Context
In an unfortunate development, a syrup by an Indian pharmaceutical firm was found by WHO to be adulterated with diethylene glycol (DEG) and ethylene glycol. This raises the question on drug regulation in India.
Drug regulatory framework in India
- The drug controller general of India (DCGI) is the head of the Central Drugs Standard Control Organisation (CDSCO) in India.
- DCGI is the head of the pharma regulatory framework in the country.
What is CDSCO and what is its role in drug approval?
- The CDSCO is a central drug authority under the Ministry of Health and Family Welfare that regulates the quality, safety, and efficacy of drugs including vaccines as per the provisions of the New Drugs and Clinical Trials Rules, 2019, under the Drugs and Cosmetics Act, 1940.
- This organisation is the nodal authority for the approval of new drugs and clinical trials in the country.
- It lays down the standards for drug control over the quality of imported drugs.
Other major functions of the CDSCO
- Bringing uniformity: It coordinates activities of several state drug control organisations and provides expert advice with a view to bringing about uniformity in the enforcement of the Drugs and Cosmetics Act.
- Power to ban: The CDSCO has the power to ban a drug that is considered harmful or sub-therapeutic under Section 26A of the act.
- Licence for imports: It is also responsible for granting licences to government hospitals or medical institutions to import drugs for the use of their patients.
- Foreign registration: The CDSCO is also a nodal authority for registering foreign manufacturers of drugs and medical devices that they want to ship to India.
