Engineers work on an experimental vaccine test for the COVID-19 at the Quality Control Laboratory in Beijing (AFP)
Government Medical Officers association (GMOA) announced last week that over 500 essential medicines are not available in the country. This is a serious statement when considering the fact that there are only 460 medicines in the Model List of Essential Medicines of World Health Organization (WHO). The model list is considered as the basic guideline for maintaining essential medicines of any member state of WHO.
The out of stock situation associated with some medicines at any given point of time is a common phenomenon which have been experiencing in most countries in the world. The concern over the shortage of medicines has been raised in this country for over 3 decades. The writer has looked at some of the out of stocks medicines in the local market currently. It is found that the shortage of those medicines has been implicated with the manufacturing quality issues. It includes Injection Propofol, Tablet Sertraline, Influenza vaccine, Meningococcal vaccine etc.
However, due to the obvious urgency, this article will only address the possibilities of a shortage of medicines in Sri Lanka due to the influence of Covid-19 pandemic situation. One of the difficulties in predicting any future shortage of medicines is due to the secrecy built into the pharmaceutical supply chain to protect pharmaceutical companies’ trade secrets. With such a situation, it is almost impossible for any expert, medicine regulator or government agency to figure out exactly what medicine may be hard to find and when with this situation might arise.
If you take your medicine pack, it may have the name of the company as the manufacturer. But it doesn’t mean that company ‘A’ manufactures that product. A lot of pharmaceutical companies hire other pharmaceutical companies to produce medicines for them which we call as contract manufacturing of medicines. Hence, it is not easy to increase or fast-forward the manufacturing of medicines with these complex manufacturing arrangements during an emergency like the Covid-19 pandemic.
Most pharmaceutical manufacturers make a certain quantum of a medicine based on demand during a 5-year period. This quantity doesn’t account easily for global emergencies such as the Covid-19 pandemic that may dramatically accelerate the demand of medicines such as Tablet Azithromycin, Tablet Quinine or Tablet Hydroxy-Chloroquine.
The out of stock situation of medicines may be due to logistical issues caused by border closures, export bans, lockdowns in third world countries supplying medicines to Sri Lanka, stockpiling in certain hospitals and by citizens.
20 medicines at risk
Probably the most possible reason for the out of stock situation of medicines within the next 3-5 months may be
It is not easy to increase or fast-forward the manufacturing of medicines with these complex manufacturing arrangements during an emergency like the Covid-19 pandemic (AFP)
due to the lack of raw materials for pharmaceutical manufacturing. In a pharmaceutical manufacturing process, the first step is to convert the raw materials into Active Pharmaceutical Ingredients (APIs). According to the World Health Organization (WHO), any substance used in any medicine which is intended to furnish pharmacological action in curing or mitigating a disease in human beings is API. There are 2,000 API manufacturers globally and most of these companies have located their factories in China. According to a recent report, Nanjing Limu Pharmaceutical Co. Ltd. in China is the biggest API manufacturer in world; which exports its API products to 181 countries. China produces over 1,500 varieties of API products with the capacity approximating 2-3 million tons annually. It is identified that 20 medicines are at risk of going into shortage where APIs of those medicines are mainly made in China.
China has certain inherent strengths in chemistry, infrastructural capabilities and low cost labour which they leverage to gain higher market share of APIs market. During the last 10 years, the Chinese API market has gained high market shares due to its cost competitiveness.
This has resulted in manufacturing of APIs, which moved away from European countries and other parts of the world largely to Asian countries, dominated by China. As a result, many API companies in other parts of the world had divested or possibly curtailed operations, leading to a further concentration of the APIs industry in China. India and Italy retain positions of second and third largest exporter of APIs.
As all 3 main exporters of APIs are being affected severely due to Covid-19 pandemic we can expect that there will be a shortage of APIs within the next 3-5 months due to this reason. Most of the API factories in China and India are still closed or just re-started production. This will be the most possible reason for the out of stock situation of medicines in Sri Lanka and other countries in next 3-5 months period.
Let us now look at how Sri Lanka should face this looming threat effectively by considering its position as a country which imports over 85% of its pharmaceutical requirements from global market.
The establishment of a Single Point of Contact (SPC) for reporting the details of out of stock medicines in state and private sectors should be attended immediately. Based on the previous consumption patterns of those medicines and the increase in demand due to pandemic, the SPC is capable of quantifying the requirements. Based on that information, the Government of Sri Lanka can prioritise the ordering of such medicines.
"As all 3 main exporters of APIs are being affected severely due to Covid-19 pandemic we can expect that there will be a shortage of APIs within the next 3-5 months due to this reason"
The Government should encourage the local pharmaceutical industry to increase production capacity for all medicines sorequired, and in particular for medicines which are potentially at risk of facing the supply shortages.
The Purchase Orders for medicines which are placed by State Pharmaceuticals Corporation (SPC) and Ministry of Health (MOH) could be cancelled by foreign pharmaceutical manufacturers by using the Force Majeure clause in tender documents which typically applies while in an event such asCovid-19 pandemic which could impair the ability of the pharmaceutical manufacturing companies to perform. In such a situation, SPC and MOH should strictly deal with those foreign suppliers and make sure that the ordered quantities are supplied on time. This writer thinks that the biggest and most important exercise in this aspect is to get a grip on possible potential issues with foreign suppliers and determine what the potential exposures are.
India’s ban on exporting 26 Active Pharmaceutical Ingredients (API) may have an impact on the local pharmaceutical manufacturing companies as the banned exports include over-the-counter painkiller and fever reducer paracetamol, a common antibiotic metronidazole and various versions of vitamin B etc. The Government of Sri Lanka should take up this matter with Government of Indian.
It is necessary to educate, monitor and control the unnecessary stockpiling of medicines by private hospitals and individuals. If this situation is not controlled, the number of medicines in the list of the out of stock medicines would surge drastically. During this pandemic, the medicine supply in Sri Lanka “is not unlike the toilet paper situation in western world,” where stores may be temporarily out of stock due to panic buying by the people and not necessarily because of major supply chain issues.
Doctors and pharmacists are the most useful persons in recommending substitutes for the out of stock medicines. Most of the medicines can be substituted with alternative medicines with the same pharmaceutical effect. It is the duty of the national health authorities to educate the doctors and pharmacists about their roles in cases of assisting the patients with regard to substitutes for the out of stock medicines.
If we are capable of taking those actions swiftly we as a country would have the least impact on its pharmaceutical supply chain due to the Covid-19 pandemic.
(The writer is a Pharmacy graduate from the Prestigious JJS College of Pharmacy, India. He has completed an MBA and holds a PhD in Management. Dr. Jayakody qualified as a certified Management Accountant in Australia. He currently functions as a director of 2 private hospitals and a chain of medical laboratories)