Mifepristone and Misoprostol sold on the sly
Use of banned abortion drugs in Sri Lanka cause concern in medical circles


The National Drugs Authority (NDA) has sought the recommendation of the Sri Lanka College of Obstetricians and Gynaecologists (SLCOG) to determine whether two separate abortion drugs now banned in Sri Lanka can be registered for legal use.

As unregistered drugs, it is illegal to prescribe or use Mifepristone and Misoprostol but these pills, sold in pharmacies on the sly, have caused widespread concern in medical circles.

Though banned, stocks are smuggled into the country concealed in the luggage of passengers returning mostly from India or through other unknown channels, industry officials asserted.

"We are still awaiting a response from the SLCOG to ascertain whether these two drugs can be approved for safe use in Sri Lanka", says Dr. Hemantha Beneragama, NDA’s Director.

"In fact, there was an application for the registration of Misoprostol but it was rejected by the NDA Committee", he explained. "We need the views of SLCOG on this".

In the US, the Mifepristone and Misoprostol regimen has been approved by the Food and Drug Administration up to 49 days’ gestation. Misoprostol is one of the drugs used for medical abortions in lieu of surgical evacuation, according to medical websites.

The advantages of medical abortion over surgical abortion include reduced invasiveness of the procedure, lack of risks from general anesthesia (which is often used for surgical abortions), and lack of risk of secondary infertility due to scarring and intrauterine adhesions. Furthermore, it is less complicated to administer and less expensive. In many countries, it is used in conjunction with Mifepristone, they reported.

"After Mifepristone is taken orally, Misoprostol is taken 24–72 hours later, causing the expulsion of the embryo and associated matter in approximately 92% of the cases".

The risk of using these two prohibited drugs in Sri Lanka is that it is done mostly without specialized medical guidance, a physician warned. "This could lead to excessive bleeding".

As the pills are banned, quacks also prescribe them as an "easy way out" but the inherent danger is that a slip somewhere down the line, sans proper medical attention, could be fatal, he cautioned.

Misoprostol is sold in most pharmacies at 150 rupees per pill to "safe customers" while Mifepristone is relatively difficult to buy at 2,000 rupees each, industry officials said. "But, the bottom line is that these banned drugs are there for the asking".

There are hefty margins on smuggling these pills as they are very cheap in India, they noted. "It’s not as risky as dealing in narcotics but the stakes are big".

Even certain gynaecologists at the De Soysa Maternity Hospital and some other government medical institutions prescribe these abortion pills, which have to be purchased from outside, they claimed. "There are always helpful contacts in these places".

"That’s right, patients do bring prescriptions for these drugs quite often, but as we don’t deal in unregistered pharmaceutical products, we turn them away", a leading chemist said. "But, it’s an open secret they are available underground".

"We are aware that these drugs are being sold surreptitiously in some pharmacies", Beneragama conceded. "Our Food and Drugs Inspectors are alert to this".

"The biggest difficulty we encounter is that these prohibited drugs are not stored in the pharmacies, but kept in another safe place", he pointed out. "It is only when they are satisfied a customer is genuine that these abortion pills are sold".

He said the NDA can conduct raids to bring the culprits to book if there is specific information. "The public can help us in this task".

Asked why the NDA is still hesitant to register these two brands widely used in Europe and USA, Beneragama replied: "Abortion laws are different in Sri Lanka".

Unregistered drugs are readily available in the blackmarket at a price, industry officials asserted. "It’s virtually a ‘you name it, they have it’ scenario".

"There are Food and Drugs Inspectors, but have they been able to bust any of these big rackets?", they asked. "It is apparent that they are looking the other way for obvious reasons".

It is common knowledge in the industry that some drugs imported from certain lesser known companies in Asian countries are totally ineffective, they said. "They are absolutely useless".

It will be interesting to find out how many brands introduced to the Sri Lankan market have just melted away within months, the officials noted. "This is because imports are promptly stopped after patients quit buying these drugs after realizing they are ineffective".

Then a different lot under other brand names are dumped here, they explained. "They play the big bucks game at the expense of suffering patients".


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