Thursday, August 09, 2012
In response to consistent pressure from external agencies to impose some kind of quality control on "traditional Indian herbal" medicines, India may very soon make it mandatory for traditional medicines to undergo clinical trials before they hit the market. However the mandatory trials may be made applicable only for new patented drugs and not for ancient formulations. See TOI report.
There are two reasons why clinical testing should be done at least on the newer patented drugs based on herbal therapy / products. Most herbal products are multi-component mixtures, and that adoption of the therapy takes place before any investigation is done. The second reason provides all the more reason to conduct scientific studies.
Even though traditional herbal therapies / products are in widespread use throughout the world, this does not mean that traditional herbal products have a favorable risk-reward ratio. The actual benefits and risks remain to be evaluated by clinical trials. However, merely making the clinical trials mandatory would be counter-productive. The manufacturers would require some sort of compensation in terms of the amount expended on clinical trials. Generally this has been done by providing some sort of incentive to manufacturers / patentees. Shamnad, in one of his earlier posts, had argued in case clinical trials are conducted, a compensatory mechanism other than data exclusivity should be used.
Our readers would also remember that data exclusivity debate was sort of closed some time last year. As Shamnad had discussed in the post, the Minister, who chaired the meeting announced that India will not accept data exclusivity norms as this would have considerable impact in delaying the entry into the market of cheaper generic drugs."
However, in the case of herbal products, my guess is that Indian manufacturers would be the ones who would be most impacted. The reason is clear: India is currently world number 2 (after China) in terms of production of herbal drugs. This essentially would reignite the data exclusivity debates. We can only hope that this time the parliamentary committee debate the issue properly.