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Cumulative updating approved biopharmaceuticals

cumulative updating approved biopharmaceuticals-47

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.

2xi 4 Medical Devices industry development (i) Setting up green‐field medical devices and equipment parks.So, take a stroll down memory lane to remember all of our past Word of the Year selections.Annual India Leadership Conclave & Indian Affairs Business Leadership Awards Nominations ( ) Finalists 2013 are announced today with votings line open organized by Indian Affairs, Asia’s biggest title in News Analysis ( from the illustrious Network 7 Media Group in association with Pharmaleaders, Breakfastnewstv, Pharmanewsprwire. Joseph Massey, Managing Director & CEO, MCX Stock Exchange Ltd. Tapping the opportunity US $ 200 Bn global industry 300 (ii) Setting up National Center for Medical Devices at NIPER Ahmedabad. It is proposed to set up 10 New new NIPERs 3000 (ii) New Schemes at Niper Mohali R&D Centre for Biologicals and NCEs R&D Centre for NDDS , Setting up 20 New Incubators , Incentive Scheme for CROs Devpt for New , Drug Discovery Partnership with International Centres of Excellence 825 (iii) Pharma Venture Capital Fund To consider investment of identified funds into a newly created specialised private equity / venture capital fund that undertakes R&D investments into companies in the pharmaceutical industry 500 (iv) Pharma Innovation and Infrastructure Development Initiative (PIIDI) Develop technical and innovation capacity of Indian pharma for manufacturing quality affordable medicines ,develop International competitiveness of the Indian Pharma so as to be the largest producer of generic medicines in the world, To make India a preferred destination for global initiatives in curing the world’s ailments specially the developing world in a value based manner 2000 (v) At NIPER Hyderabad : Setting up National Center for R&D in Bulk Drugs at NIPER Hyderabad Build competitiveness through Innovation and Productivity efficiencies in the API industry. 100 2 R&D , CAPACITY BUILDING AND EMPLOYMENT 2.1 Continuing Schemes 2.1.1 For NIPER Mohali (i) The continuation of the PG and the Ph D education The continuation of the PG and the Ph D education at present strength levels would require budgetary support 100 (ii) Capacity Enhancement for supporting required industry human resources and capacity building requirement by the Institute a. 50 (iv) Continuing scheme at New Nipers Joint development of Tuberculosis related drugs at Niper Ahmedabad and AIIMS, Delhi 1 2.2 New Schemes (i) Establishment of New New NIPERs Inorder to meet the gap of a very low graduate to postgraduate pharma education seats capacity of (51000 graduate seats vs 5100 PG seats in the entire country)there is need to set up further new Nipers apart from the 6 approved in the 11 th plan. The major weaknesses are – (a) Low per capita expenditure on health care & low health insurance, (b) Lack of adequate and trained manpower, (c) Lack of incubation and suitable ecosystem, (d) Lack of regulation/standards etc.

The SWOT analysis of Medical Device Industry shows that its major strengths are – (a) Well developed Microelectronic, Telecommunication, Software and Precision Engineering Industry, (b) Ability to attract foreign investments and (c) Ability to handle low value large volume production as per global quality standards.

500 (vii) Infrastructure support for Cold Chain for high end drugs for exports In order to enhance exports capability for high end drugs requiring exact cold chain standards till the time they are exported from the country in light of stringent developed market requirements 50 (viii) Scheme for environment standards compliance and required infrastructure support including capacity building providing financial and technical assistance to improve financial sustainability of SMEs on one hand and also safeguard the environment from the hazards associated with the unplanned growth of the industry. In addition a number of projects are being implemented for Public health, PHarmacovigilance, Regulatory capacity building for academia and industry, etc.

India’s Most Valuable 4 Wheeler Company of The Year. Emerging Medical Equipment Company of the Year 2013 Nominees. 250 (iv) Upgradation of SMEs to USFDA/EDQM/TGA and other International Standards Specific assistance for standards higher than WHO‐ GMP to selected SMEs – 250 in nos to build Competitiveness of very high standards and second line of internationally capable industry for high value pharma products for strong regulated but high value markets 500 (v) Setting up of one National and five Regional Formulation Development and Manufacturing standards training centres Scheme to set up Formulation development centres to tap the patent cliff opportunity and become global leader in Generics and Bio‐similars 160viii (vi) Establishment and upgradation of 10 Pharma Growth Clusters Infrastructure building for pharma industry particularly for SMEs – building on strength of existing Clusters so as to provide infrastructure gaps for higher production including taking care of environment, power and labs testing, etc needs. Present allocation sought for initial years operation as per advice from DONER 20 (ii) GLP/GCP/Animal House Lab Schemes For setting up of GLP compliant Labs, GCP compliant Lab and a Animal House Lab on PPP basis is under implementation 50ix (iii) Continuing R&D Schemes For Niper Mohali Niper Mohali is presently implementing a number of projects in R&D for various pharma areas like neglected diseases, infectious diseases, vector borne diseases, etc.

As regards access to quality drugs at affordable prices, apart from the price control and monitoring initiative, the Government proposes to further expand the Jan Aushadhi Scheme started in the 11 th Plan with the objective of making available unbranded generic medicines at affordable prices through the proposed 3000 dedicated outlets across the country.

As a result, the Pharma PSUs have been able to achieve a combined business of more than Rs. It is expected that they would grow in the 12 th Plan for which Government support for marketing will be required. The rehabilitation of Indian Drugs and Pharmaceuticals Ltd (IDPL) could be considered during the 12 th Plan as per approval of the Cabinet.

vi Accordingly, Hindustan Antibiotics Ltd (HAL) and Bengal Chemicals and Pharmaceuticals Ltd(BCPL) were given support of over Rs.