News
Mystery over source of blood-based drug; Indian firm denies supplying it
View(s):By Namini Wijedasa
An Indian company that official documents in Sri Lanka said had manufactured a stock of now-withheld immunoglobulin to the Health Ministry has denied it had anything to do with the medicines, leaving pressing questions about where the blood-based drug came from.
Livealth Biopharma Pvt. Ltd. has now written to the National Medicines Regulatory Authority (NMRA) asking for details of the Indian manufacturer, the Sri Lankan importer, the Indian port of dispatch and the Sri Lankan port of arrival.
It has notified the NMRA that it will officially file a complaint with India’s Central, State and Zonal Food and Drug Administration (FDA) and the Indian Customs “to ensure such intentional fraudulent companies are identified and brought to justice to save genuine exporters image and more importantly precious human lives”.
The Sunday Times contacted Livealth to get clarity on the tender for 22,500 vials of human immunoglobulin IV 5g that was reported to have been manufactured by it and imported by Sri Lanka’s Seeduwa-based Isolez Biotech Pharma AG Limited.
Adverse reactions to the drug were reported from several hospitals, leading to inquiries by health authorities.
“Please note that these products are neither manufactured nor supplied from our end,” a spokesman said. “The best part is we have never manufactured, supplied or exported these products to any party to date.”
Of the full order, 3,085 vials were supplied to and distributed by the Medical Supplies Division to hospitals between July and September, according to official documents. Health Minister Keheliya Rambukwella said a part payment of Rs. 40mn had been made by MSD. He also claimed that the consignment had cleared on the basis of a forged waiver of registration purported to have been from the NMRA CEO. Three complaints were filed with the CID, he said.
Yesterday, the Association of Medical Specialists (AMS) described as “schocking” the revelations tied to the human immunoglobulin supplies. “To the best of our knowledge, no legal proceedings have been initiated so far on this matter by the relevant authorities,” says AMS President Dr. A.D.K.S.N. Yasawardene. General Secretay Dr. R. Gnanasekeram endorsed his views.
They question who ordered the immunoglobulin and whether an emergency purchase had been necessary. They ask which officers checked the authenticity of the NMRA’s WoR (Waiver of Registration) certificate and if a credible search was done to see the product profile of the manufacturing company.
The expensive drug is given to seriously ill, even immunocompromised, patients and may be lifesaving, AMS says. It is normally manufactured from plasma obtained from 1,000 to 10,000 healthy donors and strict quality control methods are used to prevent people with underlying infections like HIV and hepatitis B and C from contributing to the final product.
“As the identity of the manufacturer of this drug is still not known, it is possible that the product may not have undergone all the stringent testing and screening procedures required for manufacturing and, thus, may be potentially contaminated with HIV and hepatitis B or C viruses,” the AMS says.
The doctors question whether the Ministry of Health will now identify patients who received the drug and screen them for possible infections; and whether the vials will also be tested for viruses. They ask whether the patients will be evaluated to check if they had benefited from the medication and, if it had been ineffective, whether they will be offered further immunoglobulin from a registered source.
“It is very disheartening to note that, whatever reasons and excuses offered by the authorities, an unregistered drug manufactured by an unknown company with doubtful efficacy and with potential risk of additional infections has been administered to unsuspecting poor patients receiving treatment for serious illnesses in the government hospitals,” AMS says.
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