Threat of toxic cough syrups remains, more nations hit: WHO

Threat of toxic cough syrups remains, more nations hit: WHO

Subject: Science

Section: Health

Context: There is an ongoing global threat posed by toxic cough syrups, and WHO is now working with six more countries than previously revealed to track the potentially deadly children’s medicines.

Content:

• The UN agency has already named nine countries where tainted syrups may have been on sale.
• The contaminated medicines could still be found for several years, as adulterated barrels of an essential ingredient may remain in warehouses.
• Also, Cough syrups and the ingredient, propylene glycol, both have shelf lives of around two years.
• Unscrupulous actors sometimes substitute propylene glycol with toxic alternatives, ethylene glycol and diethylene glycol, because they are cheaper.

Indian Medicines:

• The WHO issued safety alerts last year for Indian made products found in Gambia and Uzbekistan, and this year in Micronesia and the Marshall Islands.
• Two companies whose products have been linked to deaths have been shuttered by the authorities were Maiden Pharmaceuticals, which sold syrups to Gambia, and Marion Biotech, whose syrups went to Uzbekistan.
• Besides these cases, Indian made medicines supplied to the Marshall Islands and Micronesia have been recalled after Australian labs showing contamination.
• The contaminated syrups in Liberia were made by India’s Synercare Mumbai. The Liberian health regulator said it plans to incinerate the stock and will recall two other Synercare products as well, as a precaution.
• Health is a state subject
• The Central authority is the overall supervisory body and direct States to ensure that the raw materials used are tested for purity.
• The State gives manufacturing licences and inspects plants, etc., in line with central laws.
• The Drug and Cosmetics Act, 1940 establishes regulatory control over the import, manufacture, distribution, and sale of drugs and cosmetics in India.
  • 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).
  • This also established the Central Drugs Standard Control Organization (CDSCO) headed by Drug Controller General of India, DCGI 
    • DCGI is responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India. It also sets standards for manufacturing, sales, import, and distribution of drugs in India

• • Role of 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.
• The State Health department has to regulate the manufacturing, sales, and distribution of drugs.
• Drug Inspectors control the implementation at ground level.
• The Drugs and Cosmetics Act also has provisions of recalling of substandard drugs from the market,  to compensate the families of victims of adulteration.