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NEW DELHI: The head of the US drug regulatory body has turned down Ranbaxy Laboratories’ plea to allow drugmakers to continue exporting from banned manufacturing facilities while they take remedial measures to rectify the issues flagged.
This request was made on Tuesday by Ranbaxy Managing Director Arun Sawhney at a closed-door meeting of CEOs of leading Indian pharmaceutical companies with US Food and Drug Administration (US FDA) Commissioner Margaret Hamburg, who is currently visiting India.
According to two persons present at the meeting, Sawhney told Hamburg that the company was in ‘anguish’ because of successive actions of the US regulator. He asked her to consider framing a policy which would allow drugmakers to continue doing business in the US so that they could generate money for expensive remedial measures.
In her polite but detailed response, Hamburg said US FDA cannot change the laid-down rules to make such concessions and while companies were engaged in talks for one-off lapses, persistent mistakes were taken very seriously.
FDA upping vigilance in India
The Ranbaxy spokesman did not respond to ET’s e-mailed query on the issue. The US remains Ranbaxy’s largest market but launch of its first-to-file products in the world’s largest market have been impacted because of a series of regulatory sanctions during the last five-six years.
The FDA has banned the company from exporting medicines to the US from three units in India because of manufacturing malpractices and earlier this year it also barred the export of pharmaceutical ingredients from its plant at Toansa in Punjab.
Ranbaxy had last year paid a $500-million fine in the US and pleaded guilty to charges of falsifying data and distributing ‘adulterated’ drugs, as part of a settlement with US authorities.
Ranbaxy is not the only Indian drugmaker to invite the censure of the FDA. Many facilities of other Indian drug firms such as Wockhardt, Strides Arcolab and RPG Life Sciences have been red-flagged by the US regulator for violations last year and Indian drugmakers accounted for over half of the warning letters issued by it in 2013. This is a sharp spike compared to preceding years, and FDA is increasing its workforce as well as upping its vigilance in India, the second-largest exporter of generic drugs to the US.
The US FDA’s increased activity in India has caused concern locally and senior cabinet ministers who met Hamburg on Monday conveyed the government’s apprehension about the body’s actions.
But Hamburg sought to assuage the concerns of the assembled CEOs and told them that imposing ‘import alerts’ and blocking drugs to the US from Indian facilities was the last resort the drug regulator adopts, as this disrupts supplies and adversely affects the availability of drugs in the US market as well. The regulator prefers to first engage with the erring companies to sort out issues amicably, failing which it takes prescribed regulatory actions, she is learnt to have said. Hamburg said the USFDA was in the process of reorganising its structure and speeding up the process of approvals.
This would help clear the backlog of inspection for Indian drug manufacturers who have applied for approval from USFDA to export their products to the US. She said the FDA office in India has a mandate to conduct inspections of pharmaceutical manufacturing premises and was working towards bringing awareness about US regulatory requirements and standards among industry through capacity building workshops.
“The focus for both the industry and the regulator should be to keep pace with the changing scenario due to rapid advancements in science and technology that led to new drug discovery, biosimilars and new tools for regulators to assess safety, efficacy and quality,” she said.
Other industry captains present in the meeting included Dilip Shanghvi of Sun Pharma, Pankaj Patel of Cadila Healthcare, Habil Khorakiwala of Wockhardt, Tsutomu Une, non-executive chairman of Ranbaxy Labs, along with promoters of some other drug companies.
This request was made on Tuesday by Ranbaxy Managing Director Arun Sawhney at a closed-door meeting of CEOs of leading Indian pharmaceutical companies with US Food and Drug Administration (US FDA) Commissioner Margaret Hamburg, who is currently visiting India.
According to two persons present at the meeting, Sawhney told Hamburg that the company was in ‘anguish’ because of successive actions of the US regulator. He asked her to consider framing a policy which would allow drugmakers to continue doing business in the US so that they could generate money for expensive remedial measures.
In her polite but detailed response, Hamburg said US FDA cannot change the laid-down rules to make such concessions and while companies were engaged in talks for one-off lapses, persistent mistakes were taken very seriously.
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The Ranbaxy spokesman did not respond to ET’s e-mailed query on the issue. The US remains Ranbaxy’s largest market but launch of its first-to-file products in the world’s largest market have been impacted because of a series of regulatory sanctions during the last five-six years.
The FDA has banned the company from exporting medicines to the US from three units in India because of manufacturing malpractices and earlier this year it also barred the export of pharmaceutical ingredients from its plant at Toansa in Punjab.
Ranbaxy had last year paid a $500-million fine in the US and pleaded guilty to charges of falsifying data and distributing ‘adulterated’ drugs, as part of a settlement with US authorities.
Ranbaxy is not the only Indian drugmaker to invite the censure of the FDA. Many facilities of other Indian drug firms such as Wockhardt, Strides Arcolab and RPG Life Sciences have been red-flagged by the US regulator for violations last year and Indian drugmakers accounted for over half of the warning letters issued by it in 2013. This is a sharp spike compared to preceding years, and FDA is increasing its workforce as well as upping its vigilance in India, the second-largest exporter of generic drugs to the US.
The US FDA’s increased activity in India has caused concern locally and senior cabinet ministers who met Hamburg on Monday conveyed the government’s apprehension about the body’s actions.
But Hamburg sought to assuage the concerns of the assembled CEOs and told them that imposing ‘import alerts’ and blocking drugs to the US from Indian facilities was the last resort the drug regulator adopts, as this disrupts supplies and adversely affects the availability of drugs in the US market as well. The regulator prefers to first engage with the erring companies to sort out issues amicably, failing which it takes prescribed regulatory actions, she is learnt to have said. Hamburg said the USFDA was in the process of reorganising its structure and speeding up the process of approvals.
“The focus for both the industry and the regulator should be to keep pace with the changing scenario due to rapid advancements in science and technology that led to new drug discovery, biosimilars and new tools for regulators to assess safety, efficacy and quality,” she said.
Other industry captains present in the meeting included Dilip Shanghvi of Sun Pharma, Pankaj Patel of Cadila Healthcare, Habil Khorakiwala of Wockhardt, Tsutomu Une, non-executive chairman of Ranbaxy Labs, along with promoters of some other drug companies.
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Subscribe to The Economic Times Prime and read the ET ePaper online.