New Delhi: The Union Cabinet has approved a Memorandum of Understanding (MoU) signed on 4th June, 2023 between the Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, Government of the Republic of India and Ministry of Health, Government of the Republic of Suriname on cooperation in the field of Medical Product Regulation.
The aim of this MoU is to facilitate a constructive dialogue regarding the laws and regulations relevant to medical products, as well as other related matters.
Moreover, a framework for productive collaboration and the exchange of valuable information will be established between the Central Drugs Standard Control Organization (CDSCO) and the Ministry of Health, Government of the Republic of Suriname. This cooperation will focus on matters pertaining to the regulation of medical products in accordance with their international responsibilities.
Key objectives of cooperation between the two Regulatory Authorities include the following:
- Promoting an understanding between the Parties of each other’s regulatory framework, requirements, and processes and facilitating future regulatory strengthening initiatives for both Parties.
- Exchange of information and cooperation on Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP) and Good Pharmacovigilance Practices (GPvP).
- Recognition of Indian Pharmacopoeia.
- Exchange of safety information, including Pharmacovigilance, and adverse events where there is a particular safety concern related to the other Party. This includes safety concerns relating to medicines and medical devices.
- Participation in scientific and practical conferences, symposiums, seminars and forums organized by the Parties.
- Capacity building in mutually agreed areas.
- Coordination at the international foray.
- Any other areas of common interest.
- The MoU will facilitate the export of medical products leading to foreign exchange earnings. This would be a step towards an Atmanirbhar Bharat.
- Convergence in the regulatory practices could help in increasing the export of medicines from India and consequentially could help in better employment opportunities for educated professionals in the pharma sector.
This strategic partnership will facilitate a better understanding of medical products regulation with regard to pharmaceuticals including raw materials for pharmaceutical use, biological products, medical devices, and cosmetic products.
It will also promote an exchange of information and cooperation in areas pertinent to medical products and relevant administrative and regulatory matters within the jurisdiction of the parties.
