Mumbai (ISJ) ? Indian drug major, Sun Pharma, already facing ban in the United States, is in for more trouble from the US drug regulator for violations of current good manufacturing practice (CGMP) regulations. FDA had banned import from Sun Pharma?s Karkhadi plant in Gujarat in March.
FDA in its letter dated May 07, but posted on its website on Tuesday (May 20) warned the Mumbai-based company ?Until all corrections have been completed and FDA has confirmed corrections of the violations and deviations and your firm?s compliance of CGMP, FDA may withhold approval of any new applications or supplements listing your frim as a drug product or an API manufacturer.?
The regulator also warned, it will continue to refuse import of drugs manufactured at Sun Pharma?s Karkhadi unit to United States. Karkhadi plant, one of Sun Pharma?s 25 manufacturing units, makes antibiotic cephalosporin.
FDA has cited several shortcomings in compliance of its regulations like failure to maintain laboratory records, including complete data derived from all tests necessary to ensure compliance with established specifications and standards, failure to assign and identify raw materials with a distinctive code, batch, or receipt number, and to identify the disposition of materials, lack of professionally qualified personnel.
?Your firm frequently performs ?unofficial testing? of samples, disregards the results, and reports results from additional tests,? said the warning letter addressed to Sun Pharma?s Chief Executive Officer S. Kalyanasundaram.
USFDA has given fifteen days to Sun Pharma to take specific steps ?to correct and prevent the recurrence of violantions.?
The US regulator has enforced a series of restrictions on Indian generic drug firms over the last one year, citing serious manufacturing and quality control problems.
Indian Health Minister Ghulam Nabi Azad had termed the ban on import of Indian drugs as ?politics and business interests?. "The developed countries lay down such strict parameters to bar manufactures from developing countries from global competition," the Indian minister had told Indian Science Journal, without naming any country in particular.
Earlier, the USFDA had banned import of generic drugs from Ranbaxy Laboratories and Wockhardt.
India is the biggest overseas source of medicines for the United States and is home to over 150 FDA-approved plants.
--By NB Nair
Source: USFDA press release