SME Association head writes to President to block Health Ministry license

• Says Health Ministry attempting to give ten year manufacturing license for cancer drug ‘Bevacizumab’ to questionable pharmaceutical company

By Ruwandi Gamage

Small and Medium Entrepreneurs (SMEs) Association Chairman Sanjaya Perera yesterday said he has written to President Maithripala Sirisena, seeking to cancel a proposal by the Health Ministry to award manufacture of cancer drug ‘Bevacizumab’ to a local pharmaceutical company.     

Small and Medium Entrepreneurs Association Chairman Sanjaya Perera

Voice for Justice Chairman Sirisena Amarasekara

Women for Justice Co-Chairman Sharmila Gonawela

Perera told reporters at a media briefing organised by Women for Justice that he had taken the decision to write to President Sirisena due to a range of issues allegedly linked to the pharmaceutical company. Perera alleged that the pharmaceutical company is also in the pipeline to be awarded a manufacturing license from the Health Ministry for ten years, to manufacture and sell the drug ‘Bevacizumab’ to the State Pharmaceutical Cooperation (SPC). Perera argued that the Health Ministry should not give a ten-year manufacturing license to the pharmaceutical company, as a better drug could enter the market during that period, and the Government would be wasting public funds in purchasing the outdated ‘Bevacizumab’ when a better version may become available in the future. He also alleged that sufficient clinical trials had not been conducted on ‘Bevacizumab.’ Perera claimed that businessmen linked to the pharmaceutical company also imported two other cancer drugs ‘Trastuzumab’ and ‘Rituximab’, which also had questionable registration processes. All three drugs, namely ‘Trastuzumab’, ‘Bevacizumab’, and ‘Rituximab’ were registered in February 2016, just a month after it was registered by the Russian company, and the Good Manufacturing Practice (GMP) Audit that is required by Sri Lankan law was only acquired in September 2017.   

 “When a new drug is to be registered and used in Sri Lanka, it has to have been used in the manufacturing country for 12 months, these drugs were in the Russian market for only a month. The GMP audit for these drugs had been compiled in September 2017 in Sri Lanka, after the registration was completed. In addition, it is required that the new drug has to be approved by three other countries, and the drug must possess a World Health Organisation GMP, which was revealed that it doesn’t have, according to the statement given by Pharmacist Krishantha De Silva in April at the Presidential Commission of inquiry to investigate into acts of corruption & frauds occurred in state institutions in 2015-2018,” he said.

Perera also alleged that approval had not been given to use these drugs by the relevant medical professional bodies, and was approved by a few doctors. Sanjaya Perera also claimed he has learnt that the alleged pharmaceutical company to manufacture the drug ‹Bevacizumab› does not possess a full-scale manufacturing site.

“We have reliably learnt that this company’s operation will be limited only to importing the finished product in bulk, and to have small scale re-packaging operation with no value addition.”

Speaking at the briefing, Women for Justice Co-Chairman Sharmila Gonawela also alleged another incident where pregnant mothers were distributed more than 500 million expired folic acid tablets.

“The audit report was done in 2016 about this distribution. The supplies division is responsible for releasing these expired medication for distribution,” she added.

Despite repeated attempts by Daily FT to get a response from the pharmaceutical company, they were not available for comment.  

Pic by Lasantha Kumara