India’s proposed new agile pharma regulations will benefit innovator companies


India is overhauling its pharma regulatory norms to expedite approval process and promote innovation. Given that the country is now focused more than ever on developing novel therapies and vaccines on account of the COVID-19 situation, the move will not only remove unnecessary procedural roadblocks but also foster innovation, says GlobalData, a leading data and analytics company. 


In May 2020, a high level committee in India proposed that there will be a single-window system to accelerate the approval of new drugs. Accordingly, parallel submission of applications for new drug approval and for grant of import license and manufacturing license will be allowed. Additionally, the Central Drugs Standard Control Organisation (CDSCO) will now be the first designated point of registration for clinical trials of all drugs and vaccines, which is likely to significantly reduce the approval time to as little as three months from 12 months.


The report says, The process overhaul is a paradigm shift from the standard sequential process. The pharma industry in India has long reiterated that there is a need to come up with an agile regulatory system along the lines of those followed in the US and the EU.”


GlobalData forecasts the Indian pharmaceutical market to increase from nearly US$34.3bn in 2020 to more than US$45bn by 2025.


In 2015, India had approved US$233m (INR17.5bn) towards the strengthening of the drug regulatory system, of which only US$66m (INR5bn) was utilized until 2019. The Drugs Controller General of India (DCGI) had laid down emphasis on the initiatives to fast-track the regulatory process in 2018.


The report further says,“Although the preliminary activities for the revision of regulatory processes started way back in 2015, less than a third of the approved funding has been utilized. Faster and more judicious use of funds to streamline the regulatory processes and systems, and manpower, will boost the credibility of the regulator.”


Moreover, with the Department of Pharmaceuticals (DoP) proposal to take over CDSCO, multiple departments involved in the drug approval process will be brought under a single umbrella.


Report concludes: “The recent regulatory reforms are a clear indication that India really wants to focus on innovation in the pharma industry. The centralization process will help bring in more transparency in the existing systems with clear mapping of responsibilities and accountabilities in a time bound manner. This could mean accelerated access of multiple novel therapies and vaccines for Indian patients. It is likely to encourage even the international innovative companies to view India as a priority market from the research and development investment perspective.”