CDSCO takes away state powers for issuing No Objection Certificate (NOC) for drug’s exports from States

Posted 04 May 2024

2 min read

Since 2018, export NOC and manufacturing license were granted by State Licensing Authority for manufacturing unapproved/banned/new drugs solely for export purposes.
However, in recent notification sole licensing authority will be Central Drugs Standard Control Organisation (CDSCO).
- All manufacturers are required to obtain NOC from respective Zonal offices of CDSCO through SUGAM Portal.
- The decision comes in view of Drug Consultative Committee's observation that process of obtaining NOCs from state drug regulators for pharmaceutical products is time-consuming, further delaying export consignment.

About Indian Pharmaceutical Industry (PI)
- Widely recognised as ‘Pharmacy of the World’
- Largest provider of generic medicines globally, occupying a 20% share in global supply by volume.
- Contributes 70% of Diphtheria, Tetanus and Pertussis (DPT) and Bacillus Calmette–Guérin (BCG) vaccines, and 90% of measles vaccines.
- It is expected to reach USD 130 Billion by 2030.

Challenges in Indian Pharmaceutical Industry
- Dependence on China for Active Pharmaceutical Ingredients.
- Instances of contaminated drugs and cough syrups manufactured in India.
- Low investments in Research & Development.

Initiatives taken to strengthen Pharma Industry
- Production Linked Incentive (PLI) scheme for Pharmaceuticals.
- Strengthening of Pharmaceutical Industry Scheme.
- Scheme for Promotion of Bulk Drug Parks.

Ministry: Ministry of Health & Family Welfare.
Headquarter: New Delhi.
- It has 9 Zonal offices.
Performs its regulatory function under Drugs & Cosmetics Act, 1940 and rules 1945.
It is responsible for
- Approval of Drugs, Conduct of Clinical Trials,
- Laying down standards for Drugs,
- Control over quality of imported Drugs, etc.

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