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Central Drugs Standard Control Organisation (CDSCO)

Facts for Prelims (FFP)

Source: LM

Context: The Central Drugs Standard Control Organisation (CDSCO) will now exclusively have the authority to issue manufacturing licenses for new drugs intended for export, removing this power from state governments.

  • This change, effective from May 15, 2024, mandates that all applications for No Objection Certificates (NOCs) for export purposes be submitted to CDSCO zonal offices (through SUGAM Portal)
  • Since 2018, the State Licensing Authority granted export NOCs and manufacturing licenses for unapproved, banned, or new drugs meant solely for export purposes.

Aim: This decision aims to streamline the export process and address delays highlighted by the Drug Consultative Committee (DCC).

About CDSCO:

The Central Drugs Standard Control Organisation (CDSCO) operates under the Ministry of Health & Family Welfare, headquartered in New Delhi. It oversees regulatory functions under the Drugs & Cosmetics Act, 1940 and rules 1945. CDSCO is responsible for approving drugs, conducting clinical trials, setting drug standards, and ensuring quality control of imported drugs. It operates through 9 zonal offices across the country.