About the Department
The Department of Pharmaceuticals was created on the 1st of July in the year 2008 in the Ministry of Chemicals & Fertilizers so as to provide greater focus for the growth of the high potential Pharmaceuticals industry.
Shri Ananth Kumar is the Minister of Chemical and Fertilizers and Shri Mansukh L. Mandaviya is the Minister of State for Chemicals and Fertilizers.
The Ministry has been given the following mandate for catalyzing the growth of the pharma industry in the country –
- Drugs and Pharmaceuticals sector development
- Promotion and co-ordination of basic, applied and other research in areas related to the Pharmaceuticals sector.
- Development of infrastructure, manpower and skills for the Pharmaceuticals sector and management of related information.
- Education and training including high end research and grant of fellowships in India and abroad, exchange of information and technical guidance on all matters relating to pharmaceutical sector.
- Promotion of public - private - partnership in pharmaceutical related areas.
- International cooperation in pharmaceutical research, including work related to international conferences in related areas in India and abroad.
- Technical support for dealing with national hazards in pharmaceutical sector.
- All matters relating to National Pharmaceuticals Pricing Authority including related functions of price control/monitoring.
- All matters relating to National Institutes for Pharmacy Education and Research.
- Supporting growth of Central Pharma Public Sector Undertakings - BCPL,HAL,IDPL, KAPL and RDPL.
- Medical Devices - Industry issues relating to promotion, production and manufacture; excluding those specifically allotted to other Departments.
- To make India the Largest Global Provider of Quality Medicines at Reasonable Prices.
This Vision has to be achieved keeping the following Mission into picture –
- Develop Human Resources for Pharmaceutical Industry and Drug Research and Development
- Promote Public-Private Partnership for development of pharmaceuticals Industry
- Promote Pharma Brand India through International Cooperation
- Promote environmentally sustainable development of Pharmaceutical Industry
- Enable availability, accessibility and affordability of drugs
In order to implement the Vision and the Mission, the Department has since its creation taken up the following initiatives to catalyse the growth of the pharma industry.
- Strengthening of the National Institutes of Pharmaceutical Education and Research NIPER Mohali, Chandigarh
NIPER, Mohali is a premier institution of national Importance set up under the Act of Parliament on 26th June 1998. The institution offers Masters' and Ph.D. degrees in 14 streams and caters to the various needs of pharmaceutical industry. Presently 601 students are studying in NIPER Mohali including some foreign nationals. The number of student strength has been increased so as to provide more high skilled work force for the industry particularly in the field of research and development as well as high end pharma management.
- Establishment of New NIPERs
In order to provide further fillip to the availability of high skilled human resources in the pharma sector, the Government has set up six new NIPERs starting 2008 at Patna (Hajipur), Hyderabad, Ahmedabad, Rae Bareli, Guwahati and Kolkata. This strengthening to the skill base is catering 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. At present, new NIPERs are functioning with the assistance of the Mentor Institutes nominated for the purpose such as Indian Institute of Chemical Technology, Indian Institute of Chemical Biology, Central Drug Research Institute, Lucknow, Indian Institute of Life Sciences, Hyderabad, etc.
- Access to quality drugs at reasonable prices - The Jan Aushadhi Scheme
In order to enable access to quality medicines at affordable prices, a Campaign in the name of 'Jan Aushadhi Campaign' has been launched. The purpose of this campaign is to make available medicines at affordable prices for all, especially the poor and the disadvantaged. Under this campaign, less priced quality unbranded generic medicines are made available through Jan Aushadhi Stores. At present 107 JAS have been opened (till 12.08.2011) in the states of Punjab, Haryana, Uttrakhand, Odhisha, Rajasthan, Andhra Pradesh, West Bengal, Jammu & Kashmir, Union Territories of Chandigarh and Delhi.
- Industry Capacity Building In order to provide support to the SME Pharma industry for quality manufacturing, the Department has with the help of Ministry of Micro Small and Medium Industries expanded the Credit Linked Subsidy Scheme (CLCSS) being operated by Ministry of MSME for providing financial assistance for Technical Upgradation to Schedule-M standards. More than 140 items of plant and machinery have been added to the eligible list of equipment for which assistance can be provided. Now the Department has proposed a scheme of financial assistance to MSMEs for WHO-GMP, USFDA and other international standard manufacturing compliances.
- Projects and Schemes
The Cluster Development Programme for Pharma Sector (CDP-PS)
With a vision to catalyze and encourage quality, productivity and innovation in pharmaceutical sector and to enable the Indian pharmaceutical industry especially SMEs to play a leading role in a competitive global market, Hon'ble Minister of Chemicals and Fertilizers approved the introduction of Cluster Development Programme for Pharma Sector (CDP-PS) on 27.10.2014.
The CDP-PS is a Central Sector Scheme. The total size of the scheme is proposed as Rs.125 Crores for CDP-PS for 12th Five Year Plan.
The Scheme would be implemented on a Public Private Partnership (PPP) format through one time grant —in — aid to be released in various phases for creation of identified infrastructure and common facilities in the form of Common Facility Centers(CFC) to Special Purpose Vehicles (SPVs) set up for the purpose.
Assistance under the Scheme will be Rs. 20.00 Crore per cluster or 70% of the cost of the project, whichever is less for creation of common facilities. Some of the indicative activities under the Common facilities are:
- Common Testing Facilities
- Training Centre
- R&D Centres
- Common Logistics Centre
The Objective of Pharmaceuticals Promotion Development Scheme (PPDS) is promotion, development and export promotion in pharmaceuticals sector by extending financial support for conduct of seminars, conferences, exhibitions, mounting delegations to and from India for promotion of exports as well as investments, conducting studies /consultations, for facilitating growth, exports as well as critical issues affecting Pharma Sector. Under PPDS the Department of Pharmaceuticals on its own or through financial support by way of grant-in-aid to the Institutions, organizations, Voluntary organizations or Non-Government organizations as mentioned in Rule 206 of GFR 2005.i) Conduct training/knowledge improvement programs/activities on issues/subjects relevant to growth of pharmaceutical industry. An indicative list of subject is as under:-
- Quality Management System/Quality Improvement Program
- How to handle USFDA notice?
- Success Story Presentation-Pharmaceutical Entrepreneur
- Government regulations/guidelines for clinical trials in India versus USA, EU etc.
- Waste Management