OncoDaily Global Health & Policy, Dr. Amalya Sargsyan, medical oncologist and Vice President for Research and Intelligence at OncoDaily, spoke with Kaitlyn Jagger, U.S. Government Affairs Representative for the Indian Pharmaceutical Alliance (IPA). The discussion explored the critical role of generic medicines in oncology, the global dependency on pharmaceutical supply chains, US and India collaboration, and strategies to strengthen drug security while maintaining quality and affordability.
The interview addressed pressing concerns for clinicians, policymakers, and patients alike: drug shortages, upstream manufacturing vulnerabilities, regulatory oversight, and the economic forces shaping access to cancer treatment.
The Role of Generics in Modern Oncology Care
Jagger began by outlining her professional background, noting that she has worked in the pharmaceutical industry for over 35 years and previously led the Generic Pharmaceutical Association. She now represents the Indian Pharmaceutical Alliance, a coalition of 23 major international pharmaceutical companies involved in both branded and generic drug manufacturing.
She emphasized that the pharmaceutical ecosystem depends on a balance between innovation and access. While branded medicines benefit from patent protection and exclusivity to incentivize innovation, generics enter the market after patent expiry to improve affordability. She highlighted that generic drugs are typically priced approximately 80% lower than their branded counterparts, significantly expanding access across healthcare systems worldwide.
According to Jagger, nine out of ten prescriptions dispensed in the United States are generics, with Indian manufacturers supplying approximately 50–60% of those medicines. Over the past decade, generics have generated an estimated $1.3 trillion in savings for the U.S. healthcare system, benefiting patients, families, veterans, employers, and public payers.
For oncology patients in particular, affordability is not merely an economic issue but a determinant of treatment continuity and survival. Jagger underscored that cost remains a substantial burden for many families facing cancer diagnoses.
Supply Chain Vulnerabilities and Upstream Dependencies
A central theme of the discussion was global dependency on China for active pharmaceutical ingredients (APIs) and key starting materials (KSMs)—critical upstream components required to manufacture finished drugs.
Jagger explained that during the COVID-19 pandemic, India reassessed its own supply chain dependencies and recognized its reliance on Chinese inputs. In response, the Indian government introduced a Production-Linked Incentive (PLI) program aimed at strengthening domestic manufacturing of essential APIs and KSMs, including those used in oncology therapies such as treatments for leukemia, lymphoma, and melanoma.
She described upstream pharmaceutical inputs as analogous to critical minerals in other strategic sectors, stating that “medicine security is national security.” Policymakers in both the United States and Europe are increasingly recognizing the importance of diversifying supply chains to reduce geopolitical risk.
Jagger advocated for deeper collaboration between the United States, India, and Europe to co-develop and co-invest in critical oncology drug inputs, noting that no single country can independently manufacture all essential components in a short timeframe.
Quality Assurance and Regulatory Oversight
Addressing common concerns about the quality of generics, Jagger emphasized that regulatory oversight is robust. She noted that companies within the IPA include “lighthouse manufacturing facilities,” meaning they represent some of the highest global standards in pharmaceutical production.
She highlighted the industry’s support for:
- FDA Quality Maturity Metrics
- Unannounced inspections
- Transparency regarding country of origin
- Deployment of AI-driven and advanced manufacturing technologies
Jagger acknowledged that isolated quality issues at smaller manufacturers sometimes shape public perception. However, she stressed that enforcement actions are appropriate when problems occur and that major manufacturers adhere to stringent regulatory standards.
Importantly, she reaffirmed that FDA-approved generics must demonstrate equivalence in safety and efficacy to branded products. If they do not meet regulatory standards, they are not approved.
Drug Shortages: An Economic Root Cause
The interview also addressed recurring drug shortages in oncology, including shortages of older, widely used chemotherapy agents.
Jagger argued that the primary drivers of shortages in the U.S. are economic rather than manufacturing-related. She pointed to intense pricing pressures imposed by group purchasing organizations (GPOs) and other intermediaries, which can reduce margins to unsustainable levels for manufacturers. When only one producer remains viable in the market, supply fragility increases.
She emphasized that resolving shortages requires addressing structural economic incentives, including:
- Predictable and fair pricing
- Reform of intermediary fee structures
- Encouraging multiple manufacturers to maintain market entry
Without such reforms, she warned, the system remains vulnerable to disruption.
Addressing Fear Campaigns Around Generics
Dr. Saran raised the issue of skepticism among physicians and patients regarding generics, particularly when marketing influences perceptions.
Jagger acknowledged that branded pharmaceutical companies have historically engaged in what she described as “fear campaigns” to maintain market share. However, she reiterated that regulators—not marketing narratives—should guide clinical trust. She emphasized that FDA and European regulators require generics to demonstrate therapeutic equivalence.
She noted that generic utilization in the United States has risen from approximately 38% in 2000 to nearly 90% today, reflecting widespread acceptance and proven safety.
Trade Policy, Tariffs, and Reshoring Manufacturing
The conversation also touched on debates surrounding import tariffs on pharmaceuticals. Jagger cautioned that imposing tariffs on generics could inadvertently exacerbate shortages and increase costs.
Instead of punitive measures, she advocated for incentive-based strategies to reshore critical API manufacturing to the United States and strengthen partnerships with trusted allies such as India.
She referenced potential use of Title III of the Defense Production Act to support domestic pharmaceutical infrastructure, framing medicine supply as a strategic priority akin to defense and energy sectors.
The US and India Affordable Medicine Partnership
Looking ahead, Jagger described ongoing negotiations under the broader U.S.–India trade framework, particularly within the TRUST initiative. She expressed hope for a more formalized U.S.–India Affordable Medicine Partnership, focused on:
- Diversifying critical oncology inputs
- Expanding API manufacturing capacity
- Enhancing supply chain resilience
- Supporting sustainable generic markets
She stated that recent years have been dedicated largely to educating policymakers about upstream risks and dependency on China. Now, she believes discussions are shifting toward actionable solutions.
As she summarized, health security ultimately represents national security, and governments are beginning to recognize the urgency of proactive reform rather than reactive crisis management.
The interview underscored the interconnected nature of oncology care, global manufacturing, economic policy, and national security. While clinicians focus on individual patients, broader policy decisions determine whether treatments remain accessible, affordable, and consistently available.
Generic medicines have already demonstrated their ability to expand access and reduce financial toxicity in cancer care. Strengthening global partnerships—particularly between the United States and India—may represent a critical step toward building a more resilient, equitable oncology supply system.
As both speakers emphasized, ensuring that cost does not prevent cancer patients from receiving lifesaving treatment is not merely an economic challenge—it is an ethical imperative.
Written By Aren Karapetyan, MD