There’s a common message in Ranbaxy’s intensifying problems with drugs authorities in the US and Natco’s recent withdrawal of its application at home for a special licence to produce and export two patented cancer drugs to Nepal. It is that these reputed firms needed to do their homework on compliance with laws and norms better, especially with an increasingly tough global market.
Illustration: Jayachandran / Mint
First, USFDA’s import ban on 30 drugs from Ranbaxy’s two Indian facilities and additional scrutiny by a US Congress committee of its supplies to a US-funded AIDS relief programme can hurt India’s hard-earned, well- deserved image as a preferred global supplier of high-quality drugs and intermediates.
Ranbaxy has recently hired the services of a high-profile lobbyist, former New York city mayor Rudy Giuliani, to deal with the pressures it is facing in the US. There are suggestions that FDA is acting tough under strong political and lobbying pressures. Regardless, however, Ranbaxy need not have let matters reach this stage — it has been working with FDA on the compliance issues for two years already. Now, as Mint reported recently, Ranbaxy is facing related scrutiny by regulators in other countries such as Canada and Germany. It signals escalating trouble for the otherwise reputed firm. All this is despite the fact that FDA has stated it is not questioning the quality of Ranbaxy’s drugs.
Second, Natco’s filing for compulsory licences for Roche’s Tarceva and Pfizer’s Sutent early this year was a milestone for the generics industry and for patients in need of affordable access to life-saving drugs. It marked the first time that India’s new, product patent regime of 2005 could be tested with regard to legal flexibilities provided in WTO’s TRIPS agreement for a country to break a patent in public interest. Natco, however, tried to test the waters with a very weak case — Nepal never did declare that it needed the drugs urgently, which was required under the law. No surprise then that Natco quietly dropped its case last week. Ironically, it had earlier stridently argued that one of the patentees — Pfizer — should not even be heard in the case. But more sadly ironic is the fact that Natco is quite legally savvy — as the key contester in the Novartis cancer drug Glivec patent case, it took the battle from the Madras high court right to the Supreme Court.
Both instances raise concerns about merit — of compliance with standards and patent laws. And, in both, the stakes are high: The players could have managed their cases better.
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