- Statutory, regulatory and various quasi-judicial bodies.
- Issues relating to development and management of Social Sector/Services relating to Health, Education, Human Resources.
Central Drugs Standard Control Organisation (CDSCO)
What to study?
- For Prelims: CDSCO- key facts, about PvPI.
- For Mains: Misuse of various drugs and the need for stringent provisions to prevent their misuse.
Context: The Central Drugs Standard Control Organisation (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).
What is Pharmacovigilance Programme of India (PvPI)?
The PvPI was started by the Government of India on 14th July 2010 with the AIIMS New Delhi as the National Coordination Centre for monitoring Adverse Drug Reactions (ADRs) in the country for safe-guarding Public Health.
Pharmacovigilance is defined as the science relating to the detection, assessment, understanding and prevention of adverse effects, principally long term and short term adverse effects of medicines. The CDSCO has a nation-wide Pharmacovigilance Programme for protecting the health of the patients by promising drug safety.
The Programme is coordinated by the Indian Pharmacopeia commission, Ghaziabad as a National Coordinating Centre (NCC).
The Central Drugs Standard Control Organisation(CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India.
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.
Sources: the hindu.