European drug regulators are showing no signs of letting up in their effort to bring Indian manufacturing up to global standards. The most recent victim of agency action is Dhanuka Laboratories, which was found to have 32 shortfalls during a recent inspection.
This time, it was Croatian authorities who submitted their findings on the company found to be in violation for its processes in producing cefixime, an API used to treat bacterial infections. The authorities found one critical deficiency--relating to a quality assurance system that was “weak”--and 7 major deficiencies.
The company’s major deficiencies included shortfalls in quality assurance standards, facilities, documentation, material management, qualifications and lab controls. Dhanuka didn’t have controls to assure that its batches were up to snuff, the regulators said, and contamination was possible due to the facility not meeting GMP requirements.
Additionally, “core principles of the management of electronic documentation was found not considered (or disregarded),” according to a report posted on the EMA website EudraGMDP. The team noted that only four of 62 instruments in use at the site were fully qualified.
The regulators conducted their inspection in February and noted that a past inspection yielded a similar major deficiency relating to unqualified equipment.
As a result of the failings, the regulators have withdrawn the company’s EU GMP certificate and are considering removing marketing approval, according to the report. They’re also banning future product batches.
With annual sales of $200 million according to its website, Dhanuka is far from alone in receiving regulatory attention over manufacturing conditions. Many of its larger peers in India--Wockhardt, Sun Pharma, Ranbaxy Labs and others--have been on the receiving end of similar reports in recent years as regulatory crackdowns have hit the larger Indian pharma industry.
- access the report here