With the World Health Organization (WHO) declaring Coronavirus or COVID-19 a pandemic, it is now essential that countries and organisations that have the ability to find solutions come together, share information as much as possible and work together across borders. Already, experts are worried that the impact of Covid-19 may surpass that of the 2008 global downturn. Till date, globally, nearly 4,71,417 people have tested positive and approximately 21,295 have lost their lives to the deadly virus. On the date of drafting this article, the number of COVID-19 positive cases in India had crossed 700 (seven hundred), with 14 (fourteen) people succumbing to the disease. India is now under a full government ordered 21-day lockdown. A cure remains elusive till date. But in the words of famous author Louisa May Alcott, ‘Be comforted, dear soul! There is always light behind the clouds’. And it is this light that India needs to focus on in order to secure a future that survives the present.
India is known as the pharmacy of the world. Indian pharmaceutical manufacturers cater not only to the demand in India, but also to the increasing demand of drugs across the globe. With China as a key supplier of pharmaceutical API’s to India, the COVID-19 lockdown in China has resulted in a halt in the supply of key API ingredients/ raw materials, which has in turn affected steady manufacture and supply of life saving drugs in India. India’s exports have also consequently taken a hit. Downstream supply is suffering as a result. There is considerable angst that if the existing conditions, now exacerbated by the lockdown in India continue, there could be a potential shortage of essential and lifesaving drugs. Given the impact on China’s logistics sector and the trust deficit it is facing right now across the world, despite the Hubei province – the epicenter of the virus — deciding to go back to work, India is best placed to provide an alternative to the world in terms of being a trusted source for quality APIs.
Although, a slowdown in raw material supply may hurt certain China-dependent industries, it also presents an opportunity for Indian companies to step up to the plate and fill the void around the globe. Indian manufacturers are presented with the perfect opportunity to scale up and take China’s place in the global supply chain by building ties with companies looking to reduce dependency on China. This could pave the way for more foreign investments in India and promote the ‘Make in India’ programme.
Scope for Indian pharma companies
Against this backdrop, there is a lot of scope for Indian pharma companies to scale up and capture a large share in not just the American generic drug market, but also the European market. Europe, especially Italy, has been badly hit by Coronavirus. It has reported the second-largest number of positive cases after China. The death toll in Spain, too, has surpassed that of China.
Indian pharma companies are already taking up the challenge of producing test kits, masks, sanitizers, etc., on a war footing. Recently, Pune-based molecular diagnostics company, Mylab Discovery Solutions Pvt Ltd, received commercial approval from the Indian FDA/ Central Drugs Standard Control Organisation (CDSCO) to manufacture Covid-19 test kits. Mylab, at the moment, is the only Indian company to receive 100 per cent specificity and sensitivity in ICMR evaluation. So far, India has been sourcing its test kits from Germany, but it is becoming increasingly difficult because more and more airlines are being grounded by the day.
Further, the Indian government has instructed the Directorate General of Foreign Trade (DFGT) to restrict the export of 26 (twenty six) APIs and formulations made from them, including paracetamol, the majority of which are procured from Hubei, China, amid fears of acute shortage of these products in the future. This makes it the right time for Indian pharma companies to look at the API industry with renewed focus. In addition, the Department of Pharmaceuticals, after assessing the availability of drugs in the country, has said that the existing stock of APIs will be sufficient to manufacture everyday drugs for 2 (two) to 3 (three) months. In the event that the number of people infected by Coronavirus increases, within India as well as across the globe, there will be increased demand for medicines or drugs, and hence APIs. This is the right time for domestic pharma players to increase capex, plan the way forward and grab market share domestically as well as internationally.
Additionally, during US President Donald Trump’s recent visit to India, the Central Drugs Standard Control Organisation and the USFDA signed an MoU over safety of medical products. To put things into perspective, India is among the top 5 (five) drug exporters to the US. It exported pharma products worth USD 5.82 billion in 2018-19. India, being a bulk producer of cheaper generics, has helped mitigate demand for generic prescription drugs. The MoU between the two countries will further enhance the scope of exports of such drugs to the US. These MoUs, coupled with the situation in China, may result in good equation with the USFDA, which may help Indian pharmaceutical companies, grappling with pricing pressure and competition, earn a certification (after meeting regulatory requirements) and further access into the US market.
Need to decrease dependency
Pharmaceutical companies in India import raw materials such as intermediate and bulk drugs and starting raw materials worth USD 4.5 billion. In fiscal year 2018-19, Indian pharma companies had imported bulk drugs and intermediates worth $2.4 billion from China. It does not end here, for drugs like penicillin, amoxicillin, tetracycline, hormonal pills and essential vitamins, among others, the world completely relies on China. As can be seen, this dependency on China has had a negative impact on the industry. To end its dependency on China, the Indian government has asked pharma companies to increase production of 38 (thirty-eight) raw materials or APIs.
The Indian government has allocated Rs 15,000 crore to strengthen the healthcare sector. Various state governments are also doing their bit. But more needs to be done considering that the US Senate has approved a USD 2-trillion rescue plan. While it may be true that the sizes of the two economies cannot be compared, there is still a lot more that the Indian government can and must do, and it must do so NOW.
Some of the issues that the government needs to address immediately are:
- Uninterrupted supply chain: The global and domestic lockdown has impacted supply of raw materials. Due to the lockdown, most pharma companies don’t have enough raw materials to continue production beyond the next 20-30 days. In addition, downstream delivery has also been impacted. Additionally, the lack of manpower, given problems faced by factory workers in reaching their workplace has also contributed to the angst in the industry. The government needs to look into these issues and take appropriate measures so that the supply chain is not affected.
- Approval of new drug manufacturing facilities: Where manufacturing facilities are in short supply, the government needs to engage in expedited approval of facilities that satisfy quality standards. This will not only help in the speedy setting up of new manufacturing facilities, but will also help in meeting the deficit caused due to lack of supply from China. Not to mention the fact that such positive measures would attract investors who would want to invest in the setting up of this infrastructure, thereby aiding the Make in India initiative.
- Supply of medical devices/ equipment: India currently imports a majority of its life saving medical devices from abroad. The global lockdown has affected these imports. There is angst that these lifesaving and life improving devices such as cardiac stents, orthopedic implants etc., may face restricted supply. There is an impending need to grant approvals to more and more domestic manufacturers to cater to any issues caused by such reduced supply.
- Impact on R&D: Most research work currently is focused on COVID-19. R&D efforts to find cures and therapies for other life-threatening diseases such as Diabetes, Heart Disease, Cancer, HIV, etc., are continuing, but in the backburner. The government needs to step up its efforts to ensure that these R&D activities, too, are supported in every manner. As far as COVID-19 is concerned, the government needs to invoke expedited approval and abbreviated trial requirement provisions in the law so as to ensure speedy discovery of treatment protocols and drugs.
- Healthcare infrastructure: Compared to Italy, India’s healthcare infrastructure is at a nascent stage. If the number of Covid-19 cases rise here, there is every likelihood that the country’s hospitals, medical professionals, including nurses, will be so overwhelmed by the burden that the system may nearly collapse. Another thing to keep in mind is the fact that just because COVID-19 is of more immediate concern, other diseases have not stopped. Yet, reports indicate many hospitals are refusing to admit even serious non-Covid patients. It is therefore imperative that the government focus its energies on granting speedy approvals for more healthcare infrastructure and back up the same with governmental support.
As WHO says, only lockdowns will not help, at the most, it can delay the inevitable. The need of the hour is more testing. India ranks the lowest in terms of number of testing done per million people. Protective gears for doctors and nurses is another area of concern and India needs to ramp up production of the same as soon as possible. Indian pharma companies can certainly increase production of these key products, ensure that there is adequate availability at affordable prices (for now atleast) and further support the healthcare industry as it works night and day towards finding a cure for this pandemic and treating patients. A balanced and concerted effort on all fronts is therefore crucial.
*The author would like to thank the content editor, Devika Ghosh for her contribution.