Clinical research market in India is currently undergoing a metamorphosis with Indian CRO's playing an important role in it. With more companies looking at innovation, the world is looking at the Indian CRO's as a medium for drug discovery rather than a mere drug development destination. Apurva Shah, the group managing director and Co-founder of Veeda Clinical Research explains the changing dynamics of the industry to Suja Nair Shirodkar.

What is the overall size of the clinical research market globally and where does India stand in it?
The overall size of clinical research market globally is estimated to be in range of US$ 15to 17 billion and India stands at US$ 500 million with a growth rate approximately 15 per cent.

Do you think that the global economic crisis has affected the business interest of the Indian CROs?
It is difficult to give answers in a simple yes or no. However after analysing the situation it can be implied that the global economic crisis did have a short- term impact on the industry by slowing down the business.

But then on a positive note, it did lead to the emergence of two progressive trends. The innovator pharmaceutical companies are finding new places to do their research in a more time and cost - effective manner and India is certainly one of the favoured destinations for this due to our track record.

Secondly, due to the high cost involved in availing health care facilities, the governments of various countries are increasingly adopting generic medicines and considering that India has a very strong capability in generics ,we are seeing a big demand for our services.

The problem we are facing are not related to the changing market dynamics only but it also deals with the uncertainty on various regulatory issues in India. In short, we are creating problems for our own growth due to ignorance of the facts and lack of governance and enforcement of the law.

What are the advantages that India in particular Gujarat offers as compared to other countries?
The advantages of conducting clinical research in India is well documented and Gujarat takes the lead in providing the perfect environment to encourage it.  Gujarat has been offering a very stable business and political environment for over more than a decade and it is  expected that it will keep on strengthening it in the future as well.  This will help in fostering an ecosystem that supports R&D activites, attracting scientists and researchers from across the country to Gujarat.   

What are the regulatory issues faced by the CRO's in the country? any specific issue that you would like to highlight ?
Lack of proper regulatory guidelines act as a set back to the industry. Indian regulatory guidelines are unable to keep pace with global regulatory requirements. The general opinion is that the Indian regulatory system is more reactive than proactive, easily affected by the negative rumours.  It is found that the clinical research policies in our country are being dictated by political pressures rather than scientific reasoning.

I believe that India needs to have a stronger policy for developing research capabilities, so that we can stay ahead in the race for achieving supremacy for developing new drugs.  Most importantly research initiatives should be focused on those areas that require urgent attention especially for those diseases profiles that are prevalent among the Indian population.

Which diseases is the focus of clinical research at Veeda?
Veeda specialises in early phase clinical studies like BA/BE, DDI’s, SAD’s, MAD’s, POCs and PK/PD etc. We also have a strong focus on oncology, diabetes, CNS, dermatology and ophthalmics.

Do you think there is  shortage of skilled and experienced work force in the clinical research segment? What solutions do you suggest to tackle this issue?
Shortage of skilled manpower is not a big issues for us since the demand is equal to the supply. Companies with good reputation and track record are usually sought out by good professionals thus there is hardly any issue of lack of skilled manpower. We have not seen any problem in our company so far when it comes to demand for expert manpower. To ensure this we provide area specific training to fresh graduates so that we get trained people on the job as per our requirements. This team consisting of specialised and passionate scientists and other professional help us in achieving our goal and establishing us in this field.