Regulatory Agency of UK, MHRA (Medicines and Healthcare products Regulatory Agency) and its counterpart in India, CDSCO (Central Drugs Standard Control Organization) signed MoU to increase collaboration in the medicine area and medical devices industry to boost public safety. The promotion of their regulatory framework, requirement and processes are the central understanding of the agreement. Additional details regarding Indian regulatory framework, the list of documents required, entry strategies in India, authorized Indian agent could be found in Morulaa’s blog section under the CDSCO category.
The Drugs Controller General India, Dr Gyanendra Nath Singh said, “The MoU is going to create a new platform where patients will be given utmost importance. Quality medicine, affordability and transparency will be the tools for making medicines available to the people of the two nations”. MHRA Chairman, Professor Michael Rawlins said “We operate in a global environment and agreements such as these serve to further strengthen our ability to promote good practices and we look forward to working even closer with our Indian counterparts,”
In 2014, 49 out of 125 inspections held in Non-EU countries were conducted in India alone by MHRA. Overall the MHRA has conducted 550 inspections in UK. India accounts for 2.4 per cent of the global pharma industry and is also the third largest in terms of volume, states the India Brand Equity Foundation.
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