India expands role in global pharma R&D

Business is so brisk that Sun, with revenue of $880 million last year, predicts sales will grow 20 per cent this year and is expanding its Halol factory.

“This site specialises in making difficult things,” Sun Vice-President in charge of operations Sampad Bhattacharya, said during a recent factory tour.

The blue and gray concrete building, which will be nearly 8,00,000 square feet after the expansion, would not look out of place in the pharmaceutical manufacturing centres of New Jersey, except for the herds of cattle and buffalo wandering nearby.

India’s drug industry — on track to grow about 13 per  cent this year, to just over $24 billion — was once notorious for making cheap knockoffs of western medicines and selling them in developing countries. But India, seasoned in the basics of medicine making, is now starting to take on a more mainstream role in the global drug industry, as a result of recent strengthening of patent law here and cost pressures on name-brand drug makers in the West.

While the Indian industry has had quality-control problems, it nonetheless benefits from growing wariness about the reliability of ingredients from that other historically low-cost drug provider — China. The US is India’s top export customer for drugs.

Global market

India is becoming a “base for manufacturing for the global market,” said Piramal Healthcare Chairman G Ajay. Eventually, in Piramal perhaps overly optimistic forecast, only the very first and very last steps of the business —molecular drug  discovery and marketing —will be run by the West’s global drug giants.

Those companies “don’t create much value” in the steps in between, he said.

It is not only Indian executives, though, who are bullish about the pharmaceuticals industry here. Analysts, research groups and consultants have been making similar predictions in recent months.

Big pharmaceutical companies have come calling, too. This year, Piramal sold its generic drug business to Abbott Laboratories for $3.7 billion, the latest in a string of takeovers and joint ventures. Daiichi Sankyo of Japan helped kick off the foreign drug push into India in 2008 by buying a stake in Ranbaxy Laboratories. Last year, among other deals, GlaxoSmithKline formed a partnership with Dr Reddy’s Laboratories; Pfizer tied up with Claris Lifesciences; Sanofi-Aventis took control of Shantha Biotechnics, and Bristol-Myers Squibb opened a research centrr in India with Biocon.

“There is a lot of good talent at a much lower price in India,” said Pharma Services Network Chief Executive Jim Worrell, a consulting firm that is organising tours of Indian factories for Western pharmaceutical executives who are considering outsourcing some of their business. “What we see happening now is manufacturing and even packaging and even formulation are moving to India,” Worrell said.

The shift to pharmaceuticals is part of a subtle, broader shift in the Indian economy. Moving beyond less sophisticated, outsourced services like call centres, India has been advancing up the business value chain, particularly in law and medical diagnostics. Now it is showing a flair for manufacturing, particularly in goods demanding high-skill production and superlow prices.

Value chain

Until recently, pharmaceuticals has been “an incredibly arrogant industry that has never outsourced,” said PricewaterhouseCoopers  Associate Director Sujay Shetty. But over the next several years, he predicts, “everything in the value chain will move to different parts of the world that are cheaper,” with India a major beneficiary.

The next opportunities for India could come at the more sophisticated end of the drug making spectrum, including research and development for the world’s drug giants and even development of proprietary medicines.

“We can crack the problem of patented drug discovery in India at a much lower cost than in the West,” predicted Piramal, who held onto his research and development operation, Piramal Lifesciences Limited, when he sold the rest of his company to Abbott. Dr Reddy’s Laboratories Chief Executive G V Prasad, said that Indian drug makers had the “ability to handle product development on a massive scale at a low cost.” Dr Reddy’s original diabetes drug has completed Phase 3 clinical trials — the last step before seeking Food and Drug Administration approval — the farthest of any of its peers.  

Meanwhile, at Sun’s stucco and glass laboratory in Gujarat,  650 scientists, backed by tons of expensive machinery and 10,000 animals in cages, are at work breaking down drugs with the aim of rebuilding them in cheaper ways with fewer side effects.
Revolutionary science is not only about developing a brand-new product, said T Rajamannar, executive vice president of Sun Pharma Advanced Research. It also means learning how to make an existing drug “very efficiently,” he said.

For all the potential, though, India’s drug industry has a long way to go to fulfill its promise. India exported about $8.3 billion in drugs and services for the pharmaceutical industry in the 2008-09 fiscal year, according to government figures, up 25 per cent from the year before.

Recent growth, though, has been shadowed by quality problems. The FDA cited Ranbaxy for manufacturing violations several times in recent years, and in February ordered a review of the company’s global manufacturing operations.

In May, Sanofi-Aventis recalled vaccines made by Shantha Biotechnics that were distributed to the World Health Organisation after users complained about white sediment in the vials. In  June, after floating matter was found in some plastic IV bags, Pfizer recalled injectible drugs made by Claris Lifesciences and sold in the US.

Patent laws

Intellectual property is also an open question. Trying to change its outlaw image as a maker of illegal knock-offs, India toughened its patent laws in 2005. But dozens of intellectual property suits are still being fought between Indian and foreign firms in courts around the world. And big pharmaceutical companies still find securing protection of their intellectual property in India difficult. A study this year of pharmaceuticals from Indian wholesalers found that 3.6 per  cent of the “drugs” had no active ingredients whatsoever.

All of which is why some drug executives in the US say that their Indian peers may be too optimistic about their industry’s prospects. “Cost is one issue, and yes it is important, but there are two other critical factors: intellectual property and quality and safety issues,” said Irix Pharmaceuticals Chief Operating Officer Panos Kalaritis.

The FDA, in response to India’s growing influence, has opened two offices in India, one in Delhi and another in Mumbai.  Among other measures, the Indian offices will enable the FDA to “verify that important products and the way they are manufactured meet US health and safety requirements,” an agency spokeswoman said.

While China is the undisputed low-cost maker of a multitude of consumer goods, India may have a rare edge in the drug industry. India’s long tradition of generics has fostered a robust educational system here for pharmaceutical scientists, as well as longer experience dealing with western regulators.  The FDA has issued about 900 approvals to plants in India to import drugs or raw materials for the industry to the US, the vast majority in recent years, compared with more than 300 such approvals for China.