EDITORIALS & ARTICLES

Regulatory reform stuck in a loop in Health Ministry

Introduction

  • Policy Initiatives: The DCGI, under the Ministry of Health and Family Welfare, announced reforms on three critical issues impacting public health: drug recall guidelines, good distribution practices, and the regulation of similar brand names.
  • Objective: These measures are intended to safeguard public health by ensuring the safety and efficacy of drugs, preventing errors in prescription, and improving distribution standards.

Policy Initiatives and Their Importance

  • Drug Recall Guidelines:
    • Purpose: To swiftly remove drugs failing quality tests from the market to prevent potential harm to patients.
    • Significance: Ensures that unsafe or substandard drugs do not reach consumers, thereby protecting public health.
  • Good Distribution Practices (GDP):
    • Purpose: To regulate the storage and distribution of drugs during transit and sale.
    • Significance: Ensures that drugs are stored and handled properly, maintaining their efficacy and safety until they reach the consumer.
  • Regulation of Similar Brand Names:
    • Purpose: To avoid confusion caused by similar drug names, which can lead to prescription errors and harm to patients.
    • Significance: Reduces the risk of medication errors by ensuring that drug names are distinct and not misleading.

Historical Context and Persistent Issues

  • 59th Report of the PSC (2012):
    • Focus: Evaluated the functioning of the Central Drugs Standard Control Organisation (CDSCO) and identified issues with drug recall guidelines, drug storage standards, and confusing brand names.
    • Historical Flagging:
      • Drug Recall Guidelines: Initially flagged by the Drugs Consultative Committee (DCC) in 1976.
      • Storage Standards: Identified by the Supreme Court in 1974.
      • Brand Name Confusion: Raised by the Court in 2001.

Implementation Challenges

  • Non-Binding Nature of Guidelines:
    • Current Status: Recent drug recall guidelines (2012, 2017, 2024) announced by the DCGI lack legal enforceability.
    • Issue: The DCGI cannot create binding laws; only the Ministry of Health can, resulting in ineffective enforcement.
  • Storage Guidelines:
    • Proposal History: Proposal to adopt WHO’s GDP guidelines and make them binding was discussed in 2013.
    • Challenges: Resistance from stakeholders and anticipated pushback from trade associations due to cost implications of implementing the guidelines.
    • Recent Developments: Despite acknowledging the problem, the government has yet to finalize and enforce binding GDP guidelines.
  • Brand Name Regulation:
    • Existing Rule: Companies are required to self-declare that their brand names are not similar to existing ones.
    • Shortcomings: The rule is inadequate as it relies on self-regulation and does not address the issue of misleading or confusing names effectively.

Repeated Delays and Bureaucratic Stagnation

  • Drug Recall Guidelines:
    • Cycle: Guidelines have been proposed multiple times but lack enforceability due to their non-binding nature.
  • Good Distribution Practices:
    • Delay Reasons: The proposal to make GDP guidelines legally binding faces delays due to logistical concerns and opposition from trade associations.
  • Brand Name Regulation:
    • Ineffective Measures: Government responses have included administrative actions rather than substantial reforms, resulting in continued issues with confusing drug names.

Root Causes of Ineffectiveness

  • Leadership and Expertise Issues:
    • Role of Joint Secretary: The Joint Secretary heading the Drug Regulation Section often lacks domain expertise and institutional knowledge.
    • Impact: Frequent changes in leadership and lack of expertise contribute to ineffective policy formulation and implementation.
  • Bureaucratic Resistance:
    • Stakeholder Pushback: Pharmaceutical and trade associations resist reforms that require additional investments or operational changes.
    • Bureaucratic Tactics: The use of repeated consultations and discussions serves to delay action and avoid making binding decisions.

Recommendations for Reform

  • Strengthening Legal Framework:
    • Drug Recall Guidelines: Should be made legally binding with clear enforcement mechanisms to ensure compliance.
    • Good Distribution Practices: GDP guidelines need to be mandated as law to ensure proper storage and handling of drugs.
    • Brand Name Regulation: Introduce rigorous vetting by the regulator to prevent misleading or confusing drug names.
  • Enhanced Regulatory Oversight:
    • Regulatory Empowerment: DCGI and other regulatory bodies should have the authority and resources to enforce compliance and prevent violations.
  • Direct Intervention:
    • Prime Minister’s Office: To break the cycle of inaction, higher-level intervention from the Prime Minister’s Office may be necessary to ensure adherence to reforms and overcome bureaucratic resistance.






POSTED ON 10-09-2024 BY ADMIN
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