FDA continues import ban on Sun Pharma drugs despite pleas

The US Food and Drug Administration has refused to lift its ban on import of drugs manufactured by Sun Pharmaceutical Industries Ltd's Karkhadi plant in Gujarat, saying Sun Pharma has not taken sufficient corrective action at its bulk drugs factory to meet its rules.

''We have conducted a detailed review of your firm's initial response and note that it lacks sufficient corrective actions,'' FDA said in a 7 May letter posted on Tuesday.

The FDA had, in March, banned imports from the Sun Pharma's Karkhadi plant near Vadodara after observing violations in quality norms during an inspection in November. Sun Pharma had responded to the FDA's observations in two letters.

Sun Pharma said on Tuesday it would respond to the FDA in detail, and would comply with all the required rules.

During its inspection of the plant, the FDA noticed a failure to ensure that laboratory records included complete data derived from all production tests necessary to ensure compliance with established specifications and standards, the FDA said in the letter.

''These analyses lack the critical data including identification of the samples tested, the complete record of all raw data generated during each test, test method used, sample preparation as prescribed by the method, preparation and testing of standards, reagents and standard solutions among others,'' said the FDA letter addressed to Sun Pharma's chief executive officer Subramanian Kalyanasundaram.

''The Karkhadi factory that makes a small quantity of antibiotics contributes a negligible part to Sun Pharma's consolidated revenue,'' the firm had said in March.