While it is true that outsourcing demand for clinical trials is increasing, absence of clear regulations for good practices, similar to international standards by contract research organisations is causing apprehensions over accountability and reliability. Due to this, local research organisations may not be able to become reliable partners for overseas pharma-biotech companies.
Citing the examples of recent withdrawals by Ranbaxy and Hetero of their products from markets due to mismatch of bioequivalence tests to WHO standards, many overseas clients are adopting a wait-and-watch policy to outsource high-end research jobs from India, according to industry experts.
There is less possibility of getting higher-end, outsourced clinical research activities by Indian research organisations as there is no data secrecy act in the country, opines VVLN Sastry, country head, Firstcall India Equity Advisors Ltd.
India has many advantages like large pool of treatment-naive patients with multi-racial backgrounds, wide spectrum of diseases, subject recruitment and high subject return rates involved in clinical trials. But, at present, only lower-end jobs like data mining, theoretical studies, identification of new molecules, etc are being offered to research organisations in the country.
The reason for higher-end jobs not coming to the country is primarily lack of implementation of those regulations which are already in place internationally. After becoming experts in reverse engineering process, most of the companies seem to be on the path of data violation, says Dr Sastry.
Agrees Vikram Reddy, president of Silico Insights Biosciences India (P) Ltd, We are waiting for the implementation of the proposed National Biotech Policy. We must not lose out at a time when there are score of opportunities. At present, only confusion prevails on the norms.
Another biotech expert, who did not wish to be named, questioned, Why is there a delay in announcing the biotech policy and how long is it going to take for implementation
Perhaps the delay is because of the formation of many committees to approve the policy, opines another expert.
There might be a few more committees during the implementation part too, they feel.
According to a survey conducted by Firstcall, about 80 government and private hospitals are engaged in global and local clinical trials and the number is expected to increase mani-folds. The Indian research organisation market is estimated to be in the range of $8-10 billion. However, the awareness and adoption of good practices is yet to gain momentum.
The rules and regulations are not altogether new. In fact, some are extracts from the international protocol itself. But the penal process is not as stringent.