MHRA Bans Wockhardt from Making Drugs for European Market
July 10th, 2013 // 1:52 pm @ jmpickett
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Another drug maker in India is having problems with regulators. This time, the problem is with Wockhardt, and the Indian drug company has now been barred by the Medicines and Healthcare Products Regulatory Agency in the UK from making drugs in Europe. This move comes right after the UK regulatory body discovered that a drug plant in Waluj, India did not meet cGMP regulations.
The MHRA stated this week that if found several cGMP drug manufacturing problems, and it decided to issue a statement that noted non compliance with cGMPs for the Wockhardt plant in Waluj. The MHRA continues to assess what the implication will be on drug supplies to people in the UK.
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This move by the MHRA came right after the US sent out an import alert that banned several drugs from coming into the US. Wockhardt also had a failed inspection that caused FDA to come down hard on the company. Wockhardt stated at the time that this FDA action may cost the company $100 million. In 2012, Europe was about 28% of Wockhardt’s total sales.
This decision has come as many regulators, including FDA have increased efforts to look more closely at the international drug supply chain as there have been a number of serious drug scandals in recent times. One of the biggest scandals was with Ranbaxy Laboratories, another drugmaker in India. That firm had to pay $500 million to settle both criminal and civil charges for a serious cGMP drug scandal. This scandal also involved a drug ban in the US.
