By The National Medicines Regulatory Authority (NMRA) has reported the discovery of a forged registration document for sodium valproate 100mg tablets, leading to the suspension of the drug’s production by the local manufacturer, NewGen Lanka Healthcare (Pvt) Ltd. The NMRA filed a complaint with the Criminal Investigation Department (CID) after identifying discrepancies in the registration certificate submitted by the Health Ministry’s Medical Supplies Division (MSD).
The fraudulent certificate indicated approval for “gastro-resistant sodium valproate tablet BP 100mg,” complete with a corresponding purchase order. However, NMRA investigation revealed that NewGen only held a valid license for sodium valproate 200mg tablets, and the registration number on both the 100mg and 200mg documents was identical. Furthermore, the forged certificate lacked proper attestation as a “true copy” and was labeled as “provisional” until July 31, 2023, with a published price of Rs. 15.20 for a sodium valproate 100mg tablet.
NewGen, disputing any involvement in the forgery, claimed that although they applied for a license for sodium valproate 100mg, it had not yet been issued. The Chief Operating Officer, Jayasankha Alahendra, stated that the company had neither manufactured nor supplied sodium valproate 100mg to the MSD.
Suspension of the Drug
The National Medicines Regulatory Authority (NMRA) has reported the discovery of a forged registration document for sodium valproate 100mg tablets, leading to the suspension of the drug’s production by the local manufacturer, NewGen Lanka Healthcare (Pvt) Ltd. The NMRA filed a complaint with the Criminal Investigation Department (CID) after identifying discrepancies in the registration certificate submitted by the Health Ministry’s Medical Supplies Division (MSD).
The fraudulent certificate indicated approval for “gastro-resistant sodium valproate tablet BP 100mg,” complete with a corresponding purchase order. However, NMRA investigation revealed that NewGen only held a valid license for sodium valproate 200mg tablets, and the registration number on both the 100mg and 200mg documents was identical. Furthermore, the forged certificate lacked proper attestation as a “true copy” and was labeled as “provisional” until July 31, 2023, with a published price of Rs. 15.20 for a sodium valproate 100mg tablet.
NewGen, disputing any involvement in the forgery, claimed that although they applied for a license for sodium valproate 100mg, it had not yet been issued. The Chief Operating Officer, Jayasankha Alahendra, stated that the company had neither manufactured nor supplied sodium valproate 100mg to the MSD.
In response to the incident, the NMRA has suspended the production of all strengths of sodium valproate by NewGen pending further investigations. The regulator, responsible for ensuring the safety, quality, and efficacy of drugs, emphasized the severity of a forged registration certificate, allowing the medication to evade scrutiny.
As the MSD revisits various documents in the aftermath of health procurement scandals, including counterfeit immunoglobulin injections, the motive behind submitting a fake registration for a single contract remains unclear. Pharmaceutical industry sources urge a comprehensive investigation, expressing concerns about potential efforts to divert attention from proven scandals in the health sector. It has been independently verified that NewGen did not supply sodium valproate 100mg to the health sector, raising questions about the origin, purpose, and inclusion of the forged document in the MSD files.
by NewGen pending further investigations. The regulator, responsible for ensuring the safety, quality, and efficacy of drugs, emphasized the severity of a forged registration certificate, allowing the medication to evade scrutiny.
As the MSD revisits various documents in the aftermath of health procurement scandals, including counterfeit immunoglobulin injections, the motive behind submitting a fake registration for a single contract remains unclear. Pharmaceutical industry sources urge a comprehensive investigation, expressing concerns about potential efforts to divert attention from proven scandals in the health sector. It has been independently verified that NewGen did not supply sodium valproate 100mg to the health sector, raising questions about the origin, purpose, and inclusion of the forged document in the MSD files.
