Abbott Healthcare is challenging West Bengal’s accusation that a sample of the company’s cough syrup contained excessive levels of codeine, the second multinational to question India’s regulatory testing regime in recent months.
Whether the sample of Abbott’s popular “Phensedyl” was a genuine product or a fake has not been established, but the suspect batch of 80,000 bottles has not been recalled.
Codeine is a sleep-inducing and analgesic drug derived from morphine.
The state laboratory in West Bengal first raised the alarm last November.
Abbott Healthcare is a unit of US-based Abbott Laboratories. Abbott Laboratories also has a listed subsidiary in India, Abbott India Ltd.
In the latest dispute, the laboratory found that a sample of Phensedyl contained more than twice the labelled amount of codeine, according to several state drug officials and correspondence between regulators and Abbott.
The original test was carried out by West Bengal after Phensedyl bottles were seized near the border with Bangladesh, said Samit Saha, a state drug inspector involved in the case.
Codeine-based cough syrups are banned in Bangladesh, and smuggling is rife as people profit from higher prices there compared to India.
According to a copy of the inspector’s report, the sample contained 21.37mg of codeine per 5ml dosage, instead of 10mg specified on the label.
Saha said two other samples from different batches, however, showed normal codeine levels.
Phensedyl sales are estimated to be more than 3% of Abbott’s $1bn India revenue. The sales are dwarfed by Abbott’s global annual sales of over $20bn, but, as the Nestle case shows, fallout from safety scandals is unpredictable.
Three months ago, Nestle was forced to withdraw its Maggi instant noodles from Indian shelves because the food safety authority banned the snack after its tests showed excess lead.
A court later overturned the ban in a partial victory for the Swiss food giant, but the allegations hurt the company’s reputation and that of the country’s regulators, who operate with few staff and poorly equipped facilities.
The excessive codeine, an opium derivative, would violate Indian drugs law. It triggered a “show cause” notice against Abbott, which was sent in March by the drug regulator in Himachal Pradesh state, where Phensedyl is manufactured.
In its response in late April, Abbott denied the allegations and urged regulators to not take any action. Abbott said it had found nothing unusual in its own and third party testing of a retained sample from the same batch of Phensedyl.
The company also asked regulators to give it more information about the source of the suspect sample and the manner in which it was collected, so that it could establish whether it was genuine and proper process was followed.
“We are awaiting response from the authorities,” the company said in answer to the news agency’s query.
Excessive consumption of cough syrup with high levels of codeine can lead to health implications such as sedation, behavioral changes and drug dependence, said Amitabh Parti, a doctor at Fortis Memorial Research Institute.
In February, West Bengal listed the potentially tainted batch as “not of standard quality” in a monthly publication.
The bulletin, which is posted on the regulator’s website, is supposed to alert consumers and pharmacies in the state to suspect drugs. But the West Bengal drug controller, CM Ghosh, said he does not have the resources to follow it up.
Safety breaches and scares are common in India. According to a 2012 parliamentary report, nearly one in 22 locally produced drug samples is of sub-standard quality in India.
India has just 1,500 drug inspectors responsible for more than 10,000 factories, supplying medicines for a population of 1.2bn and exporting to nearly 200 countries.