Regulators’ Mission to Realize Modi’s Pharma Vision: Crackdown on Flamingo Pharmaceuticals for Serious Violations
By Our Business Bureau
Prime Minister Narendra Modi’s ambitious vision to position India’s pharmaceutical industry as a global leader in quality, innovation, and affordability is being challenged by regulatory violations that threaten the sector’s reputation. To align with Modi’s goal of elevating India as the “Pharmacy of the World,” regulators are intensifying efforts to enforce compliance. A prominent case is Flamingo Pharmaceuticals Ltd., which faced a closure notice from the Maharashtra Food and Drug Administration (FDA) on August 21, 2025, for severe breaches of Good Manufacturing Practices (GMP) at its Nanded facility, highlighting the ongoing battle to balance growth with accountability.
India’s Pharma Sector: A Global Powerhouse
India’s pharmaceutical industry, with over 6,000 companies producing more than 60,000 generic formulations, generates over $50 billion annually, including $23.5 billion in domestic sales and $26.5 billion in exports in FY 2023-24. Ranking third globally by volume, India supplies 20% of the world’s generic drugs and 60% of the U.S. market’s solid oral dosage forms, with projections to reach $130 billion by 2030 and $450 billion by 2047. However, persistent GMP lapses and substandard drug production pose risks to this trajectory. Since 2020, over 200 manufacturing units have been shuttered, with 144 closures in 2024 alone. Over 100 licenses were suspended or canceled, including 18 in 2023 for spurious drugs. Internationally, 10-15 Indian firms faced U.S. FDA warning letters in 2025 for Current Good Manufacturing Practice (CGMP) violations, with import bans on facilities like Viatris’ Indore plant and blacklisting by countries like Nigeria for banned opioid exports.
Domestic Crackdown: Regulatory Actions Against Flamingo Pharma
On August 21, 2025, the Maharashtra FDA’s Chhatrapati Sambhajinagar office issued a closure notice to Flamingo Pharmaceuticals’ Nanded facility (Plot No. NPH-1, Krushnoor MIDC, Pharma SEZ) following inspections from August 11-14, 2025. The inspections reportedly identified three critical, 28 major, and four minor GMP violations under Schedule M of the Drugs and Cosmetics Act, 1940, including failures in equipment cleaning, process validation, and quality control, which jeopardized drug safety. Flamingo was ordered to stop production immediately and submit a corrective action plan within 15 days, with re-inspection required to resume operations. The company’s admission to the notice without a robust response reflects a lax approach to compliance. This aligns with the Central Drugs Standard Control Organisation’s (CDSCO) intensified risk-based inspections, resulting in over 100 license suspensions and alerts on 100+ substandard drugs in 2025. Small firms face significant challenges, with 25% of 6,000 MSMEs at risk of closure by December 2025 for failing to meet revised GMP standards.
International Repercussions: US FDA Actions
Flamingo also faced international consequences when the US FDA withdrew approvals for two Abbreviated New Drug Applications (ANDAs)—Metronidazole tablets (250 mg and 500 mg, ANDA 207309) and Piroxicam capsules (10 mg and 20 mg, ANDA 207938)—in December 2024. The withdrawal resulted from Flamingo’s repeated failure to submit mandatory annual reports under 21 CFR 314.81 and 314.98, despite reminders. A Federal Register notice on August 8, 2024, offered a hearing opportunity by September 9, 2024, with data due by October 7, 2024. Flamingo’s non-response finalized the withdrawal, barring these generics from the U.S. market. Similar U.S. FDA actions targeted firms like Sun Pharma and Granules India in 2025 for issues like data integrity and sanitation, while EU and WHO regions flagged substandard exports from companies like Aveo Pharmaceuticals for opioid-related infractions.
Modi’s Vision: Balancing Growth with Compliance
Prime Minister Modi’s vision to make India a global pharma leader is supported by transformative initiatives. The Production Linked Incentive (PLI) scheme, launched in 2020 with ₹15,000 crore, has spurred ₹28,000 crore in projects by 2025, boosting domestic production of APIs and complex generics. The ₹3,000 crore Bulk Drug Parks scheme is establishing manufacturing hubs in states like Gujarat and Andhra Pradesh. The expansion of Jan Aushadhi Kendras to 25,000 by 2025 ensures affordable generics, while the India-US TRUST Initiative strengthens global supply chains. Revised Schedule M standards in 2023 align Indian GMP with global norms, facilitating exports. Modi’s August 2025 call for R&D innovation and patents supports “Make in India” and “Atmanirbhar Bharat” campaigns, aiming to position India as a leader in novel drugs.
Broader Implications: Safeguarding Public Health
Flamingo’s lapses reflect systemic challenges that could undermine Modi’s ambitions. Substandard drugs risk treatment failures or fatalities, as seen in past incidents with contaminated exports. Flamingo’s non-compliance threatens financial losses and reputational damage. Industry-wide, over 200 closures and 100+ license suspensions since 2020 highlight the need for reform. Experts advocate enhanced training, digital compliance tools, and proactive audits. As India exports to 200+ countries, aligning growth with safety is critical to prevent public health crises, especially with banned drugs prone to abuse.
Modi’s vision to elevate India’s pharma sector to global leadership hinges on uncompromising quality and compliance. The crackdown on Flamingo Pharmaceuticals, part of a broader regulatory cleansing, underscores the resolve to enforce standards, protecting public health and India’s reputation. Stakeholders must collaborate to strengthen oversight and compliance infrastructure, ensuring that India’s pharma industry, with its vast network of companies and formulations, fulfills its potential as a trusted global leader.
