Cabinet nod for inking MoU between India, UK for cooperation in medical product regulation

The Union Cabinet has given its approval for signing an MoU between the Central Drugs Standard Control Organization (CDSCO) and the United Kingdom Medicines and Healthcare Products Regulatory Agency for cooperation in medical products regulation, according to an official statement said. The main areas of cooperation between the two regulatory authorities include exchange of safety information, including pharmacovigilance where there is a particular safety concern related to the other party.

"The MoU will help in establishing 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 statement issued on Wednesday said. The other areas of cooperation include participation in scientific and practical conferences, symposia, seminars and fora organised by India and the United Kingdom, exchange of information and cooperation on good laboratory practices, good clinical practices, good manufacturing practices, good distribution practices and good pharmacovigilance practices, and capacity building in mutually agreed areas.

The agreement aims to promote an understanding between the parties of each other's regulatory framework, requirements and processes and to facilitate future regulatory strengthening initiatives for both. It also includes exchange of information on laws and regulations regarding medicines and medical devices and information exchange to support efforts to control unlicensed exports.

"It would 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 international fora," the statement said.