News
Fresh drug scandal: Both NMRA and company concerned complain to CID
View(s):By Namini Wijedasa
The National Medicines Regulatory Authority (NMRA) has complained to the Criminal Investigation Department (CID) and halted the production of an anti-epileptic drug by a local manufacturer after a “forged” registration for sodium valproate 100mg tablets was found among documents sent to the regulator by the Health Ministry.
But the origin of the fake document remains unclear, with the company—NewGen Lanka Healthcare (Pvt) Ltd.—also complaining to the CID that it was a set-up. The Health Ministry’s Medical Supplies Division (MSD) has separately asked the police to investigate.
The MSD, which was embroiled alongside top NMRA and Health Ministry officials in the counterfeit immunoglobulin scam, recently sent a large number of documents to the regulator, requesting that they be verified for authenticity.
The latest controversy broke after an NMRA employee spotted discrepancies in a single registration certificate allegedly issued to NewGen Lanka for “gastro-resistant sodium valproate tablet BP 100mg”. The MSD’s cover letter related to this certificate even said a purchase order had been issued.
The NMRA found, however, that NewGen had a valid licence only for sodium valproate 200mg tablets—not 100mg; and that the registration number on both the 100mg and 200mg papers was the same.
The forged certificate, which had reportedly been accepted by the MSD, was also not attested by a lawyer to be a “true copy”. It categorises the registration as “provisional” (valid for one year, till July 31, 2023). The price of a sodium valproate 100mg tablet is published as Rs. 15.20.
NewGen vehemently denied having generated or submitted a forged NMRA registration for the relevant drug. Chief Operating Officer Jayasankha Alahendra said that, while his company had applied for a licence for sodium valproate 100mg, it has not yet been issued.
“We categorically deny any involvement in anything like this, and we are not aware of such an issue,” he reiterated. He also said NewGen has “never manufactured nor supplied sodium valproate 100mg to the MSD”.
The NMRA has now suspended the production of all strengths of sodium valproate by the company, pending further investigations. The regulator is legally mandated to guarantee the safety, quality and efficacy of drugs and devices. A forged NMRA registration certificate means the relevant medication escaped scrutiny.
As part of a clean-up following serious health procurement scandals, the MSD is re-examining a variety of documents in its files. These include waivers of registration (WoRs) and registrations issued by the NMRA for various medical drugs and devices.
It remains a question why NewGen would submit a fake registration to the MSD to secure a single contract, having previously received purchase orders for multiple other drugs based on valid registrations. It was also not immediately clear how, amongst the large stack of NMRA registrations that the MSD submitted, only one document was found to be forged.
But given that the health sector was overrun by corrupt procurements in recent months—with the worst case being the supply of counterfeit human immunoglobulin injections to government hospitals—a thorough investigation is warranted, pharmaceutical industry sources stressed, fearing that there were efforts to divert attention from some of the worst and proven scandals.
The Sunday Times independently confirmed that NewGen did not supply sodium valproate 100mg to the health sector. Therefore, no payments appear to have been made. The forged document was, however, in the MSD files, sources confirmed, adding that how it got there, who originated it, and for what purpose are yet to be determined.
The best way to say that you found the home of your dreams is by finding it on Hitad.lk. We have listings for apartments for sale or rent in Sri Lanka, no matter what locale you're looking for! Whether you live in Colombo, Galle, Kandy, Matara, Jaffna and more - we've got them all!