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NPPA Notifies All Medical Devices As Drugs Under DPCO-2013 For Quality Control & Price Monitoring

National Pharmaceutical Pricing Authority (NPPA) has notified all medical devices as drugs under provisions of the Drugs Prices Control Order (DPCO-2013) with effect from April 1, 2020.

“Thus, all medical devices shall be regulated by the government as drugs for quality control and price monitoring. The maximum retail prices (MPRs) of all the medical devices would be monitored by the government under the provisions of Para 20(1) of the DPCO, 2013 to ensure that no manufacturer/importer increases the MRP of a drug more than ten percent of MRP during preceding twelve month and where the increase is beyond ten percent of maximum retail price, it shall reduce the same to the level of ten per cent of maximum retail price for next twelve months.”

Further, as per Para 20(2) of the DPCO, 2013 read with the Essential Commodities Act, 1955, the manufacturer/importer shall also be liable to deposit the overcharged amount along with interest thereon from date of increase in price in addition to penalty.

Government is regulating 24 class of medical devices which have been notified/regulated as drugs under Drugs & Cosmetics (D&C) Act, 1940 and D&C Rules, 1945. Of the above, 4 medical devices viz. (i) Cardiac Stents (ii) Drug Eluting Stents (iii) Condoms and (iv) Intra Uterine Device (Cu-T) are scheduled medical devices for which ceiling prices have been fixed. These 4 medical devices are under price control.

As regards remaining non-scheduled medical devices which are notified/regulated as drugs, NPPA is currently allowing MRPs under Para 20 of the DPCO, 2013 to ensure that no manufacturer/importers can increase the price more than ten percent in preceding twelve months.

(Ref : , April 3, 2020 )

Govt Announces Rs. 13,760-cr Package To Boost API & Medical Device Production In India, Industry Cheers Up

With the coronavirus outbreak disrupting supply of active pharmaceutical ingredients (APIs) and medical devices from China to India, the government has come out with four schemes worth Rs 13,760 crore to encourage manufacturing of bulk drugs and medical devices in the country and their exports.

On March 21, the Union Cabinet under the chairmanship of Prime Minister Narendra Modi had approved an expenditure of Rs. 9,940 crore and Rs. 3,820 crore for APIs and medical devices, respectively.

The PLI scheme for promoting domestic manufacturing of medical devices will have financial implications of Rs. 3,420 crore for next five years.

The medical device sector suffers from a cost of manufacturing disability of around 12 per cent to 15 per cent, vis-a-vis competing economies, among other things, on account of lack of adequate infrastructure, domestic supply chain and logistics, high cost of finance, inadequate availability of quality power, limited design capabilities and low focus on R&D and skill development, etc. There is, thus, a need for a mechanism to compensate for the manufacturing disability.

The PLI scheme aims to boost domestic manufacturing by attracting large investments in medical device sector. Under the scheme, incentive at the rate 5 per cent of incremental sales over base year 2019-20 will be provided on the segments of medical devices identified under the scheme.

Under the sub-scheme for promotion of medical device parks, common infrastructure facilities would be created in four medical device parks, which is expected to reduce manufacturing cost of medical devices in the country.

Welcoming the government’s initiative to promote medical device manufacturing in India, RajivNath, forum coordinator, AiMeD said “Such a visionary move by the government will help address Indian healthcare security concerns- the inadequacy of which is being exposed in ongoing crisis to address the coronavirus pandemic preparedness. The schemes announced will help boost local

( , March 24, 2020 ).

Other News

Cabinet Approves Promoting Domestic Manufacturing Of Medical Devices





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