IGMPI India



Regulatory concerns make Wockhardt recall 5 drugs

Wockhardt, has been facing regulatory issues all throughout this year. The latest concern of the withdrawal of GMP certificate at Chikalthana facility, Aurangabad in Maharashtra and Kadaiya, Nani Daman in Gujarat, added to the heat. After the withdrawal of the facility in Maharashtra, the company recalled 5 over-the-counter (OTC) products from the UK market.
Following this, the UK health regulator, MHRA, issued notice to wholesalers, pharmacies and clinics to return the company manufactured five prescription medicines. Out of these, four are pain relief medicines and one is to treat Type-2 Diabetes. As per the agency’s report, these medicinal products were tested and no evidence of health risk to patients in UK market was found.

As there is no evidence of the medicines of precautionary recall being defective, people need not return the medicines. It was stated that, people can continue taking the medicines as prescribed, as their benefits outweigh the risks. However, for the regulatory purposes, it is believed that the products are not manufactured in compliance with GMP standards. The new certification issued to the Chikalthana facility in Maharashtra, is a restricted GMP certificate, which allows the manufacturing of critical drugs.