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GSK’s controversial medicines not listed here, says Drugs Regulatory Authority

By Kumudini Hettiarachchi
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As a drug-giant pleaded guilty and agreed to pay massive fines amounting to US$ 3 billion in one of the “largest healthcare frauds” in history, the local drug authority assured that the three controversial medications are not registered in Sri Lanka.

Paxil, an anti-depressant, Wellbutrin used in smoking-cessation treatment, and Avandia, an anti-diabetic medication, which were at the centre of the storm in the U.S. involving GlaxoSmithKline (GSK) are not registered in Sri Lanka, Cosmetics, Devices and Drugs Regulatory Authority (CDDRA) Director Dr. Hemantha Benaragama said when contacted by the Sunday Times.

“So, if these brands are available in the country, they are here illegally,” he stressed, explaining that five other brands similar to Avandia which had been registered here about a year ago were banned by the CDDRA due to “safety issues” including being a contributory factor towards heart disease.

The generic of Paxil is Paroxetine, of Wellbutrin is Bupropion and of Avandia is Rosiglitazone, the Sunday Times understands.
There are eight other brands of Paroxetine, while there are none of both Bupropion and Rosiglitazone, Dr. Benaragama said, pointing out that Paroxetine is a slow-moving medication. Rosiglitazone is not brought into the country because this anti-diabetic medication is believed to cause heart disease.

With regard to the Augmentin-recall insisted by Hong Kong in June last year from GSK due to this antibiotic paediatric powder and syrup and the 375mg tablets containing plasticizers, the CDDRA Director said that Sri Lanka has had no issues with Augmentin. If there are any doubts about the ingredients of this medication, the CDDRA would get the ingredients tested.

Plasticizers are used to make a plastic product flexible, it is learnt and there is a permissible level. In the Hong Kong case, the plasticizers used in the manufacture of the plastic bottles in which the Augmentin powder was stored may have contaminated the powder, it is learnt.
Numerous brands of Amoxicillin Clavulanate, the generic of Augmentin, used as an antibiotic are registered in Sri Lanka, according to Dr. Benaragama.

When asked whether currently the CDDRA has banned any other medical products, Dr. Benaragama said that under Good Manufacturing Practices (GMP) being strictly followed by the CDDRA, a team will be visiting a company in New Delhi, India, tomorrow to check out “quality issues” there.

An antibiotic injection of this company was banned two years ago and now it has sought registration again. Hence the visit to check it out, he said, adding that 80% of the drug requirements of Sri Lanka are met by companies in India.
Along with this company, one product each of four other companies and 17 injections of another company had been blacklisted two years ago, the Sunday Times understands.

There was a problem with one variety of injections of the 17, but all were banned until we could be sure of GMP, said Dr. Benaragama, adding that the company cleared up the issue and has been registered again. The product in question was a pethidine injection.

GMP inspections of the other four companies have already been carried out and the reports are positive, he said, adding that their products involved an anti-allergy hydrocortisone injection, a saline injection, an anti-venom serum and an anti-histamine promethazine injection.
Urging the public to access the CDDRA website (www.cdda.gov.lk) for information on banned products, Dr. Benaragama requested anyone who has a complaint about cosmetics, devices or drugs to contact the CDDRA on Phone: 011-2698896/7 or e-mail: cdda@health.gov.lk

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