The Government of India (GoI) has taken a bold step to expedite the availability of medical treatments, potentially bringing certain life-saving therapies such as cancer and rare disorders to millions of its citizens quickly. Greenlighting this regulatory shift eliminates the need for local clinical trials for certain medicines, reflecting India’s confidence in the global regulatory landscape. The immediate benefit is that more Indian patients can access these life-saving treatments without unnecessary delays, potentially saving lives and improving health outcomes.

This move benefits Indian patients and has the potential to reshape the global pharmaceutical landscape. With India’s new policy, many multinational biopharmaceutical companies will need to reflect on how India evolves into a priority market.  

Speaking on the decision, Dr. V.G. Somani, Drugs Controller General of India (DCGI), Central Drugs Standard Control Organization, stated, “This policy shift is designed to bring the best of global medical innovation to India more swiftly. By relying on the robust data from international trials, we can ensure that Indian patients benefit from these advancements without unnecessary delays.”

This is more than just a regulatory update for multinational biopharmaceutical companies—it’s a strategic inflection point. India has long been considered a market of interest due to its significant population, favorable policy environment, and emerging middle class. Now, it has signaled its readiness to engage with the global pharmaceutical ecosystem on a new level.

The shift opens up a new market for these pharma companies. It presents an opportunity, but more importantly, a responsibility to extend their voice in India, increasing corporate brand reputation, science communication, and patient advocacy. It’s a turning point that could redefine the global pharmaceutical landscape, underscoring the weight of their role in shaping the future of healthcare.

S. Rajan, Chief Communications, Corporate Affairs and CSR officer at Roche, is among the industry leaders who applauded the GoI news: “This circular is a welcome and much-needed move. The calling out of specific drug categories will help drive a uniform and consistent understanding and avoid any delays. It is important that this is implemented well. We are hopeful that access to the latest innovations will be expedited, addressing unmet healthcare needs and benefitting Indian patients.”

Eliminating the cost barrier of conducting local clinical trials indicates that the GoI is seeking to address a public health need.  One obstacle has been removed, though others remain. Global biopharma companies still face significant challenges operating in India, primarily due to price controls impacting innovative therapies. At this time, India’s government enforces price caps that too often make it financially unviable for multinational companies to launch new, innovative drugs in this market. But it’s not impossible!

This is a favorable move to bring innovative cancer therapies and treatments for rare diseases to people in India. This remains a market of incredible potential, and biopharma companies will need to continue advancing innovative therapies and supporting them with economic solutions to make the best medicines available to more people worldwide. In the meantime, an expansion strategy to India is a medical and communication priority.

Investing in Corporate Brand Reputation

With India becoming a priority market, global pharmaceutical companies must assess how to build relationships with India’s medical and patient advocacy communities.  This is more than relying on marketing muscle. It’s about establishing a reputation as a trusted partner in health innovation and delivery in fast-emerging nations. This could involve initiatives such as collaborating with local healthcare providers, supporting patient education programs, and participating in policy discussions on health innovation and delivery in India.

Even before the GoI decision, the Indian pharmaceutical market was expected to grow to US$130 billion by 2030, up from US$42 billion in 2021, making it one of the fastest-growing health markets in the world.  The decision to embrace other nations’ regulatory moves will likely dramatically accelerate that growth.

Patrizia Cavazzoni, MD, Center for Drug Evaluation and Research, at FDA, has long tracked GoI decisions: “India’s decision to align its drug approval processes with global standards is a significant step that will foster greater collaboration. It also highlights the need for pharmaceutical companies to engage more deeply with Indian stakeholders, ensuring their corporate presence is synonymous with trust and transparency.”

Like audiences everywhere, the Indian public is increasingly discerning the corporate behaviors of those they entrust with their health.  People with urgent health concerns are excited about this decision, which will speed up access to therapies.  Companies must recognize that investing in world-class science may not be enough in the post-COVID era to secure physician support and consumer confidence.  To facilitate market entry in India requires establishing corporate identities people can trust.

The Imperative for Science-Based Communication

Effective science communication will be paramount as these companies introduce their health innovations into India. The complexities of advanced medical treatments, particularly newly approved ones, require careful explanation to health providers and the public.

Transparent, accessible communication will help demystify these innovations, fostering greater acceptance and understanding.  This also calls on major hospital provider systems that served as drug trial sites for these regulatory-approved medicines to step forward and share clinical backgrounds and best practices in patient care.

According to published studies, 87% of Indian physicians are highly engaged in continuing medical education (CMEs) and are keen to stay updated with the latest advancements in treatments and drug safety protocols, highlighting a receptive audience for apparent, data-driven communication efforts. Companies have an opportunity to lead by example, demonstrating that they are bringing innovative products to market by showing commitment to educating and empowering Indian patients and health professionals.

Dr. V.G. Somani, DCGI, emphasized the importance of clear communication in this new regulatory landscape: “Pharmaceutical companies must now rise to the challenge of effectively communicating the science behind these treatments to healthcare providers and patients. This will be crucial in ensuring that the benefits of these new therapies are fully realized.”

Patient Advocacy as a Pillar of Reputation

Most crucially, multinational pharmaceutical companies must prioritize patient advocacy in India. The recent regulatory change will undoubtedly bring some innovative treatments to the market. The policy change is a catalyst toward ensuring treatments are accessible, affordable, and aligned with patients’ needs.  However, it remains a complex challenge.  India has 1.4 billion people – as many as 400 million classified as middle class – and a diverse and complex healthcare insurance system that includes government, private, and, in some cases, a heavy reliance on consumer out-of-pocket payments.

Companies must engage with patient communities, understand their unique challenges, and advocate for solutions that address them. Organizations such as the Organization for Rare Diseases India (ORDI) and the Lysosomal Storage Disorders Support Society (LSDSS) are among the advocacy groups advocating for patients with rare diseases in India. ORDI ensures early diagnosis, treatment, and support for individuals with rare diseases, while LSDSS focuses on increasing awareness and providing access to therapies for lysosomal storage disorders.

Dr. Manjit Singh, LSDSS Executive Committee President, commented on the significance of this regulatory change: “This policy decision is a critical step forward for patients with rare diseases in India. It will help bring much-needed therapies to the market faster. Still, it also places the onus on pharmaceutical companies to ensure these treatments are accessible and affordable for all patients.”

By engaging with these patient advocacy groups, pharmaceutical companies can help amplify patients’ voices, ensuring their needs are central in developing and distributing new treatments. Over time, this will include ensuring peer-reviewed science is shared with India-based media covering health and science, prioritizing pricing strategies to ensure accessibility to patient support programs, and investing in awareness efforts so that people with these conditions understand the importance of medication adherence.

The Government of India’s decision to waive local clinical trial requirements for drugs approved by gold-standard regulatory bodies is forward-thinking and aligns with the country’s demonstrated efforts to improve health delivery for serious illnesses. Multinational biopharmaceutical companies should get the signal that India is a welcoming market ready to be at the forefront of their phyician education and patient advocacy efforts. By investing in corporate brand awareness, scientific communication, and patient advocacy, these companies can contribute meaningfully to the health and well-being of India and other emerging nations. 

One barrier to access has been lowered for innovative cancer and rare disease therapies.  In reality, others remain.  One of the biggest is that the Indian National Pharmaceutical Pricing Authority sets ceiling prices – caps – that include certain patented and innovative drugs. The pricing formula often uses a cost-plus approach, a non-starter for significant biopharma companies championing breakthrough therapies in a price-referring policy environment.  But the door to possibilities has opened wider.

In responding to the GoI welcoming decision with action, the biopharmaceutical industry can reinforce its commitment to good business, science, and patient care—a true win-win-win for all involved and a global health impact. The message is clear: Pharma companies consider the possibilities and  “Go to India!”