Hyderabad: The recalling of five lakh more bottles of blood pressure lowering drug amlodipine valstran for traces of N-nitrosodiethylamine from Aurobindo Pharma by the United States has created a stir in the pharmaceutical industry in the state.
This is the second recall in January after the first one was carried out in the first week where 80 lots were recalled.
Not only the bottles but more than 3 lakh valsartan tablets have also been recalled by the company.
The questions which are being raised are on the impurities where the traces of N-nitrosodiethylamine have been found which is identified as a carcinogen and can cause cancer in humans.
A senior member of the industry on condition of anonymity explained, “The recall is giving a bad name to the Indian generic products which have a very large market in the United States. The manner in which the recall is happening raises questions whether there was actually a problem in the manufacturing process or was there an active pharmaceutical which had traces of the contaminant. It has to be understood that the industry image and also the brand suffers.”
According to sources, senior members in the company have called for a meeting and are taking a review of these recalls which have happened consecutively.
The active pharmaceuticals for the medicines are imported from China. The presence of N-nitrosodimethylamine impurity was detected in a company in China in August by the US FDA. The contamination was found in the company and imports from China were restricted. There have been 20 countries across the globe that sources their active pharmaceuticals from China.
Another consultant with a pharmaceutical company on condition of anonymity explained, “These are batches which are found to have the contamination. These are being brought back but where are they going to be dumped. When US is recalling what are the Indian drug controllers doing? Do they have any mechanisms to check this? It is very important that the Indian drug controllers should also be alert and there is a proper check on what has to be done with these recalled medicines.”
The Bombay Stock Exchange has sought clarification from Aurboindo for this recall as they want to know what is happening and why the medicines are being called back, and they are yet to respond....