Question: Which body in India is responsible for approval of new drugs?
(a) Central Drugs Standard Control Organization
(b) Indian Council of Medical Research
(c) Drug Regulatory Authority of India
(d) Food and Drug Administration
Answer: (a)
Related facts:
- Considering the emergency and unmet medical need for Covid-19 disease, CDSCO (Central Drugs Standard Control Organization) has approved Restricted Emergency Use of Remdesivir Injectable Formulations for treatment of patients with severe COVID-19 infection.
- Also CDCSO has approved Favipiravir Tablets for mild to moderate COVID-19 infection subject to various conditions and restrictions.
- The drug Favipiravir will be sold under the brand name FabiFlu by Glenmark Pharmaceuticals.
- Remdesivir Injection production has been approved to Cipla Ltd and Hetero Drugs.
- Both Remdisivir and Favipiravir formulations are required to be sold under the prescription of medical specialists only.
Central Drugs Standard Control Organization:
- The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act.
- It exercises regulatory control over the import of drugs, approval of new drugs and clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), approval of certain licenses as Central License Approving Authority.
- It has it’s headquarter in New Delhi.
- Drug Controller General of India (DCGI) heads the CDSCO.
By-Amar Mani Upadhyay