- 12 m packets distributed to hospitals last month
- SPC claims no health risks
- GMP certification pending for nine years
The widely-used local oral rehydration solution ‘Jeevani,’ manufactured by the State Pharmaceuticals Corporation (SPC), is yet to receive the certification for Good Manufacturing Practices (GMP), it is learnt.
In a letter addressed to the Ministry of Health, College of Medical Laboratory Science President Ravi Kumudesh raised concerns about the production of ‘Jeevani’ by the SPC without a GMP certificate for nine years.
Emphasising on the gravity of the situation, particularly in light of concerns regarding medicine quality, he said: “In an environment where there is a question about the quality of medicines, it is concerning that even the legalised pharmaceutical corporation, which acts as a State supplier, does not follow prescribed standards when supplying medicines to the Ministry of Health.”
Kumudesh noted that despite reporting the issue to the National Medicines Regulatory Authority (NMRA), the SPC had not been instructed to cease operations.
The letter revealed that 12 million ‘Jeevani’ packets, valued at approximately Rs. 6 million, had been purchased last month and distributed to hospitals.
Moreover, Kumudesh expressed suspicion regarding the Health Ministry’s request for a Waiver of Registration (WOR) for the ‘Jeevani’ packets.
He also questioned the relevance of a WOR for a locally-manufactured product: “How WOR permission is relevant for a locally-manufactured product is the big dilemma. They are trying to cover up not securing a GMP certificate with a WOR certificate.”
The letter called for investigations into why the NMRA had permitted the purchase of ‘Jeevani’ from a factory lacking quality product assurance.
Additionally, Kumudesh urged inquiries into why the authorities had not conducted proper condition checks on the factory for years.
According to the ‘Guideline on GMP’ issued by the NMRA in 2019, GMP is a vital aspect of quality management, ensuring that products are consistently produced and controlled in accordance with the appropriate quality standards for their intended use and as required by regulatory authorisations.
GMP encompasses both production and quality control, aiming to manage and minimise the inherent risks in pharmaceutical manufacturing to guarantee the quality, safety, and efficacy of products.
Key principles of GMP include clearly defining manufacturing processes, conducting systematic risk assessments, and maintaining qualified personnel and adequate facilities, equipment, materials, and procedures, according to the NMRA.
Additionally, GMP emphasises thorough documentation, including records of manufacturing activities and distribution, to ensure traceability and accountability. Proper storage, transportation, and recall systems further contribute to product quality and safety. Furthermore, GMP mandates thorough investigation and resolution of complaints about marketed products to prevent recurrence of quality issues, the guideline states.
When contacted by The Sunday Morning, SPC General Manager Dinusha Dasanayake stated that ‘Jeevani’ had been manufactured and supplied to the market over the years under an open general licence.
“We’ve sent in the documents to the NMRA for a GMP certificate. The NMRA has given us provisional approval to continue our production; it’s just the GMP that is pending,” he explained.
Dasanayake said that there were no risks to consumer health, citing the presence of a quality assurance laboratory and a plant at the SPC.
“Quality is assured from both of these and it is only then that supplies are sent to the market,” he affirmed.