The Medicine and Healthcare products Regulatory Agency of UK visits India

Last week, UK Medicine and Healthcare products Regulatory Agency (MHRA) in association with UK Trade and Investment (UKTI) organised a series of seminars in India. The first seminar on the theme of UK regulatory procedures for pharmaceutical products was held in Mumbai on 3 December.

The event brought together over 100 delegates from pharmaceutical and biotech companies and research institutes in Mumbai. This was primarily aimed at industry but regulation is also an important issue for academic and industrial research so we thought we’d let you know about it.

The introduction was given by Ashish Mehta from UKTI who opened the session and welcomed the delegates that had come to soak up the knowledge presented by MHRA experts. There was an engaging talk given by Gerald Heddell, a Director at MHRA, who talked about their work and explained why the UK-India relationship is important.

I was interested to learn that over 25% of the pharmaceutical products in the UK are produced in India. He also informed us that in April next year the National Institute of Biological Standard Control (NIBSC) will merge with MHRA, which will mean a greater capability and breadth of expertise in biologics. Dr Stephen Inglis, Director of NIBSC, was also speaking at the event and in his session highlighted the biologics landscape and regulatory roles.

Dr Satish Singh, Expert Clinical Assessor from MHRA, then took the audience through the journey of centralised and decentralised procedures, and the role of the national competent authority for licensing pharmaceuticals products. I was delighted to see the presence of Indian regulator Mahesh Zagade, Commissioner of FDA Maharashtra at the event, who talked about the similarity in the Medicines Act of India and of the UK.

He also raised concern over medical devices and diagnostics regulation, which he felt needed to be in line with international standards and suggested the Indian regulatory system for devices used a similar process to the effective EU device licensing regulation.

Over lunch I discussed with Gerald MHRA’s plans for meeting state regulators in Mumbai, Ahmedabad and Hyderabad over the week followed by meeting national regulators in Delhi. They were hoping to have an agreement on working together at state and national levels. I am looking forward to seeing the positive outcomes of these meetings, which will further enhance the bilateral relationship between the UK and India.

After lunch Peter Beckingham, British Deputy High Commissioner in Mumbai, welcomed the audience back stating that the UK was very much open to business, particularly in the life science sector, and to start operations in UK by Indian businesses. This nicely led on to Jon Mowles and Ashish Mehta from UKTI highlighting great reasons for Indian companies to invest in UK such as it offers one of the lowest tax rates in Europe and is it easy and quick to set up and register a business there.

The last session of the day was run by Gerald Heddell and Mark Birse, MHRA Group Manager, who they focussed on Good Manufacturing Practice (GMP) inspections, which they presented with the aid of case studies, and how the team use a risk based inspection programme. They also talked about GMP regulations including the upcoming EU’s Falsified Medicines Directive and closed the session with the MHRA’s role in building stronger international links within the GMP arena and ongoing regulatory convergence programmes. With the strength of the UK-India bilateral relationship very much being a common theme the day was concluded appropriately by Gerald saying that MHRA recognises international collaborations and that is the reason they are here in India.

My colleague Nandita attended the seminar In Ahmadabad that was later in the week, which was held in association with the Food and Drugs Control Administration (FDCA) of the Government of Gujarat.  MHRA and UKTI called on Dr H G Koshia, from FDCA, and his team to discuss the opportunities of collaboration between MHRA and Government of Gujarat. As a result MHRA have been invited to participate in the Vibrant Gujarat Global Investors Summit scheduled in January 2013.

A third seminar was held in Hyderabad in conjunction with Dr B.L. Meena, Director General of State Drug Control in Andhra Pradesh. I think all the three seminars have been a huge success and must congratulate my colleague Priya Varadarajan for organising them. About 200 companies in India interacted with MHRA, along with three state regulators and the national regulator in Delhi.

MHRA plans to continue to visit India on regular basis to keep their engagement with Indian pharmaceutical and biotech companies, and regulators strong in the future.