Red light on Russian drugs

By Maheesha Mudugamuwa

Concerns were raised over the quality of Russian drugs in the market with the Government Medical Officers’ Association (GMOA) claiming two drugs could pose serious health issues.

The GMOA warned that the Russian manufactured Trastuzumab and Bevacizumab oncology drugs could affect cancer patients, especially breast cancer patients at the very early stage of cancer.

The GMOA alleged that Health Minister Dr. Rajitha Senaratne was attempting to create a monopoly for the aforementioned two drugs, which as they claimed are of low quality and expensive.

The GMOA also stated that the Government would incur a loss of around Rs. 50 billion if the Minister succeeded with his plan to offer a 15-year buyback guarantee for the controversial drugs.

Trastuzumab is used to treat metastatic breast cancer, the stage where the disease has spread to distant sites beyond the axillary lymph nodes. It is effective against tumours that overexpress the HER2/neu protein. It is also used as part of chemotherapy regimen for adjuvant treatment of lymph node-positive, HER2/neu protein-positive breast cancer. It can also be used to treat gastric (stomach) cancer.

Bevacizumab is a manmade antibody (IgG1) used to treat kidney, colon, and rectal cancer. It is also used to treat lung cancer (non-small cell type) and certain types of brain tumours.

GMOA Secretary Dr. Haritha Aluthge told The Sunday Morning that out of around 30 oncologists specialising in breast cancer, 28 claimed the Russian-made drug could not be prescribed for the very early stage of breast cancer.

He stressed that giving a buyback guarantee to one single company would pave the way to close avenues of new technological advances coming into the country over the next 15 years.

The GMOA informed the President and requested him to intervene and take the necessary steps to stop the arbitrary action the Minister was going to take.

In its letter addressed to the President, GMOA President Dr. Anuruddha Padeniya noted that the association had been informed that the Health Ministry Secretary and the National Medical Regulatory Authority (NMRA) Chairman were also under pressure over this issue.

Health sector at risk

Highlighting the importance of the mechanism to check the quality of the drugs imported to the country, Dr. Aluthge stressed that in 2016, Dr. Senaratne had promised to establish a laboratory with the facilities for quality checking with funds from China, but to date, no foundation had been laid to set up such a laboratory.

The whole health sector is at huge risk as the quality of all these drugs was being evaluated through clinical practices only, Dr. Aluthge alleged.

Other countries are checking the quality of each stock of imported drugs, but in Sri Lanka, they sometimes depend on certificates given by other international agencies, he said, adding that on some occasions, they checked the quality of the samples provided by the importer or the manufacturer.

Meanwhile, responding to the allegations levelled that he was importing low-quality cancer drugs to Sri Lanka, Dr. Senaratne told Parliament that earlier, there was a monopoly of the relevant drug in the market as it was only manufactured by one multinational company.

“They had the patent for 20 years and after that, the Russians started to manufacture a similar drug. The Russian drug is of the same quality as the original drug, but is available at a lower price,” he said.

This issue is not only in Sri Lanka; when the Indian Health Minister decided to break the monopoly, a similar opposition was levelled against him as well, Dr. Senaratne said.

However, when The Sunday Morning contacted NMRA CEO Dr. Kamal Jayasinghe to inquire about the quality-checking process of the drugs by the NMRA, he said drugs were only being imported by registered companies and based on the drug, the quality-checking process was different.

But Dr. Jayasinghe claimed that the drugs that were coming to the country were of good quality.

However, it was also alleged by medical professionals that there was a drug shortage in the country, and two months ago, it was reported that there was a shortage of several essential cancer drugs.

When The Sunday Morning contacted the Medical Supplies Division (MSD) Director Dr. A.T. Sudarshana, he stressed that the Government spent a total of Rs. 45 billion per year to import drugs into the country, and out of that, Rs. 2 billion was spent solely on importing cancer drugs.

However, he stressed that at present, there was no drug shortage in the country, but that several delays in the compulsory process were present.

“Usually, it takes around a month to import a drug, but if there is low demand for the drug and there is no registered company, the MSD would spend a few months until the registration process is done,” Dr. Sudarshana stressed.