With the COVID-19 pandemic making clear the urgent need to speed approvals and enable flexibility in pricing of innovative biopharmaceutical products, regulators in India have drafted a new set of measures to streamline innovative drug research and development.
Released in draft form earlier this year, the measures aim to slash in half the time it takes to get innovative products approved. To accomplish such rapid turnaround, the draft measures call for sharing data across regulatory agencies and establishing a pathway for jointly processing, inspecting, and approving products.
The plans also include establishing a digital portal that could be accessed and employed by various departments and regulators, allowing them to share information and synchronize workflows as products move through the regulatory process. Under these plans, regulatory agencies would increase their cadres of experts in testing, approving, and appropriately pricing biopharmaceuticals.
Down the line, the plans include proposals to encourage academic researchers to commercialize their research, in the way that technology transfers between academic institutions and commercial drug developers in the West has fueled innovation in the biopharmaceutical fields for decades.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8617546/