US FDA finds manufacturing errors in Cipla’s Bangalore plant

Cipla to respond to USFDA’s letter in 30 days

The US Food and Drug Administration (FDA), which recently conducted inspections in Indian drug maker Cipla’s manufacturing facility in Bangalore, has reportedly come up with several discrepancies in the manufacturing process.

According to sources the US FDA has found out nearly a dozen variations in the standard operating procedure for good manufacturing practices (GMP) quality norms to be followed by the drug manufacturer. Following this, US FDA has issued inspectional observations to Cipla seeking explanations for the violations. Cipla is expected to respond to the letter within 30 days, it is learnt.

“The deviations are of a routine minor nature, suggesting need for improvements in good manufacturing practices. One of the nine deviations is related to incorrect data entry,” a Cipla spokesman said in statement. Cipla has taken immediate steps to correct deficiencies, and will mail a formal response to FDA within the stipulated 30 days, he added.

Officials with the FDA did not make a comment on the issue.

US FDA conducts routine inspection on the manufacturing plants approved by the regulator for exporting drug products to the US. US FDA generally conducts biannual inspections for Indian plants.

Cipla, one of India’s largest generic companies,  received approvals for Stavudine and Levetiracetam from the United States Food and Drug Administration (USFDA), in March.

USFDA’s action against Cipla is the latest in a series of inspections and warning letters issued by the regulator against Indian drug makers.

Last year, FDA had banned 30 Ranbaxy form selling 30 drugs, which are manufactured at two of its plants in India, as one such inspections found a number irregularities in good manufacturing practice norms.

US FDA also issued a warning letter to Caraco Pharmaceutical, Sun Pharma’s American subsidiary, and has also halted approval of new drug applications from its Detroit facility. In November, the agency found 15 manufacturing deficiencies at Lupin’s plant in Madhya Pradesh.

While industry observers say the FDA inspection are routine, the associations representing domestic drug makers in India argue that multinational drug firms, who are keen to block India emerging as a hub for low cot generics denting the prospects of innovator products are behind the FDA inspections.