UPSC Syllabus Topic: GS Paper 2 –Issues relating to development and management of Social Sector/Services relating to Health. And GS paper 3– Indian economy. Drug Regulation in India.
Introduction
India’s pharmaceutical industry, celebrated during the pandemic for exporting drugs, medical equipment, and vaccines, now faces a credibility test. Often called the “pharmacy of the world,” it confronts a growing crisis driven by counterfeit and substandard medicines. A recent tragedy—the deaths of over twenty children in Madhya Pradesh and Rajasthan after consuming a toxic cough syrup—has intensified scrutiny. Since 2022, similar contamination incidents involving Indian syrups in The Gambia, Uzbekistan, and Cameroon have aggravated concerns. Together, these episodes raise urgent questions about drug regulation in India, especially the adequacy of national safety oversight, quality standards, and enforcement.
About the drug regulatory system in India
Drug regulation in India involves multiple government bodies and laws, both for domestic and exported drugs. Here are some key points:
- Drug regulation of Domestic Drugs:
- Central Drugs Standard Control Organization (CDSCO):The CDSCO is the primary regulatory body in India that regulates the manufacture, sale, and distribution of drugs in the country. It also conducts periodic inspections of drug manufacturing facilities to ensure compliance with Good Manufacturing Practices (GMP) and other regulations.
- Drug Controller General of India (DCGI): The DCGI is responsible for approving new drugs for marketing in India, and for monitoring their safety and efficacy.
- Drug Price Control Order (DPCO): The DPCO regulates the prices of certain essential drugs in India to ensure they remain affordable to the general public.
- State-level drug regulatory bodies: At the state level, there exist State Drug Regulatory Authorities (SDRAs), which are statutory bodies created under the Drugs and Cosmetics Act, 1940. They fall under the ambit of the respective Health Departments of each state.
- Drugs and Cosmetics Act, 1940 and its associated rules:Domestic drugs are regulated under this act.
- Drug regulation of Exported Drugs:
- CDSCO: It is responsible for regulating the export of drugs from India. It issues certificates of pharmaceutical products (CPP) to ensure that drugs exported from India meet the quality, safety, and efficacy standards of the importing country. The CDSCO also regulates the labelling, packaging, and transportation of drugs exported from India.
- The Directorate General of Foreign Trade (DGFT): The Directorate General of Foreign Trade (DGFT) organisation is an attached office of the Ministry of Commerce and Industry and is headed by the Director General of Foreign Trade. The DGFT issues guidelines for the export of drugs, including the requirement of obtaining necessary licenses, permits, and certificates. Exporters must obtain an Import-Export Code (IEC) from the DGFT to export drugs.
- Export Inspection Council (EIC): The role of the EIC is to ensure that products notified under the Export (Quality Control and Inspection) Act 1963 are meeting the requirements of the importing countries in respect of their quality and safety.
- Drugs and Cosmetics Act, 1940 and the Foreign Trade (Development and Regulation) Act, 1992: Exported drugs are regulated under the provisions of these two acts.
- The World Health Organization (WHO): It pre-qualifies certain drugs manufactured in India for use in its global health programs.
- The United States Food and Drug Administration (US FDA) and the European Medicines Agency (EMA) also regulate drugs manufactured in India for export to their respective countries.
Concerns related to drug regulation in India
- Low convictions: The conviction rate is about 5.9%, and after procedural adjustments it rarely crosses 3%, which shows weak investigations and poor case preparation.
- Outdated legal tool: The Drugs and Cosmetics Act, 1940 was designed for a different era and does not address today’s transnational, organised counterfeiting networks.
- Police exclusion: Following the Ashok Kumar (2020) ruling, only drug control officers can register offences under the D&C Act, which has created an enforcement gap that criminals exploit.
- Narrow investigations: Most cases stop at seizing spurious stock and do not trace the wider network, its finances, or the facilitators behind it.
- Weak intelligence and forensics: Agencies seldom use data analytics, forensic mapping, packaging and ink analysis, digital trails, or CDR analysis, so evidentiary chains remain fragile.
- Fragmented agencies: Drug Control, police, the Enforcement Directorate, Income Tax, and GST authorities often work in silos, which limits coordinated action.
- Evidence gaps: Scientific validation is inconsistent, reducing the admissibility and persuasive strength of evidence in court.
- Poor pharmacovigilance: Pharmacovigilance is the process of monitoring the safety of medicines once they are on the market. In India, the pharmacovigilance system is still developing, and there is a lack of awareness among healthcare professionals and patients about reporting adverse drug reactions (ADRs). For example, there have been reports of adverse reactions to the COVID-19 vaccine in India, but these have not been adequately investigated.
Way forward
- Joint jurisdiction: Parliament should amend the D&C Act to allow both police and Drug Control Officers to register cases and conduct investigations together.
- Dual-track cases: Investigators should add BNS charges—such as Section 318 for cheating and Sections 336–338 for forgery—alongside D&C Act offences, and use Section 111 to designate organised criminal enterprises when warranted.
- Constitute SITs: Governments should form national and state-level Special Investigation Teams that include police, Drug Control, ED, and forensic specialists for end-to-end probes.
- Forensic mandate: Amend the D&C Rules and agency Standard Operating Procedures (SOPs) to require comprehensive forensic protocols in all major counterfeit-drug investigations. These must include chemical and toxicological testing, packaging and ink examination, digital-footprint analysis, and Call Detail Record (CDR) mapping. Forensic Science Laboratories (FSLs) and the National Forensic Sciences University (NFSU) should standardise methods, issue certified reports within defined timelines, and provide expert testimony in court.
- Follow the money: The ED should invoke PMLA to trace and freeze illicit assets, while Income Tax and GST departments should dismantle shell entities and fake billing structures.
- Capacity building: Agencies should receive regular joint training on investigation techniques, evidence handling, and real-time intelligence sharing.
- Data-driven enforcement: A shared analytics platform should map supply chains and cross-border links, enabling targeted raids and faster prosecution.
- Collaboration with International Bodies: India should collaborate with international bodies like the World Health Organization (WHO) to adopt best practices in drug regulation. This will help ensure that Indian pharmaceutical companies are following global safety and quality standards. The authorities should also work closely with international bodies to monitor the safety of drugs that are exported from India to other countries.
Conclusion
India’s counterfeit drug problem is both an enforcement failure and a legislative gap. India must integrate regulatory specialisation with criminal investigation. A coordinated, forensic-by-default, multi-agency model—anchored in legislative reform, clear roles, and seamless intelligence sharing—can move enforcement from seizures to network dismantling. With science guiding probes and law ensuring accountability, India can protect patients and rebuild trust in its pharmaceutical ecosystem.
Question for practice :
Examine how integrating regulatory specialisation with criminal investigation can strengthen India’s fight against counterfeit drugs.
Source: Indian Express
