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Consider the following statements with reference to the Central Drugs Standard Control Organisation (CDSCO):
1. It is responsible for overseeing the import, manufacture, sale and distribution of medical device in the country.
2. It works under the Directorate General of Health Services, Ministry of Health & Family Welfare. 
Which of the statements given above is/are correct?
  • a)
    1 only
  • b)
    2 only
  • c)
    Both 1 and 2
  • d)
    Neither 1 nor 2
Correct answer is option 'C'. Can you explain this answer?
Most Upvoted Answer
Consider the following statements with reference to the Central Drugs ...
The Central Drugs Standard Control Organisation (CDSCO) has become the sole authority for issuing manufacturing licences for new drugs meant for exports, withdrawing the power from State Governments amid heightened global scrutiny of Indian made drugs.
About Central Drugs Standard Control Organisation (CDSCO): 
  • It is the National Regulatory Authority (NRA) of India for the medical devices industry under the provisions of the Drugs and Cosmetics Act.
  • It is responsible for overseeing the importmanufacturesale and distribution of medical device in the country. The CDSCO ensures that medical devices comply with safety, quality, and efficacy standards.
  • It works under the Directorate General of Health ServicesMinistry of Health & Family Welfare, Government of India.
  • The Drugs Controller General of India (DCGI) is the head of the CDSCO.
  • Headquarters: New Delhi.
  • 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;
  • Coordination of the activities of State Drug Control Organizations;
  • CDSCO, along with state regulators, is jointly responsible for the grant of licenses for certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine, and Sera.
  • The CDSCO conducts inspections and audits to ensure that medical device companies are complying with regulations related to safety, quality, and efficacy.
Hence both statements are correct.
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Consider the following statements with reference to the Central Drugs Standard Control Organisation (CDSCO):1. It is responsible for overseeing the import, manufacture, sale and distribution of medical device in the country.2. It works under the Directorate General of Health Services, Ministry of Health & Family Welfare.Which of the statements given above is/are correct?a)1 onlyb)2 onlyc)Both 1 and 2d)Neither 1 nor 2Correct answer is option 'C'. Can you explain this answer?
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