Dapke K, Phadke R, Rocha I, dos Santos Costa A, Ahmad S, Essar M, Menon V, Bassey E, Malhotra K, and Shah J. Drug supply shortage in India during COVID-19 pandemic: efforts and challenges. Harvard Public Health Review. 2021; 31.
Despite being one of the largest pharmaceutical hubs globally, India is currently facing drug supply shortage due to the COVID-19 pandemic. This paper discusses the current situation of pharmaceutical industries in India and its repercussions on general health. It also cites similar situations in other countries and the impacts of drug shortage at the moment. Several factors were found responsible for this crisis, especially during the pandemic, including shortage of manpower and disrupted transportation due to strict laws enforcing a nationwide lockdown and dependency of Indian pharmaceutical companies on China for active pharmaceutical ingredient procurement. The paper recommends measures to overcome this situation, emphasizing on relaxing the strict government policies, granting more control to the public sector, and modifying the company laws for workers. It also recommends the government to work in conjunction with the investors and innovators to help curb this problem.
India, one of the world’s largest pharmaceutical hubs, is currently facing drug supply shortage due to the ongoing coronavirus disease 2019 (COVID-19) pandemic. Drug shortage, as defined by the Food and Drug Administration, occurs when the total supply of drug products is inadequate to meet the current or projected demand at the patient level . In the past, a significant number of countries that have experienced drug shortages have been able to scale through successfully within a defined time frame with no effects on patient care. However, with the sudden occurrence of the COVID-19 pandemic, drug demand has been significantly increased, and consequently, the shortage could be disastrous and may last for a longer time than anticipated.
One example is the situation in Nigeria, wherein the imminent shortage of essential medicines and medical products during the pandemic significantly affected the health and quality of life of its population  primarily due to the economic disruption across the world. In Africa and Southeast Asia, a study revealed that antimalarial supply disruption has adversely affected the regions, with 26.7% African and 21.4% Southeast Asian respondents reporting inadequate supplies at local pharmacies. This has particularly posed hardships for people suffering from diseases like rheumatoid arthritis and lupus, since its mainstay of treatment is an anti-malarial drug like hydroxychloroquine . The lockdown and travel bans are also expected to disrupt the drug supply chain for anti-retroviral and anti-tuberculosis medicines. Experts recommend countries to proactively protect the drug supplies and make sure that there are no major stock-outs of critical medicines. This is important not just for the Indian patients but for the whole world that relies on Indian generics .
In early 2021, India was reported to occupy a 20% share by volume of supply across the world and contribute 62% of the global supply. In addition, the country has been ranked third in drug production by volume and fourteenth by quality globally . This pandemic has uncovered a healthcare dilemma that has plagued the world for quite some time, recurring shortages of essential drugs required to treat a range of acute and chronic diseases. Alongside other countries, India too has been affected by it resulting in drug shortage within the country. Consequently, in March 2020, the country restricted exportation of about 26 active pharmaceutical ingredients (APIs) in order to help curb this pending crisis .
With the ongoing COVID-19 pandemic, lockdowns have been enforced in many countries which have resulted in disrupted transportation affecting supply chains wherever outsourcing-based dependencies exist, and manufacturing shocks causing reduced productivity and output globally. Supply shortages were anticipated and seen for drug products, which during the pre-COVID-19 era had aligned themselves to cloud-based manufacturing of their APIs. Thus, several pharmaceutical companies depend on supplies from other countries like China, the top global API producer and exporter. Indian manufacturers procure around 70% on APIs from China for their drug production .
The pandemic’s impact has exposed the dependency of the Indian pharmaceutical sector on China for its API procurement and a significant proportion of key starting materials supply. Disruptions in supply chain, production capacity, and export potential are result of the containment measures, such as lockdowns and social distancing, causing manpower shortages in China’s manufacturing plants . Few manufacturers have reported that a shortage of APIs had already impacted its capacity by 20% to 30% of their normal production capacity .
Other challenges include shortage of packaging materials, disruption of transportation systems, and reduced movement of cargo flights. With a reduced number of flights, sea routes were being attempted as an alternative option, but reduced access and movement of products, delayed shipping, vessels being diverted to other ports, delayed customs clearance, and understaffed ports posed additional challenges .
With the clock ticking and an impending doom that India might face, radical interventions are necessary. There is a dire need to strengthen the supply chains by bringing in experts, diversifying the procurement through introducing duty-free imports and exempting domestic taxes, strategically stockpiling the product, and even dilution of intellectual property (IP) regulations. Any innovative product like drugs, vaccines, medical devices or other medical supplies are legally protected by patents enabling the right holders to protect their IP against third-party use .
The ongoing COVID-19 crisis has created a growing need to enable the country to manufacture essential medical supplies. Thus to counter this pandemic, there is an ardent need for the government to intervene and dilute the IP restrictions for a short-term to ensure effective deployment of medical supplies for public health and safety . This is achieved by following the regulations on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) which includes certain tools like compulsory licensing that are available to ensure access to medicines . After fulfilling certain prerequisites that are stipulated in the Indian Patent Act, the government, by way of issuance of compulsory license, can authorize or permit a third party to use an invented product or process which has been patented .
Another method by which effective dissemination of products related to public health can be ensured is by creating a global patent pool of COVID-19 related innovations, that could be managed by a trustworthy international organization. All countries should have the right to implement these innovations without the need for permission from the patent-holders or use of tools such as compulsory licensing, state acquisition, among others. This method of pooling of patent resources is also in line with the Doha Declaration on the TRIPS Agreement and Public Health [11,12].
The government also needs to improve the process by relaxing restrictions and enforcing legislations associated with drug export and making sure the drugs are at par in terms of their quality. With cases rising at an all-time high, the restrictions on shipping of products should be relaxed and the associated delays and costs need to be addressed with utmost urgency . India also needs to produce raw materials locally in order to meet the rising demand and to counter the restrictions imposed by the heavy import of APIs from China.
Effective drug procurement and distribution should also be attained to deliver on the promise of Universal Health Assurance. The government and pharmaceutical industries could partner to revive the Jan Aushadhi programme and help deliver high-quality and affordable generic medicines. With a rising mortality rate and a collapsing health system fuelled by drug shortages, an increase in production of generics is the need of the hour. Ramping up the production is the only way to deliver drugs to the patients at the earliest. With the incurring benefit, this would also facilitate medical and drug research in the country.
While the government ensures equitable access to medicines for everyone, there needs to be a substantial return on the investment and a predictable and transparent policy environment that will foster more medical innovations. Indian drugs rank among the cheapest in the world, differing by 65% and 25% respectively from their counterparts in BRICS states and SAARC countries . In this scenario, India needs to augment its financial outlay with the sole and stated objective of raising public health spend. By regulating the land and utility prices, the country can attract pharmaceutical industries from abroad to set up their units, helping small and medium-sized industries thrive by encouraging fast-track approvals. This will, in turn, also help relieve the country’s reliance on foreign raw materials . Introducing policies such as duty-free imports and exemption from domestic taxes for various manufacturers engaged in exports will also help significantly in generating revenue .
It is necessary for these recommendations to be implemented by the National Institution for Transforming India, also known as NITI Aayog, which has the ability to span across ministries and withstand populist pressures. The NITI Aayog, along with the Department of Pharmaceuticals, has recently planned an incentive scheme of Rs 3,000 crore to revive domestic manufacturing of bulk drugs and this certainly looks like a step towards a better future .
In conclusion, Indian pharmaceutical companies are responding to the rapid challenges arising from the disruption in supply chains. If the current pandemic lasts for a longer duration, it may impact the supply of APIs and the import and export of essential drugs. There is also the potential for negative impacts on both manufacturing activities and research and development. While the full impact of the global pandemic is still unknown, pharmaceutical companies need to respond, recover, and thrive.
Kartik Dapke is with Indira Gandhi Government Medical College, Nagpur, India.
Rachana Phadke is with Indira Gandhi Government Medical College, Nagpur, India.
Ian Christopher Rocha is a Registered Nurse and Licensed Professional Teacher in the Philippines. He is a graduate of Master of Health Social Science, Master of Business Administration, and Bachelor of Science in Nursing. Currently, he is studying Doctor of Medicine. His research interests include tropical medicine, public health, health social science, and education.
Ana Carla dos Santos Costa is medical student at the Federal University of Bahia, Salvador, Bahia, Brazil. She is interested in the intersection of global public health, epidemiology, neuroscience, and respiratory medicine.
Shoaib Ahmad is with Punjab Medical College, Faisalabad, Pakistan.
Mohammad Yasir Essar is with Kabul University of Medical Sciences, Kabul, Afghanistan.
Vaishnavi Menon Affiliation is with Indira Gandhi Government Medical College, Nagpur, India.
Esther Edet Bassey is a student of Medical Physiology, Faculty of Basic Medical Sciences, University of Uyo, Nigeria; where she serves as the Editor 2 of the Faculty and the Hult Prize Campus director of the University. She is passionate about making a positive difference in the society and believes that research is a great tool to achieve this aim, hence, she has co-authored several papers undergoing review with one published and she is a Research fellow with RadScholars Inc. In addition to this, she is an Alumni of the Young African Leadership Initiative (YALI) RLC West Africa fellowship and has served as an ambassador of over ten International Student conferences.
Kashish Malhotra is with the Department of Internal Medicine, Dayanand Medical College, Ludhiana, India.
Jaffer Shah is with Drexel University College of Medicine, Pennsylvania, United States.