News
Dangerous trend in health sector
View(s):- SPC buys insulin from Ukraine; More and more waivers from NMRA to bypass on quality
By Namini Wijedasa
As medical procurement controversies continue to plague the health sector, the State Pharmaceuticals Corporation (SPC) instructed the regulator to waive still further registration for consignments of high-priced insulin from Ukraine to be purchased on an “emergency” basis without tender.
The insulin orders - mainly for the country's increasing number of acute diabetic patients, are just one among scores of medications now being obtained for the public health service without thorough vetting. Legally, waivers of registration—whereby drugs are waved through by the National Medicines Regulatory Authority (NMRA) without stringent, legally-mandated checks for quality—are only permitted under exceptional circumstances.
However, an increasing number of professionals protest that these waivers (WoRs) have now become routine and are riddled in controversy. They warn that bypassing oversight has heightened the risk to public health. These purchases are sanctioned at the highest levels of the Ministry of Health.
Health Minister Keheliya Rambukwella and NMRA Chairman S. B. Jayaratne defend the issuance of WoRs. At a meeting between the Sri Lanka Medical Association and Secretary to the President Saman Ekanayake on Friday, Prof. Jayaratne claimed that when the Health Ministry requests waivers, the NMRA was bound to issue them. However, it was pointed out to him that this was not the role or duty of a regulatory mechanism.
According to documents seen by the Sunday Times, SPC Managing Director M. Y. K. Wilfred last month wrote to the NMRA seeking WoRs for 30,000 vials of insulin soluble and 12,500 vials of insulin isophane produced by a Ukrainian company named “Indar”. The local importer is Yaden International (Pvt) Ltd and the consignments are being bought as “buffer stock”.
Mr. Wilfred also notifies the NMRA CEO in writing that the Health Sector Emergency Procurement Committee (HSEPC) has made the respective awards to Yaden International subject to WoRs and that the company was the “sole bidder”.
The WoR application cites the total invoice value for the 30,000 vials of insulin soluble as US$ 121,884.8650 which amounts to US$ 4 per vial. The total invoice value for 12,500 vials of insulin isophane is US$ 50,785.3604—again US$ 4 per vial. Documents show that these prices are “exorbitant”.
The top two bidders—MJ BioPharm of India and Novo Nordisk of Denmark—offered a vial at US$ 1.55. The third one, Wockhardt of India, quoted US$ 1.65 per vial. It was only the sixth-listed bidder, Gulf Pharma of UAE, which quoted US$ 4 per vial. The tender went to Novo Nordisk.
“Insulin is a widely-used essential drug,” said a senior health sector source. “The SPC could have got its buffer stocks either from a previously registered supplier or could have advanced some batches from the present supplier. Instead, the authorities allow drugs to go out of stock and bypass due procedure under the guise of emergency procurement.”
Meanwhile, concerns are growing about the repercussions of flooding the public health sector with unregistered drugs after yet another death—this time of a 32-year-old woman who underwent surgery at the National Eye Hospital in Colombo on Wednesday—was flagged by the consultant anaesthetist who handled the operation.
The anaesthetist filed a “report of adverse reactions to medicines, vaccines, devices, traditional remedies & cosmetics” in relation to the death. In it, she placed a question mark against the propofol (brand name “Anesthefol”) that had been used. She observed that the patient had not had any significant medical history but that she went into cardiac arrest after about 20-25 minutes of being anaesthetised.
The anaesthetist states that, while they are not sure whether the cardiac arrest was owing to propofol or any other reason, she is reporting the case at the request of the hospital administration as there had been several recent issues related to anaesthetic drugs. Anesthefol was also imported from Nandini Medical Laboratories (Pvt) Ltd, India on a WoR.
Anesthefol is still not withdrawn despite the consultant anaesthetist at the Sirimavo Bandaranaike Specialised Children’s Hospital also writing to the NMRA CEO last month strongly warning of “alarming issues” related to the quality and safety of the 20-ml vials of Anesthefol.
The anaesthetist has requested the NMRA to take immediate and decisive action to withhold the distribution sale and usage of Anesthefol across Sri Lanka. However, the regulator has done none of these things and there is no evidence of an investigation based on the complaint.
Patients have reportedly experienced adverse effects—some, serious—while the propofol vials had shown the presence of floating sediment resembling oil as well as a faded white colour, authoritative sources said.
Separately, a school principal died last month from complications related to the Indian-manufactured “bupivacaine” (brand name Zupivac-H) anaesthetic injection after being in intensive care since April. She was the second fatality related to the drug. The first was a pregnant woman who had also suffered complications and died in April this year.
Zupivac-H, manufactured by Divine Laboratories (Pvt) Ltd in the state of Gujarat, was subsequently withdrawn. Tests found the batch to be substandard. The injection was imported on a WoR.
Meanwhile, another batch of unregistered propofol also caused concern in April and was withdrawn after reports of “reaction clusters” (including fever and shivering) came in from Teldeniya and Peradeniya, among other areas. Manufactured by SP Accure Labs (Pvt) Ltd, India, some samples were found to contain microbial contamination and were withdrawn while other batches are still being tested. These were also brought on WoRs.
Notwithstanding the issues with the Accure Labs propofol, authoritative sources said, more WoRs were issued to the company to bring anti-cancer medication.
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