• The Central Drugs Standard Control Organisation (CDSCO) has informed the Customs Department that import of refurbished devices is not allowed.

• The move is aimed at curtailing the influx of unregulated second-hand medical devices in the country. 

• The CDSCO said that all medical devices are regulated under the Medical Devices Rules, 2017.

• However, there is no specific provision for regulation of refurbished medical devices under the said rules. Hence, no licence is issued for import of such devices and it cannot be imported under Medical Devices Rules for sale and distribution, the CDSCO said.

Central Drugs Standard Control Organisation (CDSCO)

• The Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General of India, is the central authority for regulating the quality of drugs marketed in the country under the Drugs and Cosmetics Act, 1940. 

• Import or manufacture for sale of drugs including vaccines are regulated under Drugs and Cosmetics Act, 1940 and Drugs & cosmetics Rules, 1945 and New Drugs and Clinical Trials Rules, 2019.

• The mission of CDSCO is to safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices.

• Regulatory control over the import of drugs, approval of new drugs and clinical trials, approval of certain licenses as Central License Approving Authority are major functions of CDSCO.

• The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 have entrusted various responsibilities to central and state regulators for regulation of drugs and cosmetics. 

• It envisages uniform implementation of the provisions of the Act and Rules made there under for ensuring the safety, rights and well being of the patients by regulating the drugs and cosmetics. 

• As per the rules, products like vaccines, r-DNA derived products, stem cell derived products, gene therapeutic products, etc are always considered to be new drugs. For such products manufacturers are required to obtain manufacturing permission from CDSCO under the New Drugs and Clinical Trials Rules, 2019 before licensing the product under the Drugs and Cosmetics Rules, 1945.

• CDSCO is constantly striving to bring out transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.

• The CDSCO, with its headquarters in New Delhi, has eight zonal offices, seven sub-zonal offices, 19 port offices, seven central laboratories and six mini labs under its control.

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