized rather than temporarily disrupted.
Lacunas in Forensic Science:
- A key weakness in India’s current approach is the lack of forensic rigor in counterfeit drug cases.
- Successful prosecution depends not only on seizing fake drugs but also on scientifically proving their illegitimacy through chemical, toxicological, and packaging analyses.
- Advanced forensic methods—such as digital footprint mapping, ink and packaging forensics, and Call Detail Record (CDR) analysis—can help trace entire supply chains and uncover international linkages.
- Institutions like Forensic Science Laboratories (FSLs) and the National Forensic Sciences University (NFSU) must play a central role in capacity building, laboratory certification, and expert witness support.
- Section 111 of the BNS provides a legal foundation for declaring large-scale counterfeit medicine operations as organized criminal enterprises, allowing for stronger penalties and the formation of Special Investigation Teams (SITs).
To achieve genuine synergy between the D&C Act, BNS, and PMLA, the authors propose a five-step reform framework:
- Amend the D&C Act to allow joint jurisdiction between Drug Control Officers and the police.
- Constitute national and state-level SITs comprising officers from the police, Drug Control Department, ED, and forensic experts to investigate counterfeit drug crimes.
- Mandate forensic analysis in every major counterfeit drug case to ensure scientific validation.
- Enable financial probes through collaboration with the Income Tax and GST departments to trace money trails.
- Institutionalize inter-agency training programs focused on forensic awareness and cooperative investigation.
Way Forward:
Combating counterfeit drugs requires “the precision of science and the power of law.” India’s current approach is too reactive; focusing on regulatory action after harm is done. A coordinated, forensic-led, multi-agency investigation model, anchored in legislative reform, can transform this reactive stance into a proactive shield for public health.