Ranbaxy Laboratories may have pleaded guilty before the US department of justice for supplying fraudulent data

to that country?s Food and Drug Administration (FDA), but it would take years before the company is removed from the Application Integrity Policy (AIP) list that would allow it to resume exports to the US market from its Paonta Sahib facility in Himachal Pradesh.

The AIP list puts a halt on all approved as well as pending drug applications from the facility that comes on its radar. ?The AIP is invoked when a company?s actions raise significant questions about the integrity of data in drug applications,? states the FDA policy.

Bruce Ross, country director (India) at the FDA, told FE that ?assessing and re-establishing confidence in a manufacturer?s compliance with GMP (good manufacturing practices) and the integrity of information in new drug applications is a complex, often lengthy, process?.

?The FDA has been working with Ranbaxy and Quintiles, as required in the consent decree,? he added, without elaborating since FDA policy is not to comment publicly on a matter that is under active investigation.

Quintiles is a US-headquartered contract research company that provides services to biotechnology and pharmaceutical companies.

Analysts said that this clearly indicates that it could be years before Ranbaxy is able to convince the US authorities that it conforms to GMP and restart exports. ?These are initial steps and the company still has a long way to go before it can resume export from its Dewas (in Madhya Pradesh) and Paonta Sahib facilities to the US,? said Sarabjit Kour Nangra, vice-president, research (pharmaceutical), at Angel Broking, adding that it could take up to a year before the FDA grants Ranbaxy approvals for the facilities under scrutiny.

Experts said that the issue of faking data and adulterating drugs is different from the voluntary recall of Ranbaxy?s generic version of Lipitor ? the world?s best selling drug ? initiated in November 2012 due to glass particles found in some lots. ?That got resolved within six months. This time it will take longer since all data has to be resubmitted as fresh data and re-evaluated by the authorities,? said an industry expert.

Following the resolution of the glass particles issue, the FDA allowed Ranbaxy to resume Atorvastatin (the generic version of Lipitor) production at its Ohm Labs facility in New Jersey for the American market from April 1, 2013.

To get out of the AIP list, a company needs to conduct “a credible and adequate internal review designed to identify all instances of wrongful acts as a supplement to the Agency?s independent investigation”, according to the FDA website. The applicant?s internal review should also involve a qualified outside consultant. The company under scrutiny also needs to submit a corrective action plan which includes a description of corporate ethics and steps taken by the company to address “current wrongful acts and to prevent future occurrences”.

Ranbaxy has appointed Quintiles as its data integrity expert and Parexel, another global clinical drug research firm, as the lead current GMP auditor as it takes steps to rectify procedural and systemic problems at all its manufacturing units to comply with FDA rules. Ranbaxy has also established a project management office and an office of data reliability to implement the requirements of the consent decree it signed with the FDA in December 2011.

Last month Ranbaxy pleaded guilty to criminal charges of manufacturing and distributing adulterated drugs made at its Dewas and Paonta Sahib units and agreed to pay a $500-million penalty to the US government. The FDA has also banned 30 drugs produced at these units from import into US.

Apart from the fine, Ranbaxy will also have to bear the cost of loss of brand image as well as opportunity cost of lost businesses. ?The cost of non-compliance has been higher for Ranbaxy through loss of potential business opportunities,? said DG Shah, general secretary, Indian Pharma Alliance.

“The company agreed with the US FDA to further strengthen policies and procedures in order to continue to ensure the integrity of our data and compliance with current good manufacturing practices,? Ranbaxy said in its annual report for 2012.

Earlier, CEO Arun Sawhney had stated in a release, ?Ranbaxy has successfully launched several generic products recently across the world… We remain focused on our philosophy of ?Quality and Patients First?.?

In 2012, 40 regulatory inspections across 19 Ranbaxy sites were conduced worldwide by 21 different regulatory inspection agencies with no critical findings, as per the company?s annual report.