DRUG PRICE CONTROL ORDER 2013
New Delhi December 20, 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,