DOP To Overhaul Regulatory Norms To Expedite Approval Process And Promote Innovation

Bengaluru, 25 March 2021:

The Department of Pharmaceuticals (DoP) is contemplating an overhaul of regulatory norms to expedite the approval process and promote innovation.

Efforts are on to move towards a system of ‘single window’ on the one hand and a ‘deemed approval’ process. In order to enable the industry move towards being self-reliant, the productivity linked incentive (PLI) schemes version I and II were announced. 

Once the regulatory guidelines for faster approvals are in place, more investors and entrepreneurs will come forward to make Prime Minister Narendra Modi’s AtmaNirbhar programme a reality, said BR Sikri, co-chairman, Northern Region, CII committee of lifesciences and biotech, chairman of FOPE and VP of BDMA.

At the CII’s Regional Conference on Strengthening Indian Pharma Sector with a focus on Supportive Regulatory Framework & Enhancing Exports, Sikri as the moderator of the second session put forth a 9-point recommendation to the government and sought its immediate consideration.

First was that priority for approval of research based products. The second was for a dedicated wing in DCGI for clearances of APIs which are replacement of imports from China. Third was the need to ensure that every aspect of the regulatory outlook was India centric. Fourth was the simplification in the regulatory system to translate ease of doing business.

The fifth recommendation was to tighten the loose ends in the system. Sixth was that if a regulatory approval could not be given within a said time-frame, then it should be deemed for clearance. Seventh is either DOP or CDSCO should play vital role in industry- academia tie up. Eighth was clinical trials of new drugs and vaccines in particular should have priority over other categories of products to reduce the clearance time to prevent like Covid events in the future. Ninth was the need to omit the many redundant provisions in the Drugs and Cosmetic Act, which has no relevance.

Expressing concern about Indian pharma industry’s low compliance rate, Sikri said CDSCO needs to come up with remedial steps to ensure better performance. For instance, the compliance in European Union accounted for 98%, ROW is 94%, US and Japan is 93%, China is 90% and in the case of India, it is 83%.

Indian pharma will need to match global quality standards and adopt the international technology trends. Therefore the focus of R&D and innovation should be the priority of the government and the industry. In order to achieve this, constant and seamless interaction is needed. The country has the biggest advantage of a young and vibrant pool of pharma entrepreneurs and start-ups who can achieve this, said Sikri.Pharmabiz