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'India facing shortage of key tuberculosis drugs'

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Shortage of life saving drugs in local market, stockists blame manufacterers

MUMBAI: Some multinational companies (MNCs) have been delaying the launch of life-saving drugs in India years after getting monopoly rights, while cheaper generic versions of exorbitantly-priced medicines are going off the shelves under the product patenting law.Corporates such as Japanese firm Otsuka Pharmaceuticals , US-based Bristol Myers-Squibb (BMS) and Swiss firm Novartis are deferring the launch of medicines critical for treatment of serious non-communicable diseases like cancer, HIV, hepatitis C and TB.“MNCs keep prices of their breakthrough treatments unaffordable for many in India, and in certain cases delay the launch here, worried that the country may become a good example of reference pricing for others to follow,” a public health activist said. These MNCs target the more lucrative mature markets as against treating those in the developing world.For instance, a scrutiny of regulatory documents made available to TOI by legal experts reveal how Otsuka, which has a patent for delamanid since December 2011, has not imported even a single pack into India yet. The drug, used to treat multi-drug-resistant (MDR) TB, has not been imported in enough quantities even for the mandated local trials. This, even as WHO estimates that India is home to the most number of MDR-TB patients in the world.Novartis’s respiratory medicine Onbrez is another example. Similarly, affordable versions of anti-cancer drugs such as sunitinib and dasatinib have been taken off the retail shelves in accordance with the patent law. Those made by MNCs — GlaxoSmithKline ’s lapatinib and Novartis’s nilotinib — are exorbitantly priced.BMS, for example, got a patent for dasatinib in November 2006 and has effectively blocked generic competition, filing infringement suits in the Delhi HC against Hyderabad-based Natco Pharma. Natco’s Dasanat, priced at Rs 9,000 for a month’s treatment as against BMS’s Rs 1.66 lakh, has been withdrawn from the market.Significantly, data submitted by BMS to the government for its dasatinib version, Sprycel, shows that the maximum number of patients that could have been provided a single year’s treatment for CML in 2011-12 and 2012-13 was 300 and 508, respectively.“Nearly 10 years have passed since India introduced product patenting and slowly (the number of) medicines that are patented are growing. It is critical that provisions in the Patent Act are fully and properly implemented,” Leena Menghaney, South Asia manager for global humanitarian organization Medecins Sans Frontieres said.Under the law, if a firm gets a drug patent, it is obligated to locally “work the patent”, that is, make the drug accessible at a reasonable price.Recently, generic drugmaker Cipla asked the government to revoke five patents held by Novartis on Onbrez (indacaterol) and launched a cheaper version. It alleged that Novartis had patents on the medicine since 2008 but has not produced it in the country. Instead, Cipla alleged, Novartis had imported negligible quantities of the drug, leading to a shortage in the market.