Prashant Khadayate, Practice Head of Healthcare at GlobalData writes about out how India can supplement the acute need for hydroxychloroquine during the ongoing COVID-19 pandemic
Research organisations across the world are focussing on finding treatment and prophylaxis options to control the spread of coronavirus (COVID-19) infection. Research is focused broadly in three areas – vaccines (such as mRNA-1273), novel drugs including new chemical entities (such as Tradipitant) and new biological entities (such as CMAB-806), and repurposing of drugs already approved in other indications. However, as vaccines and new drugs will need longer time for approval, the repurposed drugs are being considered as a relatively easier way of finding the treatment and prophylaxis option.
Hydroxychloroquine emerged as biggest hope
Currently, research into repurposed drugs is largely focussed on anti-malarials, anti-rheumatoid arthritis, and anti-HIV medicines. Among them, hydroxychloroquine has emerged as the front runner globally for both prophylaxis and treatment of COVID-19 patients. Against this backdrop, India is best placed to occupy centre stage with respect to the supply of repurposed drugs, including hydroxychloroquine, for the global markets, says GlobalData, a leading data and analytics company.
It is important to find a quick solution now as the COVID-19 infection curve will flatten in the next few months in the best-case scenario. The drugs being used for repurposing have proven safety and efficacy in other indications compared to novel drugs. As a result, they can be made available quickly if approved for COVID-19 by regulatory bodies considering the COVID-19 outbreak continues to affect many countries across the globe. Furthermore, the production capacity for such generic drugs already exists in countries such as India.
A recent open-label non-randomised clinical trial in France has shown that hydroxychloroquine treatment is significantly associated with viral load reduction/disappearance in COVID-19 patients and its effect was reinforced by azithromycin. However, only 20 patients were treated with hydroxychloroquine and therefore this cannot be termed as a piece of conclusive evidence as only viral load, and no clinical endpoint, such as disease severity or mortality, showed an effect.
According to GlobalData’s Insights Investigative News, a hydroxychloroquine trial is set to begin enrolling COVID-19 hospitalised patients by early April in the NIH-backed PETAL (Prevention and Early Treatment of Acute Lung Injury) network study. The trial will enrol approximately 500 patients in multiple hospitals, but the patient number may increase. Moreover, while hydroxychloroquine has been used to treat malaria for a long time, the field still does not understand its safety profile in COVID-specific patients. Some COVID-19 patients have myocarditis and ARDS, and chloroquine has been associated with heart toxicities, adding to the concern that its use could cause more harm than good.
The National Task Force for COVID-19 in India has recommended hydroxychloroquine for treatment of high-risk patients, mainly asymptomatic healthcare workers involved in the care of suspected or confirmed cases of COVID-19 and asymptomatic household contacts of laboratory confirmed cases. Consequently, the government plans to build a stockpile of hydroxychloroquine. The plan is to initially stockpile around one million to two million doses of 200mg and 400mg each of hydroxychloroquine. Moreover, a special amendment has categorized hydroxychloroquine drug as a schedule H1 drug which means it cannot be sold over the counter to avoid misuse of the drug for self-medication.
Indian pharma players ramping up production
Indian companies have raw material manufacturing capacity that can produce 100 million hydroxychloroquine tablets. IPCA Labs has the world’s largest manufacturing facility for hydroxychloroquine. As per the information available from Zydus Cadila, the company is in a position to ramp up production volumes by fivefold to 20 tonnes per month and could even raise it to 35-40 tonnes if required. The company produces crucial raw materials in-house and will not face capacity constraints. Other players like Dr Reddy’s, Sun Pharma, Torrent, and Wallace Labs can also quickly get off the blocks to manufacture and supply hydroxychloroquine. In addition, India is willing to allow preferential export to neighbouring countries and countries affected by COVID-19 to a higher degree.
Indian pharma players have an edge in the global supply
Considering the best-case scenario that hydroxychloroquine is able to prove its effectiveness in various clinical trials and gets a go-ahead from key regulatory bodies such as the USFDA and EMA, leading Indian companies like Cadila and IPCA can leverage their manufacturing infrastructure to occupy pole position in the global race to supply hydroxychloroquine. The USFDA has already partially lifted the import ban for IPCA’s active pharmaceutical ingredients (APIs) of hydroxychloroquine sulphate and chloroquine phosphate. Around 30 countries have requested India to supply them with hydroxychloroquine.
Moreover, nearly 220 million chloroquine and hydroxychloroquine tablets for the global COVID-19 response will be donated by Novartis, Mylan, Teva, Amneal, and Bayer. However, it is important to note that companies who have committed to donate hydroxychloroquine will also require additional active drug ingredients to make more hydroxychloroquine to fulfil the demand. Hence, Indian pharma players will contribute at two levels, firstly, supplying directly to the governments in various countries, and secondly, supplying to leading global players in fulfilling their commitment towards the treatment of COVID-19.
India needs to work closely with pharma Industry
Even though, the Department for Promotion of Industry and Internal Trade (DPIIT), under the Ministry of Commerce and Industry of India, has set up a control room to monitor in real-time the status of transportation and delivery of essential commodities, the current complete lockdown in India has affected the overall pharma supply chain within the country.
Currently, hydroxychloroquine is in the limelight. However, if other repurposed drugs are approved too, then Indian players will be ready to quickly supply generics for those drugs. This will be critical to contain the spread of infection and treat severe patients at that point in time.
India can occupy centre stage with respect to the supply of repurposed drugs for the global markets. However, considering the growth of COVID-19 cases in India, domestic companies should be well prepared to meet the supply-demand within the country first before looking to export therapies. At this point, it is too early to predict the success of hydroxychloroquine. Large scale clinical trials are either ongoing or will start shortly, which in turn, will determine the effectiveness of hydroxychloroquine in COVID-19 patients.