India once again tops the list with the highest number of offending companies. Many of them were placed on the watchlist as early as 2013–2015 and have yet to meet the conditions required for removal.

Notable violators include ACI Pharma, All Serve Healthcare, Altomega Drugs, AMN Life Science, Chemfar Organics, Elegant Drugs, Euro Healthcare, Fine Pharmachem, and Mediwin Pharmaceuticals - all of which have long-standing records of violations.

Some manufacturers, such as AMN Life Science, Medico Remedies, Syncom Formulations, Minimed Laboratories, and Marksans Pharma, have been flagged for non-compliance during both pre- and post-import inspections.

In addition to Indian companies, firms from Bangladesh, China, Indonesia, South Korea, Pakistan, the United States, Italy, and Romania are also under continued monitoring.

The list includes firms like Reman Drug Laboratories, CSPC Zhongnuo, PT. Merck Tbk, Crown Pharm, and Yuyu Inc. - companies that were flagged early on but have yet to meet the criteria for lifting the mandatory pre-import testing.

Some U.S.-based companies, such as ADH Health Products and Robinson Pharma, also appear on the list, underscoring that violations are not limited to developing countries. The common thread among these 46 companies is the presence of substandard imported medicines, necessitating stricter control before market circulation.

Under current regulations, companies violating quality standards are required to undergo 6 to 12 months of pre-import inspection. Their names can only be removed from the list if no new violations are detected during that period.

That none of the 46 firms have been cleared reflects their failure to meet these requirements. Several companies have long histories of repeated or varying levels of violations, or have yet to demonstrate meaningful improvements in quality control. India’s Syncom Formulations, for example, has been cited for violations on 12 separate occasions.

The Drug Administration emphasized that the list is updated regularly to ensure transparency and to help healthcare providers and importers make informed decisions. The goal is to minimize the risk of substandard drugs reaching patients.

N. Huyen