The widely-used oral rehydration solution ‘Jeevani,’ produced by the State Pharmaceuticals Corporation (SPC), is under scrutiny for lacking Good Manufacturing Practices (GMP) certification for the past nine years. College of Medical Laboratory Science President Ravi Kumudesh highlighted this concern in a letter to the Ministry of Health, emphasizing the potential risks to medicine quality when standards are not followed, especially by a state supplier like the SPC. Despite reporting the issue to the National Medicines Regulatory Authority (NMRA), operations at SPC have not been halted.
The letter revealed that 12 million ‘Jeevani’ packets worth approximately Rs. 6 million were purchased and distributed to hospitals last month. Kumudesh also questioned the relevance of a Waiver of Registration (WOR) for a locally-manufactured product like ‘Jeevani,’ suggesting a cover-up for the absence of a GMP certificate. He called for investigations into why NMRA allowed purchases from a factory without quality assurance and why proper factory checks were not conducted for years.
According to NMRA guidelines, GMP is crucial for ensuring consistent product quality, safety, and efficacy in pharmaceutical manufacturing. It involves defined processes, risk assessments, qualified personnel, adequate facilities, and thorough documentation to ensure traceability and accountability. SPC’s General Manager Dinusha Dasanayake assured that despite pending GMP certification, ‘Jeevani’ production adheres to quality standards, backed by a quality assurance laboratory and plant at SPC, ensuring consumer health and safety.