All Med Devices Now Classified As ‘Drugs’: Government

NEW DELHI: Amid concerns related to rise in prices of essential commodities and pharmaceutical products in the wake of the Covid-19 outbreak, the Centre on Wednesday notified all medical devices sold in the country as ‘drugs’ from April 1, bringing them under the purview of price control and prohibiting companies from increasing prices of these products by more than 10% annually.
“Medical device intended for use in human beings or animals have been notified as drugs with effect from April 1, 2020, all medical devices shall accordingly be governed under the provisions of Drug Price Control Order, 2013,” an order by the National Pharmaceutical Pricing Authority (NPPA), issued on Tuesday, said.

Following this order, all medical devices used to treat a patient — be it syringes, needles, cardiac stents, knee implant, digital thermometers, CT scan, MRIs, dialysis machines — will be under government regulation.

As per the notification, four medical devices — cardiac stents, drug eluting stents, condoms and intra uterine devices (Cu-T) — are scheduled medical devices for which ceiling prices have been fixed.

The objective of the order is to ensure that no manufacturer or importer increases the price of a drug by more than 10% of the MRP during the preceding 12 months.

NPPA said the price control order was “a major tool in the fight with the emerging situation due to Covid-19”.

NPPA has also asked states to ensure availability of essential medical commodities, including personal protection equipment, masks, sanitisers, gloves, testing kits etc. In a letter to chief secretaries, the NPPA head asked states to assess stock situation of essential commodities for the next two months and also inform the Centre about production and availability details.-Times Of India