NEWS

• The Central Government is drafting a new law — “Drugs, Medical Devices and Cosmetics Act, 2025” — to strengthen India’s drug quality testing and market surveillance systems.
• Triggered by multiple complaints and alerts from global health regulators and the World Health Organization (WHO) regarding lapses in Indian drug manufacturing quality.

HIGHLIGHTS

Key Developments

• The draft Act was presented by Dr. Rajeev Raghuvanshi, Drugs Controller General of India (DCGI).
• Reviewed at a high-level meeting chaired by Union Health Minister J.P. Nadda.
• Senior officials from DCGI and Central Drugs Standard Control Organisation (CDSCO) participated.

Major Provisions of the Draft Law

• Enhanced Statutory Powers for CDSCO:
  • First-time legal authority to act immediately against fake or substandard drugs.
  • Power to enforce market recalls and penal actions.
• Digital Reforms:
  • Digitisation of licensing and regulatory approvals to enhance transparency.
  • Creation of a centralised database for drug and device monitoring.
• Quality Infrastructure:
  • Upgradation of testing laboratories and R&D facilities.
  • Improved coordination with state-level regulators for uniform quality enforcement.

 Significance

• Strengthens India’s pharmaceutical credibility in global markets.
• Ensures consumer safety and public health protection.
• Aligns with WHO and international GMP (Good Manufacturing Practices) standards.
• Supports the vision of “Quality India” in the health sector.

Challenges Ahead

• Implementation capacity of state regulators.
• Need for adequate funding and technical manpower.
• Coordination among multiple agencies for effective enforcement.