Arbitrary registration waiver for over 270 medicines by NMRA CEO

Sri Lanka’s drug regulator has arbitrarily authorised the import of over 270 medicines into the country without evaluation and thus without an assessment of quality, safety and efficacy.

The Chief Executive Officer (CEO) of the National Medicines Regulatory Authority (NMRA) has approved the import of these medicines, giving a ‘Waiver of Registration’ (WOR), Consultant Physician Dr. Ananda Wijewickrama told a media briefing on Thursday when a Sri Lanka Medical Association (SLMA) Panel revealed this serious breach of protocol.

Dr. Wijewickrama said that this serious violation came to light when a document titled ‘Issued WOR approvals for the procurement from the ICL (Indian Credit Line) pathway’ was tabled at the 74th meeting of the NMRA’s Medicines Evaluation Committee (MEC) on January 24.

The matter had also been discussed when the Health Ministry summoned a meeting of representatives of medical professional colleges such as the physicians, surgeons and microbiologists and the Government Medical Officers’ Association (GMOA) as well as the NMRA, Medical Supplies Division (MSD) and the State Pharmaceuticals Corporation (SPC).

The meeting held on Tuesday chaired by the Director General of Health Services discussed how to overcome the severe shortage of essential medicines in state hospitals. “With this registration waiver given by the NMRA CEO, medical specialists are concerned over whether there is assurance of quality, safety and efficacy,” said Dr. Wijewickrama.

Explaining the usual process with regard to registration of new medicines, he said that the NMRA’s MEC checks all the dossiers before granting registration. In instances where the country needs urgent drug imports such as when there is a sudden outbreak of disease, a disaster or life-saving drugs are needed on specific instances, a sub-committee of the MEC fasttracks the evaluation, before recommending whether a waiver of registration should or should not be granted.

The Sunday Times which saw the document granting the registration waiver to the 270-odd drugs noted a column which indicated ‘CEO/ NMRA Approval’. These approvals had been given since September last year (2022).

When asked whether any of these unevaluated medicines had been brought into the country, Dr. Wijewickrama said he did not know. When the 270-odd list given the waiver was tabled for NMRA Board approval, the members representing the professional medical colleges had insisted on an evaluation and now it has been sent to the MEC’s sub-committee.

“The irony is that when the country is hard-hit for valuable dollars, among these 270-odd medicines are also numerous non-essential medicines. There is a standard Formulary for all medicines disbursed to state hospitals, which has been prepared after exhaustive discussions with doctors, pharmacists etc., and is updated from time to time. Some of the 270-odd medicines are not in the Formulary as well,” he said.

Stressing that it is shameful to waste money on non-essential medicines when the country is utilsing a loan from India which has to be paid back and while state hospitals are crying for essential medicines of which there is a massive shortfall, he asked: “Who ordered such drugs and why and if some of these drugs are not in the Formulary and are non-essential, why has a registration waiver been granted?”

Meanwhile, a Consultant Dermatologist in the audience at the media briefing pointed out that the list even had a hair shampoo.