Power Pill

Managing director K. Raghavendra Rao delivers the sweetener. Sholinganallur in Kancheepuram, TN, where Orchid's labs are located, is about to join the ranks of Ringaskiddy in Cork, UK, where Pfizer's labs are located, as one of the few towns in the world to make sildenafilcitrate, the active ingredient in Viagra, the male impotence drug that's providing "the chemical cutting edge to the next sexual revolution".

The company has got permission from the Drug Controller of India (DCI) to make 39 tonnes of the chemical for export. It has applied for permission to make and sell pills of a Viagra-clone at home. It is even planning a nationwide contest to name the desi version. As the AGM ends—with Orchid's stock prices up to Rs 115 from Rs 77 in March when it announced its plans—shareholders were already humming a Tamil couplet in anticipation of the big-O.

'Niagara Falls in the Land of Promiscuity, Viagra Rises in the Land of the Rising Sun'

Several hundred miles west of the Land of the Rising Sun (Tamil Nadu; the rising sun is the DMK symbol) in its laboratories in Turbe in New Bombay, a group of 10 scientists at Kopran Ltd has been keeping 18-hour days for the last two months to stay in the hunt for an Indian Viagra. Word is that the antibiotic-maker too has received permission from the DCI to make the sildenafil citrate, and that the plant is set to roll within a week. But the company isn't confirming.

Meantime, in central Bombay, speculation is that Cipla, which has already despatched its first export consignment order, 20-30 kg of the magic ingredient, is considering names like Activ and Tarzia for its pill, pending government permission. So has Cipla pipped Orchid at the post? Orchid's production won't commence till early-August and the first consignment won't ship till the end of the month.

The Viagra War: Forget the buzz about Telugu NRIs stuffing their toilet kits with Viagra and dumping it on Hyderabad's doctors to dish it out at a premium. Forget its easy availability on the blackmarket, in the tacky chemists' stores around SSKM hospital in Calcutta or AIIMS in New Delhi for anywhere between Rs 750 and Rs 1,200, two to three times more than its US price of $10 a pill, underneath the counter, no questions asked. Forget Maharashtra culture minister Pramod Navalkar's claim that he isn't prepared to accept that smuggled versions of Viagra are available on Mumbai's streets after The Wall Street Journal pointed at Princess Street. Forget how easily India is getting sucked into the quality-of-life pharmacology that is the rage in the West: grow more hair, feel better, whiten your skin, straighten your teeth. The real story, less than 100 days after Pfizer unveiled its Riser, is the race for the Indian Viagra.

A clutch of copycat companies are trying to duplicate the success of the 'superstud' drug. What took Pfizer 13 years and hundreds of millions of dollars in research and development to perfect, the Indian companies have managed to do in weeks, for a fraction of the cost. With little more than access to industry literature and the internet.According to the Indian Drug Manufacturers' Association, homegrown pharmaceutical majors spend 1.8 per cent of their sales on R&D against 16 per cent spent by US companies.

The immediate objective is to make and export the active ingredient—which, says Rao, can fetch anywhere from $3,000-$20,000—to countries where Pfizer hasn't already introduced Viagra. But the long-term plan is to exploit India's huge domestic impotence market, cheap labour, and the country's lax patents and intellectual property laws to formulate the drug into pills, sell the knockoffs at a tenth the cost of the asli one, and still make a killing.

Predictably, the government, which has not as yet approved the marketing of the drug in India, is playing down the rush. "So far only four companies have applied for permission to manufacture and export sildenafil citrate—Orchid, Ranbaxy, Cipla and Uni-Chem. But only Orchid has been granted permission," says Dr P.R. Dasgupta, the Drug Controller of India. But, unofficially, between 8-10 Indian companies are said to be in the running.

Buzzword is Secrecy: Much of the activity for the moment is hush-hush. Reengineering molecules—which helped India build one of the world's biggest medicine industries—induces negative vibes among transnationals whose product-patents are filched with impunity to provide high-quality medicines at 3 to 5 per cent of the retail cost of the drugs in the West. "Indian scientists have reverse-engineered far more complicated molecules. Viagra attracted attention due to its unique properties but I don't think that by re-enginering it, we've done anything earth-shattering," says Dr S. Sarangan, Kopran's vice-president for R&D. Adds Prof. A.V. Rama Rao, former director, Indian Institute of Chemical Technology: "Indian companies like Cipla, Orchid and Ran-baxy aren't violating patent laws by making Viagra clones."

Take Ranbaxy. On top of the DCI's confirmation, Financial Express reports that it has sought permission to make 150 kg of the key ingredient in the love drug. But Ranbaxy's PR-types deny any knowledge of ongoing plans.

DITTO, the high-profile Dr Reddy's Laboratories in Hyderabad. The company's public position is that it has not joined the pack of Viagra-wannabes. "It would detract from our focus for the future—that of being known as a drug-discovery company," says an official; presumably as opposed to a re-engineering one. But inside sources aver that work to clone Viagra is proceeding at a fast clip.

 "All of them realise they're dealing with a potential blockbuster. Hence the secrecy," says Satish Srinivasan of Orchid, which applied for the DCI's permission in the first week of May—less than a month after Viagra went on sale in the US—and got it on June 5. Dr Reddy's is looking both at producing the active ingredient (for other manufacturers) and making its own formulations. Names for the pill are being bandied about in its labs—Taurus, Elanafil, Restore are the current favourites. Unlike Viagra, Reddy's tab will probably be colourless, says a source.

The inspiration: The companies in the fray make no bones about the fact that the desi Viagra was fuelled by the launch of the international one. Kopran's Sarangan, is quoted by The Wall Street Journal as saying he downloaded the chemical diagram of the molecule from the internet. Cipla reportedly began developing the drug three years ago after scouring US patent records and industry literature. The Journal quotes Cipla chairman Yusuf Hamied as saying that $250,000 from his $5.5 million annual R&D budget is used for subscriptions to foreign medical journals.

"Another scientist Chandrashekhar Gaitonde parades past an array of state-of-the-art machines that examine drugs using laser beams and infrared and ultraviolet rays. He flips through charts showing that Cipla has painstakingly replicated Pfizer's Viagra down to its chemical purity and the speed with which it dissolves. 'We see the innovator, and we match the innovator'." Yet industry-watchers say the 14-step process to make Viagra is not so difficult: 26 of the 30 raw materials used in sildenafil citrate are available locally. As Satish Srinivasan of Orchid says: "It's not a difficult technology to crack." Adds Amar Lulla, MD, Cipla: "Once the molecule gets known, Indian companies work on it."

Where will they sell? From Cipla's Lulla—who says he gets 130 calls a day for information on Viagra—to Kopran's Sarangan, everyone insists they see little potential for the drug here, either in terms of users or of the monies it will bring. In fact, Sarangan says Kopran doesn't plan marketing the product in India even if it is allowed to be made here. But Orchid's Raghavendra Rao says an estimated 30 million Indians are ready to pop the pill. Hyderabad-based andrologist Dr Sud-hakar Krishnamurti, a world-renowned authority on male impotence, claims India has a 10 per cent 'Sick Willy' population, the same as in the rest of the world. "With a billion people, there are a lot of impotent men out there, and any drug of this kind would do well," he says.

But as the SOFRES-MODE poll results show, over 34 per cent of the respondents are willing to use the pill—if not as a cure, at least out of curiosity. Adds noted sexologist Dr Prakash Kothari: "It would be a billion dollar trade in India. People have tremendous paying capacity here, and there's enormous awareness of the efficacy of the drug. Rich or poor, they all know what it is and what it does." The poll underscores the point. More women are aware of the negative effects of Viagra (45 per cent) than men (35 per cent).

Yet, more than the domestic market, it's the large export market that lights up manufacturers' eyes. Pfizer, which has patented Viagra in 31 countries, says it'll introduce the pill in 50 countries by year-end. That'll still leave out a lot of countries—in West Asia, South East Asia, Africa and South America—where the pill will be required and patent laws don't apply.

Step on the gas: "The race for the Indian Viagra will have to be fast-paced," says Dr Amit Sengupta of the Delhi Science Forum. "The Patents' Bill is likely to be tabled in the next session of Parliament. If passed, India'll have to recognise not only product patents but also grant exclusive marketing rights to the company holding a product patent anywhere in the world. In that scenario, Indian companies will be allowed to make the drug but not sell it." After the WTO came into being in 1995, developing nations like India were given a 10-year transition period in which to amend their patents laws in accordance with its stipulations. Last year, the European Union appealed to WTO about India having done nothing to change its patent laws. India lost the case and was asked to grant exclusive marketing rights by the year 2000. Till then, Indian companies are free to reverse-engineer any drug registered before '95, file for a process patent, and sell it in the domestic market as well as in countries in the same situation as India. Viagra, registered in '93, falls outside the ambit.

Pfizer sources say they don't want to bring Viagra into India, despite its large market, as they don't want to compete with the copies on a generic level. But at a broader level, the company says the copy-cat culture will only work to India's disadvantage. "Poor intellectual property rights means lower foreign investment. Companies are reluctant to bring in their star products into a country where it can be blatantly copied, because it has ramifications on its worldwide marketing and sales," says S. Ramakrishna, vice-president, corporate affairs, Pfizer. But Cipla's Yusuf Hamied says keeping drug prices low is crucial in a country of India's poverty: "The WTO agreement will make drugs prohibitively expensive, create a dangerous black market for basic medicines, and drive Indian companies out of business."

Though low price is the real upside to a desi Viagra, Orchid's Satish Srinivasan says it won't be a race to undercut: "It's not going to be dirt-cheap. And anyway, why not allow it here if people are going crazy shelling out Rs 1,200 in Chennai?"

Mass-producing homegrown manufacturers will bring the pill down to Rs 40-100, making it affordable to the middle-class. "It's a good thing as it will be available to men with mild to moderate impotence. It's bad since any general practitioner can prescribe it and any chemist can dish it out," says Dr Sudhakar Krishnamurti.

Indian companies will have to conduct bio-equivalance tests to prove their products have the same effects as Viagra. But Cipla's Lulla and sources at Dr Reddy's say it's likely the DCI will soon approve the drug. A protocol for an all-India, double-blind, placebo controlled trial has been submitted to the DCI by Dr Kothari.

While the West is cock-a-hoop with Viagra, significant voices are being heard about the side-effects, as well as the social implications if it's easily affordable and freely available here. "We'll have a problem if it begins to cost Rs 50-60," says Jairam Ramesh. The fear: a drug for a specific medical condition could end up being a cultural tool for males to flaunt their machismo and assert sexual superiority over women.

"One may reasonably expect an increase in sexual violence against women," says Dr Mira Shiva of the Voluntary Health Association of India. "It could also lead to matrimonial estrangements in older couples where the male may be hardpressed to find release for his resurgent libido. In a world ever ready to drown its angst in a cauldron of sex, I wish one could invent a pill for abstinence."

There've been several important historical milestones like the introduction of penicillin. But few have made as dramatic an impact as Viagra. It doesn't treat the underlying cause of impotence, which means the condition will continue to worsen. But boys will be boys and men will be superstud suckers. In this mass yearning for virility, is impotence poised to become an affliction of the poor?

With A.S. Panneerselvan, Lekha Rattanani, M.S. Shanker, Janaki Bahadur Kremmer and Ludwina A. Joseph