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CDSCO’s Guidelines for Unapproved Drugs Meropenem & Disodium EDTA

March 13, 2024

GS Paper III Science and Technology

Context

  • The Central Drugs Standard Control Organisation (CDSCO) has cautioned against the manufacture and sale of unapproved drugs, specifically against drugs falling under the category of “New Drugs”.

Central Drugs Standard Control Organisation (CDSCO)

  • CDSCO under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India. 
  • It is responsible for ensuring quality drugs supply across the country. 
  • DGCI has authority to give approval to new drugs and to regulate clinical trials.

CDSCO Directive: Unapproved Drugs Meropenem & Disodium EDTA

  • Awareness Among Manufacturers: CDSCO has directed that all manufacturers be made aware of the two drugs – Meropenem (an antibacterial agent) and Disodium EDTA (used to treat calcium overload).
    • It highlighted that certain manufacturers engage in the production and marketing of these drugs that have not yet been approved by the CDSCO.
  • Directive on Unapproved Drugs: It communicated to all zonal/sub-zonal offices of CDSCO and the Indian Drugs/Pharmaceutical Association forum that no new drug shall be manufactured for sale unless the licensing authority approves it.
    • Moreover, a person who intends to manufacture a new drug in the form of Active pharmaceutical ingredients (API) or Pharmaceutical formulation shall make an application for grant of permission to the central licensing authority as per the specifications.
Also Read: A News Drug For Chronic Kidney Disease

News Source: The Hindu

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