- The World Health Organization has said that a batch of contaminated India-made cough syrup has been found in the Marshall Islands and Micronesia.
- 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 The 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 primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.
- 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.
- New Drugs, Medical Devices and Cosmetics Bill, 2022: To accommodate changing requirements and encourage the adoption of new technology, the Ministry of Health and Family Welfare released a draft bill in July 2022 to replace the existing Drugs and Cosmetics Act 1940. This act governs drug importation, production, and distribution across the country.
- Central Drugs Standard Control Organization: It is the apex department of the Central Drugs Standard Control Organization (CDSCO) of the Government of India.
- CDSCO is a regulatory body for Indian pharmaceuticals and medical devices.
- It comes under the Ministry of Health and Family Welfare.
- Drugs Controller General of India: Drugs Controller General of India (DCGI) is the head of department of the Central Drugs Standard Control Organization of the Government of India
- 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.
Indian Pharmaceutical Industry
- The Indian pharmaceutical industry ranks third globally in pharmaceutical production by volume and is known for its generic medicines and low-cost vaccines.
- India is a major exporter of Pharmaceuticals, with over 200+ countries served by Indian pharma exports. India supplies over 50% of Africa’s requirement for generics, ~40% of generic demand in the US and ~25% of all medicine in the UK.
- India also accounts for ~60% of global vaccine demand, and is a leading supplier of DPT, BCG and Measles vaccines. 70% of WHO’s vaccines (as per the essential Immunization schedule) are sourced from India.