Abbott faces heat over high level of codeine in cough syrup

Close on the heels of Nestle’s run in with Central and State food authorities on the alleged presence of enhanced levels of lead and MSG (mono sodium glutamate) in Maggi noodles, another multinational seems to be up the same creek.

Healthcare major Abbott finds itself in the dock over its cough syrup Phensedyl and the alleged presence of increased levels of codeine in it. The finding by the drug regulator of Himachal Pradesh has been denied by the company.

But that’s where the similarity ends between the Nestle and the Abbott cases. Especially since the ingredient found in enhanced levels in the latter is codeine – a controlled substance.

In layman terms, the government rations the use of this narcotic product to companies to make products such as cough syrups. And product distribution and sales are extremely regulated with records as it comes under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, says a regulatory expert familiar with the product.

Nevertheless, Abbott has written to the Drug Controller General of India and the Himachal Pradesh drug authority, besides the authority in West Bengal, which had also flagged the concern. “We are awaiting response from the authorities,” the company said.

In fact, Maharashtra Food and Drug Commissioner HS Kamble told BusinessLine that the issue was discussed last week and field officers were told to continue to pick up samples and test them. However, he added, about four months ago a similar exercise had found the products in the State to be safe.

In its defence, following the findings in Himachal Pradesh and West Bengal, Abbott said that its products were manufactured to the highest standards and went through rigorous testing.

When it received news on suspect samples, Abbott said, they tested a “retained sample” (from the batch in question) both in-house using its own method of analysis, and 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,” Abbott said.

Meanwhile, the company 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. 

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