Following reports of two widely used drugs for cancer patients namely ‘transtuzumab’ and ‘bevacizumab’ which were imported from Russia incurring a possible loss of Rs. 3.8 billion during the past two-and a-half years, the Small and Medium Entrepreneurs Association (SMEA) has requested President Maithripala Sirisena to appoint a special Presidential Commission to investigate the matter.
SMEA president Sanjaya Perera told a press conference last week that these low-quality drugs are not scientifically tested in Russia nor are they in use in the country of origin.
These are two Russian drugs do not have the Food and Drug Authority (FDA) approval in the US which is considered the benchmark for drugs, he said.
A veteran oncologist speaking on the condition of anonymity, told the Sunday Observer that the use of bio similar drugs was one of the growing problems not only in Sri Lanka but also the entire world.
“These drugs are not some other capsules, but are actually proteins. Therefore, low-quality substitutes lead to more complexities,” he said.
He said 30% of all cancer patients are given transtuzumab, one of the two Russian drugs. Even though the National Medicines Regulatory Authority (NMRA) in Sri Lanka, has a universal guideline to follow when registering drugs to be used the country. The matter is now before the Court of Appeal.
No sooner, the Ministry of Health registered these drugs, Roche Pharmaceuticals had filed a case against the registration in court. The case is still pending in the Court of Appeal. In 2016, 25 oncologists sent a letter to the Secretary, Ministry of Health and Indigenous Medicine that these unsafe drugs be stopped as the FDA had approved other cheaper drugs which are already available in the market.
When inquired about the allegations and probable loss, the Director General of Health, Dr. Anil Jasinghe said that he cannot comment on the incident as it wasn’t under his purview. Sanjaya Perera told the press conference at the Abhayaramaya in Narahenpita that a Rs. 8.1 billion loss had been incurred during the same time period by the Ministry of Health and State Pharmaceuticals Corporation (CPC) importing other drugs.
Several attempts, by the Sunday Observer, to contact Wasantha Perera, Secretary to the Ministry of Health and Indigenous Medicine, failed.