The move would mean these equipments will have to undergo clinical trials before launch and also print MRPs
The drug controller is all set to notify a number of medical equipments including defibrillators and dialysis machines as drugs. While the notice issued by the Central Drugs and Standards Control Organisation (CDSCO) issued last week does not talk about the intention of the move, it is widely believed to be the first step in exerting some control over the prices of these items. More importantly, designation as a drug would mean that these devices would have to undergo trials before being launched in India.
The proposal to include all implantable medical devices and other high end equipment under the purview of Section 3 (b) (iv) of the Drugs and Cosmetics Act, 1940 as Medical Devices was discussed by the Drugs Technical Advisory Board (DTAB) in its 79th meeting held on May 16. The section lays down that the definition of drug would also include “such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board.”
Once medical devices are notified as drugs, they will have to print MRPs too. This is as per an order by the National Pharmaceutical Pricing Authority
The devices that are proposed to be covered are
- All implantable medical devices
- CT scan equipment
- MRI equipment
- Defibrillators
- Dialysis machine
- PET equipment
- X-Ray machine
- Bone marrow cell separator
These are the latest additions in a spate of similar moves by the apex drug regulator in the country. Last year 15 other items including cardiac stents, orthopaedic devices and other equipment were designated as drugs. For the latest addition to that expanding list, the drug controller has sought feedback from stakeholders before the decision is notified in the official gazette.
Once medical devices are notified as drugs, they will have to print MRPs too. This is as per an order by the National Pharmaceutical Pricing Authority.
