Viagra hits the market with limitations

By Stevie Emilia

JAKARTA (JP): After a three-month delay, the "wonder pill" Viagra, as it frequently dubbed, will finally be sold here -- with several restrictions -- starting in August, at the price of US$10 per tablet.

The drug can be prescribed by any doctor who has completed a one-day training session on erectile dysfunction and its prevention organized by the Indonesian Medical Association.

In March, the Ministry of Health's Director General of Drugs and Food Supervision Sampurno approved Viagra's marketing here, but it could only be prescribed by medical specialists, such as urologists, internists, cardiologists and doctors working at medical clinics specializing in impotency.

Sampurno said the new regulation was carefully made and he dismissed speculation about possible abuse of the pills.

He explained the change was made following recommendations by the medical association, saying that 80 percent of erectile dysfunction cases were treated by general physicians and not specialists.

The recommendation was then brought to the National Committee of Drug Evaluation, which later agreed that general physicians could prescribe the drug only after completing the training.

"Besides, the urologists themselves, only about 100 of them, said that they could not handle those with erectile dysfunction alone," Sampurno told The Jakarta Post by phone on Monday.

At present, it is estimated there are around six million people suffering from erectile dysfunction across the country.

Sampurno said the ministry would also monitor the drug within a six-month evaluation period to prevent any abuse.

Viagra, which restores a man's ability to respond naturally to sexual stimulation, is a strong medicine only effective for those suffering from impotency and is not recommended for people suffering from certain diseases, such as hypertension, he added.

"Viagra is not to be used for fun. With the monitoring system, we expect there will be no abuse of the pill," Sampurno said.

Viagra's local manufacturer, PT Pfizer Indonesia Tbk., is required to prepare an information sheet on the drug, including its side effects, for doctors and related medical workers. The information sheet is approved by the Ministry of Health's directorate general of drugs and food supervision.

Every month, the manufacturer is also required to report the monitoring results of Viagra's side effects, supply and distribution to the directorate general.

Apart from following the training, doctors should report any findings of the drug's side effects to the ministry.

The first training session in Jakarta was held last Saturday at the Hotel Mulia Senayan and was attended by around 1,200 doctors.

The medical association's chairman, Merdias Almatsier, said the training program materials were prepared with guidance from the Indonesian Erectile Dysfunction Advisory and Training Council.

He added that other medical institutions could also hold similar training courses after receiving accreditation from the association. Accredited institutions will be able to train doctors with materials and guidance provided by the association.

Merdias said the training was held with the serious intention of preventing the abuse of the drug.

For instance, doctors were not allowed to simply register and then be given certificates without completing the whole session, he said.

"Doctors are required to follow the whole session," Merdias said after opening the training program here. "By attending the whole session, they will get clear information and treat those with erectile dysfunction well and rationally."

The names of doctors participating in the training session would then be delivered to the Ministry of Health before being given to pharmacies that provide Viagra (sildenafil citrate).

After Jakarta, similar training sessions will be held this month in Medan, Bandung, Semarang, Surabaya and Denpasar.

Every pharmacy is required to make a written request to the distributor before being able to get the drug.

And under the ministry's regulation, pharmacists themselves must personally give the drug to customers and provide them with accurate information. The pharmacies are also required to record all sales of Viagra.

Since its approval by the U.S. Food and Drug Administration in March last year, more than 11 million Viagra prescriptions have been written globally. It is now available in more than 70 countries.

But here, Viagra -- which works by increasing the blood flow to the penis necessary for establishing and maintaining an erection -- has been found in many places long before its official marketing, at prices ranging between Rp 90,000 and Rp 125,000.

Pfizer acknowledged the situation and pledged to compete with the illegal distributors.

"If the rupiah keeps strengthening, we can compete much better," the company's pharmaceutical director Simon Tobing told journalists during a press education forum last Thursday.

In Indonesia, Pfizer will provide 25 milligram and 50 milligram Viagra pills directly imported from the U.S., while most illegal distributors sell 100 milligram pills. It will start producing the drug here after evaluating the market's response.

Although the company regards Indonesia as a potential market, in its initial marketing here the company does not expect to reap a huge profit, but said it was focusing more on education programs.

"Many (erectile dysfunction patients) do not have the awareness to consult doctors about their problem yet," Simon said.

"From about six million people suffering from erectile dysfunction, only about 10 percent of them consult doctors. Others live with their problem, while others try to find a solution on their own," he added.

The company's marketing director, Noko Sumanto, says that erectile dysfunction is now a well-known common medical condition.

"It is no more a social stigma and there's no need to hide yourself away... it's ok to talk about it."