Q. Consider the following statements:
- National Pharmaceutical Pricing Authority (NPPA) is a statutory body.
- NPPA is responsible for regulating the prices of drugs.
- Central Drugs Standard Control Organization is headed by Drugs Controller General of India (DGCI)
- DCGI is the direct licensing authority for Class C and Class D devices.
Which of the statements given above is/are correct?
Answer:
Only 2, 3 & 4
Notes: The National Pharmaceutical Pricing Authority (NPPA) was established on August 29, 1997, as part of the Department of Chemicals and Petrochemicals. It regulates drug prices to ensure availability, accessibility, and affordability, enforcing the Drugs Price Control Order and setting Maximum Retail Prices (MRP) for scheduled drugs. The Drugs Controller General of India (DCGI) heads the Central Drugs Standard Control Organization, overseeing the licensing of specific drug categories, including blood products, IV fluids, vaccines, and sera. The DCGI sets manufacturing and distribution standards and enforces the Drugs and Cosmetics Act. Following the Medical Device Rules 2017, the DCGI also serves as the Central Licensing Authority for medical devices, directly licensing Class C and D devices while coordinating with State drug controllers for Classes A and B.