CA Foundation · Business Laws · Indian Regulatory Framework
Prem Ltd., a pharmaceutical company, has applied for government approval to manufacture a new drug. Under the Drugs and Cosmetics Act regime, which body is vested with the authority to grant or refuse approval for manufacturing new pharmaceutical formulations?
The Central Drugs Standard Control Organisation (CDSCO) is the apex authority responsible for approving or rejecting applications for manufacturing new drug formulations in India.
- AState Pharmaceutical Regulatory Authority
- BCentral Drugs Standard Control Organisation (CDSCO)Correct
- CIndian Council of Medical Research (ICMR)
- DNational Board of Accreditation
Explanation
The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, is the apex regulatory body empowered to grant or refuse approval for new drugs and formulations. State authorities assist in inspection but cannot grant approval for new drugs. ICMR focuses on research; NBA accredits educational institutions.
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