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Substandard medicines: President offers solution within two weeks
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By Kumudini Hettiarachchi
Action will be taken within the next two weeks to defuse the crisis around substandard medicines and drug failures, President Ranil Wickremesinghe has assured.
While assuring that he would hold extensive discussions with the Health Ministry shortly to bring about a solution to the controversies around medicines, the President had also suggested that the process of ordering medicines should be streamlined so that all medicines were ordered by one source.
These critical issues had been discussed at length by the President when the Government Medical Officers’ Association (GMOA) met him on Thursday evening.
Currently, medicines are ordered by different sources. These include the State Pharmaceuticals Corporation (SPC) directly; the Medical Supplies Division (MSD) through the SPC; the State Pharmaceuticals Manufacturing Corporation (SPMC) which deals with purchases from local manufacturers; and hospitals buying local purchases directly whenever they are faced with a shortage.
The discussion had also revolved around direct medicine purchases on a government-to-government basis without the involvement of third parties which is reportedly fostering corruption.
While the meeting had been attended by President’s Chief of Staff Sagala Ratnayake and President’s Secretary Saman Ekanayake, the participants from the GMOA were its President Dr. Darshana Sirisena, Secretary Dr. Haritha Aluthge and Executive Committee members.
On Friday, the GMOA had met Health Minister Keheliya Rambukwella to discuss how to streamline and regulate processes to help provide a continuous supply of quality medicines to the people at affordable prices.
Meanwhile, the Sunday Times learns that following a meeting between the GMOA and the Sri Lanka Chamber of the Pharmaceutical Industry (SLCPI) on July 11, the latter has proposed some measures to “improve accessibility of quality pharmaceuticals at affordable prices”.
The SLCPI headed by Prathaban Mylvaganam has suggested the following measures in a letter sent on July 25:
- Create an Essential List of Medicines based on the annual budget allocation for pharmaceuticals, prioritizing essential medicines to avoid shortages throughout the year and improve payment delays to suppliers.
- Implement a comprehensive software system that connects hospitals, the MSD, the SPC and the National Medicines Regulatory Authority (NMRA) to ensure timely procurement of essential medicines and prevent delays.
- Introduce a transparent and practical tender procedure by removing one-sided tender clauses to promote fairness and encourage participation from a wider range of suppliers.
- Reduce the lead time of the SPC in procuring medicines while still allowing for urgent purchases during sudden outbreaks. Minimize emergency purchases and, when necessary, co-ordinate with existing suppliers to procure at the same price instead of opting for new suppliers at exorbitant prices.
- Establish a transparent payment method for suppliers based on age analysis. This will ensure timely payments and foster better relationships between the SPC/MSD and suppliers.
- Avoid making exceptions routine in the procurement of medicines, such as issuing Waivers of Registration (WORs). Exceptions should be minimized to maintain a standardized and efficient procurement process.
The SLCPI has also made some recommendations on how to improve the efficiency of the NMRA. These include increasing regulatory staff to address the backlog and expedite registration; a transparent pricing mechanism; clear guidelines and streamlining of the regulatory process; an accredited online platform to improve efficiency; prioritizing the registration of molecules with fewer than five brands registered in the country to encourage competition and broaden availability of essential medicines; and sharing critical decisions of the Medicine Evaluation Committee (MEC) with the pharmaceutical chamber to keep stakeholders informed.
“There should be no restriction on the number of brands to be registered for each molecule, as an unrestricted number of registrations can lead to increased competition, which may result in more competitive prices,” it says, seeking an improvement in the facilities of the National Medicines Quality Assurance Laboratory (NMQAL) or alternative options to test drugs to ensure quality and safety.
“An effective pharmacovigilance system should be implemented as a priority to address concerns of medicine quality and patient safety,” the SLCPI adds.
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