"Suicide" Inducing Drug in India: Need For More Stringent Drug Regulation

Bloomberg reports on a very troubling case of a “suicide inducing” diet control drug, that though not likely to be approved in the US, has been approved in India. It notes, in pertinent part:

” Sanofi-Aventis SA’s Acomplia weight- loss pill, linked to suicide, is becoming popular in generic form in India. That may end the product’s chances of ever reaching the U.S., where it has been delayed by regulators. Cipla Ltd. and Ranbaxy Laboratories Ltd. are among six drugmakers exploiting a loophole in India patent laws, selling copies of the medicine under names like Slimona and Defat. The pills are sold without prescription for as little as 12 cents.

Should the knockoffs, used without supervision, lead to an increase in suicides, the U.S. Food and Drug Administration’s opposition may stiffen. The drugmaker’s shares, near the lowest in two years, won’t rise anytime soon because the company has few medicines to replace Acomplia’s lost sales, analysts said. Sanofi had predicted Acomplia would generate $3 billion a year. “This is going to be potentially disastrous,” said Jeffrey Mechanik, an endocrinologist at Mt. Sinai Hospital in New York. “People are going to be over-dosing” if generics flood the market and people take them inappropriately, he said.

“Under Indian intellectual property law, pharmaceutical companies can use a process called reverse engineering to make drugs patented before 1995. The patent on Acomplia, which regulates hunger impulses, dates to 1994. Sanofi hasn’t heard from Indian authorities on some of the company’s patent applications filed after 2000, spokesman Jean- Marc Podvin said. Sanofi received approval to sell Acomplia in India in May, the same month as the generic-drug makers. The company hasn’t decided whether to sell its branded version there.

“We’re evaluating our options,” Podvin said. “Of course, it’s a concern.” A pharmacy in New Delhi’s commercial center sells the pills for the equivalent of 22 cents apiece. At another in Mumbai, the tablet can be bought for 5 rupees (12 cents). No Warning The Indian regulator approved rimonabant, or generic Acomplia, requiring patients get a prescription and medical advice on its risks. Those include depression and anxiety –side effects that were serious enough to prompt an FDA panel of advisers to reject the pill. Both stores sold the medicine without an explanatory leaflet or a doctor’s note.

European regulators, who approved the medicine last year, tightened prescribing rules last month to say Acomplia shouldn’t be used by those taking antidepressants or who have depression. ``There is a risk that if you can just buy it over the counter and really want to lose weight for that wedding, you may end up committing suicide before you get married,” said Stephen Bloom, a professor of metabolic medicine at London’s Imperial College. “The rest of the world will watch. It’s very kind of the Indian nation to be testing drugs for us like this.”

Torrent Pharmaceuticals Ltd. started selling its version, Rimoslim, two months ago and aims to sell 100 million rupees’ worth within 12 months. Rimoslim is “an extremely affordable therapy for the masses,” the Ahmedabad-based company said in a statement on its Web site in May. Asked via e-mail whether there were concerns about patient safety, Ruchir Modi, Torrent’s vice president of marketing, said “we can only wait and see how this unfolds” with the FDA.”

Can we afford to wait and see “how this unfolds”, when people’s lives are in danger??

What is interesting in the above report is the spin on “intellectual property rights” and the indirect suggestion that India’s rather “weak” patent protection for the drug in question is somehow to blame. Drug safety has nothing to do with intellectual property rights–and is a separate concern altogether. In other words, the presence or lack of a patent covering Sanofi’s drug is not determinative of the issue of whether or not the drug is “safe” and “effective” and merits regulatory clearance. And this is precisely why we have a “patent office” deciding whether a drug is patentable and a separate “drug regulator” deciding whether, irrespective of the patent, the drug is “safe and effective” for use by consumers. A patent is testimony to the fact that the drug in question is really “inventive”, whereas a regulatory clearance from the drug regulator endorses the fact that the drug is “safe and effective”–and without such regulatory clearance, a drug cannot be introduced into the market.

Anyway, it is deeply troubling that when the drug has already received negative reviews from an FDA panel, it has not only been approved in India but is selling across the counter in large quantities.

The pathetic state of drug safety regulation in India has not quite merited the attention that it deserves. I guess we’ve been too caught up in the “patent” debate to give this more pressing concern over drug safety our due attention. Our drug regulatory framework is a mess–with both central and state regulators having jurisdiction over drug safety issues, and with companies often indulging in forum shopping to locate the most lax state regulator.

The government needs to take note of incidents such as this and to ramp up the regulatory structure to ensure that drug safety and consumer welfare come first. Else, as Professor Bloom rightly notes, we’ll continue to be a “testing” ground for the rest of the world.