DRUG PRICE CONTROL ORDER 2013
The
new Drug Price Control Order (DPCO) 2013 came into being w.e.f 15th
May, 2013. Under the new DPCO 2013 the prices of 348 drugs covering around 652
formulations have been brought under price control. As per the provisions of
DPCO, 2013 prices are now being fixed based on the average Price to the
Retailer (PTR) of the medicine having market share more than or equal to one
percent of the total market turnover adding 16% margin to retailer thereto.
All the previous DPCOs, 1970, 1979, 1987 and 1995 were based on cost to
manufacturers with post manufacturing expenses.
Under
DPCO, 2013 the powers to Review are vested with the Government. After
fixation of prices of medicines under DPCO, 2013, the Department has received
as many as 75 cases for Review under para 31 of the DPCO, 2013 out of which 21
have been disposed off/closed after due examination with the approval of the
competent authority.
JAN
AUSHADHI SCHEME
In November, 2008, the Department
launched Jan Aushadhi, with a view to make available quality medicines at
affordable prices to the economically weaker sections of the society, through
retail outlets of Jan Aushadi Stores (JAS). The first JAS was opened at
Amritsar Civil Hospital on 25.11.2008. Since then 157 JAS have been opened in
the States of Punjab, Haryana, Odisha, Andhra Pradesh, Rajasthan, Delhi,
Uttrakhand, West Bengal, Jammu & Kashmir, Himachal Pradesh, Jharkhand and
UT of Chandigarh. Bureau of Pharma PSUs of India (BPPI) was set up by the
Department for implementation of the Jan Aushadhi Scheme.
The Government
approved a New Business Plan on Jan Aushadhi campaign for making available
quality medicines at affordable prices to all. It aims to open 3000 stores
during the 12th Plan Period. During the year 2013-14, it is proposed
to open a minimum of 500 new stores. The projections for opening of a minimum
number of stores in the years 2014-15, 2015-16 and 2016-17 are 750, 1000 and
750 respectively. Further, to enhance availability of drugs at stores, basket
of drugs has been widened to 361 medicines.
PHARMACEUTICALS
PURCHASE POLICY
The Cabinet on 30th October 2013
approved the Pharmaceuticals Purchase Policy for 103 drugs produced by five
Pharma Central Public Sector Enterprises (CPSES) namely, Indian Drugs and
Pharmaceutical Ltd. (IDPL), Hindustan Antibiotics Ltd. (HAL), Bengal Chemicals
and Pharmaceutical Ltd. (BCPL), Rajasthan Drugs and Pharmaceuticals Limited
(RDPL), and Karnataka Antibiotics & Pharmaceutical Limited (KAPL) and their
subsidiaries, where Government of India held 51% or more shares, for a period
of five years from the date of notification. This would be applicable to
purchases by Central Government departments, their Public Sector Undertakings
and Autonomous Bodies, etc. This would also be applicable to purchase of
medicines by State Governments under Health Programmes funded by Government of
India such as National Rural Health Mission etc.
NATIONAL
PHARMACEUTICAL PRICING AUTHORITY (NPPA)
The National Pharmaceutical Pricing
Authority (NPPA), an independent body of experts under the Ministry of
Chemicals and Fertilizers, formed in the year 1997continues to be delegated
with the powers to exercise the functions of the Central Government in respect
of various paragraphs of the DPCO, 1995 and DPCO, 2013. The functions of NPPA include fixation
and revision of prices of scheduled bulk drugs and formulations, Monitoring of
prices of decontrolled drugs and formulations, Implementation and enforcement
of the provisions of DPCO in accordance with the powers delegated, Monitoring
the availability of drugs, identify shortages, taking remedial steps, etc.
NATIONAL PHARMACEUTICAL PRICING POLICY
(NPPP), 2012
The
Government notified National Pharmaceutical Pricing Policy (NPPP), 2012, on
07.12.2012 to bring the prices of essential medicines, as listed under National
List of Essential Medicines-2011, under price control. The NPPP, 2012
envisages regulation of the prices of formulations only identified on the basis
of essentiality of drugs. Further, the basis of fixing the ceiling price of formulations
has been changed from cost based to Market Based Pricing (MBP).
CLUSTER DEVELOPMENT PROGRAMME FOR PHARMA
SECTOR
A Cluster Development Programme,
a Central Sector Scheme, is also implemented for developing pharmacy sector in Public
Private Partnership (PPP) format in clusters.
PHARMACEUTICALS TECHNOLOGICAL
UPGRADATION ASSISTANCE SCHEME (PTUAS)
Pursuant to
Planning Commission’s letter dated 1.1.2012, the Department approached Small
Industrial Development Bank of India (SIDBI) to provide input for soft loan
scheme. The Department has also constituted a technical committee to suggest a
list of equipments and machinery required for WHO GMP (Good Manufacturing
Practices)/other international GMP certification and to work out their
estimated cost of procurement/installation. The proposal has been sent to
Planning Commission.
NATIONAL
INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH (NIPER)
NIPER, Mohali was initially
registered as a society under the Societies Act. The faculty for the institute
was appointed in 1994. In 1998, Parliament enacted National Institute of
Pharmaceutical Education & Research Act, 1998. NIPER was declared as an
“Institute of National Importance” under the Act of Parliament on 26th
June 1998. NIPER is a member of Association of Indian Universities. Thereafter
the Government has set up six new NIPERs at Hajipur, Hyderabad, Ahmedabad, Rae
Bareli, Guwahati and Kolkata. All these NIPERs are aimed to cater to the
growing demand of the pharmaceutical industry for highly trained man power for
continuous growth of the pharmaceuticals sector with increased focus on
R&D, particularly after the amendment of Indian Patent Act. At present,
new NIPERs are functioning with the assistance of the Mentor Institutes.
NIPER conducts regular education programmes for academia and
industry in various disciplines and helps the Indian Pharmaceutical Industry in
solving their R&D related requirements. NIPER has upgraded facilities for
achieving the highest level of efficiency in imparting education and events.
OTHER BASIC FACTS WITH RESPECT TO INDIAN
PHARMACEUTICAL INDUSTRY:
•
Over
US$ 25 Billion turnover, comprising nearly 60% of domestic market and 40%
exports.
•
Cumulative
Average Growth Rate of around 14% since last 5 years. However, the growth rate
has somewhat declined in recent past.
•
Around
10,500 registered manufacturing units.
•
Ranked
3rd globally in volume and 14th in value,
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KSP/NSK/SG