Q. Consider the following statements:
1. Central Drugs Standard Control Organization (CDSCO) provides general information about drug regulatory requirements in India.
2. CDSCO under Ministry of Chemicals and Fertilizers.
Which of the statements given above is/are not correct?

[A] 1 only

[B] 2 only

[C] Both 1 and 2

[D] Neither 1 nor 2

Answer: B
Notes:

Regulation of the Pharma Sector in India:

  • Drugs and Cosmetics Act, 1940:Regulates the import, manufacture, distribution and sale of drugs in India.
  • Central Drugs Standard Control Organization (CDSCO)provides general information about drug regulatory requirements in India. It comes under Ministry of Health & Family Welfare,
  • National Pharmaceutical Pricing Authority (NPPA)enforces the Drug Price Control Order and regulates prices of medicines. It comes under Ministry of Chemicals and Fertilizers
  • The Pharmacy Act, 1948regulates the profession of Pharmacy in India.
  • The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954provides to control the advertisements regarding drugs; it prohibits the advertising of remedies alleged to possess magic qualities. Schedule Y of The Drugs and Cosmetics Act guides the requirements of clinical trials.

Source: EPIC October 2021

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