Abbott Healthcare has challenged West Bengal drug controller's finding that its cough syrup Phensedyl contained codeine beyond the permissible level, becoming the latest multinational to dispute the conclusions of a state regulator's testing framework.
The pharma major, part of US-based Abbott, has also asked the state drug regulatory authority to provide more information about the source of the suspect sample and the manner in which it was collected.
"Abbott has requested the State Drug Controller to provide more information about the source of the suspect sample and the manner in which it was collected, to establish whether the sample was collected from genuine trade channels through proper process under the Drugs and Cosmetics Act," a Abbott India spokesperson told PTI.
The West Bengal Drug Controller had issued a show-cause notice to the Mumbai-based drug firm for a sample of Phensedyl in April this year. The company replied to the show-cause notice in the same month.
The batch of Phensedyl, from which the state government authorities picked up the sample, was manufactured by the company in February 2014 and distributed in March 2014.
As soon as Abbott received information about the suspect sample, the company tested a retained sample both in-house using its own method of analysis, as well as by an accredited independent laboratory.
"Results of both tests found that the retained sample complied with the required specifications and standards, including the codeine content. We therefore remain confident in the quality of our product," the spokesperson said.
The company added that all of its pharmaceutical products are developed and manufactured to the highest standards for safe and effective use.
Phensedyl accounts for about a third of the Indian cough syrup market. Abbott Healthcare is a unit of US-based Abbott Laboratories. Abbott Laboratories also has a listed subsidiary in India, Abbott India Ltd.
In 2010, Abbott had acquired domestic formulations business of Piramal Healthcare for USD 3.72 billion, thus becoming a leading player in the Indian pharmaceutical market.
In May this year, the Uttar Pradesh Food Safety and Drug Administration had asked FMCG major Nestle India to withdraw a batch of popular Maggi noodles from the market after it was allegedly found to contain high levels of lead.
Next month, the company decided to take Maggi off the shelves after a controversy erupted over its contents, prompting several states to ban the 'two-minute' noodles.
The Bombay High Court later overturned the ban in a partial victory for the Swiss food giant, but the allegations hurt the company's reputation.
