Trade Unions allege that the Health Ministry and the State Pharmaceuticals Corporation (SPC) has obtained 1.2 million sachets of ‘Jeevanee’ produced at the ORS manufacturing unit of the SPC that lacks the Good Manufacturing Practices (GMP) certification.
‘Jeevanee’ is a locally produced Oral Rehydration Salt (ORS) which is used as an oral treatment for dehydration.
In a letter dated on Dec. 29, 2023, the additional secretary of the Health Ministry – Dr. Sunil de Alwis has requested the National Drug Regulatory Authority (NMRA) to issue a Waiver of Registration (WOR) in this regard.
However, the NMRA Chairman – Dr. Ananda Wijewickrama has said a WOR isn’t necessary as this product isn’t imported to the country.
Noting that during a meeting chaired by the Health Minister on Dec. 21, 2023, it was discussed that the product had been used in hospitals for during the past several years, the NMRA chairman had added that therefore, they had no objection for the product to be distributed by the Medical Supplies Division to state hospitals.
Accordingly, 1.2 million Jeevanee sachets, valued at Rs. 60 million, had been procured.
When questioned over the procurement, the NMRA Chairman has stated that while the said factory did lack the GMP certification, ‘Jeevanee’ was also not registered as a drug.
In Oct. 2015, NMRA officials had carried out an inspection of the said ORS manufacturing unit and in Jan. 2016, the NMRA had urged the SPC to correct the shortcomings mentioned in the inspection report and inform the NMRA of its progress.
Accordingly, the unit had informed the NMRA that measures are being taken to secure the GMP certification.
Meanwhile, President of the Academy of Health Professionals (AHP) – Ravi Kumudesh has remained skeptical of the move to procure the ‘Jeevanee’ stock.
Noting that the questionable Human Immunoglobulin, which has become a major issue these days, had also been produced at a factory in Seeduwa that lacked GMP certification, Mr. Kumudesh says that it was unusual to seek a WOR for locally manufactured products.
He also said that procuring products from such manufacturing units, also showed that drugs in the country are not regulated.
Noting that officials deviating from quality processes also raises questions on accountability.
Noting that the NMRA has not clarified the matter in a way that regulated the procurement process, the AHP President points out that the procured ‘Jeevanee’ has already been prescribed to patients while NMRA has not informed to shut down the manufacturing process either until the GMP certification is secured.
The Medical Research Institute of Sri Lanka has confirmed that the COVID-19 variant currently spreading in the Asian region has also been identified in the country.
Dr. Jude Jayamaha, a specialist in viral diseases at the Medical Research Institute, stated that patients infected with the Omicron subvariants LF.7 and XFG are being reported locally.
Dr. Jayamaha explained that this finding was confirmed through research conducted on biological samples collected from several hospitals across the island.
However, he emphasized that there is no need for undue fear regarding these COVID-19 variants.
Health authorities have also stressed the importance of vulnerable groups—such as pregnant mothers, the elderly, and those with chronic illnesses—following health guidelines, including wearing face masks and avoiding crowded places.
Dr. Jayamaha reiterated that new COVID-19 variants emerge periodically, and health authorities are continuously monitoring the situation, so the public should remain calm.
(newswire.lk)
(This story, originally published by newswire.lk has not been edited by SLM staff)
The Miss World organization has announced its quarter-finalists, selecting 40 contestants from across Asia, Europe, Africa, and the Americas.
Sri Lanka’s Anudi Gunasekara, was not selected in the top 40, despite being recognized for her impressive performances in the Multimedia and Head-to-Head challenges.
The top 40 consisted of 10 contestants each from Asia & Oceania, Europe, Africa and the Americas.