• The Central Drugs Standard Control Organisation (CDSCO) has listed samples of more than 50 drugs, including paracetamol, Pan D, calcium and vitamin D3 supplements, and anti-diabetes pills, as “not of standard quality” in its latest report.

• The batches of medicines flagged by the country’s central drug regulatory authority in its drug alert for August are of companies such as Alkem Laboratories, Hindustan Antibiotics Limited, Hetero Labs Limited, Karnataka Antibiotics and Pharmaceuticals Ltd, Nestor Pharmaceuticals Ltd, Priya Pharmaceuticals and Scott-Edil Pharmacia Ltd.

• While batches of some drugs failed the ‘dissolution test’ as per Indian Pharmacopoeia (IP) and failed the ‘Assay’ and ‘water’ test as per IP, some were identified as spurious or having uniformity of volume issues.

• Meanwhile, drug companies including Sun Pharma and Torrent Pharma termed the medicines flagged in the central drug regulatory authority’s report as “counterfeits” and not manufactured by them while asserting that their products conform to quality standards.

• The CDSCO’s drug alert for August included samples from batches of medications such as Shelcal, Vitamin B Complex with Vitamin C Softgels, vitamin C and D3 tablets and Ciprofloxacin tablets.

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 nine zonal offices, seven sub-zonal offices, 18 port offices, seven central laboratories and six mini labs under its control.

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