After Nestle India and India's food regulators' clashed over excessive lead content in Maggi, another set of regulators appear to be gearing up for a similar showdown. Drug regulators have asked with multinational drug major, Abbot Pharma, to explain a contaminated sample of Phensedyl--found during a random inspection--and one of the company's most popular brands of cough syrup.
A Reuters investigation found that a state-run laboratory in West Bengal last November found that a sample of Phensedyl, a brand of cough syrup that accounts for at least 3% of Abbot India's $1 billion revenue, contained more than twice the labelled amount of the key chemical ingredient, codeine.
The excessive codeine, an opium derivative, would violate Indian drugs law and the government has formally asked Abbott to explain the contaminated samples, which are centrally manufactured at its plant in Himachal Pradesh.
The offending samples contained 21.37 mg of codeine per 5 ml dosage, instead of 10 mg specified on the label. Excessive consumption of cough syrup with high levels of codeine can lead to sedation, behavioural changes and drug dependence, Amitabh Parti, a doctor at Fortis Memorial Research Institute, told Reuters.
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.
In its response in late April, Reuters reported, 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.
Though there is yet no ban on the Phensedyl, the dispute between regulators and the company could potentially inflate like it happened with Maggi.
Though a Bombay High Court order overturned the ban on Maggi last month, it was only after the company took a hit of Rs 450 crore, including destroying over 30,000 tonnes of the instant noodles since June when it was banned because of alleged excessive lead content.
The issue also brings afore concerns over India's understaffed regulatory bodies that have often have too few inspectors to effectively monitor claims of spurious foods and medicine.
Abbott Healthcare is a unit of U.S.-based Abbott Laboratories. Abbott Laboratories also has a listed subsidiary in India, Abbott India Ltd.