News
Barrage of criticism against NMRA by SLMA
At the SLMA media briefing (from left): Dr. Palitha Abeykoon, Dr. Vinya Ariyaratne and Dr. Ananda Wijewickrama. Pic by Dilushi Wijesinghe
Serious charges with regard to several critical issues were levelled against the country’s drug watchdog by senior health experts this week, with a counter explanation following speedily on Friday morning.
While the powerful Sri Lanka Medical Association (SLMA) fired off a strong letter to President Ranil Wickremesinghe on Monday and also held a media briefing on Wednesday, the drug watchdog, the National Medicines Regulatory Authority (NMRA) was quick to respond to these charges when asked by the Sunday Times.
Referring to the “current crisis” with regard to pharmaceuticals and the NMRA, SLMA President Dr. Vinya Ariyaratne told the media that the specialists treating patients across the country are worried about the quality of medicines that they have to use.
“We fear that the public would lose trust and confidence in the state health sector,” said Dr. Ariyaratne, underscoring that there were doubts about the quality of medicines with ‘Waivers of Registration’ (WORs) being “misused”.
He said that this is an emergency situation which needs to be addressed immediately.
The former head of the NMRA’s Pricing Committee Dr. Palitha Abeykoon detailed the “right procedures” that need to be followed by any good regulatory authority to ensure efficacious and quality medicines.
There are “big issues” surrounding the NMRA’s laboratory which is good but needs “denuma saha puhunuwa thiyena” (knowledgeable and trained) pharmacists, he said, going onto explain that the IT system of the NMRA should also be secure when storing data and be transparent, which is not possible now. There should also be a strong and knowledgeable Pricing Committee. There is a need to further strengthen the NMRA systems.
SLMA’s President-elect Dr. Ananda Wijewickrama raised serious concern over the dragging of feet in appointing experts from clinical colleges to the NMRA Board as well as a Professor in Pharmacology. Up to now the two nominees from the College of Surgeons and the College of Obstetricians & Gynaecologists have not been appointed. Usually there are four from such colleges and the two nominees from the College of Physicians and College of Paediatricians are already onboard. The other two specialists and the Pharmacology Professor whose technical knowledge is also important are yet to be appointed. This has a major impact on the decisions of the NMRA which, in turn, would impact patients.
He also referred to the transfer of 23 trained senior pharmacists from the NMRA back to the Health Ministry. They have received WHO training in the past years on medicine regulation and their transfer would hinder the functioning of the NMRA including such regulation.
According to Dr. Wijewickrama even though the Health Ministry gave an assurance that it had secured funds from the World Bank, the Asian Development Bank and the Indian Credit Line to make sure that there would be no shortages of medicine this year (2023) , it had not happened though six months were already over. “Emergency purchases are still being made and also WORs. So quality, efficacy and safety of medicines cannot be assured.”
The SLMA, meanwhile, has pointed out to President Wickremesinghe, in its letter dated June 26, that several poor-quality medicines and quality failures are reported, due to these medicines being hastily imported without proper evaluation and registration, supposedly to overcome shortages.
The SLMA has stated:
The Health Minister has so far failed to appoint a Professor of Pharmacology, Medical Specialists already nominated by the College of Surgeons and the College of Obstetricians and Gynaecologists and a qualified pharmacist/senior lecturer or Professor in Pharmacy to the NMRA Board to provide technical expertise.
The NMRA’s Pricing Committee responsible for negotiations to approve retail prices of medicines is no longer functioning.
The NMRA’s Committee to Evaluate Quality Failures has also not been re-appointed.
Many senior experienced pharmacists who have been involved in evaluations of pharmaceuticals at the NMRA have suddenly been transferred back to the Health Ministry, leaving a grossly inadequate number of pharmacists. This can directly affect the quality assessment of drugs prior to registration.
Alleging that the SLMA believes that there is a “deliberate” attempt by some of those in authority to sabotage the work of the NMRA, it has said that medical professionals and the public, are losing faith in the quality and safety of drugs.
“This is particularly in view of the cavalier attitude displayed by the NMRA Chairman during his discussions with the media,” the SLMA adds, requesting urgent steps by President Wickremesinghe to address these matters.
| NMRA Head deftly counters volley | |
 Prof. S.D. Jayaratne With regard to the critical issue of ‘Waivers of Registration’ (WORs), NMRA Chairperson Prof. S.D. Jayaratne, when asked by the Sunday Times, said that such WORs are issued under special circumstances, as stipulated under Clause No. 109 of the National Medicines Regulatory Authority (NMRA) Act. Such permission may be granted (a) on a request made by the Health Ministry or (b) on a request made by an individual or an organization recommended by the Health Ministry. He said that with the country facing the worst financial downturn in history in 2022 and 2023, health sector finances were the most affected. As such, the government and the Health Ministry had to take drastic measures to overcome possible drug shortages. Various countries such as India and various development partners, private donors and individuals came forward to assist Sri Lanka on humanitarian grounds. In the process, the government had to resort to available funding sources such as the Indian Credit Line and many other sources which were offered on conditional terms. “The NMRA observed that there were not many registered suppliers participating in this procurement process. Therefore, considering the crisis situation, the NMRA had to accede to the ‘justifiable’ request of the Health Ministry for WORs. Around 114 WORs which included 92 donations were issued in the first half of 2022 (last year) and 495 WORs including 229 donations and 233 for other special government procurements on international aid in the second half of 2022,” said the NMRA Head. Dealing with other allegations, Prof. Jayaratne said the NMRA was established under NMRA Act No. 05 of 2015 with the objective of ensuring availability of efficacious and good quality medicines at an affordable price according to the needs of the country. Under the Act’s provisions, the Health Minister has the authority to appoint members to the NMRA. The NMRA Board comprises 3 ex-officio members (the Director General of Health Services, a nominee of the Treasury Secretary and the NMRA’s Chief Executive Officer). The 10 appointed members are from the main professional colleges (4) and other professionals who have gained eminence in the fields of Management, Law, Accountancy and Health (4) respectively; 1 Professor in Pharmacology; and 1 senior professional in the field of Pharmacy. Prof. Jayaratne conceded that currently the position of the Professor in Pharmacology is vacant. However, he said that the functionality of the NMRA Board is dependent on the majority of members, with the Board having a more administrative function. There is no hindrance to routine functions and activities of the Board as the Board can consult three eminent Pharmacologists who are part of the Medicines Evaluation Committee (MEC). The MEC, established under Clause of 43 of the NMRA Act, evaluates all medicines and supports the registration process. “Steps are being taken to appoint a suitable Professor in Pharmacology to the NMRA Board as a matter of priority,” he said, pointing out that a Senior Lecturer in Pharmacy has already been appointed and is serving on the Board together with other professionals. With regard to the ‘Recall Committee’, Prof. Jayaratne said that this committee had not been formulated since the establishment of the NMRA and until April 4, 2022. Under the current NMRA administration, this committee has been convened twice and has been dealing with the backlog and making final decisions with regard to revoking medicine registrations. Taking up the issue of the Pricing Committee, the NMRA Chairman said that it should be appointed under Clause 118 of the Act. Such a committee has a three-year mandate. The tenure of the last Pricing Committee ended on November 15, 2022 (last year) and the terms of the members were extended twice on February 14, 2023 (this year) and May 14, 2023, until the new committee was appointed. This new committee, headed by a respected Economics Professor and comprising expert members as required by the Act, has begun its functions. Except during the transitional period, no gaps have been experienced in the committee’s functions. Referring to the “serious allegations” of delays in reviewing dossiers, he said that a backlog in the registration and licensing process has been reported over the past 8-10 years. These registrations are handled by pharmacists and on many occasions, even during the earlier Board of Management’s tenure, these pharmacists had been given warnings to regularize their work and clear the backlog. “A majority of these pharmacists have been seconded on a temporary basis from the Health Ministry. As such, the NMRA including its earlier Boards of Management has constantly requested them to get absorbed into the NMRA’s permanent cadre, which would enable the NMRA to fill all vacant positions permanently. However, despite many discussions over many years, this group of pharmacists has not wanted to join the NMRA as its permanent staff, as they were enjoying both the departmental benefits of the Health Ministry and those of the NMRA,” he said. With the final deadline and the option for absorption being set for May 23, 2023, which they did not comply with under the conditions stipulated by the NMRA, the NMRA had been compelled to release them back to the Health Ministry to facilitate the completion of the recruitment process for a permanent cadre for the NMRA. Concerns have been raised whether the NMRA has adequately qualified staff/ pharmacists to continue the drug evaluation process and registration, he said, pointing out that currently there are 11 highly qualified and trained very senior pharmacists for this purpose and 26 assistant pharmaceutical assessors. A majority of these teams comprise graduates with Bachelors in Pharmacy (B.Pharm/BSc. Special in Pharmacy) and have higher qualifications unlike a majority of those with only a diploma who have been released to the Health Ministry, the NMRA Head added.
|
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!