India and Netherlands Medical products Regulation
Source: PIB
GS II: Bilateral, regional and global groupings and agreements involving India and/or affecting India’s interests
Overview
- News in Brief
- Central Drugs Standard Control Organization (CDSCO)
- Netherlands
- India-Netherlands Bilateral Relations
Why in the News?
The Union Cabinet was apprised of a Memorandum of Intent (MoI) signed between the Central Drugs Standard Control Organization (CDSCO), the Ministry of Health and Family Welfare, Government of India and the Ministry of Health, Welfare and Sport, Kingdom of the Netherlands.
News in Brief (India and Netherlands Medical products Regulation)
- The MoI was signed on 7th November, 2023.
- The MoI seeks to establish a framework for fruitful cooperation and exchange of information.
- The MoI between the regulatory authorities of the two countries will facilitate a better understanding of medical product regulation about pharmaceuticals
- This includes raw materials for pharmaceutical use, biological products, medical devices and cosmetic products.
- Convergence in regulatory practices could help in increasing the export of medicines from India
- MoI helps in better employment opportunities for educated professionals in the Pharmaceutical sector.
- The MoI will facilitate the export of medical products leading to foreign exchange earnings.
- This would be a step towards an Atmanirbhar Bharat.
Central Drugs Standard Control Organization (CDSCO)
- The Central Drugs Standard Control Organisation(CDSCO) under the Directorate General of Health Services, Ministry of Health & Family Welfare.
- It is the National Regulatory Authority (NRA) of India.
- Its headquarters is located at FDA Bhawan, Kotla Road, New Delhi 110002
- It has nine zonal offices, seven sub-zonal offices, eighteen Port offices, seven central laboratories and six mini-labs spread across the country.
- The Drugs & Cosmetics Act,1940 and Rules 1945 have entrusted various responsibilities to central & state regulators for the regulation of drugs & cosmetics.
- It envisages uniform implementation of the provisions of the Act & Rules made there for ensuring the safety, rights and well-being of the patients by regulating the drugs and cosmetics.
- CDSCO is constantly striving to bring out transparency, accountability and uniformity in its services to ensure the safety, efficacy and quality of the medical products manufactured, imported and distributed in the country.
- Under the Drugs and Cosmetics Act, CDSCO is responsible for
- Approval of Drugs
- Conduct of Clinical Trials
- Laying down the Standards for Drugs
- Control over the quality of imported Drugs in the country
- Coordination of the activities of State Drug Control
- Organizations providing expert advice with a view of bringing about uniformity in the enforcement of the Drugs and Cosmetics Act.
- Further, CDSCO along with state regulators, is jointly responsible for granting licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.
Netherlands
- Former name Holland
- The Netherlands, is a country in northwestern Europe.
- The official language is Dutch
- Borders
- Germany to the east
- Belgium to the south
- North Sea coastline to the north and west
- Maritime borders with the United Kingdom, Germany, and Belgium.
- 26% situated below sea level.
- Amsterdam is the country’s capital.
- It is a parliamentary constitutional monarchy.
India-Netherlands Bilateral Relations
- Water, Agriculture and Health (WAH) are 3 priority sectors of cooperation besides technology and innovation.
Indian Diaspora
- The Netherlands hosts the second-largest Indian Diaspora (after the UK) in Europe.
- Totalling around 2,60,000 comprising 60,000 Indians and 2,00,000 strong Surinami-Hindustani community of Indian origin.
- The Netherlands is a popular education destination for Indian students, particularly in the field of science & technology.
Trade and Commercial Relations
- Netherlands is India’s 4th largest trading partner in Europe in 2021-22.
- It is the 4th largest investor in India.
- Exports worth USD 12 billion and imports worth approx. USD 5 billion.
- Cumulative FDI inflows from the Netherlands to India from April 2000 to June 2022 amounted to USD 43 billion.
- 300 Dutch companies are present in India.
- 300 Indian companies, including all major IT companies such as TCS, HCL, Wipro, and Infosys.
Ports/Shipping/Inland Waterways
- Both sides signed an MoU in the fields of Ports and Maritime Transport and Logistics in 2008.
- Special focus on research and development, shipbuilding, innovation and sustainability.
- The 4th Indo-Dutch Forum on Smart & Sustainable Port-Led Development was held in September 2020.
S&T and Space
- Netherlands Organization for Scientific Research (NWO) collaborates with major national funders of research in India.
- The Netherlands was India’s partner country in the Technology Summit 2019.
- The Netherlands was a partner country with India for the Global Bio India 2021 Virtual Summit.
Healthcare cooperation
- MoU for Cooperation in the Field of Healthcare and Public Health was signed in January 2014.
- Aims to promote global research collaboration in emerging health challenges associated with communicable diseases and antimicrobial resistance.
- India and the Netherlands cooperate through a Joint Working Group on Health led by the Ministry of Health
- 3rd meeting of this JWG was held in April 2021.
Renewable Energy
- The Netherlands signed the Framework Agreement of the International Solar Alliance (ISA) in May 2018.
- India is one of the convening countries of the Global Commission on Adaptation (GCA), headquartered in the Netherlands.
- NITI Aayog and the Embassy of Netherlands, signed a Statement of Intent in 2020 to work together to support the decarbonisation and energy transition agenda.
Cultural Cooperation
- Yoga is very popular in the Netherlands.
- The Gandhi Centre has been functional in The Hague since 2011.
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