Topics covered:
- 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 and about Isotretinoin.
- 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 issued safety guidelines for Isotretinoin.
CDSCO has directed Drug Controllers of all the States and Union Territories to monitor the sale, manufacture and distribution of Isotretinoin.
Background:
Isotretinoin is an oral drug, which is used in the treatment of severe acne. Isotretinoin capsules of 10 mg/20 mg were approved by CDSCO in 2002 for the treatment of cystic and conglobate acne, and severe nodular acne unresponsive to antibiotic therapy.
It was later found that Isotretinoin can cause birth defects in progeny if not taken without proper guidance.
About CDSCO:
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 to 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.
Mains Question: It is said that India is becoming home to production and trial of substandard drugs in recent years. In your opinion, why such drugs are produced and distributed? How can they be regulated? Critically comment.
