The transnational pharmamafia, some corrupt official in the Health Ministry and other vested interest are still trying to sabotage the implementation of the national medicinal drugs policy in line with Prof. Senaka Bibile’s essential medicines concept.
After a delay of more than 10 years, President Maithripala Sirisena who was earlier the Health Minister, had personally ensured that legislation to implement the Senaka Bibile policy was approved by Parliament in May last year. About six months later, the National Medicines Regulatory Authority (NMRA ) began work to evaluate some 15,000 varieties of drugs that were registered for import and sale. The main objective of the NMRA was to test the quality, safety, efficacy, the cost and the need for the drugs. It was the long term intention to reduce the number of drugs being imported to about 1,000 varieties of different dosages so that quality drugs could be made available to the people at affordable prices.
But the Daily Mirror learns that a mafia is trying to sabotage this mission which will be the first step towards restoring a health service where the patients’ well-being is given top priority. According to information available to the Daily Mirror, a television channel repeatedly reported that due to that NMRA’s slackness, essential drugs were going out of stock. The report showed a letter from the Health Services Director General mentioning eight medicines that were out of stock. Three were vaccines.
The NMRA is given the responsibility of testing and assuring the quality, safety and efficacy of medicines and medical devices. When an importing company applies for the registration of a medicine, it has to submit details. These include the place of manufacturing, the standards of manufacturing plants and whether the drug is registered in that country. A medicine is registered only after studying these details and other analytical data. After the evaluation, the NMRA is empowered to issue a ‘no objection letter’ (NOL) for the import of a drug. However, the Daily Mirror learns this NOL system has been grossly abused over the years by some officials in the Ministry of Health. Around 1,000 NOLs had been issued during the first six months of last year before the setting up of the NMRA. These NOLs were issued by the then Drug Regulatory Authority.
According to information many are the tactics used by some Health Ministry officials in abusing the NOL process. One of the worst cases involves the drug ‘lorazepam.’ The State Pharmaceuticals Corporation (SPC) had awarded the tender to an unregistered supplier and an NOL was requested. The cost was more than Rs. 33 million. When the request came to the NMRA’s Chief Executive Officer Prof. Krishantha Weerasuriya, he noticed that four lorazepam brands had been registered. He called the four companies and asked why they did not apply for the tender and they said they were not aware. He asked them to send quotations. The SPC re-evaluated the tender and it was awarded to a registered supplier. The cost was a mere Rs. 250,000. The CEO’s action thus helped to save as much as Rs. 33 million in public funds. More so Sri Lanka got a quality drug. The amount of money pick-pocketed from innocent unsuspecting patients could be figured out from this example.
Another shocking case involved a drug ‘Nimotuzumab,’ an anti-cancer drug. This was given provisional registration for one year by the earlier regulatory authority. In 2015, the Health Ministry purchased this drug at a cost of Rs. 150 million. When the application for re-registration of the drug came to the NMRA, its chairman Prof. Laal Jayakody and Prof. Weerasuriya made inquiries and found that the drug is still in trial stage. In other words, it is not still approved for the treatment of cancer in most countries. The NMRA refused to register this drug. This not only saved another Rs. 150 million in public money, but also prevented the use of Sri Lankan patients as guinea pigs to test this cancer drug.
We urge the President, the government and Sri Lanka’s people to protect the NMRA from the drug mafia, corrupt officials and other vested interest so that the spirit of Prof. Senaka Bibile will come alive again to revive our health service. It may be necessary for the President to bring the NMRA directly under him, because of the corruption in the Ministry of Health.