The
Gazette of India-Extraordinary PART II Section 3 Sub-Section (11) Ministry of Chemicals and Fertilizers Department of
Chemicals and Petrochemicals New Delhi, dated the 6th January,
1995
S.O.18(E).In exercise of the powers
conferred by section 3 of the Essential Commodities Act, 1955 (10 of
1955), the Central Government hereby makes the following
Order, namely:
1. Short title and commencement
-
This Order may be called the Drugs
(Prices Control) Order, 1995
It shall come into force on the date of
its publication in the Official Gazette
2. Definitions - In this Order,
unless the context otherwise requires:
a.
"bulk drug" means any pharmaceutical,
chemical, biological or plant product including its salts, esters,
stereo-isomers and derivatives, conforming to pharmacopoeial or other
standards specified in the Second Schedule to the Drugs and Cosmetics Act,
1940 (23 of 1940), and which is used as such or as an ingredient in any
formulation
b. "capital employed"
means net fixed assets plus working capital of a manufacturer in relation to manufacture of bulk
drug
c.
"ceiling price" means a price fixed by
the Government for Scheduled formulations in accordance with the
provisions of paragraph
d. "dealer" means a person carrying on the
business of purchase or sale of drugs, whether as a wholesaler or retailer
and whether or not in conjunction with any other business, and includes
his agent
e. "distributor" means a distributor of
drugs or his agent or a stockiest appointed by a manufacturer or an
importer for stocking his drugs for sale to a dealer
f. "drug" includes:
(i)
all medicines for internal or external
use of human beings or animals and all substances intended to be used for,
or in the diagnosis treatment, mitigation, or prevention of any disease or
disorder in human beings or animals, including preparations applied on
human body for the purpose of repelling insects like
mosquitoes
(ii)
such substances, intended to affect
the structure or any function of the human or animal body or intended to
be used for the destruction of vermin or insects which cause disease in
human beings or animals, as may be specified from time to time by the
Government by notification in the Official Gazette
(iii)
bulk drugs and
formulations
g.
"Form" means a form specified in the
Second Schedule
h.
"formulation" means a medicine processed
out of, or containing one or more bulk drug or drugs with or without the
use of any pharmaceutical aids, for internal or external use for or in the
diagnosis, treatment, mitigation or prevention of disease in human beings
or animals, but shall not include:
(i)
any medicine included in any bonafide
Ayurvedic (including Sidha) or Unani (Tibb) systems of
medicines
(ii)
any medicine included in the
Homeopathic system of medicine
(iii)
any substance to which the provisions
of the Drugs and Cosmetics Act, 1940 (23 of 1940) do not
apply
i.
"free reserve" means a reserve created
by appropriation of profits, but does not include reserves provided for
contingent liability, disputed claims, goodwill, revaluation and other
similar reserves
j.
"Government" means the Central
Government
k.
"import" with its grammatical variations
and cognate expressions means bringing into India from a place outside
India, and "importer", in relation to any goods at any time between their
importation and consumption, includes any owner or any person holding
himself out to be the importer
kk.
"local taxes" means any tax or levy
(except excise duty included in retail price) paid and/or payable to the
Central Government or State Government or any Local authority under any
law by the manufacturer or his agent or dealer;"*(1)
l. "manufacture" in relation to any drug, includes any process or part of a
process for making, altering, finishing, packing, labeling, breaking
or otherwise treating or adapting any drug with a view its sale and
distribution, but does not include the compounding or dispensing of any
drug or the packing of any drug in the ordinary course of retail business,
and "to manufacture" shall be construed accordingly m.
"manufacturer" means any person who manufactures a drug n.
"net-worth" means the paid-up share capital of a company plus free
reserve, if any, and surpluses excluding outside investments which are not
readily available for operational activity o. "non-Scheduled bulk
drug" means a bulk drug not specified in the First Schedule
p.
"non-Scheduled formulation" means a formulation not containing any bulk
drug specified in the First Schedule
q. "pre-tax return" means
profits before payment of income-tax and surtax and includes such other
expenses as do not form part of the cost of formulation
r. "price
list" means a price list referred to in paragraphs 14 and 15 and includes
a supplementary price list
s. "retail price" means the retail price
of a drug arrived at or fixed in accordance with the provisions of this
Order and includes a ceiling price
t. "retailer" means a dealer
carrying on the retail business of sale of drugs to customer u.
"Scheduled bulk drugs" means a bulk drug specified in the First
Schedule
v. "Scheduled formulation" means a formulation containing
any bulk drug specified in the First Schedule either individually or in
combination with other drugs, including one or more than one drug or drugs
not specified in the First Schedule except single ingredient formulation
based on bulk drugs specified in the First Schedule and sold under the
generic name
w. "sale turn-over" means the product of units of
formulations sold by a manufacturer or an importer, as the case may be, in
an accounting year multiplied by retail price inclusive of sales tax, if
any, paid on direct sales by the manufacturer or importer but does not
include excise duty and local taxes, if any
x. "Schedule" means a
Schedule annexed to this Order
y.
"Wholesaler" means a dealer or his agent
or a stockiest appointed by a manufacturer or an importer for the sale of
his drugs to a retailer, hospital, dispensary, medical, educational or
research institution purchasing bulk quantities of drugs
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