Understanding Indo-UK health regulations

Research between India and the UK is growing and joint research funding between both countries now exceeds £100 million. An important strand in this research co-operation is health and biopharma. But if this research is to become real-world treatments and medical products, regulations in both countries will come into play. Therefore, regulations which support collaboration, and well informed communities on both sides, are things we’re keen to support.

With that in mind, I led a delegation to the UK in March 2013 to understand the UK regulations and learn best practices. The group were keen to establish contacts with the UK regulators and play a part in future research engagements with both countries. The delegation comprised Dr. Monika Bahl who is the Director-Portfolio (Clinical) Management, CDSA, Ms. Sonia Gandhi, Programme Manager, BIRAC and Balram Sankaran, scientist from the Sree Chitra Tirunal Institute of Medical Sciences, which is well-known for its innovations in medical devices.

The cold, damp London weather did not deter our mission. Our first stop was at the Medicines and Healthcare Products Regulatory Agency (MHRA). In fact the MHRA is in India this week on a roadshow touring various cities. The MHRA is responsible for regulating all the medicines and medical devices, blood and blood products in the UK by ensuring they work and are acceptably safe.

What struck us was that it was generating its own funding unlike India’s CDSCO. There are clear, well defined processes at MHRA for each of the strands of the products that were being regulated including very strict deadlines for decision making. MHRA works with the EU through the European Medicines Agency (EMA) and their expert committees.  When it comes to medical devices, the MHRA also appoints notified independent private bodies who check and verify that manufacturers and devices meet relevant requirements.

Our next stop was at the Human Tissue Authority (HTA), a watchdog that licenses storage and use of human tissue for purposes such as research, patient treatment and teaching.  They regulate bone banks, eye banks, stem cell banks etc.

Next, at the EMA, it was our turn to share India’s regulations. Monika, assisted by Balram and Sonia, did a splendid job in presenting it and explaining questions raised by the EMA. EMA is responsible for the scientific evaluation of applications for European Union marketing authorisations for human and veterinary medicines. Most of the Agency’s scientific evaluation work is carried out by its scientific committees, which are made up of members from EU countries, as well as representatives of patient, consumer and healthcare-professional organisations.

Lastly we also visited the National Institute for Health and Care Excellence (NICE) which provides evidence based independent advice to the department of Health, NHS and social care practitioners leading to improvement in healthcare standards. A lot of NICE material is available free online on their website which any healthcare practitioner or provider can download for use.

More widely, there is a great deal of interest in Indo-UK collaboration across regulation and quality control of drugs and medical devices. And an agreement to work together through agencies such as the CDSCO, India, and the UK MHRA, UK, to encourage exchange of information, collaborative inspections, and technical cooperation.  Expect to hear more on this in my future blogs.

Overall, during the visit we were left with a feeling that making medicines and products safe and efficient is a humongous task and all countries need to pitch in their bit. We also wished that someone invented a device that could bring the Sun and its warmth out from the clouds whenever one wanted in the UK! But I think that much more difficult than the first!!

I’ll leave you with a comment from Balram Sankaran: “It was a good learning experience and a great opportunity to directly interact with the key people in UK’s regulatory system and to have face to face discussions. I am sure that this opportunity to interact will culminate in a long term professional partnership and interaction for evolving still better global regulatory practices.”