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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 :
http://www.pharmabiz.com/NewsDetails.aspx?aid=122187&sid=1
, 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
manufacturing.”
(
http://www.pharmabiz.com/NewsDetails.aspx?aid=121939&sid=1 , March 24, 2020
).
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