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D Day tomorrow as NMRA and CDDRA end tug of war
The tug-of-war between the much-awaited National Medicines Regulatory Authority (NMRA) and the Cosmetics, Devices and Drugs Regulatory Authority (CDDRA) chief is set to end tomorrow, the Sunday Times learns.
Prof. Laal Jayakody assumes duties as NMRA Chairperson, with the documents being handed over to him by Health Minister Rajitha Senaratne while Health Ministry Secretary Dr. D.M.R.B. Dissanayake looks on
While the NMRA began functioning on July 2, with a concerted effort to clear the massive backlog that had come from the earlier system, CDDRA Director, Dr. Amal Harsha de Silva, has been unwilling to hand over and leave, as is required, NMRA member and Consultant Physician, Dr. Ananda Wijewickrama told the Sunday Times.
When contacted by the Sunday Times, Dr. de Silva who alleged that the transition had not been smooth, said that he was preparing all the files and would be handing them over tomorrow (Monday).
This would bring to an end a saga that has been hampering the smooth-running of the NMRA, it is learnt.
“We are already clearing the backlog that has come from the earlier system,” assured Dr. Wijewickrama, explaining that drug registrations and prices are also the immediate focus of the NMRA. “We are hoping to complete the two essential tasks of regularizing the registration of drugs and finalizing a mechanism through which drug-prices can be regulated to benefit the public within about two months.”
Refuting allegations of delays in the registration of drugs, he said there has been no disruption in the work as the National Medicines Regulatory Authority Act, No. 5 of 2015, under which the NMRA has been established, has provisions to use the old regulations when necessary until new regulations are introduced.
From left are the Acting Director-General of Health Services, Dr Jayasundara Bandara; the Secretary of the State Ministry of Health, Pearl Weerasinghe; the Health Ministry Secretary, Dr. D.M.R.B. Dissanayake; Health Minister Dr. Rajitha Senaratne; NMRA Chairperson Prof. Laal Jayakody; and NMRA members Dr. Kapila Ranasinghe and Prof. Narada Warnasuriya at the function which marked the inauguration of NMRA work
Dr. Wijewickrama also stressed that earlier drug-pricing had been haphazard. “Ad hoc,” is how he describes drug-pricing, pointing out that while some pharmaceutical companies were following a 10-year-old formula of adding 65% to the cost, insurance and freight (CIF) value of drugs, other companies were making huge profits amounting to as much as 500% on their drugs.
With the urgent aim of “providing good quality and safe drugs at an affordable price”, the priority of the NMRA is very clear, he reiterated.
However, the NMRA’s saga began with an allegation of making appointments during election time, with specific reference to the appointment of Prof. R. Laal Jayakody as its Chairperson and the recommendation that Emeritus Prof. Krishantha Weerasuriya be appointed as its Chief Executive Officer. (See box for NMRA composition)
There have also been allegations that the transition of work from the CDDRA to the NMRA which is operating from the same offices has not been smooth.
Charging that the NMRA has ignored the ruling of the Commissioner of Elections, Mahinda Deshapriya, given in the first week of July that no new appointments should be made whatsoever, CDDRA sources pointed out that the Commissioner had stated that if new appointments and promotions are done they should be in a transparent manner where there is no room for complaints. They should also be done without political interference.
The source said that drug regulation was now in a state of flux, as with the setting up of the NMRA, the regulations governing the CDDRA have been repealed. “The hasty implementation of the NMRA has left a vacuum in the registration of cosmetics, devices and drugs, the issuance of import licences and all the work undertaken earlier by the CDDRA,” the source said.
Similar concerns were expressed by the President of the Sri Lanka Chamber of the Pharmaceutical Industry, Lt. Col. Chandra Jayaratne (Rtd) who said that though both Health Minister Dr. Rajitha Senaratne and NMRA officials have promised a “seamless transition”, there seems to be a big “seam”.
Nothing is happening, said Mr. Jayaratne, adding that registrations and the issuance of import licences have come to a virtual halt.
Adding to the confusion, according to CDDRA head, Dr. Amal Harsha de Silva, were instructions by Health Ministry Secretary Dr. D.M.R.B. Dissanayake to him and the National Drug Quality Assurance Laboratory (NDQAL) head and their staff “to continue as before”.
According to Dr. de Silva, he himself has sought clarification from the Health Ministry what his ‘substantive post’ is as against ‘covering-up’ duties, for he believes that his ‘substantive post’ is as the CDDRA head, while he is performing ‘covering up’ duties as the Director of the Health Education Bureau (HEB).
Pointing out that transferring the state-run CDDRA to a ‘body corporate’ should be done as smoothly as possible, Dr. de Silva said that currently the CDDRA is making lists of all the files as well as movable and immovable property along with all court productions secured in raids in the CDDRA’s possession. “By Monday the lists should be ready to be handed over to the NMRA,” he said.
Referring to so-called allegations of NMRA members being appointed during election times, Dr. Wijewickrama pointed out that all of them, except the CEO, were appointed in mid-June. The relevant Gazette with the effective date of the NMRA which was signed by the Health Minister on June 18 came out on June 25. Parliament was dissolved at midnight on June 26 and the NMRA came into being before the dissolution.
Only the appointment of Prof. Krishantha Weerasuriya — who has “a vast knowledge and experience not only in Sri Lanka but other countries while working for the World Health Organization” — to the post of CEO was submitted to the Cabinet on June 18, according to him, and is being processed now.
Reiterating that the NMRA members met the Commissioner of Elections the day before assuming duty, Dr. Wijewickrama says that they were informed by the Commissioner that there was no problem in taking up duties as “it was an essential thing”. He had told them to be transparent and apolitical whenever an appointment is made to the NMRA.
With both the CDDRA and the NDQAL coming under the NMRA, the staff has been re-assigned by the Health Ministry to work for the NMRA, said Dr. Wijewickrama, explaining the current situation. “While the NDQAL along with its Director, Ajith Priyadarshana, will become a division under the NMRA, the CDDRA will also be managed by the NMRA.”Dealing with the issue of the CDDRA head, Dr. Amal Harsha de Silva, Dr. Wijewickrama explained that he is in fact the Director of Medical Technology & Supplies and as such held the reins of the CDDRA.
The sequence of events had been that before the transition took place, the Health Ministry Secretary had informed both the CDDRA and the NDQAL in two common letters to the staff “to continue as usual” until further instructions were issued to them. This was followed up by a letter on July 2, by the Secretary, to Dr. Amal Harsha de Silva that he should hand over the CDDRA and cover-up duties of the Director of the HEB.
On July 3, Health Minister Dr. Rajitha Senaratne had informed Dr. Amal Harsha de Silva verbally to hand over the CDDRA to the NMRA and he had promised to do so by July 6, says Dr. Wijewickrama, adding that he had however not done so.
According to Dr. Wijewickrama once again on July 8, the Health Ministry Secretary had informed Dr. Amal Harsha de Silva in writing, to leave the CDDRA office, stating that he was disturbing the work of the NMRA.
With the NMRA Act coming into effect all movable and immovable property of the CDDRA is vested with the NMRA, he added.
Meanwhile, strongly rejecting speculation that the NMRA has made new appointments ranging from 160 to 1,200, he said that about 200 cadres have been identified but no recruitment will take place until after the General Election of August 17.
When contacted by the Sunday Times, Elections Department sources said there had been one complaint with regard to the appointment of officials to the NMRA. The Elections Commissioner had already discussed the matter with the NMRA.