Question

14. In recent past Medical regulatory authorities and institutions are making news. Identify the correct option with respect to these institutions.

• A. A. The Central Drug Standards Control Organization (CDSCO) is India’s main regulatory body for pharmaceuticals and medical devices.
  
• B. B. The Drug Controller General of India (DCGI) is responsible for the approval of the manufacturing of certain drugs (vaccines, large volume parenteral, blood products, r-DNA derived), specific medical devices, and new drugs.
  
• C. C. In India, the manufacturing, import, sale, and distribution of medical devices are regulated under India’s Drugs & Cosmetic Act and Rules (DCA)
  
• D. D. All the statements above are correct
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Answer 1

The correct option is D D. All the statements above are correct

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14. Answer: D

Explanation:

• The Central Drug Standards Control Organization (CDSCO) is India’s main regulatory body for pharmaceuticals and medical devices.
• The Drug Controller General of India (DCGI) is the key official within the CDSCO. The DCGI is responsible for the approval of the manufacturing of certain drugs (vaccines, large volume parenterals, blood products, r-DNA derived), specific medical devices, and new drugs.
• In India, the manufacturing, import, sale, and distribution of medical devices are regulated under India’s Drugs & Cosmetic Act and Rules (DCA)