September 14, 2015
By Alex Keown, BioSpace.com Breaking News Staff
NEW DELHI – Abbott Healthcare is challenging an Indian government’s accusation that the company’s Phensedyl cough syrup contained excessive amount of codeine, Reuters reported this morning.
In November 2014, a lab in West Bengal, India, reported that a sample of the cough syrup it tested contained more than twice the listed amount of codeine, Reuters said. The samples are alleged to contain 21.37 mg of codeine per 5 ml dosage, instead of 10 mg specified on the label.
Excessive codeine, which is a derivative of opium, would violate Indian drug laws, Reuters said. Amitabh Parti, a doctor at Fortis Memorial Research Institute told Reuters that excessive consumption of cough syrup with high levels of codeine can lead to health implications such as sedation, behavioral changes and drug dependence. Reuters said the samples were tested after a batch of the medication was seized as smugglers attempted to carry the batches of Phensedyl into Bangladesh. Codeine-based cough syrups are banned in Bangladesh, which means the medication can be sold at much higher prices by the smugglers. Abbott India, a division of Abbott Healthcare, told Reuters that Phensedyl is often copied by counterfeit drug makers and sold as the brand. The company said all of its socks of codeine have been accounted for and have asked the Indian government to show them the samples that were tested in West Bengal.
There is no word yet on whether or not the samples are legitimate Abbott products and as a result, the company has not recalled the 80,000 bottles on the shelves in India. Phensedyl accounts for approximately 3 percent of Abbott India’s annual $1 billion revenues, the Huffington Post said.
Abbott is the second company this year to challenge an Indian inspector’s report. In August, an Indian courting Bombay overturned a ban on Nestle India’s noodle dish Maggi, which an inspector said had a high lead content.
Reuters reported India has just 1,500 drug inspectors responsible for more than 10,000 factories, supplying medicines for a population of 1.2 billion and exporting to nearly 200 countries. There have been some issues of drugs manufactured in India from being marketed overseas due to manufacturing issues. In 2008, the U.S. Food and Drug Administration (FDA) banned the sale of medicine from Indian drug maker Ranbaxy due to manufacturing violations. In March, the FDA issued a warning letter to Apotex Inc. over manufacturing violations at a plant in Bangalore, India. In its letter the FDA said lab workers failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards. The FDA also said the lab workers failed to establish appropriate procedures to prevent bacteria from developing. Apotex Inc. was also forced to recall more than 65,000 bottles of blood pressure medication made at the Bangalore plant after testing discovered impurities in the medication.
