For many executives in Mumbai and Hyderabad, the relentless pressure of U.S. FDA compliance can feel like a punishing tax on success. According to IQVIA research, Indian companies supplied about 47% of generic prescriptions filled in the U.S. by volume in 2022; medicines from Indian companies provided $219 billion in savings to the U.S. health care system in 2022 and a total of $1.3 trillion between 2013 and 2022. Yet, the cost of maintaining “inspection ready” facilities is rising while margins on simple generics are thinning.
The market punishment for noncompliance can be immediate and severe; just look at early 2025, when Granules India saw its stock drop 8% overnight following a single warning letter from the U.S. FDA. Within this landscape, it can be easy to view these regulations purely as a defensive cost centre or a massive expense just to keep the factory lights on.
However, when we spoke with our associates in the United States, the narrative flipped from “burden” to “strategic asset.” The reality is that the FDA’s enhanced oversight is acting less like a barrier and more like a filter for the next massive growth frontier: biosimilars. With the U.S. biosimilars market projected to explode from $22 billion to $90 billion by 2034, American buyers are looking for partners with strong compliance cultures, not just the lowest price. As we saw with Aurobindo Pharma recently, companies that demonstrate a “culture of quality” can weather regulatory observations without the catastrophic stock volatility that hits their less prepared peers.
Ultimately, compliance is more than an expensive box ticking exercise; it can be an investment to create a valuable product differentiator. In a crowded market, FDA pre-approval inspection readiness can avoid hangups in the ANDA approval process and provide a formidable shield in product liability litigation. The choice facing Indian pharma today is stark, we can treat FDA standards as an unfair cost and slowly lose relevance, or we can embrace them as the premium entry fee to the high value US markets of tomorrow. This rings especially true with FDA’s creation of an ANDA pilot program in October 2025 that is explicitly designed to reward ANDA applicants who test in the United States.