Indian biotech startup sector – a rapidly growing business segment – has expanded tremendously in the post-COVID era. The biotech startups aim to develop innovative healthcare products, which have huge potential to make substantial contributions to the Indian economy. During the COVID-19 pandemic, a fast regulatory approval process to meet the urgent medical need benefited the bio-entrepreneurs. Recent initiatives of the Indian government have encouraged many academicians, scientists, and technocrats to become entrepreneurs. They expect swift regulatory approvals, which can facilitate fast entry into the market and accelerate the journey from startup to unicorn. This brief review discusses regulatory challenges faced by Indian bio-entrepreneurs and suggests pragmatic regulatory approaches to ease their burden.
Start-up strategy for success
The founders of start-ups are mostly academic basic scientists, who have innovative product ideas but are not experienced in clinical trials for product development and regulatory approval of products for marketing. They have limited funds, which are dependent on achieving important product development milestones. Hence, they are focussed on the rapid completion of the development of products which can move quickly from bench to bedside. The Indian regulatory environment would appear very demanding to these entrepreneurs.
Indian regulatory intricacies
Central Drugs Standard Control Organisation (CDSCO) has the primary responsibility and authority for the regulation of products. Other government organisations e.g. Department of Biotechnology or the Indian Council of Medical Research (ICMR) have an advisory role for certain product categories. The regulatory system is based on New Drugs and Clinical Trials Rules (NDCTR) 2019, guidelines, processes, checklists, and review by advisory committees. The rules are often amended through Gazette Notifications. Bio-entrepreneurs are interested in developing a diversity of new healthcare products based on new sources, new targets or new formulations. The spectrum of such products includes new chemical entities (NCE), new drugs with new indications or new routes of administration or new dosage forms, modified or sustained release formulations, novel drug delivery forms, vaccines, medical devices, and in-vitro diagnostic medical devices. The clinical development and regulatory approval requirements would be different for each of these products. However, the CDSCO website, which is the main source of regulatory information, does not guide regulatory requirements for specific state-of-the-art innovator products or links to relevant info available on the other government department websites. Divergent regulatory requirements between NDCTR 2019 and Medical Device Rules 2017; between NDCTR 2019 and biologics guidelines; and the need for animal studies for approved new drugs with modified or new claims would make the regulatory process time-consuming and costly for a startup. This scenario may make startup companies explore countries like Australia or Canada for clinical trials, which have less cumbersome regulatory approval processes.
Rationalising regulatory requirements
Internationally, health authorities play an active role in guiding bio-entrepreneurs in navigating the regulatory path. US Food and Drug Administration’s Center for Drug Evaluation and Research’s (CDER) Small Business and Industry Assistance (SBIA) helps industry stakeholders have immediate access to resources, education and training to support them in planning efficient developmental processes. CDER’s Pre-Submission program allows start-ups to obtain FDA’s feedback on specific questions to guide product development or application preparation. FDA had also planned a conference on innovation in Medical Product Development Regulatory Education for Industry (REdI) which included:
1) Drug track to address major advances and innovation across various aspects of the drug development spectrum,
2) Devices track to provide an overview of marketing approval and best practices for quality, safety and effectiveness,
3) Biologics track to focus on the product development approach for vaccines and other biological products.
European Medicines Agency (EMA) offers advice to micro, small and medium-sized enterprises (MSMEs) about regulatory requirements by phone or email. SMEs can also meet the EMA team to discuss regulatory strategy for product development and understand available procedures, guidance, and incentives.
ICMR and CDSCO’s MedTech Mitra is a laudable initiative that aims to foster the development of affordable and accessible indigenous medical devices/ In-vitro diagnostics by providing strategic handholding support to MedTech innovators for clinical evaluation, regulatory facilitation and uptake of new products through consultation meetings for innovators. MedTech Mitra website (medtechmitra.icmr.org.in) has details of Clinical Investigation Centres – Indian Clinical Trial and Education Network (INTENT) and Clinical Performance Evaluation Centres. A Public Relations Officer has been deputed by CDSCO to provide information to bio-entrepreneurs regarding regulatory requirements for the commercialisation of their products. However, the bio-entrepreneurs working on state-of-the-art new drugs, medical devices, in-vitro diagnostic tests, and biologics would wonder whether such regulatory advice would help develop international standard products. There is an urgent need for Indian health authorities to take major initiatives to help this budding industry.
Some useful approaches could be:
- A special division within CDSCO targeting the specific requirements of bio-entrepreneurs
- User-friendly website with comprehensive information for a diversity of healthcare products
- User guide describing an overview of procedures to support product-specific IND and NDA processes
- Guidelines and decision tree flow charts to educate the bioentrepreneurs about regulatory expectations of non-clinical and clinical development requirements, especially for new drugs with new claims or modifications
- Create awareness amongst advisory committees and regulatory officers about the unique needs of bio-entrepreneurs
- Pragmatic approach in review of regulatory documentation tailored to the development of specific products
- Formal written regulatory advice after regulatory consultation meetings or email queries on regulatory strategy questions from bio-entrepreneurs Indian innovators, who are creating innovative healthcare products, would play a vital role in fulfilling unmet medical needs of patients of today and the future. They expect the Indian health authorities to facilitate their product development journey in becoming Atmanirbhar!