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India-made Syrups and Deaths in Gambia

  • 08 Oct 2022
  • 3 min read

For Prelims: WHO, Diethylene glycol and Ethylene glycol, CDSCO, DGCI.

For Mains: Drug Regulatory Norms in India.

Why in News?

Recently, the World Health Organisation (WHO) issued an alert about four Indian-manufactured cough syrups, which are said to be linked to acute kidney injury in children and 66 deaths in the small West African nation of The Gambia.

  • The WHO analysis of samples of each of these products had confirmed the presence of “unacceptable amounts of diethylene glycol and ethylene glycol as contaminants”. These ingredients are not allowed in food or drugs, as they can cause abdominal pain, vomiting, diarrhoea, headache, severe renal injury and neurological toxicity.
  • The company said these were not sold in India and are only for export markets already approved by the DGCI.

What are the Related Regulations in India?

  • The Drugs and Cosmetics Act:
    • The Drugs and Cosmetics Act, 1940 and Rules 1945 have entrusted various responsibilities to central and state regulators for regulation of drugs and cosmetics.
    • It provides the regulatory guidelines for issuing licenses to manufacture Ayurvedic, Siddha, Unani medicines.
    • It is mandatory for the manufacturers to adhere to the prescribed requirements for licensing of manufacturing units & medicines including proof of safety & effectiveness, compliance with the Good Manufacturing Practices (GMP).
  • Central Drugs Standard Control Organisation(CDSCO):
    • Prescribes standards and measures for ensuring the safety, efficacy and quality of drugs, cosmetics, diagnostics and devices in the country.
    • Regulates the market authorization of new drugs and clinical trials standards.
    • Supervises drug imports and approves licences to manufacture the above-mentioned products.
    • CDSCO regulates export of drugs in India, any manufacturer with the certification from CDSCO can export drugs outside India.
  • Drugs Controller General of India:
    • DCGI is the head of department of the CDSCO of the Government of India responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India.
    • DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India.

Source: HT

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