The Indian pharmaceutical industry could be about to step up to the big league with the launch of a new original diabetes drug, Lipaglyn, developed by homegrown pharma group Zydus Cadilla. With annual revenues of $1bn, Zydus’ chairman and managing director Pankaj Patel, expects the new drug, which tackles both high blood sugar and cholesterol in a single pill, to more than double that amount, calling it a potential “blockbuster”.
Due to be released in the coming months in India, it will take another 3-5 years of clinical trials before being cleared for sale in the more tightly regulated western markets. After years of the Indian pharma industry producing cheap knock-offs of western medicines, it is “time for India to give back,” according to Patel, “(having) benefited for years from the research and development efforts in other countries.”
This reputation for a culture of imitation drug production has led to repeated accusations from western pharma companies of poor IP protection by Indian authorities. US giant Pfizer, among others, have called on lawmakers to do more to protect the millions spent on R&D, which will not be turned into revenues if the Indian generics market is allowed to continue churning out cheaper alternatives. This culminated in US Secretary of State John Kerry discussing the issue with Indian policymakers during his recent visit to the country.
But that has still not stopped some companies falling foul of the Indian system, with the Supreme Court rejecting Novartis’ bid to protect its new leukemia drug with a patent in January, paving the way for India’s pharma companies to produce generic versions at a fraction of the cost. Gleevec, which can cost up to $31,000 a year in India is now being undercut by the generic version, which costs just $2,100 a year.
Still, Zydus’ Lipaglyn could be the start of a move from generics manufacture to original research across the rest of the Indian pharma industry. G. Shah, secretary-general of the Indian Pharmaceutical Alliance, sees this latest development as critical if Indian pharma companies, such as Glenmark and Biocon are to compete on the world stage; “Our credibility is at stake now… People have been branding us as a copycat industry, and this is a departure from that,” he said. “We are not just copycats, but we are transforming into creating original research products also.”
Zydus have spent close to $450m developing new drugs since 2001, while Glenmark spent nearly $1billion on R&D in the last year alone. However, not everyone shares this enthusiasm, with Gayatri Saberwal of the Institute of Bioinformatics and Applied Biotechnology, Bangalore, last year voicing his concern over the Indian pharma sector’s R&D abilities. Based on analysis of the patents being granted in the sector, he found a tiny minority were for genuinely original research, thus making the “prospects for original drug discovery in India poor,” he said. “There is probably a long way to go for Indian companies to undertake highly innovative work”.
Just what success the Indian industry is able to achieve internationally will not become apparent on these shores for some time yet, with the development of news drugs taking years. So we will have to stick to our tried and tested remedies in the short term at least, just as the Indian generics industry will also continue to cause a headache for western pharma companies until their original research starts to bear fruit. Pass the parcetamol.