Ranbaxy's side of the story!
The dust seems to have settled over the Ranbaxy's case related to the alleged quality issues by the USFDA in a US court. The development not only led to a fear among the general public in India but also raised serious questions on whether the generic drugs are low on quality. However, Ranbaxy feels that much was made out of the entire story and out of context references would not serve any purpose for Indian pharma industry.
Ranbaxy in a straightforward response to the queries from BioSpectrum, has clarified that technically it did not lose the case in the US court over any quality issues. Rather it says that the fine was a part of the settlement. Giving their version of the story, the Ranbaxy spokesperson mentioned, "On May 13, 2013, Ranbaxy announced conclusion of a previously disclosed investigation by the U.S. Department of Justice (DOJ) of data integrity and manufacturing processes at certain Ranbaxy facilities in India. In anticipation of this settlement with the DOJ, Ranbaxy had earlier in 2011 made a financial provision of US$ 500 million. Therefore the recent settlement with DOJ does not materially impact Ranbaxy's current financial situation or performance."
Talking about the need for the company to move on, the spokesperson said, "It's important to note that the investigation related to conduct which occurred several years ago and Ranbaxy is a different company today. The steps we have taken over the recent years reflect the wide-ranging efforts of the current board and management to address certain conduct of the past and ensure that Ranbaxy moves forward with integrity and professionalism in everything we do."
The Apollo hospitals that has earlier kept the Ranbaxy drugs on hold later worked with Ranbaxy to validate the necessary documentation in line with quality standards followed by International quality certifying authorities. In a statement, it said, "Ranbaxy has provided us Batch quality certification for all their products certified by the Government approved certifying laboratories. The reports completely satisfy the quality norms stipulated by WHO-GMP, Department of Pharmaceuticals, Govt of India as well as Drug and Cosmetic Act. We have also understood the stance of the DGHS of India in this regard and received confirmation from them that there are no quality issues in the Ranbaxy Products currently marketed in India. We are glad that this issue has been resolved. We will continue to stock and dispense Ranbaxy products across all our pharmacies and continue to provide the best patient care without missing a beat."
Also, the recent story of the PIL dismissal by Supreme Court for banning Ranbaxy drugs in India too gives them some respite in India.
On being asked about their recent activities, Ranbaxy spokesperson revealed, "We have invested more than US$ 300 million in upgrading our facilities, in training, hiring the best consultants to impart skill-sets to the employees at Ranbaxy. All these will go to ensuring that Ranbaxy continues to have the best standards in the industry. We are fully committed to upholding the high standards that patients, prescribers and all other stakeholders expect."
Dismissing any negative publicity for the company, the spokes person in exclusive interaction with the BioSpectrum elaborated, "Ranbaxy is the best known pharma brand from India. It has earned the respect of stakeholders all over the world. There is a lot of faith, trust and belief all over the world. Our stakeholders, including regulators and doctors have reposed faith and confidence in us. We believe they will continue to trust us as we operate from the paradigm of ‘Quality and Patients First'.
"Responsible companies such as Ranbaxy have earned India the reputation of being pharmacy to the world. We sincerely believe that because of their very high standards of operations these companies will continue to build the credibility of India as pharmacy to the world," he concluded while stressing on the fact that Ranbaxy is very much active in the pharma space.