GoI regulates 24 classes of medical devices as drugs

On April 1, 2020, the National Pharmaceutical Pricing Authority revised the ceiling price of 883 scheduled formulations. The authority also informed that the disruption of supply of Active Pharmaceutical Ingredients are returning to normalcy.

Highlights

The NPPA has notified 24 classes of medical devices as drugs under Drugs and Cosmetics Act, 1940. The prices of other non-scheduled medical devices are being monitored by the authority. The authority has also come up with a ruling that no manufacturers or importers shall increase the price of these listed devices by not more than 10% for another 12 months.

The devices are to be monitored and treated as drug for quality control and price monitoring.

Active Pharmaceutical Ingredient

The Active Pharmaceutical Ingredient is that part of the drug that produces the intended effects. Some of the drugs have multiple APIs to treat different symptoms.

India believes that Indian APIs should get US FDA approval. This is because, exporting a US FDA approved API is easier all over the world. This is because, several drug companies believe and import FDA approved APIs.

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