With Sri Lanka’s Health sector still in crisis, the Daily Mirror has information about some shocking discoveries made by the National Medicine Regulatory Authority (NMRA) which was appointed last year to implement Prof. Senaka Bibile’s essential medicines concepts and provide quality drugs at affordable prices.

Recently Health Minister Rajitha Senarathna called for the resignation of the NMRA’s Chairman Prof. Laal Jayakody and its Chief Executive Officer Prof. Krishantha Weerasuriya. But later Dr. Senarathna requested the two eminent personalities to come back and they did so for the sake of the people. 

According to information we have, the NMRA has saved millions of rupees through properly implemented regulatory processes during the past few months. In addition, going beyond its usual work, the NMRA has intervened to get medicines supplied from registered sources, rather than importing unregistered medicines of unknown quality

The State Pharmaceutical Corporation (SPC), the supply arm of medicines for the Ministry of Health, had requested the NMRA to issue a ‘NOL to buy the drug Lorazepam. The reason given for asking the NOL was that suppliers of the registered drug had not applied for the tender. The total value of the consignment was Rs. 36 million. Prof. Krishantha Weerasuriya, who is well known for his tough, but straight actions, called registered suppliers of the drug and asked why they had not tendered. They said that they were not aware. Prof. Weerasuriya then asked them to send their quotations and they complied. The SPC re-evaluated the tender and it was awarded to a registered supplier. The cost was Rs. 250,000. This action of the CEO not only saved more than Rs. 35 million in public money, but also gave Sri Lanka’s a quality- assured drug.

The NOL is issued when a drug which is not registered in Sri Lanka is brought to the country. If this is not issued by the NMRA, Sri Lanka Customs will not allow the drug. However, as the quality, efficacy and safety of unregistered drugs are not known, NOLs are meant to be issued only in unavoidable circumstances. This system was highly abused before the NMRA was established. There is an instance where the former Cosmetics Drugs and Devices Authority issued an NOL to import a ‘Gotukola’ extract. 

The drug Nimotuzumab, an anti-cancer drug, was given provisional registration for one year by the CDDA. With this registration, the Ministry of Health bought this drug at a cost of Rs. 150 million last year. When the application for re-registration of the drug came to the NMRA, Prof. Jayakody and Prof. Weerasuriya looked into the manufacture of this drug and found that it was still in the trial stage. Also it is still not approved for treatment of cancer. So they refused to register the drug. This saved another Rs.150 million for this year. Medical experts say that this action not only saved money, but also saved Sri Lanka’s cancer patients from being used as Guinea pigs to test these medicines.

According to information given to the Daily Mirror, the SPC requested another nol to import 60,000 tablets of ‘Primaquin’, a drug used in treating Malaria. This was for the Medical Supplies Division of the Ministry. Knowing that Malaria has almost been eradicated in Sri Lanka, Prof. Weerasuriya called the Anti-Malaria Campaign and asked whether it needed this quantity. The answer was an emphatic “No”. The Prof. informed the SPC that the drug was not needed and the order was cancelled, saving several more lakhs. 

Sources from the SPC and the MSD say there are many more similar instances where the intervention of the two Professors of the NMRA not only saved millions of rupees but also assured the buying of registered drugs of known quality, safety and efficacy rather than buying a drug on a no objection letter. Under the guidance of the two Professors, the NMRA, SPC and MSD have formed a forum to discuss how Sri Lanka imports drugs on the basis of five factors - quality, efficacy and safety, the cost of the drug and the need for it. The aim is to avoid the waste of money and assure quality, safety and efficacy.

Two important questions arise from these findings. Whether the attempted removal of the two Professors from the NMRA was because, they were acting with honesty and integrity while saving money. It is obvious that someone, or many, were disturbed when their commissions, amounting to millions of rupees, were denied. The second question is what action the government will take against the culprits who wasted or tried to waste public money by buying unregistered drugs using NOLs.