U.K. regulators find issues with Indian-owned API distributor Relonchem

Products manufactured by Relonchem--Courtesy of Relonchem

U.K. regulators have revoked the license of an Indian-owned API distributor after finding a host of problems at its operations in Cheshire. But the Medicines and Healthcare Regulatory Agency (MHRA) says that Relonchem will be allowed to import some "critical" meds under strict oversight if it is found to be the key supplier.

Relonchem is owned by Indian API maker Marksans Pharma, which bought the marketer in 2008 for 100 crore rupees ($15 million) as a way to get deeper penetration into both the U.K. and EU markets.

According to a report filed in the EU's inspection database, during a February visit, inspectors were unimpressed with Relonchem's systems for investigating product that was potentially out of specification. Inspectors said the Quality Management System lacked "robust product review and lack of appropriate root cause investigation into deviations."

They said the company was not carefully certifying batches, giving the OK to batches that were suspect. They found it had shipped in a large number of batches from manufacturing sites in India that were exposed to temperature excursions during transportation but didn't bother to see what impact that had on the batches.

Inspectors recommended withdrawing the company's GMP certificate for now, but is still reviewing whether products should be recalled. The agency said it had to determine if some of the products would be classified as critical, products for which there is no feasible alternative in the market.

The MHRA took similar steps in 2013 when the agency was concerned with the certification processes India's Wockhardt was using for products it manufactured at a plant in Chikalthana, India. It didn't initially require recalls and allowed the drugmaker to continue to sell in the U.K. more than a dozen products it believed were critical. Later, it decided to have Wockhardt recall 5 products from the market, and then this last January the MHRA updated its position on Wockhardt's importation of critical drugs. It banned all APIs coming out of the Chikalthana plant, one of two it had taken action against, saying the Wockhardt facility would have to pass a new inspection before it would be allowed to sell any products in the U.K.

- access the regulatory action here