Medical bodies oppose proposed NMRA registration waiver for drug imports

■ Reveals registration waiver has been sought by MoH to import around 300 medicine varieties

■ Expresses concerns sub-standard, nonevaluated medications may be supplied to public hospitals in the process

■ Says waiver requested contravenes recommendations made by President on procurement process

Several leading medical bodies in Sri Lanka have written to President Ranil Wickremesinghe in protest against the cabinet’s request to waive National Medicines Regulatory Authority (NMRA) registration to import drugs from several locally-unregistered Indian suppliers under the Indian Credit line.

In the letter dated 27 January 2023, the Councils of the Ceylon College of Physicians, College of Surgeons of Sri Lanka, Sri Lanka College of Obstetricians and Gynaecologists and the Sri Lanka College of Paediatricians said it is concerned about the request placed before the board members of the NMRA and the Medicinal Evaluation Committee (MEC) to provide a waiver of registration for around 300 varieties of medicines to be purchased by the Ministry of Health from Savorite Pharmaceuticals Ltd and others from the ICL under a cover of a cabinet decision.

The medical experts of the bodies said they are concerned about the possibility of sub-standard, non-evaluated medications being provided to public sector hospitals due to attempts by the officials of the Ministry of Health to obtain a non-evaluated registration waiver, contravening the recommendations of the President as the Minister of Finance when granting the cabinet approval for this process.

They also noted that despite being classified as essential life-saving medicines, several drugs listed under those that must be imported are in no way as life-saving as being claimed.

“The attempts of the Ministry of Health to subvert the Finance Ministry directives as well as the move to import non-lifesaving medicines falsely declaring them to be so and attempt to as well as asking for a WoR for an antibiotics supplier from the company had multiple quality failures in injectable antibiotics, makes us question the bona fides of the Ministry of Health officials,” the bodies said.

“We believe that the usual registration or purchase process can be carried out within a quick time frame to ensure quality, safety and cost-effectiveness of the medicines sought to be obtained from the said company,” they further added.

The organisations called on the President to intervene and to compel the Ministry of Health to act within the NMRA Act and the Finance Ministry procurement directives to ensure accountability and transparency of processes as well as to ensure an uninterrupted supply of timely, good quality, safe and cost- effective medicines to the hospitals in Sri Lanka.