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i EXECUTIVE SUMMARY The Indian pharmaceutical Industry has witnessed a robust growth of around 14% since the beginning of the 11 th Plan in 2007 from about Rs 71000 crores to over Rs1 lac crores in 2009‐10 comprising some Rs62,055 crores of domestic market and exports of over Rs 42,154 crores.This also amounts to around 20% of total volume of global generics.
More than 65% of India’s requirement of medical devices and equipments are met through imports with domestic production being largely restricted to low technology disposable equipments.
This Vision is – “To make India the Largest Global Provider of Quality Medicines at Reasonable Prices.” The Vision is to be achieved as per the following Mission: • 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 ii In order to realise the Mission, the Department has set the following Goals for 12 th plan: • Production size of USbn and export size of over USbn. • Develop Pharma Infrastructure and Catalyze Drug Discovery and Innovation • Develop Pharma Human Resources through increased M. D programs in NIPERS • Provide Infrastructure and staff for new NIPERs and strengthen NIPER Mohali • Open 10 new NIPERs • Jan Aushadi Campaign and implementation of Business Plan for setting up of 3000 Jan Aushadhi Stores (upto Subdivision level in the country) • Incentivizing Private Sector for development of new Drugs for diseases endemic to India For the achievement of these Goals, it is necessary for the Indian Pharmaceutical Industry to become globally competitive through world class manufacturing capabilities with quality and cost efficiency of production capacity and radical upgradation of research and development capabilities for new drugs and associated activities like clinical trials and contract manufacturing.
• Upgradation of SMEs to WHO‐GMP and training of professionals therein. There is need to develop world class support infrastructure both for production and research.
The major opportunities are‐ (a) Huge market potential ,(b) Growing opportunities in export market, (c) Growing demand on account of changing demographic profile, increasing incidences of life style diseases like cancer, CNS and diabetics, etc.
The major threats are – (a) Growing competition in export markets, (b) Increasing dependency on imports, (c) Unorganized market for medical disposables, (d) Lack of regulations in medical disposables and surgical items.
The projected human resource requirement is around an estimated 21.5 lacs by 2020.
Based on this it is proposed to fill the HR requirements through Schemes such as (a) Expanding the student output at NIPER Mohali (b) Development of 6 New NIPERS already sanctioned in the 11 th Plan and (c) Setting up of 10 New NIPERs etc.
However, the Industry is quite fragmented and comprises of nearly 10,500 units with majority of them in unorganized sector.
Of these, about 300‐400 units are categorized as belonging to medium to large organized sector with the top 10 manufacturers accounting for 36.5% of the market share.
Accordingly, it is proposed to continue schemes for strengthening of the NPPA, for such functions as ‐ (a) Strengthen Monitoring and Enforcement Work, (b) Building Consumer Awareness about pricing and availability and (c) Creation of NPPA Cells in States, etc.
The present market size of Medical Devices and Equipments is around Rs 15,000 crores.
Accordingly, the recommendations made by the Task Force under Dr.