Q. Consider the following statements about Regulation of the Pharma Sector in India:
1. National Pharmaceutical Pricing Authority (NPPA) enforces the Drug Price Control Order and regulates prices of medicines.
2. NPPA comes under Ministry of Chemicals and Fertilizers.
Which of the statements given above is/are correct?
Red Book
Red Book

[A] 1 only

[B] 2 only

[C] Both 1 and 2

[D] Neither 1 nor 2

Answer: C
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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