“INDIA WAIVES LOCAL TRIALS FOR GLOBALLY APPROVED DRUGS”

Why in the news?

India’s government has waived local clinical trial requirements for drugs approved in the U.S., U.K., Japan, Australia, Canada, and the EU. This aims to enhance drug accessibility and affordability.

About Policy Change for Drug Approvals:

  • Waiver of Clinical Trials: The Union government has decided to waive the requirement for clinical trials in India for drugs approved in the U.S., U.K., Japan, Australia, Canada, or the EU.
  • Categories for Waiver: The waiver applies to five categories:
    • Drugs for rare diseases
    • Gene and cellular therapy products
    • New drugs used in pandemic situations
    • New drugs for special defence purposes
    • Drugs with significant therapeutic advances over current treatments.
  • Regulatory Framework: The order, issued by the Central Drugs Standard Control Organisation, modifies Rule 101 of the New Drugs and Clinical Trial Rules, 2019, allowing for the exemption of local clinical trials based on approvals from specified countries.

Impact on Drug Accessibility:

  • Enhanced Access: The policy aims to make drugs manufactured abroad more accessible and affordable in India by streamlining the approval process.
  • Pharma Industry Reaction: The Organisation of Pharmaceutical Producers of India (OPPI) has welcomed the move as progressive, highlighting its potential to expedite drug approvals and improve patient access to essential medications.
  • Call for Broader Waivers: OPPI advocates for extending waivers to additional therapeutic categories to further enhance access to innovative treatments.
INDIA WAIVES LOCAL TRIALS FOR GLOBALLY APPROVED DRUGS - UPSCsource:slideshare
World Drug Report 2024 Highlights:

  • Annual Report: Released by the UN Office on Drugs and Crime (UNODC).
  • Drug Users: 292 million people used drugs in 2022, a 20% increase over ten years.

Most Used Drugs:

  • Cannabis: 228 million users
  • Opioids: 60 million users
  • Amphetamines: 30 million users
  • Cocaine: 23 million users
  • Ecstasy: 20 million users
  • Emerging Threat: Nitazenes, potent synthetic opioids, have increased overdose deaths.
  • Treatment Access: 64 million people with drug use disorders; only 1 in 11 receive treatment.
  • Gender Disparity: Women are less likely to receive treatment compared to men.
  • Legal Consequences: 7 million people had formal police contact, 2.7 million prosecuted, and over 1.6 million convicted for drug offences in 2022.

Key Regulation of Drugs in India:

Drugs and Cosmetics Act, 1940:

  • Governs the regulation of drugs and cosmetics.
  • Includes guidelines for issuing licences for manufacturing Ayurvedic, Siddha, and Unani medicines.
  • Provides regulatory framework through the Drugs and Cosmetics Rules, 1945.

Central Drugs Standard Control Organisation (CDSCO):

  • Sets standards for drug safety, efficacy, and quality.
  • Regulates market authorization for new drugs.
  • Oversees clinical trial standards.

Drugs Controller General of India (DCGI):

  • Head of CDSCO, responsible for drug approvals.
  • Approves licences for specific drug categories like blood products, IV fluids, vaccines, and sera.
  • Establishes standards for drug manufacturing, sales, import, and distribution in India.

Related Government Initiatives:

Production Linked Incentive (PLI) Scheme for Pharmaceuticals:

  • Offers financial incentives to increase domestic production of pharmaceutical products.
  • Aims to enhance global competitiveness and reduce import dependency.

Promotion of Bulk Drug Parks Scheme:

  • Supports the establishment of bulk drug manufacturing facilities.
  • Provides infrastructure and financial assistance to boost domestic production.

Strengthening Pharmaceuticals Industry Scheme:

  • Focuses on improving the infrastructure and capabilities of the pharmaceutical sector.
  • Encourages research and
  • development, and supports industry growth.

National Medical Devices Policy, 2023:

  • Aims: to promote domestic manufacturing of medical devices.
  • Seeks to enhance innovation, regulatory framework, and market access for medical devices.