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Regulatory News | 05 October 2015
As more drugs and active pharmaceutical ingredients (APIs) are manufactured in India, foreign regulators are increasingly looking to strengthen relations with India's Central Drugs Standard Control Organisation (CDSCO).
On Monday, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) did just that, signing a Memorandum of Understanding (MOU) with CDSCO, as part of plans to increase collaborations between the two countries to keep medicines and medical devices safe.
Nearly 25% of UK medicines are made in India, and upon importation, each batch is tested for safety, quality and efficacy. And similarly to their US Food and Drug Administration (FDA) counterparts, MHRA assessors inspect Indian sites to ensure Good Manufacturing Practices (GMP). In 2014, MHRA conducted more than 125 inspections in non-EU countries, 49 of which were in India.
MHRA chairman, Professor Sir Michael Rawlins said, “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."
Under their first MOU, the regulators agreed to promote each other’s regulatory frameworks, requirements and processes. The deal will also include the facilitation and exchange of information and opportunities for technical cooperation of mutual benefit, helping to ensure both regulators are better equipped to protect public health.
The agreement is similar to those already in place between MHRA and other regulators in China and the US, although it is a standalone bilateral document. CDSCO has also previously made efforts to align itself further with FDA and the European Medicines Agency.
Dr. Gyanendra Nath Singh, India’s Drugs Controller General, added: "Quality medicine, affordability and transparency will be the tools for making medicines available to the people of the two nations."
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.
Tags: CDSCO, MHRA, India, UK, GMP inspections