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Commerce Unions allege that the Well being Ministry and the State Prescribed drugs Company (SPC) has obtained 1.2 million sachets of ‘Jeevanee’ produced on the ORS manufacturing unit of the SPC that lacks the Good Manufacturing Practices (GMP) certification.
‘Jeevanee’ is a domestically produced Oral Rehydration Salt (ORS) which is used as an oral therapy for dehydration.
In a letter dated on Dec. 29, 2023, the extra secretary of the Well being Ministry – Dr. Sunil de Alwis has requested the Nationwide Drug Regulatory Authority (NMRA) to subject a Waiver of Registration (WOR) on this regard.
Nonetheless, the NMRA Chairman – Dr. Ananda Wijewickrama has mentioned a WOR isn’t mandatory as this product isn’t imported to the nation.
Noting that in a gathering chaired by the Well being Minister on Dec. 21, 2023, it was mentioned that the product had been utilized in hospitals for throughout the previous a number of years, the NMRA chairman had added that subsequently, they’d no objection for the product to be distributed by the Medical Provides 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 acknowledged that whereas the mentioned manufacturing unit did lack the GMP certification, ‘Jeevanee’ was additionally not registered as a drug.
In Oct. 2015, NMRA officers had carried out an inspection of the mentioned ORS manufacturing unit and in Jan. 2016, the NMRA had urged the SPC to right the shortcomings talked about within the inspection report and inform the NMRA of its progress.
Accordingly, the unit had knowledgeable the NMRA that measures are being taken to safe the GMP certification.
In the meantime, President of the Academy of Well being Professionals (AHP) – Ravi Kumudesh has remained skeptical of the transfer to obtain the ‘Jeevanee’ inventory.
Noting that the questionable Human Immunoglobulin, which has change into a significant subject today, had additionally been produced at a manufacturing unit in Seeduwa that lacked GMP certification, Mr. Kumudesh says that it was uncommon to hunt a WOR for domestically manufactured merchandise.
He additionally mentioned that procuring merchandise from such manufacturing items, additionally confirmed that medicine within the nation are usually not regulated.
Noting that officers deviating from high quality processes additionally raises questions on accountability.
Noting that the NMRA has not clarified the matter in a manner that regulated the procurement course of, the AHP President factors out that the procured ‘Jeevanee’ has already been prescribed to sufferers whereas NMRA has not knowledgeable to close down the manufacturing course of both till the GMP certification is secured.
(Supply : Aruna)
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