Updated on 17 August 2012
Additionally, critics and supporters alike have called for a revision of the 100 patients rule. Whether it is sufficient for a nation of 1.2 billion or whether this size of patient pool is necessary for a drug that has already been thoroughly tested in clinical trials, albeit in a different country, needs to be addressed.
The curious case of invisible hands
Among other things, the report brought to light the nexus between doctors and pharma companies. It highlighted cases and presented definitive evidence of clear involvement of a third party in the process.
In case of the drug Clevudine (Phamasset), three experts, located at different corners of the country, sent in identical, word by word, letters of recommendation advising the approval of the drug. The third party presence becomes even more obvious in the case of Ademetionine (Akums) where all the four letters of recommendation carried the same mistake of addressing the letters to Directorate General of Health Services instead of DCGI. One of the opinions was also obtained within a day, raising questions on how the study of the drug was carried out in such a short time. The standing committee thus expressed if indeed there was a pair of "invisible hands" that were writing the letters of recommendation for drug approvals.
In another case for Pirfenidone (Cipla), four letters of recommendation from different parts of the country were obtained on the same day and were documented in a consecutive fashion as well, raising suspicions about another agency that collected all these reports and deposited them at the DCGI.
The report not only highlights the inadequacies present in the current Indian system, but also shows how similar drug regulatory bodies of other countries handle similar procedures. It shows how in the case of the USFDA, the comparatively large pool of experts - twenty medical practitioners - showed independent ways of thought and differed in final assessment. A remarkable fact was that these decisions and opinions were in the public domain on their website. Mr Prashant Reddy, blogger at SpicIP, one of the most authoritative blogs on IP protection, said, "The existing framework of drug regulation is more than 60 years old and so far its provisions have been amended mainly for the industry. The hitherto lack of information about CDSCO functioning has always been an issue. Transparency in a regulatory environment is necessary, especially when it comes to health matters."
In India, the expert opinions have also been placed far from public scrutiny unlike other countries as highlighted in report. Negative they might be, but the committee felt that the expert opinions deserve to be in the public domain as they have a paramount effect on the safety of the public.