Cadila faces new regulatory problems as WHO piles on the pain

It has been a tough few months for India's Cadila Healthcare. After having two plants slapped by the FDA with a warning letter, the Indian drugmaker has now had a vaccines facility cuffed in a notice of concern by the World Health Organization (WHO) after it was found faking data about contamination issues at the facility.

Cadila acknowledged the WHO issues with its vaccine plant in Moraiya on Wednesday in a filing with the Bombay Stock Exchange and said that it is responding to them. It didn't mention that it had suspended manufacturing and recalled all the batches of Lyssavac-N (antirabies vaccine) manufactured after April 2015 inspections. According to the document Cadila has manufactured the vaccine under WHO authorization since 2008.

The WHO criticized the plant for poor environmental monitoring and quality assurance. It said, for example, that workers had not written reports about 5 batches of vaccine that had been rejected because of contamination. In October the company provided a list of products it had recalled that included 64 final bulks or batches of nonprequalified VaxiRab N vaccine, as well as prequalified Lyssavac N vaccines for shipment to countries that include Angola and Georgia.

The drugmaker said it has already taken steps to address the problems, including bringing in a consultant to do an audit of the plant, removing some employees who had acted "casually" about GMP standards and making all employees sign a pledge that they will act ethically.

During a meeting with Indian drugmakers and regulators last month, FDA officials noted that Indian companies often fire workers after problems have been uncovered during inspections but urged company management to put the responsibility where it belongs. Simply firing low-level employees who did not create the situations "will not help," Thomas Cosgrove, director of FDA's office of manufacturing quality, chastised.

Cadila has had its share of FDA problems. In January, Cadila reported that it received a warning letter for a formulation facility, also in Moraiya, as well as its Zyfine API plant in Ahmedabad. Cadila insisted at the time that it takes quality seriously and will do what is necessary to meet FDA expectations. "We are committed to resolve all the issues and revamp our quality systems and processes as the top most priority," it said at the time.

- read the BSE filing
- access the WHO Notice of Concern here