Drugmaker Abbott Healthcare is challenging an Indian state’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. Abbott Healthcare is a unit of US-based Abbott Laboratories. Abbott Laboratories also has a listed subsidiary in India, Abbott India Ltd.
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.
The state laboratory in West Bengal first raised the alarm last November. The previously unreported case underlines the weakness of India’s unwieldy and poorly resourced drug and food regulatory system, the uncertainty it creates for foreign and domestic companies operating there and the potential risk to consumers.
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. 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.
Phensedyl sales are estimated to be more than 3 percent of Abbott’s $1 billion India revenue. The sales are dwarfed by Abbott’s global annual sales of over $20 billion, but, as the Nestle case shows, fallout from safety scandals is unpredictable.
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.
Safety breaches and scares are common in India. According to a 2012 parliamentary report, nearly one in 22 locally produced drug samples are 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 1.2 billion and exporting to nearly 200 countries.
The federal government wants to improve regulation of the key sector, and plans to spend $263 million in the next three years to strengthen the national and state regulatory system with additional equipment and staff and new laboratories.