Updated on 17 August 2012
Mr Prashant Reddy, blogger at SpicIP, one of the most authoritative blogs on IP protection said that, "Data exclusivity remains a sticky issue. Since the Indian pharmaceutical industry is dominated by generic companies, who stand to be affected greatly if it comes into play, it will continue to be one."
In a nutshell, what it means is that MNCs that carry out clinical trials for their drugs in the country currently do not have exclusive rights over this data for a stipulated time, unlike some other countries. It does raise the question why MNCs would invest in carrying out trials if that data can be taken by other generic companies freely. This has certainly stopped them from adhering to the set rules for drug approvals.
The ripple effect
Along with the pharma industry, the next in line to be most affected by this report has been the CRO community. Mr Shoibal Mukherjee, chief medical officer, Quintiles India, and head, Asia Medical Sciences Group, said that, "In the last two years, there have been long delays in regulatory approval of clinical trial applications in India. Further, uncertainties relating to the regulatory environment in India have led to some sponsors excluding India from their global development plans. Consequently, we would not be surprised to find significant reductions in the annual number of clinical trial approvals in the last two-to-three years."
Dr Bopanna too added that there have been delays in approvals for clinical trials, "Currently, these approvals are taking more than six-to-eight months, and and with the release of this report, this delay might increase."
However, the critical issue is the follow through or the lack of it. The Mashelkar report in 2007 on the CDSCO had similarly provided recommendations for the revamp of the organization, though much was left to be desired with the action taken following that report. A three-member committee comprising Dr V M Katoch, secretary and DG, ICMR; Dr P N Tandon, president, National Brain Research Center; and Dr S S Aggarwal, former director, Sanjay Gandhi Postgraduate Institute of Medical Sciences, have been set up to look into the report and suggest appropriate measures.
This happens to be crunch time for the Indian government to not just stop at acknowledging the report but also take some much needed definitive action by acting on its recommendations. As the deadline for the expert committee constituted for looking into the report draws to a close, the industry and general public alike wait for concrete action to be taken.