Usha Sharma – Mumbai
With the aim to UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is in dialogue with three state regulatory authorities – Maharashtra State Food and Drugs Association, Gujarat FDCA and Andhra Pradesh FDA – for signing Memorandum of Understanding (MoU) aimed at more transparency and better understanding of regulatory procedures.
Gerald W Headdell, Director – Inspection, Enforcement and Standard Division, MHRA said, “India is a major supplier of medicines to the UK accounting for 20 per cent of the medicines imported into UK. Nearly 70 per cent generics available in the UK are from India itself. And we think these numbers are likely to increase in the future as well. As a regulator it is my responsibility to ensure the safety and authenticity of medicines imported from other countries. Since India is the largest supplier to UK we are initiating MoUs and talks with different state FDAs in line with these responsibilities.”
Headdell continued, “This will be a purely knowledge sharing project, which will help both the countries better understand the respective countries’ regulations.”
Mahesh Zagade, Maharashtra FDA commissioner said, “Maharashtra itself exports 40 per cent medicines to the UK. Thus it is very Important to understand the requirements and be in line with their standards. To understand this better, we are in discussion with the UK MHRA towards signing an MoU. We foresee that this will help accelerate the growth of Maharashtra based pharma companies.”
Headdell further mentioned that they are scheduled to have a discussion with the Drugs Controller General (India) (DCGI) to get a better understanding of regulatory issues at the national level as well.
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