USFDA Poses Import Alert on Ratlam Plant of Ipca Labs for Violations of Production Practices

Ipca Laboratories have announced on Friday that it had received an import ban for its active pharmaceutical ingredients (API) manufacturing facility at Ratlam, Madhya Pradesh by the US Food and Drug Administration (FDA). The company mentioned this in an statement – "US FDA has issued an import alert to the said manufacturing facility on January 22, 2015." some critical observations in Form 483 were noted on the inspection done by US FDA last year following which a voluntary decision was taken by the company to temporarily suspendAPI shipments to the US from July 2014.

These observations were related to the laboratory practices along with data integrity in a few cases. Form 483 includes communication of certain manufacturing or procedural issues in respect to functioning of a plant and seeking of corrective measures. Import alert is not mandatory with such observations as these are purely inspectional. Morgan Stanley provided a research report on Ipca Labs which showed that in its Ratlam facility, there is approximately Rs 300 crore in sales (formulations + API) to the US market in 2013-14, which is 9% of Ipca sales.

The report said that "We believe the import alert will set back the prospects of a recovery in US business (using captive API) by 1-2 years. Abbreviated new drug approvals (ANDAs) filed using API from Ratlam will not get approved until the facility falls back in compliance. We expect remediation cost at Ratlam to rise. Potentially, there could be a collateral damage to its API business from non-US markets as well, in our view."

Exclusion from the import alert is provided to four APIs – hydroxychloroquine sulfate, propanolol hydrochloride, trimethoprim and ondansetron which are manufactured at the Ratlam Unit. A pharma analyst also said that "Ratlam is the only US FDA approved API plant which is commercialized hence entire US revenues (formulations and APIs) will get impacted due to this voluntary stoppage. Ipca does not have an alternate supplier for its formulations and getting another supplier for its existing formulations will take nearly 1.5-2 years due to regulatory processes involved. Ipca currently has 40 ANDA filings and 18 approvals and markets 8 products in the US."

Form 483 has also been received by Ipca for its Indore plant which implies further risks of adverse regulatory action by the FDA.