Winds of change in India’s generic drug industry

The announcement last week that United States pharmaceutical giant Gilead would allow seven Indian companies to make a cheap, generic version of Sovaldi — its cure for the hepatitis C virus and one of the world’s best-selling drugs — was rightfully hailed as a victory for patients in the developing world. Instead of paying US$84,000 (S$106,410) for a 12-week course of treatment as in the US, patients in India and 90 other nations will soon be able to obtain a 24-week course for less than US$2,000.

So why are some of the loudest protests about the deal coming from the Indian pharmaceutical industry? The main industry lobby group, which represents the 19 biggest Indian pharmaceutical firms, has come out in opposition, despite the fact that three of its members signed the deal with Gilead. The Indian Pharmaceutical Alliance insists that the science behind Sovaldi is not new and hence not subject to patent — the same argument that allowed Indian drugmakers to churn out some US$24 billion worth of other generics last year. The Alliance wants dozens of India’s 300 established pharmaceutical companies to be allowed to produce a version of Sovaldi, not just seven of them.

Ironically, Gilead’s decision to choose Indian companies rather than those from other emerging economies, or even the US, was itself an acknowledgement of the competitiveness and skill of the local drug industry. It is the third largest in the world by volume and 14th by value (since generics are sold cheaply). Half of its revenues in 2013 were generated by exports to markets outside India. The country boasts the largest number of manufacturing facilities approved by the Food and Drug Administration outside the US.

TO PROFIT OR DO GOOD?

Originally, Indian law recognised only process, not product patents. That paved the way for an explosion of copycat manufacturing between the 1970s and 1990s. World Trade Organization rules later forced a change. But even now, Indian law has a loophole disallowing patents if the science behind the discovery is not new, or if a new drug represents merely a minor modification of an older drug.

The biggest Indian pharmaceutical companies would normally have united behind this position. In recent years, however, the domestic market has grown brutally competitive. The top 10 firms now command only 37 per cent of the market, with no single player in double digits. The government imposes severe price controls on more than 300 drugs, dampening profits. And many foreign markets remain closed to Indian-made knockoffs because of stronger patent protections.

The seven companies that signed up with Gilead, which include familiar names such as Cipla and Ranbaxy Laboratories, have clearly decided that they need to adopt a different strategy to maintain profitability. Not that long ago, Cipla dramatically challenged multinational drug companies, supplying a copycat cocktail of anti-HIV drugs to sub-Saharan African countries for US$350 when their international market price was US$15,000. Now, the prospect of bigger margins is simply too attractive to pass up.

A split in the Indian pharmaceutical industry isn’t necessarily a bad thing for India or for the rest of the world. Critics have a fair point when they argue that US$2,000 is still too expensive for patients in emerging economies, many of whom don’t have access to insurance; the agreement also leaves out several key middle-income countries such as China. But top Indian companies have to find ways to remain profitable. Some have tried to venture into original research, but the costs are high and the results unpredictable. Partnering with drug majors in the West — whether to produce cheaper versions of drugs or to conduct outsourced research and trials — is one obvious solution.

For the global pharmaceutical industry, the fact that some Indian companies are willing to look beyond rip-off generics opens up a host of possibilities. Drug discovery is expensive, and the prospects for future cures depend on keeping the profit incentive intact. At the same time, the pressure to sell at a discount in poorer countries is not going to go away.

If the Western majors can outsource this task to cost-competitive Indian companies, while cutting back the threat of indiscriminate copycat versions, they might just be able to strike a balance between profit and social responsibility. Almost everyone should win — or at least, more people would than under the current system. BLOOMBERG

ABOUT THE AUTHOR:

Dhiraj Nayyar is a journalist in New Delhi and editor of “Surviving the Storm: India and the Global Financial Crisis.”