Chapter.

8
NATIONAL PHARMACEUTICAL PRICING
AUTHORITY
price control over drugs was first
aggression by drugs (Display of Prices)introduced India in the aftermath of the Chinese
in
0k3 These were (promulgated) under theorder 1962 and the drugs (Control of Prices) order
Defense of India Act.
Thereafter series of Drug Price Control orders were issued. Drugs
1066 and the Drugs (Price Control) Order of (Price Control) Order of
Commodities Act 1955"
1970 were issued under the "Essential
Thereafter the Drugs (Price Control) Order 1979 and Drugs (Price Control) Order 1987
were issued to implement of drug policy 1978 and drug policy 1986.
Drug (Price Control) Order 1995 was issued in order to implement Drug
Policy of 1994.
The Central Government (Department of Pharmaceuticals) has notified the Drugs (Prices
Control) Order, 2013 (DPCO 2013) in exercise of the powers conferred by section 3 of the
Essential Commodities Act 1955. This order has been published in official Gazette on
15th May 2013. Drug (Prices Control) Order 2013 replaces Drugs (Prices Control) Order 1995.
New Drugs (Prices Control) Order 2013 has brought prices of 348 essential drugs (all
formulations) mentioned in the National List of Essential Medicines (NLEM) under control
against the DPCO 1995, controlling prices of only 74 drugs and their formulations.
8.1 OBJECTIVES
(i) To ernsure availability of essential medicines at reasonable prices.
(i) To provide sufficient opportunity for innovation and competition to support the
growth of industry.
(m) To meet the qoals of employment and shared economic growth of all.
8.2 DEFINITIONS (PARAGRAPH 2)
terms are defined.
For the purpose of this DPCO 2013, the following
(a) Act:It means the Essential Commodity Act, 1955.
means any pharmaceutical,
(b) Active Pharmaceutical Ingredient or Bulk Drug : It
isomers, analogues and
chenical, biological or plant product including its salts, esters, Cosmetics Act, 1940
Drugs and
derivatives, conforming to standards specified in the
which is used as such or as an ingredient in any formulation.
and
symbol, trademark or any other feature that
() Brand: It neans a name, term, design,
those of other sellers.
Identifies one seller's drug as distinct from
(8.1)
 National Pharmaceutical Pricing
Pharmaceutical Jurisprudence
(d)
8.2

Ceiling Price:It means a price fixed by the Government for Scheduled formulations in
Authority
accordance with the provisions of this order.
(e) Dealer : It means a business of purchase or sale of
person carrying on the
whether as a wholesaler or retailer and includes his agent.
drugs,
) DIstributor :It means a person engaged in the work of distribution of drugs and
dealer.
Gudes an agent or a stockist for stocking drugs for sale to a
(9) Existing Manufacturer :It means manufacturer existing on the date oT publication of
tiis order in the Official Gazette.
(h) Form :Aform specifiedin the Second Schedule.
() Formulation: It means a medicine processed out of or containing one or more drugs
with or without use of any pharmaceutical aids, for internal or external use or in the
diagnosis, treatment, mitigation or prevention of disease.
It does not include
) Any medicine included in any bonafide Ayurvedic (including Sidha) or Unani (Tib)
systems of medicines;
(1) Any medicine included in the Homoeopathic system of medicine; and
(i) Any substance to which the provisions of the Drugs and Cosmetics Act, 1940
(23 of 1940) do not apply;
() Generic Version of a Medicine : It means a formulation sold in pharmacopoeial name
or the name of the active pharmaceutical ingredient contained in the formulation,
without any brand name.
(k) Government: The Central Government.
() Import: It means bringing adrug into India from aplace outside India for its sale.
(m) Local Taxes :It means any tax or levy (except excise or import duty included in retal
price) paid or payable to the Central Government or the State Government or any local
body under any law for the time being in force by the manufacturer or his agent or
dealer.
(n) Manufacturer: It means any person who manufactures, imports and markets drugs tor
distribution or sale in the country.
(o) Market share : It means the ratio of domestic sales value (on the basis of
moving
annual turnover) of a brand or a generic version of a medicine and the sum of
tota
domestic sales value of all the brands and generic versions of that medicine sold in tne
domestic market having same strength and dosage form.
(p) Margin to retailer : It means a percentage of price to retailer.
(g) Market based data : It means the data of sales related to a drug collected or obtained
by the Government as deemed fit, trom time to time
smetics
1940.Act terms
per ee) (Zo) (zo) (zb) (za) (2) (v) I) (w)
Non-scheduled () National 0
to Dy agency. duties
ScheduledRetailer Retail Pharmacoeconomics
Schedulereferred Price pricli
est. Price value Medicines.
which Essential of hot h
Cecential a 2011 the
one Wholesale Wholesaler
retaler, New duties
time.
are
combinspidosages
necig fienotdandification twelvMovie ng prMaice ximumretail
the list of are of is PharTnaceutical
terms price and to th e Drug: time as
as one Medicines
to list
Department hospital, :A retailer :A not
publcorisrhedespondingmonthment
s ioned Jurisprudence
:A
bydealer does same t he included
It inand annualapplulitcmablatSuech,
and Price formulation
: The : pharmaceutical price specified essential ofmonth in
the schedule Ageneric drug means theupdated by turnover
not formulation drug price
expressions Index: dealer price : list the domesticsales on
dispensary, carrying include The or Official the of
efinitions of referred with a
version :It in strengths
offormulation
a Ministry of
the It:
Industrial appended or fixed price formulation in the
Annual : means the specified another pack. means
:
his on local Gazette. medicines
the market, In drug
are Any by drug First
medical, or the of to : first of same a
It as tothe
given used
Policy
wholesale
agent brand
to
formulation,
the taxes. in to a
Schedule. Health particular
retail paragraphs scientific means dosages druglaunched
listedin schedule monthwhere be
this Government drug a another.
launched ceiling 8.3
inbut : sold
and educational order.
or name.
business at either and It
Essential are a a means in sales
the to
price stockist which formulation, and the by Family the month price
Promotion, discipline listed
by order
this of the
not included 24
of for strengths
changing National an previous or
index it and National List the
Commodity defined or
engaged sale a is manufacturer existing
or Welfare valuemeans National
new sold 25 that not retail
Government research
of in of
and the List year
in al of Pharmaceutical
the drugs drug. to asthe listed revised byas or Cumulative that Consumer price
thiscommodities in includes compares dosage listed of th e is
Act, a strength of
institution the First to retailer Medicines in
EssentialGovernment
bythrougn subtracted.
order. in th e MeciCines,
Essential plus
1955 customers. the
of sale Schedule a the and sales andlocal
India, which
supplementary National
or is Pricing
Meaning
Drugsand National Li s t of
as or of therapeuticstrengths dosages added whereAuthority
taxes
drugs a value
announcedfrom any whether includes drug
List from
of and for and
such time other to or of or
of
a