News
Two key personnel desert drug authority
The lackadaisical attitude of the Government in providing the necessary staff and infrastructure to carry out the monumental task of the National Medicinal Regulatory Authority (NMRA)/ has led to the resignation of two key personnel last week.
Chairman Prof. Lal Jayakody and Chief Executive Officer (CEO) Prof. Krishantha Weerasuriya had tended their resignation from the NMRA citing personal reasons.
However the Sunday Times learns that the duo decided to leave because of lack of staff and support from Health Ministry officials.
The NMRA was constituted in July 2015 to bring down the number of pharmaceutical drugs imported into the country. The task was to reduce the almost 15,000 brands that flood the market and import quality drugs in their generic forms
Prof. Jayakody said that there were serious problems – too much work, little infrastructure and more administration work that had dampened their spirit in carrying out the work, effectively.
He said that due to the enormous amount of paper work they were not able to use their technical skills to the full to implement the task they were assigned for.
He said that the Cosmetic Devices & Drug Regulatory Authority (CDDA) staff under the Health Ministry were absorbed into the NMRA and that the workers were in limbo as to their status. As public servants they were entitled to a pension but with the change they were not given any assurance pertaining to the employee status. He said that the Health Ministry was non -committal and could not give them any assurance or letters of appointments.
In the last eleven months since the NMRA was formed the Authority had received several applications to import drugs. As it is important to regulate strictly to allow affordable and good quality drugs into the market, the importers were questioned and denied registration if not satisfied.
“We have been strict with the private sector – they have legitimate grievances in the industry,” he said.
However he assured that there has been no shortage of drugs in the public hospitals or private the sector hospitals and they have not received any complaints during their tenure in office.
He held that NMRA cannot be held responsible for any shortage of drugs in the market. “We are only concerned with the import licences. Any shortage of drugs has nothing to do with us. The supply chain is responsible,” he said.
Any delays in approving was because the registered companies had not evaluated their files for a considerable period of time. “Some have been sitting on it over a year and seeking registration within days.
Prof. Krishantha Weerasuriya refused to give reasons for his resignation but said they are satisfied with the work they have done. “We have succeeded in registering quality medicines and improving technical standards of the registrations,” he said.
Also he said that it was never their intention to stay for the whole period of their appointments “Once we have achieved our objective we have moved out. It is up to persons who succeed us to improve the other areas at the NMRA.”
A member, said that the NMRA by following proper regulatory process has saved millions of rupees for the government in the last eleven months.
The official who wished to remain anonymous said it has gone beyond its mandate to ensure quality drugs imported into the country. He said the NMRA has been careful that the drugs came from registered sources preventing exploitation by unscrupulous importers.
Several No Objection Letters (NOL) and attempts to import unwanted medicines and drugs still under trial stages were stopped.
In the past the importers have been using NOL (used only to import non registered drugs into the country in a time of emergency) to import drugs in order to avoid paying registration fee to NMRA.
According to NMRA figures for the first six months in office (01 July to 31 December) the Medicines Regulatory Division has issued 667 full registration certificates, 791 provisional registrations and rejected 330.
The Medical Devices Evaluation Sub-Committee has issued 269 full registrations, 815 provisional registrations and rejected 283 applications.
General Secretary, Society of Government Pharmacist, Ajith P. Thilakaratne said though the pair had good pharmacology knowledge lacked experience in the administration field. “They encountered many obstacles as the cadres in the NMRA were not filled,” he said.
He said another drawback was the professors failing to consult stakeholders when refusing registrations. “They took unilateral decision this worked against them” he said.
The Quality Assurance Labs (QAL) have not been supportive of the NMRA. Thilakaratne said the QAL has been delaying approval of samples thereby slowing the approval process and creating a demand for the drugs in the market.
“The NMRA alone cannot bring down the number of drugs and the price. There should be a concerted effort from all concerned organizations,” he said.
President, Sri Lanka Chambers of Pharmaceuticals, Colonel Chandra Jayaratne representing importers said the two professors had tried their best but failed to deliver.
He opined the number of drugs in the market should be decided by market sentiments and that restricting the number of drugs will only push up the prices. “There will only be a few players in the market, the tender prices will go up and competition will come down. Eventually prices of drugs will shoot up even higher,” he said.
Also he said that there is an urgent need to streamline the QAL to expedite approval of drugs. Have only a few accredited manufacturers to avoid the influx of low quality drugs and sort out problems of credibility through email correspondence. “This will quicken the process,” he said.
Meanwhile Health Ministry, Secretary, A. Jayawickrema said that Professor of Clinical Pharmacology, Kelaniya University, Prof. Asitha De Silva is tipped to take office as chairman ,NMRA.