How CRDMO Leaders can Leverage the BioSecure Act for New Opportunities

In an exclusive interview with India Pharma Outlook Magazine, Kapil Choudhury, Head of Global Business Development, Aurigene Pharmaceutical Services, shares how the Indian CRDMO leaders can equip themselves for the incoming business resulting from the ruling of the BioSecure Act. Kapil has nearly 17 years of professional experience and has a solid pharmaceutical background across leadership profiles. Currently, he is leading the business development for Aurigene Pharmaceuticals, a fully-owned subsidiary of Dr. Reddy's, focusing on growing the business by providing exceptional customer services for global pharma and biotech companies.

Given the recent amendments to the BioSecure Act, how well is the Indian CRDMO industry positioned to capitalize on this opportunity?

The Biosecure Act amendments present a significant opportunity for India's CRDMO industry. This Act focuses on enhancing global biosecurity standards, controlling the movement of biological agents, and enforcing stricter regulatory compliance. Though still in the legislative process, the Act is expected to pass soon. This legislation could mark a pivotal moment for the Indian CRDMO industry as it strengthens its appeal for global outsourcing and partnerships.

India has the largest number of FDA-approved plants outside the U.S. and a deep understanding of global regulatory standards, making it a reliable partner for international pharmaceutical companies. Combined with highly skilled scientists and rich experience with manufacturing generics, biosimilars, vaccines, and biologics, the country is well positioned to be a development and manufacturing partner for new medicines.

With the development of new biotech and special economic zones, India's infrastructure supports the growing demand for high-quality medicines. Programs like the production-linked incentive (PLI) scheme, the Make in India initiative, and investments in areas like Genome Valley are drawing significant global investments to India's CRDMO industry.

Given the anticipated influx of orders, what steps should Indian pharmaceutical companies take to strengthen their reputation and readiness?

With rising interest from major pharmaceutical players, particularly following the Biosecure Act’s provisions, Indian companies stand to attract significant attention and investment. Over the next few months, global pharmaceutical companies are expected to make strategic decisions, and India is likely to be favored due to the Biosecure Act’s eight-year grandfathering clause, which supports a gradual transition. To capitalize on this opportunity, CRDMOs should prioritize the following critical areas for immediate action:

Investing in Science, Technology, and Infrastructure: Companies must continue enhancing their scientific capabilities, innovation, and infrastructure. This means significant investments in advanced equipment and facilities to match the industry's evolving global standards. A strong focus here lies on digitalization, improved productivity, and high ESG (Environmental, Social, Governance) standards to contribute to a sustainable supply chain.

Building and Nurturing Talent: The CRDMO sector needs specialized talent, but only a few professionals in India have the necessary experience. CRDMO services demand a unique, service-oriented approach. Addressing this talent gap involves cultivating expertise in both scientific research and CRDMO processes, including drug discovery and development. This is crucial for scaling up operations and competing with international players who have a larger pool of skilled professionals.

Companies should work at the grassroots level to tackle this talent gap by engaging with academic institutions, promoting careers, especially for women in fundamental science, and attracting young talent to the CRDMO sector. This outreach and nurturing of a service-oriented mindset will help build a robust talent pipeline and drive long-term growth in India's CRDMO industry.

Given concerns about data security, especially regarding genomic data, what measures should the Indian pharmaceutical sector focus on?

Data security is an escalating concern, especially as the global focus on data protection intensifies, particularly in sensitive fields like genomics. In India, frameworks such as the National Cybersecurity Policy and the Digital Personal Data Protection Bill 2023 provide governance for data security and privacy. For biosafety oversight, the Review Committee on Genetic Manipulation (RCGM) under the Department of Biotechnology (DBT) is central in regulating the safety and compliance of genetically modified products, including vaccines and gene therapies. While data security itself is addressed by national cybersecurity laws, regulatory bodies like RCGM play an indirect role in ensuring responsible data handling practices for genetically modified products.

Over time, Indian companies have built considerable trust with global partners. Concerns around data exclusivity, particularly before India transitioned from a process to a product patent regime, have diminished. Transparency remains essential to maintaining trust with international partners, and Indian companies are increasingly educating partners about regulatory processes and approvals to build confidence.

 While review processes through bodies such as the RCGM can be lengthy, this is largely due to rigorous documentation requirements and comprehensive assessments. Streamlining these processes while upholding quality standards is a priority for India’s regulatory landscape. Additionally, certain regulatory pathways, such as waivers for phase III clinical trials for products already approved by stringent regulatory authorities, enable faster approval and controlled data exchange.

India must stay vigilant to maintain this trust, as even a single data breach could harm its reputation. Regulatory bodies like the RCGM and other oversight committees provide essential biosafety and compliance oversight, ensuring secure practices in the handling and approval processes for genetically modified and biologic products.

You recently attended CPHI Milan; how was your experience, and what were your takeaways from the event?

This year’s CPHI event was again vibrant and dynamic, attracting widespread participation across the global pharmaceutical value chain.

 Sustainability took center stage, with many companies showcasing eco-friendly practices and robust ESG standards. This commitment to environmental responsibility was evident on the show floor, with features ranging from sustainable giveaways to reusable booth materials.

 AI-driven drug discovery and development was another key theme across every stage—from R&D to supply chain management. At Aurigene Pharmaceutical Services, we are investing in our own AIDD (AI-assisted Drug Discovery) platform to accelerate drug discovery for our partners, highlighting how AI is becoming integral to innovation and efficiency in pharma. Technology-driven supply chain management, with advancements in track-and-trace capabilities and automation, was also a major focus.

 With rising biosecurity concerns, many companies are exploring India as an alternative manufacturing hub. Concerns about the impacts of current geopolitical tensions were also palpable, as instability in various regions could reshape the global pharmaceutical landscape.

India’s CRDMO infrastructure is advancing rapidly with robust government and market support. Leading CRDMO players are making substantial investments in this space. Aurigene is investing significantly across three key areas: enhancing manufacturing capacity, expanding infrastructure, and upgrading technology to meet rising global demand and further establish India as a preferred pharmaceutical hub.