Mumbai (ISJ): British medicines watchdog on Thursday (Oct 17) asked pharmacies, dispensing clinics and wholesalers to return five medicines manufactured by Indian drug-major Wockhardt. The advisory by Medicines and Healthcare Products Regulatory Agency (MHRA) follows manufacturing deficiencies at the Chikalthana unit of Wockhardt.
Most of the medicines recalled by MHRA are used for pain relief, but one medicine is used to treat Type 2 diabetes (Gliclazide). MHRA however, cleared 10 prescription-only drugs made at the Chikalthana factory that can be supplied to health facilities in the UK. The regulator said, those who are currently using the recalled-medicines need not stop its use. This is due to concerns over continuity of supply, benefits of patients of continuing to take these medicines outweigh the risk from any quality concerns with the drugs.The manufacturing deficiencies identified by the MHRA during the inspection of Wockhardt’s Chikalthana site in July 2013 included, poor record keeping relating to the manufacture and testing of the medicines made at the site, and inadequate validation and production controls for medicines. The MHRA is working with Wockhardt and other international regulators to resolve this. “People can be reassured that there is no evidence of a safety risk from the medicines made at Wockhardt’s Chikalthana site so it’s important people continue to take their medicines as prescribed,” said Gerald Heddell, the MHRA’s Director of Inspection, Enforcement and Standards. “Ten prescription-only medicines can continue to be made at the Chikalthana site and can still be supplied to patients in the UK. This is because, due to concerns over the continuity of supply, the benefits to patients of continuing to take these medicines outweigh the risk from any quality concerns with the medicine,” added Heddell. “We are working with the Department of Health to ensure that people have access to the medicines they need. Anyone who has questions should speak to their pharmacist or GP.” The MHRA said, though there is no evidence of a patient safety risk from medicines that have been sold in the UK, the act is in the interest of public health as poor manufacturing standards means the quality of medicines is not guaranteed. Wockhardt said the regulator will issue a restricted GMP (good manufacturing practice) certificate to the site alongwith a statement of non-compliance. This will enable the company to continue exporting some critical drugs to the UK, because there is no feasible alternative in the market. Chikalthana plant, which makes a generic version of the high blood pressure drug Toprol, had also come under the scanner of US Food and Drug Administrator, for possible violation of its standards.
