News

Unannounced FDA Checks Add New Compliance Layer for Indian Drug Firms

The U.S. Food and Drug Administration (FDA) has announced that it will now conduct unannounced inspections at pharmaceutical manufacturing sites in India and China, in a move aimed at tightening regulatory oversight of facilities that supply nearly 40% of the generic medicines consumed in the United States.

• By Pooja Chaturvedi Sah
• New Delhi
• Jun 05, 2025

News

The U.S. Food and Drug Administration (FDA) has announced that it will now conduct unannounced inspections at pharmaceutical manufacturing sites in India and China, in a move aimed at tightening regulatory oversight of facilities that supply nearly 40% of the generic medicines consumed in the United States.

The decision, announced on May 6, 2025, comes as the FDA looks to level the playing field between domestic and overseas manufacturers, who have traditionally received advance notice before inspections. The U.S. regulator said the surprise visits will help identify real-time compliance lapses and improve drug quality standards.

“For too long, foreign companies have enjoyed a double standard—given advance notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning. That ends today,” said Dr. Robert Califf, FDA Commissioner, in the official release.

Surge in FDA Inspections in India

FDA inspection activity in India has sharply risen since post-pandemic travel restrictions were lifted. According to data reported by Reuters, the FDA carried out over 200 inspections in India in 2023, up from just 63 in 2022. The agency is also deploying more drug inspectors to its India office in Delhi.

Sarah McMullen, the FDA’s Country Director for India, said: “We are putting every effort into increasing the number of inspections and requesting more drug investigators to be stationed here.”

India is home to over 600 FDA-registered manufacturing units. Many of these companies are crucial to the U.S. supply chain for generics, active pharmaceutical ingredients (APIs), and over-the-counter drugs.

Recent Compliance Setbacks for Indian Companies

Several Indian pharmaceutical firms have recently come under the scanner, facing Form 483 observations, warning letters, or import alerts following FDA inspections:

Granules India received a warning letter in February 2025 citing inadequate cleaning validation, deficient batch record reviews, and other quality control lapses at its Telangana facility.

Piramal Pharma was issued a Form 483 for its Maharashtra API unit in February 2025, flagging data integrity issues, poor equipment maintenance, and lapses in quality assurance.

Sun Pharma, India’s largest drugmaker, was issued a warning letter in June 2024 for CGMP violations at its Dadra facility, including failures in lab controls and out-of-specification investigations.

Jagsonpal Pharmaceuticals made headlines in early 2025 when it allegedly restricted FDA inspector access and delayed the handover of key records. The firm is currently working with consultants to address the violations.

Intas Pharmaceuticals and Kilitch Healthcare also received warning letters in 2023 and 2024 respectively, with both cases involving poor manufacturing controls and documentation.

Trump's MFN Order and U.S. Policy Impact

The FDA crackdown also coincides with the return of Donald Trump to the U.S. presidency and his renewed push to lower drug prices. On May 12, 2025, Trump signed an executive order enforcing a “Most Favored Nation” (MFN) pricing model that mandates U.S. drug prices be pegged to the lowest rate charged in other developed countries.

The policy aims to cut prices of branded medicines by up to 80%. However, its impact on Indian pharma is expected to be limited in the short term.

“The MFN model is largely directed at high-margin innovator drugs. Indian generics, which account for 90% of prescription volume in the U.S. but only 13% of spending, are unlikely to be directly affected,” said Sudarshan Jain, Secretary General of the Indian Pharmaceutical Alliance (IPA).

Nonetheless, industry analysts caution that continued focus on price controls, potential U.S. import tariffs, and higher regulatory scrutiny may affect margins and increase compliance costs for Indian exporters.

How Indian Pharma Is Responding

Indian pharmaceutical companies are preparing for stricter scrutiny by investing in automation, quality assurance, and regulatory preparedness. Internal audit mechanisms have been strengthened, and several companies have hired U.S.-based consultants to help align with FDA standards.

Some firms are also expanding their footprint in the U.S. to better manage supply chains and regulatory risks:

Syngene International, a Biocon subsidiary, acquired its first biologics manufacturing site in the U.S. in early 2025.

Sun Pharma completed the acquisition of New York-based Checkpoint Therapeutics in March 2025, boosting its American operations in oncology and immunology.

Industry groups are also lobbying for greater transparency in FDA communications and faster remediation timelines, especially in cases where violations are procedural rather than safety-related.

According to the Ministry of Commerce, India’s pharmaceutical exports to the U.S. stood at $9.8 billion in FY2024-25. Maintaining regulatory compliance is vital for sustaining this trade.

Outlook

With FDA inspections becoming more frequent and unpredictable, Indian pharmaceutical companies are under pressure to meet higher global benchmarks. Trump’s drug pricing push adds a fresh layer of uncertainty.

While Indian generics are unlikely to lose their cost advantage, such decisions present both challenges and opportunities for India's pharmaceutical industry. And as India continues to play a central role in the global pharmaceutical supply chain, how the industry navigates these regulatory and geopolitical headwinds will shape its standing for years to come.