The $500 million fine on Ranbaxy by US authorities after it pleaded guilty to “felony charges” for violating drug manufacturing norms is “a wake up call” for Indian pharmaceutical industry,according to Biocon Chairman and Manging Director Kiran Mazumdar-Shaw.
While stating that the issue must be utilised for making regulatory environment “more robust” in India,Shaw,however,said there should not be a “knee jerk reaction” to the episode as the drug maker has taken corrective action.
“I think this (Ranbaxy issue) is something which I believe is a wake up call. We can use this as a very good inflection point to make a very robust environment where we build a quality pharmaceutical industry,” Shaw said.
The issue should also propel Indian regulators to be more pro-active and vigilant to build Indian pharmaceutical market,she added.
Shaw,however,said the drug maker has taken corrective action and its products have since been cleared by various regulatory agencies worldwide,including USFDA.
“We should not have knee jerk reaction to Ranbaxy,today I totally don’t agree with hospitals saying we will not sell Ranbaxy products,this is ridiculuous…Ranbaxy has taken corrective action and they have got approvals from USFDA,they have got approvals from other regulatory agencies,” she said.
When asked if the issue would impact Indian drug industry’s reputation globally,Shaw said: “Our reputation is still very good,it is about building now on that reputation and making sure that the Ranbaxy backlash is only temporary,that’s the main thing.
“One bad incident should not tarnish our image (abroad),we should have the strength to be able to bear that and we should also have strength internally to bear it.”
Questions have been raised over drugs supplied by Ranbaxy after the company last month pleaded guilty to “felony charges” in the US and agreed to pay USD 500 million penalty for violation of approved drug manufacturing standards at its two plants in India. It was the largest settlement by a generic medicine maker with US authorities till date.
In 2008,the USFDA had banned 30 generic drugs produced by Ranbaxy at its Dewas (Madhya Pradesh) and Paonta Sahib and Batamandi units in Himachal Pradesh,citing gross violation of approved manufacturing norms.