The strengthening of the regulatory system of the CDSCO (Central Drugs Standard Control Organisation) is a major move announced in the budget, says Dr Soumya Swaminathan. “It will pave the way for India to improve the in-house scientific capacity of the regulator and thereby move in the direction of getting to being a World Health Organisation (WHO) Listed Authority (WLA).”
The WLA is a coveted benchmarking system and is for regulatory bodies that meet global standards for medical products (drugs or vaccines), which, she feels, should ideally should be the goal for India. Also, the former and first chief scientist of WHO feels, “this will also be crucial for the biopharma mission announced in the budget. Therefore, both need to go hand-in-hand because the path to innovation-led growth has to be accompanied by a strong in-house regulatory strength.”
Budget proposal aims to align CDSCO with global regulatory standards
Dr Swaminathan was referring to the portion of the budget speech where finance minister Nirmala Sitharaman proposed the move to “strengthen the Central Drugs Standard Control Organisation to meet global standards and approval timeframes through a dedicated scientific review cadre and specialists.”
She said this following the announcement on the biopharma mission of the government. Here she pointed to India’s disease burden shifting towards non-communicable diseases, like diabetes, cancer and autoimmune disorders and in the light of these the need to encourage biotech.
She said: “Biologic medicines are key to longevity and quality of life at affordable costs. To develop India as a global Biopharma manufacturing hub, I propose the Biopharma SHAKTI with an outlay of ₹ 10,000 crores over the next 5 years. This will build the ecosystem for domestic production of biologics and biosimilars.
The Strategy will include a Biopharma-focused network with 3 new National Institutes of Pharmaceutical Education and Research (NIPER) and upgrading 7 existing ones. It will also create a network of over 1000 accredited India Clinical Trials sites.” Many have welcomed this move.
Industry leaders seek higher budgetary support and faster reforms
In fact, in her expectations from the budget, Kiran Mazumdar-Shaw, founder and chairperson of Biocon, the leading biopharma company from India, had hoped the finance minister will take steps towards making significant budgetary allocation to support bio-manufacturing and for scientific capacity building and for talent training.
These, coupled with steps to hasten regulatory reforms would be an ideal mix and stay crucially linked to regulatory science capacity building in the country.