Needs more than the regulator, Pg11.

Key Highlights:

• India's pharmaceutical industry is facing a crisis due to the increasing prevalence of counterfeit and substandard drugs, leading to public health risks.
• The conviction rate for counterfeit drug cases in India is critically low, at approximately 3%, highlighting the ineffectiveness of current investigative processes.
• A Supreme Court verdict, Ashok Kumar (2020), has inadvertently hindered law enforcement by restricting the registration of offenses under the Drugs and Cosmetics Act, 1940 (D&C Act), to drug control officers only.
• The Bharatiya Nyaya Sanhita (BNS) offers avenues for police investigations under sections addressing cheating, forgery, and falsification, providing an alternative legal pathway.
• A multi-agency approach involving the Enforcement Directorate (ED), Income Tax Department, and GST authorities is essential to target the financial networks supporting counterfeit drug operations.

Detailed Insights:

• The current investigative processes under the D&C Act are inadequate for tackling modern transnational crimes due to the absence of data analytics and inter-agency intelligence.
• Excluding the police from directly registering cases under the D&C Act has created an enforcement vacuum exploited by counterfeiters, necessitating a reevaluation of jurisdictional protocols.
• Joint investigations by the Drug Control Department and the police would enable simultaneous enforcement of the D&C Act and general criminal laws under the BNS, enhancing accountability.
• Utilizing forensic tools such as chemical analysis, digital footprint mapping, and Call Detail Record (CDR) analysis is crucial for building irrefutable evidence chains in court.
• Amending the D&C Act to permit joint jurisdiction, forming Special Investigation Teams (SITs), and mandating forensic analysis are key steps to combat counterfeit medicine crimes.
• Financial probes through the ED, Income Tax Department, and GST authorities can neutralize the operational capacity of counterfeiters by targeting their financial backbone.
• Declaring large-scale counterfeit medicine operations as organized criminal enterprises under Section 111 of the BNS allows for a more coordinated and comprehensive response.

Key Concepts Involved:

• Counterfeit Drugs: Medications produced and sold with the intent to deceive, misrepresenting their origin, authenticity, or effectiveness.
• Drugs and Cosmetics Act, 1940 (D&C Act): Indian legislation that regulates the import, manufacture, distribution, and sale of drugs and cosmetics.
• Bharatiya Nyaya Sanhita (BNS): The new Indian penal code, set to replace the Indian Penal Code (IPC), addressing criminal offenses.
• Prevention of Money Laundering Act (PMLA): Indian law enacted to combat money laundering and provide for the confiscation of property derived from illicit activities.