In early August, India’s Central Drug Standard Control Organisation (CDSCO) decided to eliminate the need for local Indian clinical trials for certain drugs if they have already been approved in the EU, US, UK, Australia, Japan, and Canada. This new regulation and new waiver have been recorded under the 2019 — Rule 101 of the New Drugs and Clinical Trials Rules. Specifically, new drugs in certain categories, orphan drugs, drugs used in pandemic situations, cell and gene drugs, or drugs that are better than already registered drugs for certain diseases, will be under this directive. The Indian government wants to fast-track these drugs as well as other medical products to get them to the Indian population as soon as possible. Accordingly, some foreign and domestic drug manufacturers will surely benefit since they will now be able to reduce clinical trial costs and timelines to market their products in India.
India’s Organization of Pharmaceutical Producers Association was pleased with this new Circular that reduced clinical trial requirements. In addition, this organization is hoping that reduced local clinical trials in India will be carried over for other categories of drugs already approved in the same advanced countries. This group is also seeking clearer guidance on what constitutes new drugs that are better than existing therapies. Who will make this determination, and when can the industry expect more details? Overall, the organization hopes this will be the start of aligning India’s drug availability closer to global healthcare.
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.