The UK Medicines and Healthcare products Regulatory Agency (MHRA) that looks at regulations pertaining to medicines, devices, advanced medicinal products, nanotechnology and tissue engineering, is keen to strengthen its relationship with Indian regulatory authorities. In a recent exclusive face-to-face interview with BioSpectrum at London, Prof. Kent Woods, Chief Executive, UK MHRA, discusses about the agency's India strategy.

What are the strategies adopted by MHRA for India?

India is very important as a partner-country to the UK for pharmaceuticals, not just for large scale generic products but also for biotechnology products, and as a site for clinical trails. Because of this, India will get considerable priority in our  international strategy. Today, we have about 50 inspection visits to India per year, with an average of one visit per week. And that offers not just manufacturing, but also GCP and distribution support.

In terms of contribution of Indian manufacturers to UK pharmaceuticals, about 25-26 percent of all marketing authorization for generics in the UK comes from an Indian manufacturing site. Last year, we visited India and met government officials, the office of the Drug Controller General of India (DCGI). The purpose of our visit was to make personal contact with officials in India, to interact with companies about the prospects of marketing their products into the European Union, and find areas of regulatory difficulty that they would like to discuss with us, and also to inform ourselves better with respect to the dynamics of an emerging nation like India.

Our meetings in India were very successful, we made some strong contacts that would help in initiating agreement between the two regulatory offices. We have developed contacts with the Indian industry. We are looking for support from government officials so as to enhance the availability of regulatory information to the Indian companies. It is just a question of making us more easily accessible to Indian companies and to provide support when needed.

What are the challenges in India that the MHRA is willing to tackle?  Are there any concerns in the field of clinical research in India?

Due to the rapid change in the situation, building the capacity for inspection is a real challenge. The Director of Inspections at MHRA has had discussions in India for joint initiatives between inspectors from both the countries. The real challenge is the pace in which the Indian pharmaceuticals industry  is developing, and the scale of work that is required to set up a GCP and GMP inspections. The problems, in general, are the same everywhere because we are all involved in a globalized industry and, therefore, there is increased interaction between the countries in the globalized system.

In clinical trials, there are no concerns in particular. But, many Indian companies are looking at the opportunities in the EU market. So, we would like to be an agency that provides information and support in terms of  regulations, to companies that are in early stage of development.

Which are the other emerging nations the MHRA is focusing on a priority basis?

India and China are high priority areas for us because of the scale of trade between these countries. We also  have a number of links with other parts of the world for different reasons, for instance, we have established links with the Saudi Arabia agency, visited Ghana for pharmacovigilance, established contacts with world regulatory agencies such as the FDA and the DGA in Australia and Health Canada.

How will you compare the developments in India and China?

In China, there is a rapid pace of change in APIs, but, now, there are a lot of clinical trials happening in China. The pharmaceuticals industry is also more likely to take off. With respect to China, MHRA is more concerned about understanding API manufacturing, whereas in India, it is more of generics finished products and in both the regions, MHRA focuses on the rapidly growing biotechnology and clinical trial sector. These are exciting and productive times to be in these countries.

With innovation being the main focus for the UK life sciences industry, how is MHRA promoting innovation in EU?

We work  quite closely with the UK government through a group called Ministerial Industry Strategy group and looking actively at innovation. Today, there is a wide spread concern on the pace of development of completely  new products in the market. There is a project that has been initiated by the UK government to accelerate market access to products where there is a  strong public need and where there is a solid research base. Our intention is to bring the time lines of these very products down, and we will bring out guidelines and proposals to address this issue. This shows our commitment towards promoting innovation in the field.