Dr Reddy’s recalls blood pressure drug
pharmafile | June 20, 2014 | News story | Manufacturing and Production | Dr Reddy's, India, blood pressure, metoprolol succinate, recall, toprol
Indian generics manufacturer Dr Reddy’s Laboratories is in the midst of recalling more than 13,000 bottles of blood pressure medicine metoprolol succinate in the US, according to media reports.
A generic version of AstraZeneca’s beta blocker Toprol, the drug apparently failed a dissolution test. These tests are designed to see how long a drug takes to release its active ingredient and, therefore, how it might perform in a patient’s body.
It is significant because India’s pharma industry supplies 40% of OTC and generic prescription drugs consumed in the US.
The recall was voluntarily begun by Dr Reddy’s last month and posted on the US Food and Drug Administration website last week, Reuters reports. Indian firm Wockhardt also recalled over 100,000 bottles of the same drug last month for a similar reason.
India’s pharma sector last year pledged to meet the government’s target of raising exports to $25 billion by 2016 – they are currently running at around $15 billion a year and have grown at an ‘explosive’ rate of 24% over the last four years, according to a local trade body.
A report says that Dr. Reddy’s, Lupin Labs, Sun Pharma, Ranbaxy and Cipla invested over $500 million in R&D in 2013, which is already allowing increased innovation in manufacturing processes to help to lower the cost of medicines production.
But the country’s pharma industry has still been beset by quality issues affecting top-tier Indian generic manufacturers such as Ranbaxy and Wockhardt, which have called the safety of exported medicines into question.
FDA investigators are directly targeting Indian drug plants such as Ranbaxy’s under new quality control measures, and the regulator has already said that it needs to have more inspectors on the ground in India.
The FDA is to increase staff in the country from 12 to 19 as concerns grow over just how well made – and safely exported – medicines are in India.
Adam Hill
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