As per new drugs price control regime i.e. Drugs (Prices
control) Order, 2013 (DPCO 2013), every manufacturer (including
importer/ marketer) of a scheduled drug/ non-scheduled drug is
required to issue a price list and supplementary price list, if
any, in Form V of Schedule II to the DPCO 20131, to all
dealers (including retailers), State Drug Controllers, and
Government/ National Pharmaceutical Pricing Authority (NPPA)
indicating the name of product, composition, pack size (inclusive
of applicable duties) and maximum retail price (MRP).
As per the DPCO 2013, scheduled drugs and those drugs which are
specified in the First Schedule attached to the DPCO 2013 and non
scheduled drugs are those drugs which are not mentioned in the said
Schedule of the DPCO 2013.
So far as medical devices are concerned, the Ministry of Health
and Family Welfare, Government of India vide various notifications
has specified certain medical devices as 'Drugs' under
Section 3(b) (iv)2 of the Drugs and Cosmetics Act, 1940.
The list of medical devices notified as drugs under the Drugs and
Cosmetics Act, 1940 is as follows:
In addition to the above medical devices, the following products
are also regulated as 'Drugs' under the Drugs and Cosmetics
Act, 1940 and Rules made thereunder and the same are Blood Grouping
Sera, Ligatures, Sutures and Staplers, Intra-Uterine Devices (Cu-T)
(Scheduled Drug), Condoms (Scheduled Drug), Tubal Rings, Surgical
Dressings, Umbilical Tapes and Blood/ Blood Component Bags.
The above medical devices have been notified as drugs under the
Drugs and Cosmetics Act, 1940 and such medical devices can further
be divided into two parts i.e. scheduled formulations and non
scheduled formulations under the DPCO 2013.
Among other things, the manufacturers/importers of the above
notified medical devices are required to issue a price list and
supplementary price list, if any, in Form V of Schedule II to the
DPCO 2013, to all dealers (including retailers), State Drug
Controllers, and Government/ NPPA indicating the name of product,
composition, pack size (inclusive of applicable duties) and maximum
retail price (MRP).
It is realised by the NPPA that majority of the manufacturers
(including importers and marketers) are not at all, or not
regularly issuing price list/ supplementary price list in Form V of
Schedule II to the DPCO 2013, to State Drug Controllers and the
Keeping in view the above non-adherence on the part of the
manufacturers/importers of the notified medical devices, the NPPA
provided final opportunity vide its show cause notice on 16
February 2015 to all manufacturers/importers/marketers of notified
Medical Devices (who have failed to submit Price list/
Supplementary Price list in Form V of Schedule II to the DPCO 2013)
to file the relevant details.
It is also stated in the said show cause notice that if the
supply is made by the wholesaler to the hospital directly, the
column related to PTR (Price to Retailer) in the Form V may be left
blank and in lieu of it the Price to Wholesaler (including
applicable duties) may be mentioned separately as a footnote.
The NPPA is empowered not only to regulate/fix the prices of
scheduled formulations including notified medical devices (which
have been included in the First Schedule of the DPCO 2013) but also
to monitor the prices of non scheduled formulations including
notified medical devices (which have not been included in the First
Schedule of the DPCO 2013) to ensure that no manufacturer increases
the maximum retail price of a drug more than ten percent of maximum
retail price during preceding twelve months. In absence of the
price list, it becomes difficult to the NPPA to
regulate/fix/monitor the prices of scheduled formulation and non
scheduled formulations. Therefore, the NPPA vide its above notice
has directed all the manufacturers/importers of the notified
medical devices to supply their price lists. Further, non
submission of the price list will amount to contravention of the
provisions of the Essential Commodities Act, 1955 which attracts
imprisonment and fine under section 7 of the Essential Commodities
1. paragraphs 24 and 25 of the DPCO
2. Section 3 (b) (iv): Drugs includes 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.
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