India may lobby US officials if the FDA ban on Ranbaxy meds and ingredients is not revoked following corrective actions taken by the generic drugmaker,The Economic Times reports, citing senior officials in the Indian commerce department.
Ranbaxy has told the commerce department it made procedural corrections at its manufacturing plans to conform with FDA rules and is in the process of informing the FDA. Some in India's pharmaceutical industry believe the ban could be a ploy by the US pharma lobby to discourage Indian drugmakers, since it produces cheaper generics (back story on FDA ban).
"There is nothing wrong with the quality of the drugs banned by the US. There were small procedural violations pointed out by the USFDA. Ranbaxy has informed us that those violations have been corrected and it would now invite the FDA to come and inspect its facilities,” a commerce department official told ET. "We have no objections when genuine concerns are addressed. But if quality issues are unnecessarily raked up as non-tariff barriers, we will surely discuss the matter with the US."
The Commerce & Industry minister Kamal Nath wrote his US counterpart, Human & Health Services Secretary Michael Leavitt last month, pressing for an early resolution of the issue.
“The company (Ranbaxy) has been fully co-operating with the concerned authorities and is willing to take appropriate steps to bring all concerns and issues to a closure. Since June 2008, requests for the company to meet the FDA and gain a better understanding of US’ concerns have been fully addressed,” the minister pointed out.
The chemicals minister Ram Vilas Paswan also wrote Leavitt last month, seeking intervention and the external affairs ministry may also take up the issue with the US government, according to sources.
However, this could not be independently confirmed. Paswan wrote to the external affairs minister Pranab Mukherjee, asking for Ranbaxy's case to be taken up through the Indian Embassy in the US.
2 Comments
The drama and positioning is interesting. Ranbaxy might have corrected the deficiencies but the if the documents are showing a signature of an employee who was not present at the site is a suggesting that we do not have to comply with the regulations. It is arrogance and a direct snub at regulators and the customers.
It is a shameful act.
The whole premise of drug quality is that the onus is on the drug company to prove that every batch of material is safe for public consumption.
The reason for all the paperwork is so that inspectors can go in and verify that safety testing is being performed properly.
When you start finding falsified documentation it calls the whole quality system into question. Did the company intentionally conspire to falsify data, or did they merely inadequately control their quality system to ensure this kind of fraud was not possible? Neither is acceptable.