Major drug manufacturer Ranbaxy laboratories may be facing trouble in the US over quality issue of its medicines, but its drug producing plants for domestic consumption have got a clean chit from the country’s drug regulator, Drug Controller General of India (DCGI).
The UK and World Health Organisation (WHO) have already said that there is no evidence of any of Ranbaxy’s products being of unacceptable quality. However, the US has banned import of drugs from Ranbaxy’s plant at Mohali in Punjab alleging that it did not meet their manufacturing standards.
Sources in the Health Ministry said that following complaints that the company was not adopting standard manufacturing practices, the company’s manufacturing facilities for the drugs meant for Indian consumption were inspected. Except for minor issues the production process was found to be of standard quality. They also said that the company has already taken steps to rectify the minor errors and there was no reason to worry about its manufacturing practices.
For the last five years, Ranbaxy has been in trouble with US drug authorities. In 2008, US Food and Drug Administration (USFDA) issued a warning raising quality concerns and alleged that the company did not follow standard manufacturing practices at its Paonta Sahib manufacturing unit. Then in 2012 again, USFDA raised similar concerns about Ranbaxy’s manufacturing plant at Mohali.
However, the WHO, after undertaking a series of inspections recently at its sites, including the Paonta Sahib unit, which also manufactures drugs on WHO’s prequalified list, gave a green signal to its products.
“There was no evidence to warrant any further action by WHO-PQP, or indeed by those SRAs who participated in this inspection,” WHO had said in its statement adding that WHO-PQP has continued to monitor Ranbaxy and all other manufacturers on the WHO list.
However, Ranbaxy’s sale continues to be adversely effected in the US market by the ban on its products. It was imposed after the US drug regulator said that it inspected Ranbaxy’s Mohali facility in September and December 2012 and identified “significant” quality control violations, including a failure to adequately investigate manufacturing problems and failure to establish adequate procedures to ensure manufacturing quality.
Meanwhile, the USFDA has alleged that tablets embedded with ‘black fibre’ that was suspected to be hair from an employee’s arm, ‘black spots’ of oil from machines in tablets and absence of running water in toilets were observed at the drug manufacturing facilities at Ranbaxy’s Mohali unit, PTI reports.
“There is a failure to thoroughly review any unexplained discrepancy in the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed,” the USFDA has said.
The USFDA further said in response to the presence of black spots observed during tablet compression, “the investigation did not include chemical analysis of the tablet or contaminated tablets to support the absence of contamination and the root cause, which was determined to have originated from oil in the compression machine.”
The USFDA also pointed out the lack of hygiene in the toilet complexes of the plant.“During the course of the inspection, the toilet facility adjoining the change room of the raw material storage area did not have running water for hand washing and toilet flushing,” it said.