Authoritarian health officials blacklist genuine companies

Oncologists deeply concerned over ‘fast tracking’ of cancer drugs
Shady players thrive



Describing the ongoing practice of ‘fast tracking’ cancer-related drugs as "totally unacceptable", the Sri Lanka College of Oncologists last week lashed out at, what it termed, "authoritarian attitudes of health officials" who blacklisted genuine companies, while shady players remained intact.

"We are deeply concerned over the prevailing situation because companies which have done a fine, honest job in the pharmaceutical industry are being blocked by suspending them to pave the way for dubious elements to rule the roost", says Dr. Mahendra Perera, the President of the College.

"Oncology drugs cannot be ‘fast tracked’ the way one would opt to buy rice or dhal from the marketplace. These are medicines to save human lives. The molecules of new drugs should be evaluated and we need to take our own time to do it", he explained.

For whose benefits are these drugs fast-tracked?, the senior specialist queried. "We are not all happy with the present set-up".

The College wrote to the Health Ministry Secretary on these issues three months ago, but there has been no response so far, he complained.

The end users are patients and in case of substandard drugs, there is no efficacy, no response and resultant side effects, the senior Consultant Oncologist pointed out. "The consequences of using substandard life-saving drugs can be disastrous".

"We have asked the health authorities to ensure that all new cancer drugs are registered through the College of Oncologists, which represents all oncologists in Sri Lanka", Dr. Perera told The Sunday Island.

"There has to be a comprehensive evaluation by oncologists of the molecules of these drugs to be certified as safe and effective", he stressed.

"During the process of evaluation, we also look at all aspects — the manufacturers, available literature, clinical trials and the use of the drugs in the respective countries. For example, if it is an Italian product, we ascertain whether the drug is, in the first place, used in Italy, the country of manufacture", he explained.

Substandard oncology products are not purified properly as purification is a very costly process, he pointed out. "Naturally, they come cheap as they lack efficacy, fail to react and cause side effects to patients".

He said that when the health authorities send files of different drugs to the College, two oncologists are assigned to study each product and make recommendations within a minimum period of one month. "Of course, depending on the product, a complete evaluation could take more time".

In the biosimilar category of oncology drugs, proper clinical trials are mandatory. If anybody wants to register drugs under this segment, there should be a proper clinical trial in Sri Lanka or overseas, Dr. Perera noted.

There is no generic of a biosimilar as the genes of humans are different from one another. They are akin to fingerprints. With lung cancer amongst men and breast cancer amongst women heading the list, the demand for oncology drugs has grown over the years, health officials said.

Attempts to reach Health Secretary, Dr. Nihal Jayathileka for comment were futile as repeated calls and a SMS to his mobile phone went unanswered.

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