According to sources, Ranbaxy would be granted 30 days to respond to DCGIs 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 $300 million since 2009 in upgrading its facilities, automating data-testing processes, adequately staffing all quality functions, training people and hiring global consultants.
The DCGI had conducted a similar exercise in 2008, when the USFDA raised the red flag for non-compliance of good manufacturing practices at Dewas and Paonta Sahib units, but had found nothing particularly alarming.
According to Director General of Health Services, Jagdish Prasad, even the FDA has not found fault with the quality and efficacy of drugs produced by Ranbaxy. There were some lacunae in the process of manufacturing, which were
against specific guidelines of the US regulator.
Ranbaxy Laboratories shares on Friday closed down 2.57% at R407.15 on the Bombay Stock Exchange.