Down but not out …

Ranbaxy’s regulatory woes continued as the US FDA imposed an import alert on its third factory, the Mohali unit. The Paonta Sahib and Dewas plants were already under the scanner, and coming after Ranbaxy’s assurances post the consent decree was signed in January 2012 as well as a hefty $500 million settlement paid this year, this latest regulatory slap on the wrist is sure to cast more doubts on the company’s commitment to clean up its act.

It’s cold comfort that other pharma plants in India too are at the receiving end of regulatory rebukes. Wockhardt’s Waluj facility recently received a US FDA warning with inspectors listing serious non-compliance issues like finding torn data records in washrooms. Agila Specialities, which had just received the government’s nod to be acquired by the US-based Mylan from its parent company Strides Arcolab, too received a warning letter from the US FDA.

The frequency of warning letters and import alerts from the US FDA to pharma companies based in India has increased in the recent past for two major reasons. Firstly, the US FDA today has more inspectors in India than ever before, up from seven to 19. Secondly, these inspections are not by prior appointment as in the past but surprise visits, giving manufacturers no time to cover their tracks.

Inspite of the increased regulatory scrutiny, not just from the US FDA but other global regulators, Indian companies are not giving up without a fight. Ranbaxy’s press statement promised that the company will “review the details and continue to fully cooperate with the US FDA and take all necessary steps to resolve the concerns at the earliest.” So also, Mylan’s accquisition of Agila remains on track.

In fact, Ranbaxy continues to adopt a combative stance when it comes to defending its Abbreviated New Drug Application (ANDA) filings when challenged. The most recent challenge is Watson Laboratories’ Paragraph IV Certification Notice for a generic version of Absorica (isotretinoin capsules), a product that is licensed from Ontario-based Cipher Pharmaceuticals. Ranbaxy announced that together with Cipher, they intend to vigorously defend Absorica’s intellectual property (IP) rights and pursue all available legal and regulatory pathways in defense of the product. This stance is indicative of the tenacity and fight-for-every-inch attitude required to survive and thrive in today’s pharma industry.

Focusing on niche areas is but one of the strategies of pharma companies to build a differentiating edge As the cover story in this issue, ‘Searching for the silver lining’ analyses, geriatric medicine is finally getting the attention it truly deserves. Even Google has jumped on the healthy ageing bandwagon, launching what is being dubbed as a search for immortality. Google bosses seem to hope that their superior data-mining skills will find new perspectives to known facts on age-related diseases. For now, ageing might slow us down but that does not mean we are out …

Viveka Roychowdhury
Editor

[email protected]