NMRA’s endeavour to usher medicine into the digital economy

By Uwin Lugoda The digitalisation of government processes and institutions have long been considered one of the first steps towards building a technologically smarter community due to the increase in access and transparency it provides the public. Sri Lanka first began this journey in December 2017 when the Ministry of Telecommunication and Digital Infrastructure, with the support of McKinsey and Company, embarked on the process of developing Sri Lanka’s Digital Economy Strategy. Following this, many other industries came up with initiatives that helped digitise their own institutions, the most recent of which being the pharmaceutical industry. The National Medicines Regulatory Authority (NMRA) opened its new digital submission portal to the public on 1 September in order to add efficiency and transparency for their stakeholders. The NMRA is the national body that regulates medicinal products in the country and provides market authorisation through regulation for medicine or medical products for the use of patients in Sri Lanka. The organisation was established through an act of parliament on 1 July 2015, repealing and replacing the Cosmetics, Devices, and Drugs Act. While the organisation is a part of the Ministry of Health, the NMRA acts as an independent body governed by a board. NMRA Chairman Prof. Asitha de Silva stated that the NMRA has a fundamental responsibility to ensure that the public has access to that medicine without going into financial hardship, and therefore hopes that its digitalisation would lead to better transparency for their stakeholders to enable them to work better with the organisation. Entire process digitalised The NMRA primarily started this initiative in March 2019, when they launched their updated and newly integrated user-friendly website. The website offered users a fresh online experience with easier access to in-depth information about NMRA’s services and industry-relevant news including regulatory details, medicine and medical equipment legislation, and clinical trials. The website was accompanied by a new social media channel to further communicate and update all the relevant information regarding medicines and their regulations. This digitalisation of the NMRA is applied to both its work flow and document management systems, and allows all stakeholders including big pharmaceutical companies, pharmacies, and patients to submit their applications, make payments to the NMRA, and receive approval online. “The NMRA is not doing any more paper-based work; this process even provides a payment gateway, which needs to be used if applications are to go through. This makes the information more accurate and applications more complete.” According to Prof. de Silva, 90% of medicines in Sri Lanka are imported, and these imports are usually handled by the country’s pharmaceutical industry, making them the NMRA’s biggest stakeholder. He explained that the approval process for companies to either get a market authorisation or even a license for transporting certain products is a long one and needs to go through certain operating procedures conducted by an expert committee. Due to this extensive procedure, the stakeholders usually lose track of their submissions and would not know which phase their submission was in. However, he explained that, thanks to the digitalisation, these stakeholders can now track the progress of their submissions. “When a company that imports medicine applies, they will now have their own portal online from which they can track and see what goes on.” This digitisation is set not only to benefit the big companies, but also the pharmaceutical industry as a whole. Prof. de Silva stated that the digitalisation initiative also benefits patients and pharmacies as well, due to them being able to conduct the entire process online, for both personal user licenses and pharmacy licenses, respectively. Pharmacies registered through the NMRA are heavily vetted in several fields before being issued a license for the sale of medicine or medical products. These aspects include the presence of a qualified pharmacist at the point of dispensation of medicine to patients, whether the environment is air-conditioned or not, and how they store the medicine, to name a few. According to Prof. de Silva, the patients can now easily identify NMRA-registered pharmacies online. In addition, he said they are hoping to include a QR code in each pharmacy to add further convenience to the patients. Patient benefits Speaking from the patient’s point of view, he stated that patients who require medicine or medical products that are usually not authorised in Sri Lanka can apply for personal user licenses online without having to come to the NMRA to both apply and collect it. “By digitalising the NMRA, we can regulate everything more efficiently and make it easier for the people to work with the NMRA for their licensing purposes.” Extensive stakeholder involvement Prof. de Silva stated that before initiating the digitalisation, the NMRA together with the Information and Communication Technology Agency of Sri Lanka (ICTA) conducted workshops with the relevant target markets such as the Sri Lanka Chamber of Medical Devices and pharmacist to get them used to the new digitalisation. “We engaged with the industry in a very effective and robust way to ensure that they will be online when we are online.” He explained that during these workshops, the reactions from the industry as a whole were very positive because they saw NMRA’s attempt at increasing efficiency and transparency. Sri Lanka Chamber of Medical Devices Industry President Erandajith Ranasinghe stated that as an organisation focused on overcoming key industry concerns, the Chamber is fully supportive of the initiative taken by the NMRA. Ranasinghe stated that the Chamber believes the e-system would help streamline the registration process, reducing timelines and providing a transparent system with equal opportunity. He went on to explain that this transition from the traditional process is vital when it comes to keeping up with the fast-paced development of the global pharmaceutical industry. According to Ranasinghe, the digitalisation is beneficial for their ongoing projects with NMRA, which include the Medical Devices Classification Guidelines and Regulations, which they are hoping to implement soon. “Because of the new regulations and e-system, importers of medical devices will be entitled to hassle-free dossier preparations and submissions.” Prof. de Silva explained that currently, the NMRA is training people on how to use its systems, and therefore only the pharmacy license and personal license submission portals are available online, with the pharmaceutical company license being digitalised at the end of September. Photo krishan kariyawasam