INDIA’S DRUG REGULATION NEEDS AN OVERHAUL

THE CONTEXT: The tragic deaths of five women in Ballari, Karnataka, between November 9 and December 5, 2024, have drawn national attention to the issue of substandard drugs in India. These women, who had undergone cesarean sections at the Ballari District Hospital, developed severe complications such as acute kidney injury and multi-organ dysfunction after being administered Ringer’s lactate solution. Investigations revealed bacterial and fungal contamination in the IV fluid supplied by Paschim Banga Pharmaceuticals through the Karnataka State Medical Supplies Corporation Limited (KSMSCL).

SERIES OF TRAGEDIES INVOLVING SUBSTANDARD DRUGS IN INDIA SINCE 2020

• • Jammu (2020): The deaths of 12 children were linked to cough syrup contaminated with diethylene glycol, a toxic substance.
  • Gambia (2022): The deaths of 70 children were attributed to Indian-manufactured cough syrups containing diethylene glycol and ethylene glycol. This incident led to international scrutiny of India’s pharmaceutical exports.
  • Uzbekistan (2022): Another 18 children died due to a similar contamination issue involving Indian-made syrups.
  • Cameroon (2023): Twelve children succumbed to substandard paracetamol syrup exported from India.
  • Delhi (2023): Three children died after being administered contaminated injections.
  • Chandigarh (2022): Five patients at PGIMER died due to bacterial endotoxins in an injection, despite state-level testing identifying contamination.
  • Colombia (2023): Four children died after consuming substandard drugs imported from India.

STATUTORY FRAMEWORK AND INSTITUTIONAL HIERARCHY:

CENTRAL LEVEL:

• • Drugs & Cosmetics Act 1940: The Drugs and Cosmetics Act of 1940 is the cornerstone legislation regulating the import, manufacture, distribution, and sale of drugs and cosmetics in India. Key features include:
    • Ensuring the safety, efficacy, and quality of drugs and cosmetics.
    • Regulating clinical trials and new drug approvals.
    • Establishing standards for drug manufacturing and testing.
    • Providing penalties for violations and adulteration.
    • The Act has undergone several amendments to keep pace with evolving pharmaceutical practices and public health needs. Recent updates have focused on strengthening regulations for clinical trials and addressing challenges in online drug sales.
  • Central Drugs Standard Control Organization (CDSCO): CDSCO is India’s national regulatory body for pharmaceuticals and medical devices, operating under the Ministry of Health and Family Welfare. Its primary responsibilities include:
    • Approval of new drugs and clinical trials.
    • Setting standards for drugs, cosmetics, and medical devices.
    • Regulating drug imports and exports.
    • Coordinating with state regulatory authorities.
  • Central Drugs Laboratory (CDL): The Central Drugs Laboratory in Kolkata is the national statutory laboratory for drug and cosmetic quality control. CDL’s role as an appellate authority is critical in resolving disputes between manufacturers and regulatory bodies. Its key functions include:
    • Acting as an appellate authority for drug quality disputes.
    • Conducting quality control tests on imported and domestically manufactured drugs.
    • Preparing and maintaining national reference standards.
    • Training drug analysts and WHO fellows.

STATE LEVEL:

• • State Drug Control Departments: They implement and enforce drug regulations within their respective states. Their duties include:
    • Licensing and inspecting drug manufacturing facilities.
    • Monitoring drug quality in the local market.
    • Investigating cases of drug adulteration and taking legal action.
    • These departments coordinate with CDSCO to ensure uniform implementation of drug laws nationwide.
  • State Drug Testing Laboratories: State Drug Testing Laboratories support the regulatory functions of State Drug Control Departments by:
    • Analyzing drug samples collected by drug inspectors.
    • Providing scientific evidence for regulatory actions.
    • Assisting in quality control of locally manufactured drugs.
    • The effectiveness of these laboratories varies across states, with some facing infrastructure and skilled personnel challenges.

OTHER RELEVANT BODIES:

• • Pharmacovigilance Programme of India (PvPI): PvPI, coordinated by the Indian Pharmacopoeia Commission, monitors and reports adverse drug reactions (ADRs) in India. Key aspects include:
    • Establishing ADR monitoring centers across the country.
    • Collecting and analyzing ADR reports.
    • Providing recommendations to CDSCO for regulatory actions.
  • National Pharmaceutical Pricing Authority (NPPA): While not directly involved in drug safety regulation, NPPA is crucial in ensuring drug affordability and accessibility. Its functions include:
    • Fixing and revising prices of controlled drugs.
    • Monitoring drug prices in the market.
    • Enforcing provisions of the Drugs (Prices Control) Order.

THE ISSUES:

• • Quality Control Failures: This incident reveals a concerning pattern of conflicting assessments between state and central laboratories. The Principal Secretary of Karnataka’s Health Department emphasized this issue in his letter to the Drugs Controller General of India (DCGI), requesting an investigation into CDL’s functioning.
  • Lack of Transparency in CDL Functioning: The CDL does not publicly make test reports, protocols, or personnel qualifications. This opacity hinders peer review and public trust in the drug regulatory system. The CDL’s resistance to Right to Information (RTI) requests further exacerbates the issue. As noted in a Central Information Commission case, the CDL has shown “complete negligence and laxity” in dealing with RTI applications, reflecting a disregard for transparency laws.
  • Outdated Sample Handling and Testing Processes: The system involves wax and brass seals, with final test reports communicated via postal mail. This approach creates vulnerabilities in the chain of custody and increases the risk of sample tampering. While the industry employs cutting-edge technologies, the regulatory framework lags. This disparity affects the accuracy of test results, legal proceedings, and public safety.
  • Jurisdictional Limitations and Federal Challenges: India’s federal structure poses significant challenges in implementing uniform drug regulations nationwide. State governments face limitations in addressing inter-state issues, as evident in the Ballari case, where the manufacturer and CDL were outside Karnataka’s jurisdiction.
  • Pharmacovigilance and Post-Market Surveillance: India’s pharmacovigilance system faces difficulty detecting and responding to adverse drug reactions (ADRs). The system still struggles with underreporting. India’s contribution to the global safety database reached only 3%. This underscores the need for a more proactive approach to drug safety monitoring. There is a need to shift from a reactive to a proactive stance in identifying and mitigating drug safety risks.

 THE WAY FORWARD:

• • Immediate review of CDL’s functioning and decision-making processes: Evaluating CDL’s testing protocols and decision-making processes to ensure scientific rigor and consistency. Assessing the qualifications and training of CDL personnel to guarantee competence in handling complex drug quality issues.
  • Implementing transparent reporting mechanisms: Establishing a public database of CDL test reports, protocols, and personnel qualifications. Implementing a system for real-time reporting of drug quality issues to relevant stakeholders.
  • Strengthening state-level quality control measures: Increasing the number of drug inspectors and testing facilities at the state level. Implementing the Strengthening of States’ Drug Regulatory System (SSDRS) scheme more effectively. Providing advanced training to state drug control personnel in modern testing and inspection techniques.
  • Modernization of sample handling and testing procedures: Implementing blockchain technology for secure sample tracking and chain of custody. All drug testing laboratories should have advanced analytical techniques like mass spectrometry and high-performance liquid chromatography. Developing a national digital platform for real-time sharing of drug quality data between central and state authorities.
  • Enhancing coordination between state and central authorities: Strengthening the role of the Drugs Consultative Committee (DCC) in ensuring uniformity in regulatory practices across states. Establishing a centralized database of drug manufacturers, products, and quality control data accessible to all regulatory bodies. Implementing regular joint inspections and quality control exercises between CDSCO and state authorities.
  • Promoting drug quality and safety research: Allocating dedicated funding for drug quality control and safety monitoring research. Encouraging collaboration between regulatory bodies, academic institutions, and the pharmaceutical industry for cutting-edge research in drug safety. Establish Centers of Excellence in Drug Regulatory Science to drive innovation in regulatory practice and technology.

THE CONCLUSION:

The interconnected issues of quality control failures, lack of transparency, outdated processes, jurisdictional limitations, and challenges in pharmacovigilance highlight the complex landscape of drug regulation in India. Addressing these issues requires a multifaceted approach involving technological upgrades, legislative reforms, and enhanced coordination between state and central authorities.

UPSC PAST YEAR QUESTIONS:

Q.1 “To achieve the desired objectives, it is necessary to ensure that the regulatory institutions remain independent and autonomous.” Discuss this in light of the experiences in the recent past. 2015

Q.2 What do you understand by fixed-dose drug combinations (FDCs)? Discuss their merits and demerits. 2013

MAINS PRACTICE QUESTION:

Q.1 Examine the challenges in implementing the Drugs and Cosmetics Act of 1940, in the context of evolving pharmaceutical practices. What key reforms are needed to make this legislation more relevant and effective in the 21st century?

SOURCE:

https://www.deccanherald.com/opinion/indias-drug-regulation-needs-an-overhaul-3304070