Earlier this week, GlaxoSmithKline Pharmaceuticals Ltd (GSK) had voluntarily recalled ranitidine hydrochloride tablets produced in India following alleged detection of genotoxic nitrosamine NDMA by US drug regulatory authorities. The move followed the US pharmaceutical regulator's caution note alerting patients and health care professionals that N-nitrosodimethylamine (NDMA) was found in samples of ranitidine. NDMA "is classified as a probable human carcinogen based on results from laboratory tests".
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Ranitidine, sold under the trade name Zinetac, is commonly used to reduce stomach acid. While it is a Rs 200 crore focus brand in India, the company will soon figure out a way to deal with the financial impact of the recall, GSK Pharma VP and South Asia MD A Vaidheesh told CNBC-TV18.
“For us, the sales or profits are not the first priority at this point of time considering that this issue is being discussed with regulatory authorities. Our responsibility is to make sure our patients get the first priority,” he added.
Edited excerpts from the interview:
Tell us about the recall of ranitidine or Zinetac and the impact on the company's financials?
This is a recent event. GSK globally was contacted by regulatory authorities about the N-nitrosodimethylamine (NDMA) levels. While the tests and investigations are going on, as a precautionary approach on a global basis we have announced a recall and that includes India.
As far as we are concerned, patient is our first priority. So we need to make sure at this point of time, till the time conclusions are there, that products are recalled.
How worried should patients be?
Since it’s a recent event I would recommend the patients to talk to their respective doctors about the limiting factor in this. The only thing one should do is to ignore rumours and instead talk to the medical practitioner.
For GSK, ranitidine would be a Rs 200 crore drug; is that the market size?
Yes, it’s in and around approximately that size, but for us the sales or profits are not the first priority at this point of time considering that this issue is being discussed with regulatory authorities. Our responsibility is to make sure our patients get the first priority. Therefore, I wouldn’t be worrying too much at this point of time whether it’s a Rs 180 crore of Rs 200 crore medicine.
In terms of financial impact, what do you assume it would be because currently you are recalling all of the products from the market? So financially can you give us a sense in terms of what the impact would be?
It’s too premature to give the financial impact because we are expecting some test results to come by the end of September or during the first week of October and only then we will get to know. As far as we are concerned we will find out a way to manage the financial impact as a company. We have a track record of managing financial setbacks.
Would it be one of your top 10 products in India?
Yes, it’s one of our focus brands and I am sure that we should be able to get some new protocols and how we should be promoting the brand. We will wait for the results.
In terms of active pharmaceutical ingredient (API) suppliers, what kind of steps have you taken when it comes to Saraca Laboratories, SMS Lifesciences India and Dr Reddys Laboratories?
Saraca is one of the API suppliers and that is also being assessed right now, being investigated. So we should be in a position to get some sense of what we should be doing with that particular source.Regarding Dr Reddys, we do not market it here. Otherwise all otherAPI-related products are kept on hold till the time we get the final confirmation.