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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.

 

About CDSCO

  • 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.
  • Tags :
  • CDSCO
  • Pharmaceutical Industry
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