Unit II -Approved regulatory bodies and agencies.pptx

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This article includes a list of general references, but it lacks sufficient corresponding inline citations. (August 2020)
A regulatory agency (regulatory body, regulator) or independent agency (independent regulatory agency) is a government authority that is responsible for exercising autonomous dominion over some area of human activity in a licensing and regulating capacity.

These are customarily set up to strengthen safety and standards, and/or to protect consumers in markets where there is a lack of effective competition. Examples of regulatory agencies that enforce standards include the Food and Drug Administration in the United States and the Medicines and Healthcare products Regulatory Agency in the United Kingdom; and, in the case of economic regulation, the Office of Gas and Electricity Markets and the Telecom Regulatory Authority in India.

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Last edited on 17 August 2024, at 19:32
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1. UNIT II Technology development and transfer Approved regulatory bodies and agencies , TT agencies in India

2. CONTENTS Approved regulatory bodies and agencies , TT agencies in India- APCTD, NRDC, TIFAC, BCIL, TBSE / SIDBI

3. Approved regulatory bodies and agencies

4. Approved regulatory bodies and agencies The principal regulatory bodies entrusted with the responsibility of ensuring the approval, production and marketing of quality drugs in India at reasonable prices are: The Central Drug Standards and Control Organization (CDSCO) The Drugs Controller General of India (DCGI) The Food and Drug Administration (FDA or USFDA) The Therapeutic Goods Administration (TGA) Medicines and Healthcare products Regulatory Agency (MHRA )

5. 1.The Central Drug Standards and Control Organization (CDSCO) The Central Drug Standards and Control Organization (CDSCO), located under the aegis of the Ministry of Health and Family Welfare. The CDSCO prescribes standards and measures for ensuring the safety, efficacy and quality of drugs, cosmetics, diagnostics and devices in the country. Regulates the market authorization of new drugs and clinical trials standards; supervises drug imports and approves licences to manufacture the above-mentioned products .

6. 2.The Drugs Controller General of India (DCGI) The Drugs Controller General of India (DCGI), With respect to licensing and quality control issues, market authorization is regulated by the Central Drug Controller, Ministry of Health and Family Welfare, Department of Biotechnology, Ministry of Science and Technology (DST) and Department of Environment, Ministry of Environment and Forests. State drug controllers have the authority to issue licences for the manufacture of approved drugs and monitor quality control, along with the Central Drug Standards Control Organization (CDSCO).

7. The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the Control and supervision of food safety, tobacco products, dietary supplements, prescription and over the counter pharmaceutical drugs(medications),vaccines, biopharmaceuticals, blood transfusions, medical, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. 3.The Food and Drug Administration (FDA or USFDA)

8. 4.The Therapeutic Goods Administration (TGA) The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health , and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products. Almost any product for which therapeutic claims are made must be entered in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia .

9. Medicines and Healthcare products Regulatory Agency (MHRA) regulates the medicines, medical devices and blood components for transfusion in the UK. 5.Medicines and Healthcare products Regulatory Agency (MHRA)

10. Technology Transfer Agencies in India

11. Technology Transfer Agencies in India APCTT ( Asian & pacific centre for transfer of technology) NRDC (National research development corporation) TIFAC ( Technology information, Forecasting and assesmement Council) BCIL ( Biotech consortium India limited) TBSE ( Technology bureau for small enterprises)

12. APCTT ( Asian & pacific centre for transfer of technology): It is a United Nations Regional Institution under the Economic & Social Commission for Asia and the Pacific (ESCAP). Established in 1977 in Bangalore, India. In 1993, the centre moved to New Delhi, India. The main objective of APCTT is to strengthen the technology transfer capabilities in the Asia –Pacific region and to facilitate import/export of environmentally sound technologies to/from the member of countries.

13. APCTT Contin.. APCTT implements developing projects funded by international donors. APCTT undertakes consultancy assignments in various technology transfer areas. The activities of APCTT are thus focused on three specific area: -Technology innovations for sustainable development -Technology transfer and commercialization -Start-ups and technology based small and medium sized enterprises (SMEs).

14. APCTT Functions Research and analysis of trends,conditions,and opportunities. Advisory services Dissemination of information and good practices Networking and partnership with international organizations and key stakeholders. Training of national personnel, particularly national scientist and policy analysts.

15. NRDC [National research development corporation]: The NRDC was a non departmental government body established by the British Government to transfer technology from the public sector to the private sector. The NRDC was established in India in 1953 to develop & promote technologies developed at various R & D institutions . In 1981, the NRDC was combined with the National Enterprise Board to form British Technology Group.

16. NRDC Contin.. NRDC involved in transfer of technologies ,inventions,patents,and processes from the national research and development institutions and universities that are under the Control of the department of Scientific and Industrial Research Ministry of Science and Technology. The main aim of the NRDC is promotion ,development and commercialization of TT from public sector to private sector.

17. NRDC Vision To be a leading technology transfer organization in India. Mission To promote and develop , nature and commercialize innovative , reliable , and competitive technologies from R&D institutes through value addition and partnership. To sensitize and R&D institutions and industry about technologies that need to be develop and commercialized. Typically the NRDC would patent the product for commercial exploitation and earn royalties as private sector companies generated sales from those products.

18. NRDC Contin.. Programmes undertaken by NRDC Promotion of technology commercialization in the country and abroad dissemination of information through R&D industry meet Conferences ,seminars, workshops Exhibition Foreign exhibition Publication

19. NRDC Contin.. Programmes and Budgetary Allocations Programme for development of technology inspiring for commercialization Digital knowledge base for commercialization of innovations Digital portal Membership and subscription Technology value addition Basic engineering design package Market survey on assigned technologies Development projects and value addition of priority projects Promotion of innovation in Rural and North East Region. Entrepreneurship Development Programme in backward and rural areas through innovative appropriate technology.

20. Programmes and Budgetary Allocations 2.Programme for inspiring inventors and innovators Innovate India conference Intellectual property and innovation facilitation Intellectual property and technology facilitation centre Knowledge management programme for promotion of innovators/technologies. NRDC university facilitation innovation centre. Other IPR activities

21. On line IPR and knowledge management courseware for certificate programme Promotion and propagation of inventions and innovations Prize award to meritorious inventions and open source technologies Patent assistance, patent seminar, patent search Technology knowledge management programme Techno commercial support scientist, innovators and student for process trial and validation of technologies. 2.Programme for inspiring inventors and innovators

22. TIFAC ( Technology information, Forecasting and assesmement Council) TIFAC is an autonomous organization set up in 1988 under the Department of Science & Technology. The main objective of TIFAC is to promote and support the technology, innovations in selected areas of national importance. TIFAC embarked upon the major task of formulating a Technology Vision for the country in various emerging technology areas. May play a major role in developing strong foresight framework and network for the country by carrying out foresight studies in crucial sectors of national importance.

23. TIFAC contin .. TIFAC concentrates on technology innovation and development through various sustained programs between industry and academia . TIFAC released its Vision 2020 under the leadership of Dr.APJ Abdul Kalam, the former chairmen of TIFAC IN 16 technology areas in 2016 . TIFAC has been inaugurated by Hon'ble Prime minister of India Shri.Narendra Modi in 12 thematic areas of national priorities and importance in Mysuru, Karnataka. The 12 thematic area are, Education, Food and agriculture,Energy,Habitat,Infrastructure,Medical science and healthcare,water,Environment,Transportation,Manufacturing,Materials,Information and communication Technology.

24. BCIL [Biotech consortium India limited]: BCIL, New Delhi was incorporated as public limited company in 1990 under the Company Act, 1956. BCIL is promoted by the Department of Biotechnology, Ministry of science and technology, Government of India and All India Financial institutions. BCIL’s major functions include the development and transfer of for the commercialization of biotechnology products, project consultancy, biosafety awareness & human resource development .

25. BCIL has been successfully managing several Flagship schemes & programs of the department of biotechnology. A few has been listed below 1.Biotechnolgy Industrial Training programme (BITP) 2.Biotechnolgy industry partnership programme (BIPP) 3.Small business innovation research initiative (SBIRI) Schemes Undertaken by BCIL

26. Strengths of BCIL BCIL was aimed for providing the necessary linkages among stakeholders and business support to facilitate the acceleration of commercialization of biotechnology. BCIL assist scientists, technologies research institutions,universities,first entrepreneurs, the corporate sector, national and international organizations, central government, bank and financial institutions. BCIL works in the following aspects: Technology transfer, Project consultancy, Fund syndication, Information dissemination ,Manpower training and placement related to biotechnology.

27. Recent technologies Transferred by BCIL S.no Technology title Biotechnology sector Year 1 Hemorrhoid Treatment device Medical device 2018 2 Shigella vaccine Vaccine 2019 3 Improved Bt (Bacillus thuringiensis) cotton technology Vaccine 2020 4 Brucella vaccine Animal vaccine 2020

28. TBSE ( Technology Bureau for Small Enterprises) It was established in the year 1995. TBSE provides the opportunity to the small enterprises to at the global level acquisition of technology or establish business collaboration. TBSE works under development commissioner ,ministry of micro, small and medium enterprises and is partially funded by office of development commissioner, small scale industries and government of India.

29. The important features of TBSE are: TBSE Offers a professionally managed system for technology and collaboration search. TBSE build up confidence between partners. TBSE has proper mechanism for arranging technology and finance. TBSE provides a gateway to global technology market through networking. TBSE takes up project appraisal and preparation of business plan.

30. SIDBI (Small Industrial Development Bank of India) SIDBI was established on April 2,1990 ,through and Act of Parliament , under the Department of Financial Services, Government of India . It is a development financial institution in India. The head quarter is situated at Lucknow,Uttarpradesh. The purpose of SIDBI is to provide refinance facilities and short term lending to industries , and serve as the principal financial institution in the Micro, Small and Medium Enterprises sector.

31. THANK YOU