MHRA, Indian Regulatory Authorities Plan Collaboration

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 10-06-2015 17:15


The Medicines and Healthcare products Regulatory Agency (MHRA), the UK's regulatory authority, has signed a memorandum of understanding (MOU) with its counterpart body in India. This agreement is intended to increase collaboration between the two countries in the area of medicines and medical devices with the aim of further improving public safety in the two countries. This 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. Gyanendra Nath Singh, India’s Drugs Controller General, and MHRA Chairman, Professor Sir Michael Rawlins. It provides a formal agreement between the two organizations and seeks to strengthen relations between the UK and Indian governments.

The central understanding of the agreement include promotion of each other’s regulatory frameworks, requirements, and processes. The MHRA said that significant outcomes will include the facilitation and exchange of information and opportunities for technical cooperation of mutual benefit to ensure the regulators are better equipped to protect the health of the public.

In 2014, MHRA carried out more than 550 inspections in the UK and 125 in non-EU countries, 49 of which were in India. 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.MHRA said that it is important that MHRA assessors continue to inspect Indian sites to ensure compliance with good manufacturing practices.

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 the United States although it is a standalone bilateral document in its own right, according to the MHRA.

Source: MHRA


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