Oncology drugs purchases run into a storm: Supplies suffer critical breakdown

Board of experts to be appointed



Amidst a conflict with the College of Oncologists on the procurement of an Indian drug to treat cancer patients, a comprehensive board of experts comprising oncologists and pharmacologists is expected to be appointed for evaluation and recommendation on government tenders, a high-ranking health official said yesterday.

This unprecedented move comes in the wake of last week’s cancellation of a multi-million rupee tender by the Director-General of Health Services (DGHS) to procure life-saving drugs to treat patients suffering from advanced breast, lung and pancreas cancer.

The prevailing indecision has led to a critical breakdown in the supply of the vital drugs, resulting in many deaths and the prolonged agony of cancer patients, officials said.

"In the face of opposition by oncologists, we have no option, but to appoint a broad committee of experts to evaluate and recommend procurement", Health Secretary, Dr. Nihal Jayathilake said.

He said the College of Oncologists had rejected the Indian-made product on the basis that it was not evaluated by oncologists for its safety, efficacy and quality. "As a result, they declined to recommend its purchase".

This particular drug had been registered by Dr. Hemantha Beneragama, the Director of Cosmetics Drugs and Devices Regulatory Authority (CDDRA) under the controversial "one-day fast track" system. Hence, the supplier was allowed to tender as a new entrant to the market.

"This one-day registration process came under a lot of flak, but the fact that it was registered, the supplier was permitted to bid", Jayathilake explained.

With the College of Oncologists opposing its procurement until it was evaluated and recommended by them, the DGHS had to cancel the tender, he pointed out. "There is a big price difference between the Indian and US products from two different suppliers".

It is true that the government will be saving millions of rupees by purchasing the Indian brand, but apart from the pricing, safety and quality issues should also be addressed, the Secretary noted. "We cannot compromise on that".

The two drugs are priced Rs. 38,000 (Indian) and Rs. 73,000 (USA) per vial, respectively.

"Yes, patients are suffering as this vital drug is not available in government cancer hospitals", Jayathilake conceded. "While procuring drugs of a high standard, we must also break the monopoly".

"As there is a crisis, we will purchase what the proposed board of experts recommend", he said. "Otherwise, there will be a conflict as oncologists reject drugs which they had not approved to be used on patients".

It is a pathetic situation as patients have been denied the care they deserve due to the tug-of-war, medical officials said. "Without life-saving drugs, many will continue to die".

The tender had been cancelled by the DGHS, who chaired the tender board meeting, despite the Chairman of the Technical Evaluation Committee (TEC), giving the green light for the procurement of a time-tested US product, they said.

Pricing is not the determining factor as the top priority is whether a particular drug is of top quality standard, safe and effective on cancer patients, Dr. Mahendra Perera, President of the Sri Lanka College of Oncologists, emphasized.

"Just because a supplier offers a product at a low price, it doesn’t mean the drug is safe for use", he said. "It has to be proven through a process of evaluation and clinical trials".

"This is a sad situation because patients are dying due to the non-availability of adequate stocks of this drug for more than seven months", he complained

He said that Abraxane is a vital drug used in the treatment of patients suffering from advanced breast, lung and pancreas cancer. "We just get a vial or two when sufficient stocks are required to treat scores of suffering patients".

"Of course, this drug is costly because it is an original USA product, but as oncologists, we are concerned about the safety, efficacy and quality of products rather than the price factor", he told The Sunday Island.

In any case, the government allocates Rs. 1.5 million per cancer patient each year and vital drugs are purchased on a name-patient basis from suppliers, he noted.

Perera, a senior Consultant Oncologist at the Maharagama Cancer Institute (MCI), also serves as the head of the Health Ministry’s TEC on oncology drugs.

"Patients at the MCI are suffering without this vital drug", he pointed out. "It is important to prolong their lives".

He said that a generic drug from India was a bidder, but the Sri Lanka College of Oncologists had not evaluated and sanctioned this product as safe for use on cancer patients in Sri Lanka.

"During the process of evaluation, it is standard procedure to also look at all aspects — the manufacturers, available literature, clinical trials and the use of the drugs in the respective countries", Perera explained.

"We do contact oncologists in the respective country of manufacture and ascertain whether the drug is, in the first place, used there or blacklisted", he said. "These drugs are a matter of life and death for patients".

Rejecting the practice of "fast-tracking" drugs, he said, "We have written to Health Secretary, Dr. Nihal Jayathilake and the Director-General of Health Services to ensure that all new oncology-related products are registered through the College, which represents all oncologists in Sri Lanka".

"Without allowing patients to be poisoned, we need to evaluate these drugs and not compromise safety", he noted. ""The consequences of using unsafe, substandard drugs can be disastrous".

He said that substandard oncology products are not purified properly as purification is a very costly process. "Naturally, they are offered cheap as they lack efficacy, fail to react and cause side effects to patients".

"We appoint a three-member committee of oncologists for a comprehensive evaluation of the molecules of each drug seeking registration to be certified as safe and effective", Perera underscored.

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