Pharmacy

Is it really a catch-22 situation when one tries to excel in innovation amid regulations? While one cannot overemphasize the criticality of innovation to sustain growth and expand application avenues, a robust regulatory framework ensures compliance as per prescribed norms. Some of the ground realities related to this came to the fore during the recently concluded Bangalore INDIA BIO 2011. .Although it is obvious to have such operational challenges during the drug approval process, the worrying factor is the extent and impact it has on the efficacy as well as competitiveness of India's biopharmaceutical pipeline in the global market.

The intent is clear. India can and has the potential to play a major role in the global biotechnology space, especially when it is in this new emerging phase. However, as most in the industry feel, the existing regulatory environment has not been a great facilitator in this transition. Rather it seems to have slowed down the pace of drug development. Case in point is the incidence of destroying and remaking time-consuming products already manufactured. Apart from the extra money spent on remaking the product (which is already quite expensive), valuable time is lost in re-manufacturing the product to have the mandatory clearance(s). Also, there are questions raised about the level-playing field for Indian companies vis-a-vis multinationals as far as a standard regulatory protocol is concerned.

The bigger question that one needs to address, and sooner the better, is the way forward for this sector from the present predicament. To begin with, it calls for an incisive introspection and effective collaboration on the part of policy makers and the industry to put in place specific time-bound ways and means by which the operational excellence of the regulatory mechanism can be augmented significantly. If it needs an overhaul of the existing  system, so be it!

The urgency is very much apparent and India cannot afford to miss the emerging global opportunities in the biotech domain. Finally, the laws of the land should not only be supreme but also be subject to review from time to time.