UK and India regulators agree to co-operate more closely

Published: 5-Oct-2015

With the aim of improving public safety in both countries

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has signed a Memorandum of Understanding (MoU) with its counterpart in India in a move which aims to improve public safety.

The MoU has been signed by the MHRA and India's Central Drugs Standard Control Organisation (CDSCO), part of the Ministry of Health and Family Welfare of Republic of India, under which the two countries plan to increase collaboration on medicines and medical devices and promote each other’s regulatory frameworks, requirements and processes.

It is hoped that the collaboration will facilitate the exchange of information and opportunities for technical co-operation of mutual benefit.

Approximately 25% of UK medicines are made in India and each batch is tested on importation to ensure it is safe, of good quality and effective. The MHRA also inspects Indian pharmaceutical manufacturing sites to ensure that Good Manufacturing Practice standards are adhered to.

'It’s essential that the commitment to good quality manufacturing comes right down from the top levels of management to those on the factory floor, and throughout the entire industry,' said MHRA Chairman, Sir Michael Rawlins.

'Indian firms already accept and understand this, and the MOU is part of a concerted effort to ensure the UK and wider global public continue to have access to quality and safe medicines.'

The agreement, signed by Rawlins and Dr Gyanendra Nath Singh, India’s Drugs Controller General, is similar to those already in place between the MHRA and regulatory bodies in China and the US, although it is a standalone bilateral document in its own right.

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