The Medicines and Healthcare products Regulatory Agency (MHRA) has today (5 October 2015) signed a Memorandum of Understanding (MOU) with its counterpart body in India. This agreement will increase collaboration between the 2 countries in the area of medicines and medical devices with the aim of further improving public safety in the 2 countries.
This is the first MOU agreed with the Central Drugs Standard Control Organisation (CDSCO), part of the Ministry of Health and Family Welfare of Republic of India and was signed by Dr Gyanendra Nath Singh, India’s Drugs Controller General, and MHRA Chairman, Professor Sir Michael Rawlins. It provides a formal agreement between the 2 organisations, and strengthens relations between the UK and Indian governments.
The central understandings of the agreement include promotion of each other’s regulatory frameworks, requirements and processes. Significant outcomes will include the facilitation and exchange of information and opportunities for technical cooperation of mutual benefit, helping to ensure the regulators are better equipped to protect the health of their respective publics.
MHRA Chairman, Professor Sir Michael Rawlins said:
We are committed to protecting the health of UK citizens and that’s why we are continuing to formalise our collaborative efforts with key partners like India.
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.
Dr Gyanendra Nath Singh commented:
The MoU signed between MHRA and CDSCO 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.
In 2014, MHRA carried out more than 550 inspections in the UK and 125 in non-EU countries, 49 of which were in India. The India Brand Equity Foundation states that the Indian pharma sector accounts for about 2.4% of the global pharma industry and is the 3rd largest in terms of volume.
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 and it is important that MHRA assessors continue to inspect Indian sites to ensure Good Manufacturing Practice – a globally recognised regulatory framework.
Sir Michael Rawlins added: “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.
“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 signing of the MOU took place at CDSCO’s headquarters in New Delhi and was followed by a series of meetings to discuss next steps.
The agreement is similar to those already in place between MHRA and other counterpart bodies in China and America, although it is a standalone bilateral document in its own right.