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Medicines and Healthcare products Regulatory Agency (MHRA) signs Memorandum of Understanding (MOU) with its counterpart body in India.

The Medicines and Healthcare products Regulatory Agency (MHRA) has signed a Memorandum of Understanding (MOU) with its counterpart body in India on Monday 05th October 2015. 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.

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.

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.

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The CMA on 15 September 2015 has published guidelines to help policymakers assess the potential impact that their proposals could have on competition.

Through lower prices and greater choice the Competitive markets have benefited consumers, by encouraging suppliers to create new products and different ways of bringing products to markets.

Government intervention in markets - including through regulation and legislation - can have the unintended side effect of restricting competition in a number of ways. These Competition and Markets Authority (CMA) guidelines provide policymakers with advice on how to assess whether proposals could affect competition adversely. The guidelines also suggest ways in which proposals could be re-designed in order to support competition.

There are 2 parts to the guidelines. Part 1 provides an overview of when and how policymakers can consider the competition implications of their proposals, including understanding whether a detailed competition assessment is necessary. Part 2 provides practical advice on how to conduct a competition assessment.

The guidelines complement the Green Book and Better Regulation Executive’s processes by providing a more detailed guide for how policymakers can take competition considerations into account when developing proposals.

According to CMA Senior Director, Research, Intelligence and Advocacy, The CMA is keen to promote competitive markets and, as government itself recognises, the policies developed by other parts of government can help or hinder that.

These guidelines are intended to help policymakers assess the impact policy proposals may have on competition, whilst achieving their original public policy goals. We will continue to work with government departments to assess specific policy proposals as they arise.

This new guidance from the CMA will help policy makers consider the impact of new regulation and identify where existing rules are getting in the way.

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7 October 2015
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