News
NMRA granted at least 186 waivers “under special pathway” for SPC drugs: Report
View(s):Importers bypassed the NMRA’s WoR Committee legally mandated to vet requests for waivers
By Namini Wijedasa
In the three months between September 19 and December 29, the National Medicines Regulatory Authority (NMRA) granted at least 186 waivers of registration (WoRs) for drugs intended for the State Pharmaceutical Corporation (SPC) with a bulk of the orders going to just five importers, records show.
All exemptions of registration were issued “under special pathway”, according to the documents. This means that, in accordance with an ad hoc procedure the NMRA introduced in September last year, importers even bypassed the NMRA’s WoR Committee which comprises specialists and trained pharmacists legally mandated to vet requests for waivers.
WoRs are usually not granted without oversight and must follow a process established by law. In the absence of any regulatory oversight, however, these WoRs were sanctioned entirely by the NMRA’s Chief Executive Officer.
There is no provision for this in the NMRA Act, former Health Minister Rajitha Seneratna pointed out in Parliament this week, during the debate on the no-confidence motion against incumbent Health Minister Keheliya Rambukwella. And it meant that hundreds of medications were brought into the country without any form of independent testing or detailed documentation checks.
The Health Ministry provided the list of WoRs for September to December 2022 to Parliament’s Sectoral Oversight Committee on Health. The Sunday Times has a copy of the document which indicates that nearly 60 percent of orders went to Yaden International (Pvt) Ltd, Pharma Associates, Pharmatec (Pvt) Ltd, Slim Pharmaceuticals (Pvt) Ltd and ABC Pharma Services (Pvt) Ltd.
Of these, Yaden dominated the list with 36 out of 186 WoRs, or nearly 20 percent of orders. Slim Pharmaceuticals followed with 21 WoRs, Pharmatec and Pharma Associates with 17 each, and ABC Pharma with 14.
Yaden International, also recently sought a waiver to import stocks of high-priced insulin from Ukraine. The request for a WoR was conveyed to the NMRA through the SPC Managing Director.
The documents do not state how these suppliers were selected–whether they made walk-in offers to the Ministry of Health or whether they were approached by the Health Ministry to provide medication. The prescribed procurement procedure was not followed. The majority of drugs are from India. The documents also do not reveal pricing details for comparison against market rates.
Batches of medication brought by three suppliers were subsequently withdrawn after complications were reported. They are “Propofol 1% injection for intravenous infusion 20ml vial” manufactured by Nandani Medical Laboratories (Pvt) Ltd of India and imported by Novachem Lanka (Pvt) Ltd; “Prazosin tablets BP 1mg (Prazoright)” manufactured by Alvita Pharma (Pvt) Ltd of India; and “Bupivacaine Hydrochloride in Dextrose injection USP 5mg-80mg/ml” manufactured by Divine Laboratories (Pvt) Ltd and imported by Slim Pharmaceuticals.
Separately, between December 14, 2022, and February 24, 2023, at least 47 more WoRs were issued to import drugs for the Medical Supplies Division. The bulk of these were from Savorite Pharmaceuticals (Pvt) Ltd of India.
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