DRUG LICENSING (Syllabus: GS Paper 2 – Health & Regulation)

News-CRUX-10     15th September 2023        
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Context: The Union health ministry has recently proposed significant changes to its drug licensing program, aiming to establish uniformity throughout India to enhance drug safety

  • This move comes after domestically manufactured cough syrups were reportedly associated with the tragic deaths of children.

Drugs Related Regulations in India

  • The Drugs and Cosmetics Act: The primary purpose of these regulations is to oversee and regulate drugs and cosmetics within the country.
  • Scope: These guidelines pertain to the issuance of licenses for the production of Ayurvedic, Siddha, and Unani medicines.
  • Mandatory Compliance: Manufacturers are obligated to conform to specified criteria for both licensing manufacturing units and medicines. This includes providing evidence of safety and efficacy and adhering to Good Manufacturing Practices (GMP).

Central Drugs Standard Control Organisation (CDSCO)

  • About: CDSCO establishes standards and measures to ensure the safety, effectiveness, and quality of drugs, cosmetics, diagnostics, and medical devices within the country.
  • Export Regulation: CDSCO plays a role in regulating the export of drugs from India.
  • Manufacturers with CDSCO certification can export drugs to other countries, expanding India's pharmaceutical presence internationally.

Drugs Controller General of India (DCGI)

  • Licensing Approval: The DCGI serves as the department head of the Central Drugs Standard Control Organization (CDSCO) under the Government of India. 

o One of their primary responsibilities is approving licenses for specific categories of drugs, including blood and blood products, IV fluids, vaccines, and sera within India.

  • Standard Setting: DCGI plays a pivotal role in establishing standards for the manufacturing, sales, import, and distribution of drugs across India.
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