Shortage of tocilizumab: Government steps up efforts to secure stocks

  • Stocks ordered by MSD through SPC in April yet to arrive
  • Tender being finalised to bring 200 vials for state sector
  • Suppliers promise stocks within four days of receiving tender
  • Ministry permits four pvt. companies to bring stocks for pvt. sector

By Maheesha Mudugamuwa 

Despite it being two months since the World Health Organisation (WHO) recommended tocilizumab, a drug used to treat arthritis, as a treatment for patients severely ill with Covid-19, Sri Lanka is still struggling to secure new stocks to meet the growing local demand, especially from private hospitals.

As learnt by The Sunday Morning, the stocks ordered by the Medical Supplies Division (MSD) of the Ministry of Health through the State Pharmaceuticals Corporation (SPC) in April are yet to be received.

According to Secretary to the State Ministry of Production, Supply, and Regulation of Pharmaceuticals Dr. R.M. Saman Kusumsiri Rathnayake, the tender to bring down the injection was to be finalised last week, following the selection of the lowest bidder out of three private bidders. The tendering process was opened to the private sector with the consent of A. Baur & Co. (Pvt.) Ltd., currently the sole importer of tocilizumab in Sri Lanka.

“We have already planned to bring down 200 vials for the state sector, and once the tender is finalised, the supplier would bring down the injection within four days,” Dr. Rathnayake said.

In the meantime, the Ministry had permitted four private companies to bring down the injection for the private sector.

“We have given the authority to four companies after finalising a certain price and specific location at which they are to sell the drug,” Dr. Rathanayake said, adding that none of the private importers are allowed to sell the injection in a place other than what was specifically mentioned.

He said the same goes for the price at which the private companies are to sell the injection, adding: “We took these measures to avoid the injection being sold at higher prices.”

When contacted by The Sunday Morning, National Medicines Regulatory Authority (NMRA) Chief Executive Officer (CEO) Dr. Kamal Jayasinghe said the NMRA had opened registration for companies willing to bring down tocilizumab with the consent of A. Baur & Co. (Pvt.) Ltd., considering the issues faced during importation and also to avoid any shortages in the local market.

In June, the US Food and Drug Administration (FDA) issued an emergency use authorisation (EUA) for the drug Actemra (tocilizumab) for the treatment of hospitalised adults and paediatric patients (aged two years and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Actemra is not authorised for use in outpatients with Covid-19.

In clinical trials of hospitalised patients with Covid-19, Actemra, in addition to the routine care patients receive as Covid-19 treatment, which includes corticosteroid therapy, was shown to reduce the risk of death through 28 days of following up and decrease the amount of time patients remained hospitalised. The risk of patients being placed on ventilators or death through 28 days of following up had also decreased, according to the FDA.

The antibody treatment blocks an inflammatory protein called IL-6 that accompanies rheumatoid arthritis. That same protein plays a role in some of the serious symptoms in people with severe Covid-19 infections.

However, the latest surge in cases caused a global shortage, and Genentech, the company that manufactures Actemra, cannot meet the present demand. The company last month said the demand for the drug increased to more than 400% beyond its pre-Covid levels in just two weeks.

In such a backdrop, Sri Lanka’s health sector trade unions allege that the shortages reported from time to time during the past one-and-a-half years had exposed the weaknesses of the health sector.

As alleged by them, the country’s health sector had shown a slow response to the developments in the world, especially relating to Covid-19 treatment and management.

They further alleged that it takes more than one to two months for the local system to adapt to global changes, especially to new technologies, which poses a serious risk to the lives of the people.

Speaking to The Sunday Morning, Sri Lanka Association of Government Medical Laboratory Technologists (SLAGMLT) President Ravi Kumudesh stressed that the Government’s first and main responsibility should be to save the lives of the people and to avoid the death rate from going up as much as possible.

The shortage of tocilizumab or any other essential drug or equipment urgently needed for Covid-19 patients demonstrates that the health sector was not prepared to face such a pandemic situation this year, even after it went through an unexpected situation last year, he added.

“We were told that the request letter for permission to bring down tocilizumab was on the Health Secretary’s table for more than a month, as the secretary was always trying to save money for the Government,” Kumudesh alleged.

Elaborating further, he stressed that unless the Government controls the spread of the virus, taking the necessary precautions and preparing to face unexpected situations, the development of the country’s economy would be a distant dream.

“Those who advise the President don’t understand the long-term impact the virus could have on the economy if it spreads at this speed,” he stressed.

Meanwhile, responding to the alleged illegal grey market selling of counterfeit tocilizumab injections, NMRA Food and Medicines Inspection and Legal Action Division Head Amith Perera told The Sunday Morning that the Authority was keeping an eye on unusual activities happening in the local market and monitoring developments.

“We have already informed Sri Lanka Customs to be vigilant especially of the courier items arriving to Sri Lanka, as we got some information that the stocks were being sailed marked as food items,” he said, adding that both the Customs and the NMRA are monitoring the situation.

“As of now, the NMRA has not found any such illegal stocks within the country,” Perera noted.

When contacted, a CAA official noted that the raids on medicines, including the controversial tocilizumab, were being conducted by the NMRA and that the CAA had no involvement.

Tocilizumab, sold by Roche as Actemra and RoActemra, is the second drug WHO recommended for Covid-19 treatment, the first recommended drug being dexamethasone in September 2020.

Tocilizumab belongs to the class of drugs called monoclonal antibodies (mAbs) that are used for the treatment of various diseases, including cancers.

Early last month, the FDA revised its EUA for REGEN-COV (casirivimab and imdevimab, administered together), authorising REGEN-COV for emergency use as post-exposure prophylaxis (prevention) for Covid-19 in adults and paediatric individuals (aged 12 years and older; weighing at least 40 kg) who are at high risk for progression to severe Covid-19, including hospitalisation or death.

During a media briefing held in Colombo last Tuesday (31 August), State Minister of Production, Supply, and Regulation of Pharmaceuticals Prof. Channa Jayasumana announced that permission was granted for the importation of REGEN-COV to Sri Lanka. He added that REGEN-COV should only be administered under expert medical advice.