Drugs and Cosmetics Act 1940 Current Affairs - 2020

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.

Medical Devices now to be regulated under Drugs and Cosmetics Act

On February 11, 2020, Ministry of Health and Family Welfare announced that medical devices are to be brought under Drugs and Cosmetics act (DCA). This is to come into effect from April 1, 2020

Highlights

According to the regulation, every product that is used to treat a patient will now be under the ambit of DCA. It includes MRI, CT scan, thermometer, dialysis machines, etc. A list of 37 devices has been included. This includes medical devices used on animals as well.

Drugs and Cosmetics Act

The DCA regulates manufacture, distribution and import of drugs in India. It was passed in 1940. The act was prepared based on the recommendations of Chopra Committee that was constituted in 1930.

The term Drug in the act includes substances and diagnostic devices as well. The act provides guidelines for sale, display, prescription and storage of drugs. The act has so far been amended in 7 times.