Cabinet approves signing of MoUs between India and Suriname in the field of medical products regulation
The Union Cabinet, chaired by the Prime Minister Narendra Modi, approved Memorandums of Understanding (MoUs) signed on June 4, 2023 between Indian drug standard and control organisations and the Ministry of Health, Government of the Republic of Suriname for cooperation in the field of medic product regulation and recognition of Indian Pharmacopoeia (IP).
An MoU was signed 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. This was signed during the visit of the President of India to Suriname.
Another MoU was signed between the Indian Pharmacopoeia Commission (IPC), ministry of health & family welfare, Government of India and the Health Ministry of Republic of Suriname.
The purpose of the MoU signed by CDSCO is to facilitate a constructive dialogue on the laws and regulations pertinent to medical products as well as other relevant matters.
The MoU seeks to establish a framework for fruitful cooperation and exchange of information between the CDSCO and Ministry of Health, Government of the Republic of Suriname in matters relating to Medical products regulation in line with their international responsibilities.
The main areas of cooperation between the two Regulatory Authorities include 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 forum organized by the Parties.
Capacity building in mutually agreed areas, Coordination at the international fora, Any others areas of common interest. The MoU will facilitate 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 export of medicines from India and consequentially could help in better employment opportunities for educated professionals in the pharma sector.
The signed MoU between the regulatory authorities of the two countries will facilitate better understanding of medical products regulation with regard to pharmaceuticals including raw materials for pharmaceutical use, biological products, medical devices and cosmetic products, said the ministry of health and family welfare.
The MoU will promote exchange of information and cooperation in areas pertinent to medical products and relevant administrative and regulatory matters within the jurisdiction of the parties.
Under the MoU signed by the IPC, the parties recognize the importance of developing close cooperation and exchanging information in the field of the regulation of medicines in accordance with their respective laws and regulations.
The other understandings based o. This MoU are to accept Indian Pharmacopoeia (IP) as a book of standards for medicines in Suriname so as to ensure quality of medicines being manufactured and/or imported in Suriname; to accept the Certificate of Analysis issued by Indian manufacturers per IP and to do away with requirement of duplicate testing of the medicines in Suriname; to get IPRS and Impurity standards from IPC at reasonably low cost to be used during the quality control analysis; to have better scope for development of generic medicines and contributing to availability of affordable medicines in Suriname; to promote an understanding of pharmacopoeia in regulatory framework, requirements and processes; to facilitate the exchange of information and documentation relating to the development of monographs of IP; to enhance the ability of regulatory authorities in the provision of their services relating to or in connection with public health, to meet the needs of their respective population; and to explore opportunities for technical cooperation in areas of mutual benefit in the development of monographs and future technologies.
The MoU will facilitate export of medical products leading to foreign exchange earnings.
International recognition of the Indian Pharmacopoeial Standards has several benefits to the Indian pharmaceutical sector including that it would boost the export of Indian pharmaceutical products to these countries as it would remove double regulation, duplication in testing and post importation checks. Indian drug exporters would thus, gain a competitive edge and trade would become more remunerative.
Further, importing nations would gain access to quality Indian medical products at affordable prices.
Manufacturers in importing countries would have better scope for development of generic medicines contributing to availability of affordable medicines to their citizens.
The various reference standards and impurity standards would become available to these manufacturers at a reasonable cost.
Convergence in the regulatory practices could help in increasing export of medicines from India and consequentially help in better employment opportunities for educated professionals in the Pharmaceutical sector.
The Indian Pharmacopoeia (IP) is officially recognized by five countries: Afghanistan, Ghana, Nepal, Mauritius and the Republic of Suriname. The Ministry seeks to expand the nations which recognize the IP, said the Ministry of Health.
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