With the Australian drug regulator allowing sale of antacid ranitidine made by Strides Pharma, analysts say clarity will emerge in the ensuing weeks as most companies would have submitted their test results to the regulators.
In September, several companies, including British drugmajor GlaxoSmithKline Pharma (GSK), Hyderabad-based Dr Reddy’s Laboratories (DRL) had withdrawn their ranitidine products from the markets after the US Food and Drug Administration (USFDA) raising concerns over the presence of a cancer-causing substance in some ranitidine products.
Following this, ranitidine manufacturers in different countries (including the US, the EU, and India) were asked by the respective drug regulators to conduct tests for determining the concentration of an impurity (N-nitrosodimethylamine or NDMA) in the ranitidine they supply. This order came in the wake of a citizen petition filed by Valisure (a US pharmacy that chemically validates all the products it delivers to end users).
NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. The USFDA, however, has not asked patients to stop taking ranitidine at this time.
ICICI Direct in a recent report noted most Indian suppliers of ranitidine had already submitted their test results.
“A few have reported positive outcomes. JB Chemicals announced that NDMA level in its ranitidine is within acceptable limits. SMS Pharma also announced the same and TGA Australia reported that 20 of 23 ranitidine batches from Strides Pharma had NDMA within acceptable limits whereas it was higher for most other companies,” the report said.
Companies whose ranitidine products had higher NDMA concentration have been directed by TGA Australia to recall the batches.
A GSK Pharma spokesperson informed they were awaiting results from tests.
GSK’s British parent has sent the samples for testing. Meanwhile, JB Chemicals had informed the stock exchanges that their API vendors have got their products analysed.
“Our API vendors have got their product analysed according to international guidelines to verify the presence of NDMA. They have reported that the NDMA is well within the permissible limits. In addition, the company has also initiated analysis of the samples of all Rantac formulations for the presence of NDMA. We have to inform that initial report received indicate NDMA is well within the permissible limit,” it said.
Ranitidine sales account for 2 per cent of Strides sales and 6 per cent of its profit after tax (PAT), for DRL it is less than 1 per cent of sales and PAT, while for JB Chemicals, it is about 10 per cent of sales and 18 per cent of PAT. Sriraam Rathi, analyst, ICICI Securities, felt the TGA order would be positive for Strides as it could easily increase market share in Australia. “If USFDA too testifies that the NDMA level in Strides’ API is within acceptable limits, it would be a further booster to the company, which already has the highest market share,” he added.
Analysts thus said it expected clarity to emerge in coming weeks. Regulators in most countries are investigating this matter and we believe clarity would emerge in ensuing weeks, as most companies would have submitted their test results to the regulators.
The companies had stopped fresh shipments of ranitidine products to regulated markets while several companies have started voluntary recall pending clarity.