Context: The Central Drugs Standard Control Organisation (CDSCO) granted official marketing authorization for Qdenga®, approving India’s first-ever dengue vaccine.
About India’s First Approved Dengue Vaccine (Qdenga®):
What It Is?
- Qdenga® is a live, attenuated tetravalent dengue vaccine engineered using recombinant DNA technology. It uses a dengue virus type-2 backbone into which genes encoding surface proteins from the other three dengue serotypes are inserted. This structure provides balanced protection against all four dengue virus strains (DEN-1, DEN-2, DEN-3, and DEN-4).
Developed and Imported By:
- Manufacturer: Developed and manufactured by Takeda GmbH, Germany.
- Indian Importer: Imported and distributed locally by M/s Takeda Biopharmaceuticals India Pvt. Ltd.
Key Features of Qdenga®:
- Target Age Group: Indicated for the prevention of dengue disease in individuals between 4 and 60 years of age.
- Two-Dose Immunization Schedule: Administered as a 0.5ml subcutaneous injection in a two-dose regimen given three months apart (at month 0 and month 3).
- Global Regulatory Credentials: Possesses World Health Organization (WHO) prequalification and approval in over 42 countries, including the European Union, the UK, Indonesia, and Thailand, backed by over 24 million doses distributed globally.
- Proven Indian Phase III Validation: Regulatory approval followed a successful pivotal Phase III trial in India, confirming high immunogenicity and safety across diverse Indian populations.
About the CDSCO:
What It Is?
- The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory authority of India for pharmaceuticals, medical devices, and cosmetics. It operates under the Directorate General of Health Services within the Ministry of Health and Family Welfare.
Established In: Headquartered in New Delhi, the CDSCO derives its statutory authority from the Drugs and Cosmetics Act of 1940 and the Drugs Rules of 1945.
Key Functions:
- Approval of New Drugs and Vaccines: Scientific evaluation and market licensing of new drugs, biologicals, and vaccines before commercial release in India.
- Control Over Drug Imports: Grants licenses to import active pharmaceutical ingredients (APIs), finished formulations, and high-risk medical devices, ensuring compliance with Indian quality standards.
- Clinical Trial Governance: Regulates, approves, and monitors all phases of clinical trials conducted across India to protect participant safety.
- Standardization and Quality Surveillance: Coordinates with State Licensing Authorities (SLAs) to enforce uniform drug quality under the Drugs and Cosmetics Act, taking action against sub-standard or spurius medications.
