Editor’s (re)View: Not a good week for India’s Sun Pharma and API manufacturer Hikal

The U.S. Food and Drug Administration appears to be ratcheting up its regulatory enforcement activities when it comes to Indian drug and active pharmaceutical ingredient (API) manufacturers, with Sun Pharmaceutical Industries Limited and Hikal Limited both cited by the agency for serious violations of current Good Manufacturing Practice (cGMP).  

This week, Sun Pharma announced that following an FDA inspection in June at its troubled Halol factory in Gujarat, India — which resulted in the issuance of a Form-483, with eight observations — the regulator has now classified the facility as “Official Action Indicated” and “not fully compliant” with cGMP.

“The Halol facility is under Import Alert, resulting in the refusal of shipments from the facility into the U.S., barring certain exemptions due to drug shortage, until the facility becomes fully compliant with FDA and cGMP standards,” according to Sun Pharma’s announcement. In December 2022, the Halol facility was similarly placed under Import Alert by the FDA.

Pharma Manufacturing analyzed the FDA’s recently released Complete Response Letters (CRLs) issued between 2020 and 2024, finding that 74% involved quality/manufacturing issues — including problems with manufacturing processes, facility inspections, or chemical, manufacturing and controls (CMC). Several companies were hit with multiple CRLs over those years, including Sun Pharma.

This week, the FDA revealed that since 2020 Indian API manufacturer Hikal has “failed to adequately determine the root cause of approximately 22 complaints” from customers “related to metal contamination” in its APIs. The agency slapped Hikal with a warning letter in August 2025 which was posted on the FDA’s website on Tuesday, following a February 2025 inspection of the company’s facility in Jigani, India.

Hikal’s “significant” cGMP deviations included failures in quality control with the FDA deeming the company’s APIs to be “adulterated” under the Federal Food, Drug, and Cosmetic Act. In particular, the regulator called out the failure of a Hikal quality unit to ensure that quality-related complaints are investigated and resolved.

Hikal told the FDA that “particles were metallic in nature and were beyond the detection limit” of its metal detector used to remove particles in APIs. However, the metal detector is now working satisfactorily, according to the company.

“The current performance of the metal detector does not provide adequate assurance that previous API lots met established safety and quality standards,” the FDA wrote in its warning letter to Hikal. “Also, your conclusion that your metal detector works adequately stands in contrast to customer complaints indicating contamination with metallic particles.”

The good news is the FDA’s oversight of manufacturers in India, including inspections of manufacturing facilities, seems to be working on some level in determining if these sites meet standards of quality and safety. The bad news is these companies have repeated cGMP violations over several years.