New Delhi: India and the UK will soon establish a framework for fruitful cooperation and exchange of information in the field of medical products’ regulation, facilitating exchange of information and cooperation in various fields related to the sector and control unlicensed exports and imports of medical products.
The move comes after the Union Cabinet, chaired by Prime Minister Narendra Modi, on Wednesday approved the signing a Memorandum of Understanding (MoU) between India and the UK on cooperation in medical products’ regulation.
The pact will be signed between India’s Central Drugs Standard Control Organisation (CDSCO) and the UK Medicines and Healthcare Products Regulatory Agency (UK MHRA).
The MoU will help establish a framework for fruitful cooperation and exchange of information between the CDSCO and the UK MHRA in matters relating to medical products’ regulation in line with their international responsibilities.
The main areas of cooperation between the two regulatory authorities include exchange of safety information, and pharmacovigilance, where there is a particular safety concern related to the other party, which includes safety concerns relating to medicines and medical devices.
The pact will help in participation in scientific and practical conferences, symposia, seminars organised by India and the UK.
It will facilitate in exchange of information and cooperation on good laboratory practices (GLP), good clinical practices (GCP), good manufacturing practices (GMP), good distribution practices (GDP) and good pharmacovigilance practices (GPvP) between the two countries.
It will also help in capacity building in mutually agreed areas.
The pact will help in promoting an understanding between the parties of each other’s regulatory framework, and facilitate future regulatory strengthening initiatives for both the parties.
The MoU will support in exchange of information on laws and regulations regarding medicines and medical devices.
Both the countries will be able to share information and support efforts to control unlicensed exports and imports. They can also coordinate at the international fora.
The pact would also facilitate better understanding of the regulatory aspects between the two sides and could help in increased cooperation in the field of medical products regulation and better coordination in the international fora.
Ms Kalinga