• The Drugs Controller General of India (DCGI) has prohibited the production and export of all combinations of pain-relief medicines tapentadol and carisoprodol.

• There were news reports that unapproved combinations of these drugs were exported to West African countries by Indian pharmaceutical manufacturer Aveo Pharmaceuticals, causing an opioid crisis there.

• The DCGI has asked the drug control authorities of the states and Union territories to immediately withdraw all export NOCs (no-objection certificates) and manufacturing licences granted for any combination of these two drugs.

Unapproved combination 

• Tapentadol is an opioid medication used to treat moderate to severe pain. Carisoprodol is a muscle relaxant that works on the centre of the brain and spinal cord to relieve pain.

• Both tapentadol and carisoprodol are individually approved by the Central Drugs Standard Control Organisation (CDSCO) in India. Tapentadol is approved in 50, 75 and 100-mg tablet forms as well as 100, 150 and 200-mg extended-release tablets. However, a combination of tapentadol and carisoprodol is not approved in India.

• Neither of these drugs is included in the NDPS (Narcotic Drugs and Psychotropic Substances) list in India.

• Approximately 1.3 crore tablets/capsules and 26 batches of APIs (Active Pharmaceutical Ingredients) of Tapentadol and Carisoprodol were detained to prevent further distribution of these potentially dangerous drugs.

• An export consignment of Tapentadol 125 mg plus Carisoprodol 100 mg, destined for Ghana, has also been put on hold at the Mumbai Air Cargo, pending further investigation.

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.

(The author is a trainer for Civil Services aspirants.)