The initial inspection of Ranbaxy’s Dewas and Paonta Sahib facilities, conducted by the Drugs Controller General of India (DCGI), has revealed some deficiencies in the manufacturing processes. However, sources said these “deficiencies” are not “serious” enough to attract any penal action or suspension.
According to sources, Ranbaxy would be granted 30 days to respond to DCGI’s inspection report and initiate any
“remedial” action as recommended in the report. “A final report would be submitted to the health ministry after two months,” officials aware of the development told FE.
The initial inspection report is based on three counts: whether drugs are being prepared, packed and stored under sanitary conditions, whether they are being labelled in a prescribed manner and if they match with mentioned defined qualities.
Apart from evaluating the facility, the DCGI is also taking sample packs from retailers and the manufacturing units to check the final product for any form of “adulteration”,
which would include checking for foreign particles as well as quality and strength of the finished medicine.
“Under the Indian laws, it is important to ensure that hygiene factors are maintained during the production process; packaging and labelling is done as per the prescribed norms and final medicine matches with pre-defined specifics in terms of quality, strength and efficacy,” a health ministry official said, adding that these formed the basis for the Ranbaxy inspection.
The DCGI inspection was ordered by the health ministry in May this year after Ranbaxy pleaded guilty before the US department of justice for providing false data to the US Food and Drug Administration during 2006-08. The pharma company also agreed to pay a fine of $500 million.
When contacted a Ranbaxy spokesperson said that he was not aware of any such report by the DCGI. However, in an earlier interview with FE, managing director Arun Sawhney had said, “There was nothing unusual about the inspection of our units by any regulator, including those in India, in the last couple of months. There has been no disqualification for any drugs by the DCGI.”
Sawhney had said that the company had invested more than