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1.2 mn. Jeevanee sachets procured from substandard SPC manufacturing unit
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.
(Source : Aruna)
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President Wickremesinghe meets Elon Musk to discuss starlink implementation in Sri Lanka
President Ranil Wickremesinghe has met with billionaire and investor Elon Musk on the sidelines of the 10th World Water Forum High-Level Meeting being held in Indonesia.
During the meeting, Wickremesinghe and Musk discussed the implementation of ‘Starlink’ in Sri Lanka.
It was emphasized that Sri Lanka is committed to expediting the application process to connect the country to the global Starlink network, according to the President’s Media Division (PMD).
Minister Jeevan Thondaman, accompanying the President on his two-day visit to Indonesia, tweeted: “President and Elon discussed Sri Lanka’s recovery, economic potential, and new opportunities for investment. Great to have two visionary leaders come together for Sri Lanka.”
Elon Musk arrived in Indonesia’s resort island of Bali on Sunday to launch Starlink satellite internet service in the world’s largest archipelago nation.
The billionaire head of Tesla and SpaceX, and owner of social platform X, arrived by private jet on the idyllic “island of the gods,” renowned for its tropical beaches, terraced rice paddies, mystical temples, and colorful spiritual offerings.
Musk is slated to launch the service alongside Indonesian President Joko Widodo in a ceremony later Sunday at a public health clinic in Denpasar, the provincial capital of Bali.
Musk will also sign an agreement to enhance connectivity in the country’s health and education sectors.
During his first in-person visit to Bali, Musk is also scheduled to participate in the 10th World Water Forum, which seeks to address global water and sanitation challenges.
–With agencies inputs
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