The Medicines and Healthcare products Regulatory Agency (MHRA) has signed a Memorandum of Understanding (MOU) with its counterpart body in India. The agreement will increase collaboration between the two countries in the area of medicines and medical devices with the aim of further improving public safety.
It is the first MOU agreed with the Central Drugs Standard Control Organization (CDSCO)—part of the Ministry of Health and Family Welfare of Republic of India—and was signed by Dr. Gyandedra Nath Singh, India’s drugs controller general, and Sir Michael Rawlins, MHRA chairman professor.
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.
In 2014, MHRA carried out more than 550 inspections in the U.K. and 125 in non-E.U. 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 third-largest in terms of volume.
About 25% of U.K. medicines are made in India. Each batch is tested on importation to ensure it is safe, of good quality and effective. It is important that MHRA assessors continue to inspect Indian sites to ensure Good Manufacturing Practice—a globally recognized regulatory framework.
The agreement is similar to those already in place between MHRA and other counterpart bodies in China and America, although it is a stand-alone bilateral document in its own right.