Guaifenesin: WHO issues alert

• The World Health Organization reported that a batch of contaminated India-made cough syrup has been found in the Marshall Islands and Micronesia.

About

• Guaifenesin is an expectorant used to relieve chest congestion and symptoms of cough.
• Samples of the Guaifenesin Syrup TG Syrup from the Marshall Islands were analysed and it was found that the product contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
  • Diethylene glycol and ethylene glycol are toxic to humans when consumed, and can prove fatal.
• The latest alert comes months after the WHO linked other cough syrups made in India to child deaths in Gambia and Uzbekistan.

Regulation of Drugs in India

• Drugs and Cosmetics Act, 1940: The Act regulates the import, manufacture, and distribution of drugs in India.
• The Drugs and Cosmetics Act, 1940 was amended by the Drugs & Cosmetics (Amendment) Act, 2008 to provide for more stringent penalties for manufacture and trade of spurious and adulterated drugs.
• Central Drugs Standard Control Organization (CDSCO) is a regulatory body for Indian pharmaceuticals and medical devices.
  • It comes under the purview of Ministry of Health and Family Welfare.
  • It is headed by Drugs Controller General of India (DCGI).
  • It is 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.