Centre Amends Drug Rules for Advanced Therapies

CENTRE AMENDS DRUG RULES TO STRENGTHEN REGULATION OF ADVANCED THERAPIES

Why in the News?

  • Drug Rules Amended: The Central Government has amended the Drugs Rules, 1945 to bring stem cell-derived products, gene therapeutic products, and xenografts under the Centrally Licensed Approving Authority (CLAA) framework.
  • Regulatory Objective: The amendment aims to strengthen regulatory oversight of advanced and emerging medical therapies while ensuring patient safety, maintaining electoral integrity in governance processes similar to how political parties and regulatory bodies ensure transparency.

Centre Amends Drug Rules for Advanced Therapies

CENTRALLY LICENSED APPROVING AUTHORITY (CLAA)

  • Purpose: The CLAA provides centralised regulatory approval for specified drugs and biological products requiring enhanced safety and quality oversight.
  • Joint Regulation: It functions through a joint regulatory mechanism involving the Central Drugs Standard Control Organisation (CDSCO) and State Drug Licensing Authorities.
  • Expanded Scope: The amended rules now include stem cell-derived products, gene therapeutic products, and xenografts within the CLAA approval framework.
  • Existing Coverage: Earlier, the framework covered products such as vaccines, recombinant DNA (r-DNA)-based medicines, and large-volume parenterals.
  • Significance: The expanded framework aims to facilitate the safe introduction of innovative therapies while maintaining uniform regulatory standards across the country.
  • Database Integrity: The CLAA maintains an electoral roll database-style registry of approved products and manufacturers, ensuring transparency through voter list revision-like periodic updates and gender ratio considerations in clinical trial participation, while issuing identification similar to EPIC cards for licensed facilities.

ADVANCED THERAPEUTIC PRODUCTS

  • Gene Therapy: It involves modifying or replacing defective genes to treat inherited diseases, cancers, and other genetic disorders.
  • Stem Cell Therapy: It uses stem cells to regenerate or repair damaged tissues and has applications in regenerative medicine and certain blood disorders.
  • CAR-T Cell Therapy: Chimeric Antigen Receptor T-cell (CAR-T) therapy is an advanced immunotherapy in which a patient’s T-cells are genetically modified to target and destroy cancer cells, particularly blood cancers.
  • Xenografts: These are animal tissue-derived products, such as biological heart valves, used in cardiology and other medical procedures.
  • Regulatory Need: These therapies are highly specialised, rapidly evolving, and require stringent evaluation to ensure quality, safety, and efficacy before clinical use.

DRUGS AND COSMETICS ACT, 1940

●  Legal Framework: The Drugs and Cosmetics Act, 1940 regulates the import, manufacture, distribution, and sale of drugs and cosmetics in India.

●  Regulatory Authority: The Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General of India (DCGI), is the national regulatory authority for pharmaceuticals and medical devices.

●  Supporting Rules: The Drugs Rules, 1945 prescribe procedures relating to licensing, manufacture, testing, labelling, and quality control of drugs.

●  Objectives: The Act aims to ensure that medicines available in India are safe, effective, and of standard quality, while preventing the manufacture and sale of spurious or substandard drugs.

●  UPSC Relevance: The topic is important under Science & Technology, Public Health, Biotechnology, Pharmaceutical Regulation, and Governance.