Topic: Statutory, regulatory and various quasi-judicial bodies
4) In the recent times misuse of drugs has been on rise in India and the need for stringent provisions to prevent their misuse has become the need of the hour. In this context discuss the major functions played by the Central Drugs Standard Control Organization (CDSCO) in regulating the manufacture, sale and distribution of Drugs.(250 words)
Why this question:
In the recent past the Central Drugs Standard Control Organization (CDSCO) has asked commonly-used antibiotics manufacturers to ensure its details be made available to the general public. This decision was taken considering directives from the National Co-ordination Centre of the Pharmacovigilance Programme of India (PvPI). Thus it is important for us to know the functions of CDSCO.
Key demand of the question:
The question must highlight About CDSCO, its role as a regulator, its functions and significance.
Discuss – This is an all-encompassing directive – you have to debate on paper by going through the details of the issues concerned by examining each one of them. You have to give reasons for both for and against arguments.
Structure of the answer:
Begin with brief on CDSCO, how they function.
- Discussion should include the following aspects –
- About CDSCO: The Central Drugs Standard Control Organization(CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India.
- What are its Functions ?
- Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of New Drugs, Conduct of Clinical Trials,
- laying down the standards for Drugs,
- control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
- CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.
- Discuss issues or concerns if any associated with it.
- Explain its significance.
Conclude with way forward.