Press Esc to close

Past shortcomings rectified, regulators can check: Ranbaxy

Gurgaon, Jun 13, 2013, (PTI): 17:01 IST
Ranbaxy Laboratories's Chief Executive Arun Sawhney poses for a picture at his office in Gurgaon on the outskirts of New Delhi June 13, 2013. Ranbaxy Laboratories, India's No.1 drugmaker by sales, plans to file three to four generic drug applications every year that can earn it a six-month marketing exclusivity in the United States, Sawhney said on Thursday. REUTERS
Stressing that it has rectified past "shortcomings" and its drugs are safe and efficacious, Ranbaxy Laboratories today said it will co-operate fully with any regulator from anywhere in the world wanting to investigate its manufacturing practices.

The company, which pleaded guilty to 'felony charges' for violating manufacturing norms and agreed to pay USD 500 million penalty to US authorities, also defended selling in India some of the medicines out of the 30 generic drugs banned by USFDA, saying those were also sold in other parts of the world as they were "safe and efficacious".

"I recognise that there were shortcomings in the past. We have taken adequate measures to ensure that those shortcomings will not trouble us in future," Ranbaxy Laboratories CEO and Managing Director Arun Sawhney told PTI in an interview.

He said Ranbaxy has invested more than 300 million dollars in recent years in infrastructure of manufacturing, quality, resourcing and training to strengthen its system to prevent such incident happening again.

Reiterating that the company is following strict quality standards, Sawhney said: "Not only regulators from India...Any regulator in the world if they wish to have information from Ranbaxy we will be happy to provide them. We will be very co-operative in providing all information that is required by any regulator from anywhere in the world."

He, however, said the company is not aware of any probe by Indian authorities after questions were raised over the quality of its drugs following the developments in the US.
When asked about Jaslok Hospital issuing advisory against Ranbaxy drugs, he said: "By and large all the hospitals in India are prescribing Ranbaxy drugs. We respect internal processes of each and every hospital as just we respect any of the internal processes of each of any one of our customers."

Sounding unworried about a similar advisory by Apollo Pharmacy, he said: "We have reasons to believe that due to the fact we operate from the paradigm of quality and patience first that we would get continued patronage from all the hospitals and all the stakeholders like doctors and patients."

Asked how the company could sell in India some of the 30 generic drugs banned by USFDA in 2008, Sawhney said: "We sell those drugs in all other markets of the world, even to the country next to the US--Canada. We are selling to Europe, Australia, South Africa. Those molecules, we are selling all over the world."

The company is not selling those drugs in the US due to restrictions arising out of the consent decree it had signed, he said, adding the products per se were "not inferior or sub-standard".

Elaborating further, Sawhney said the delayed testing of stability samples was considered to be a non-cGMP (current good manufacturing practice) activity. So the data that was generated based on delayed testing stability samples was non-GMP data.

"So the products that were put on the market based on a non-GMP data was described as adulterated products (in the US). Does that make Ranbaxy products inferior, sub-standard, contaminated, spurious? The answer is no," Sawhney asserted.

He cited public advisories issued by WHO, TGA Australia, Health Canada, MHRA UK, Irish Medicines Board and MCC South Africa stating Ranbaxy drugs are of "acceptable quality".
"We have testimonials of regulators from all over the world that our drugs are of acceptable quality, safe and efficacious," Sawhney said.

When asked if the previous Ranbaxy management should be held responsible for the current issue that the company is facing, Sawhney said: "This is all about the company, it is a company issue, we own the issue, we will resolve it."

On the resumption of exports from its Poanta Sahib and Dewas plants to the US, he said: "I can't put a timeline to it but once we fulfil all the obligations that we have under the consent decree, we would be getting back into the business. We are determined to do it as fast as as we can."

Go to Top

Most trending stories
Photo Gallery
Girls taking selfie in front of Gateway of India replica, it is made by Institute of Baking...

Girls taking selfie in front of Gateway of India replica, it is made by Institute of Baking...

Commissioning of Scorpene Class Submarine INS Kalvari at the Naval Dockyard in Mumbai...

Commissioning of Scorpene Class Submarine INS Kalvari at the Naval Dockyard in Mumbai...

Prime Minister Narendra Modi shows his finger marked with indelible ink, as he leaves...

Prime Minister Narendra Modi shows his finger marked with indelible ink, as he leaves...

Congress president-elect Rahul Gandhi meets with the families of fishermen affected by Cyclone...

Congress president-elect Rahul Gandhi meets with the families of fishermen affected by Cyclone...

Uttar Pradesh Chief Minister Yogi Adityanath and Samajwadi Party leader Azam Khan on their way...

Uttar Pradesh Chief Minister Yogi Adityanath and Samajwadi Party leader Azam Khan on their way...

An Indian army paratrooper jumps from a plane carrying an Indian national flag...

An Indian army paratrooper jumps from a plane carrying an Indian national flag...

Women waiting in a queue to cast their votes during the second phase of Assembly elections...

Women waiting in a queue to cast their votes during the second phase of Assembly elections...

Indian Youth Congress workers shout slogans while being detained by the police during a protest...

Indian Youth Congress workers shout slogans while being detained by the police during a protest...

Ghulam Nabi Azad, Derek O'Brien, Anand Sharma, Mallikarjun Kharge, Farooq Abdullah and others...

Ghulam Nabi Azad, Derek O'Brien, Anand Sharma, Mallikarjun Kharge, Farooq Abdullah and others...

Pope Francis receives a credential letter from Sibi George, new Ambassador of India to Holy See...

Pope Francis receives a credential letter from Sibi George, new Ambassador of India to Holy See...

Like us on Facebook

Copyright 2017, The Printers (Mysore) Private Ltd., 75, M.G Road, Post Box 5331, Bengaluru - 560001
Tel: +91 (80) 25880000 Fax No. +91 (80) 25880523
Powered by Yodasoft Technologies Pvt. Ltd.