Relevance:
The Department of Chemicals and Petrochemicals with the Ministry of Chemicals and Fertilizers issued a gazette notification titled Ethylene Glycol (Quality Control) Order, 2022 on December 29, a day after Uzbekistan alleged 18 child deaths in Samarkand from consumption of a medicinal syrup manufactured by an Indian drugmaker.
About:
- Diethylene glycol (DEG) and Ethylene glycol both are sweet-tasting, colourless, odourless liquid.
- Commonly used in the commercial preparation of antifreeze.
- Ethylene glycol is used in the production of polyester fibres, paints and polyethene terephthalate (PET)
- DEG because of its hygroscopic property, is used in brake fluid, cigarettes, treatment of paper and some dyes.
- It is an excellent solvent for many relatively insoluble substances.
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.
Ethylene Glycol (Quality Control) Order, 2022:
- The order came after the Centre consulted the Bureau of Indian Standards on the matter.
- In respect of specific goods or articles, the Bureau of Indian Standards shall be the certifying and enforcing authority.
- Any person who contravenes the provisions of this Order shall be punishable under the provisions of the said Act.
Source: DownToEarth
