Description
Efforts from the Health Minister, Keheliya Rambukwela to obtain Cabinet approval for “waiver of registration” (WOR) granted by the National Medicines Regulatory Authority (NMRA) for medical drugs imported under the Indian Credit Line. This policy is in place to short circuit the usual procurement process to secure medical drugs citing an emergency.
The Cabinet approved purchases from two companies named Savorite Pharmaceuticals (Pvt) Ltd and Kausikh Therapeutics (P) Ltd., the latter which has already been blacklisted by the State Pharmaceutical Corporation (SPC) owing to a failed sample and product defect. It is currently not NMRA-registered. For medicines to be sold in Sri Lanka, the NMRA must license the supplier’s manufacturing facility in keeping with World Health Organisation (WHO) standards as well as register its local agent and each drug to the company name. This is to ensure that the quality of individual products meets requisite standards. Where Savorite was a first-time supplier with neither its manufacturing site nor medical goods being listed with the local regulator, NMRA- Kausikh has a different story. In two separate incidents in 2015 and 2017, medicine imported from Kausikh had notable irregularities and poor quality.
In addition to obtaining WORs for these two companies, complaints were raised about fairness of awarding the said WORs when other companies didn’t have the option to bid or bypass competitive tenure.
What is the corruption
Alleged non-compliance with procurement guidelines including the emergency procurement process and potential abuse of process and power by the Minister of Health and the Chief Executive Officer of the NMRA, among others.
What has been done
- TISL filed a Fundamental Rights petition (SC/FR 65/2023) against the decision taken by the Cabinet of Ministers, the Minister of Health, the Ministry of Health, and the National Medicines Regulatory Authority (NMRA) to procure medical supplies from two Indian private companies, based on serious doubts that have arisen regarding the lawfulness of the procurement process.
- The Supreme Court, granting leave to proceed, stated that serious doubts have arisen regarding the quality, safety, and efficacy of the pharmaceuticals purchased under the Indian Credit Line from The Savorite Pharmaceuticals (Pvt) Limited.
- Court granted two interim reliefs;
– Suspension of further importation of pharmaceuticals pertaining to the decision without obtaining a further order from the Court after proving that the quality and safety requirements are satisfied, and the procurement is lawful.
– Release for use the two consignments that have already reached Sri Lanka only after the conducting necessary tests, and the NMRA expressing its independent decision assuring the safety, quality, and efficacy of the already imported pharmaceuticals.
What can be done
- The individuals and authorities responsible for the alleged procurement violations in importation of medical supplies be held accountable.
- The NMRA’s authority to grant waivers of registration be reviewed and regulated.
- An investigation into any possible corruption or misconduct related to the procurement process be conducted by CIABOC.
- Policy amendments are needed to clearly define and restrict the arbitrary use of waivers of registration.
- Procurement policy amendments
Links
TISL Press Release – TISL Files FR Petition Over Human Immunoglobulin and Other Controversial Medical Supplies – Transparency International Sri Lanka
TISL’s case update: https://www.tisrilanka.org/tisl-files-fr-case-regarding…/
Sunday Times ; 13 August 2023, NMRA admits quality failures of some imported drugs with registration waivers. https://www.sundaytimes.lk/230813/news/nmra-admits-quality-failures-of-some-imported-drugs-with-registration-waivers-528100.html
Newswire.lk. (2023, April 7). Court allows proceeding with case against recent medicines purchased : https://www.newswire.lk/2023/04/07/court-allows-proceeding-with-case-against-recent-medicines-purchased/
