India Standards Portal

Central Drugs Standard Control Organization (CDSCO)

Central Drugs Standard Control Organization (CDSCO)

The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act, 2008. Main function of CDSCO are approval of New Drugs, Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organisations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.   

Standard formulation activities:

Drugs have not been taken at present under the purview of this Standards Portal. However, the Ministry of Health and Family Welfare, Govt. of India under Gazette notifications has notified certain medical devices to be considered as drugs under Section 3, Clause (b), Sub clause (iv) of the Drugs and Cosmetics Act. At present 14 medical device and 8 substances are notified and accordingly the standards of these 14 medical devices are formulated/updated and controlled by CDSCO through the different provisions of the Drugs & Cosmetics Act as given below. 

  • GMP Requirements are specified under Schedule M III of the Act
  • Requirements on Labeling of Medical Devices specified in Rule 109-A of the Act.
  • Standards for Medical Devices are prescribed in Rule 125-A  of the Act.

The Ministry of Heatlh and Family Welfare has notified the Medical Devices Rules, 2017 that enables compulsory licensing of the medical devices from time to time. Rule 7 of the MDR, 2017 makes the following provisions for the standards to which the devices shall conform:

Product standards for medical device.— (1) The medical device shall conform to the standards laid down by the Bureau of Indian Standards established under section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or as may be notified by the Ministry of Health and Family Welfare in the Central Government, from time to time. (2) Where no relevant Standard of any medical device has been laid down under sub-rule (1), such device shall conform to the standard laid down by the International Organisation for Standardisation (ISO) or the International Electro Technical Commission (IEC), or by any other pharmacopoeial standards. (3) In case of the standards which have not been specified under sub-rule (1) and sub-rule (2), the device shall conform to the validated manufacturer’s standards.

CDSCO has seven laboratories all over the country for analysis of Drugs and Pharmaceuticals, Cosmeitcs and Medical Devices manufactured/imported in the country.

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