That’s the concern after hearing the Sanofi-Aventis diet pill, which is linked to suicide, is becoming popular in generic form in India. Six Indian generic drugmakers, including Cipla and Ranbaxy Labs, are exploiting a loophole in local patent laws, selling copies under names like Slimona and Defat, and the pills are sold without prescription for as little as 12 cents, Bloomberg News reports.

If these over-the-counter knocks offs, which are being used without supervision, cause an increase in suicides, the FDA is unlikely to ever approve Acomplia. Two months ago, an FDA panel rejected the diet pill over this issue and Sanofi subsequently withdrew its application.

“This is going to be potentially disastrous,” Jeff Mechanik, an endocrinologist at Mt. Sinai Hospital in New York, tells Bloomberg. “People are going to be over-dosing”‘ if generics flood the market and people take them inappropriately.

Indian regulators approved generic Acomplia, but require patients get a prescription and medical advice on risks, including depression and anxiety. But Bloomberg reports two pharmacies sell the med without an explanatory leaflet or a doctor’s note. One in New Delhi’s commercial center sells the pills for the equivalent of 22 cents apiece, and another in Mumbai sells it for 12 cents.

“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,” Stephen Bloom, a professor of metabolic medicine at London’s Imperial College, tells Bloomberg. “The rest of the world will watch. It’s very kind of the Indian nation to be testing drugs for us like this.”

Under Indian intellectual property law, drugmakers can use a process called reverse engineering to manufacture drugs patented before 1995. The Acomplia patent dates to 1994, and Sanofi hasn’t heard from Indian authorities on some of the company’s patent applications filed after 2000, spokesman Jean-Marc Podvin says.

Sanofi received approval to sell Acomplia in India in May, the same month as the generic makers, but hasn’t decided whether to sell its branded version there. “We’re evaluating our options,” says Podvin. “Of course, it’s a concern.” Sanofi still plans to make the drug available in the US. In a statement Aug 1, Sanofi said Acomplia has a “positive risk benefit ratio” when used in the “appropriate population.”

European regulators, who approved Acomplia last year, tightened prescribing rules last month to say Acomplia shouldn’t be used by those taking antidepressants or who have depression.

India is growing obese. Almost a third of women and more than a fifth of men living in urban areas are considered overweight, according to a government survey last year. Indian men are three to four times more likely than East Asian, African American, Hispanic or Caucasian men to develop insulin resistance that leads to diabetes, according to a study last year in the Proceedings of the National Academy of Sciences.

Unregulated use of the medicine that leads to reports of serious side effects could spell trouble for Sanofi, researchers say. “Doctors should be very careful because in all the clinical trials, there was a slight increase in anxiety and depression,” says Andre Scheen, head of diabetes, nutrition and metabolic disorders at the University of Liege, Belgium, who led a clinical trial on Acomplia.

India’s Torrent Pharmaceuticals started selling its version, Rimoslim, two months ago. Rimoslim is “an extremely affordable therapy for the masses,” the company said 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, wrote Bloomberg “we can only wait and see how this unfolds” with the FDA.

S.K. Wangnoo, a senior consultant endocrinologist at Indraprastha Apollo Hospital in New Delhi, says the medicine should only be used by “a selected group of patients who are not able to control their appetite despite all efforts by diet counselors, behavior therapy or psychotherapy.” Those patients “must be told about the side effects and be checked by a doctor every month,” adding that he’s cautious about prescribing the med, especially after it wasn’t approved by the FDA.

G.R. Sumathi, who runs Cash Pharmacy in downtown Bangalore, says he’s selling at least one box of Defat every day.