Indian clinical trials market to grow at 30% to touch $ 600 m in 3 years

All the major pharmaceutical and biotech players as well as major CROs are making India their base for conducting global clinical trials

Clinical trial outsourcing market in India is forecasted to grow at a CAGR of over 30% during 2010-2012 to around US$ 600 million by 2012, says new report by RNCOS.

India will become one of the highest growing clinical trial destinations in the world, with this kind of growth, according to the study titled “Booming Clinical Trials Market in India”.

India is becoming a major hub for clinical studies because all the major pharmaceutical and biotech players as well as major CROs are making India their base for conducting global clinical trials.

Finding and recruiting patients – the most crucial part of the clinical research — who can qualify for a clinical trial, is relatively much easier in India as compared to the Western countries.

Increasing prevalence of diseases and low cost of clinical trials are other factors promoting this market. Syngene and Quintiles are right on top in terms of market share in a market which are rather crowd with more than 100 firms working in India in the clinical trial market.

However, weak IPR protection, lack of trained staff, etc., which are blocking the proper growth of the market. So, in order to ensure proper growth of the industry, these issues need to be addressed efficiently.

The Indian government needs to take several iniatives to ensure an easy approval system for promoting foreign investments, the report said.

In June, Indian government has made registration of all clinical trials conducted in the country mandatory from 15th June 2009. The new registration norm will be applicable to the clinical trials started after 15th June 2009, stated the notification from the Central Drugs Standard Control Organisation (CDSCO) –the DCGI’s office.

Registration of clinical trials in the registry has not been held compulsory in India so far, even though India has become a sought-after destination for outsourcing clinical studies for drug makers across the world.

Currently, a total 987 clinical studies are being run at various centers in India, according to ClinicalTrials.gov, a service by US National Institutes of Health. As of now, only less than 25 of the nearly thousand ongoing clinical studies are registered in India with the Clinical Trials Registry because such registration formalities were voluntary for the companies.

Dr Surinder Singh, DCGI, has been reiterating the need for making the registration of clinical studies mandatory for sometime now. Recently, Dr Singh announced in press gathering that clinical trials registration, along with their auditing, would be made compulsory in India, as part of his efforts to bring in more accountability and transparency into the controversial clinical trail industry. “

Registration of clinical trials in a publicly accessible registry is very important as it improves the accountability of the stake-holders and also ensures that key information is made available to the public,’’ stated the notification dated 1st of June, 2009.

The Clinical Trials Registry- India (CTRI) has been set up by the ICMR’s National Institute of Medical Statistics (NIMS) and is funded by the Department of Science and Technology (DST) through the Indian Council of Medical Research (ICMR).

The idea behind setting up of the Clinical Trials Registry-India (CTRI) is to encourage all clinical trials conducted in India to be prospectively registered before the enrollment of the first participant and to disclose details of the 20 mandatory items of the WHO International Clinical Trials Registry Platform (ICTRP) dataset.

The CTRI dataset is meant to: 1) improve transparency and accountability, 2) improve the internal validity (details of the methods of the trial that produce reliable results, primarily the method of random sequence generation, concealment of allocation, blinding of participants and investigators, and inclusion of all participants results) of trials right from the design,through conduct and reporting, 3) conform to accepted ethical standards and 4) lead to reporting of all relevant results of all clinical trials in India and the region.

The CTRI is an online register of clinical trials being conducted in India.