Local production of APIs in India for COVID-19 repurposed drugs likely to offer competitive advantage, says GlobalData

The local production of the active pharmaceutical ingredients (API) for some of the key COVID-19 repurposed drugs including remdesivir, favipiravir and hydroxychloroquine (HCQ) is likely to offer a competitive advantage for the formulations manufactured in India in terms of supply and price, says GlobalData, a leading data and analytics company.

According to GlobalData’s COVID-19 Executive Briefing, COVID-19 has spread to 189 countries with over 6 million confirmed cases.  The US, Brazil, Russia, Spain, the UK, Italy, India, France, Germany, and Peru are the worst hit countries.

Recently, four Indian generic pharma companies Cipla, Jubilant, Hetero and Mylan received non-exclusive licenses from Gilead to manufacture and distribute generic remdesivir in 127 countries. Limited global availability of the raw materials and lengthy process are significant barriers for the rapid production of remdesivir. Additionally, remdesivir is an intravenous formulation, and hence sterile manufacturing facilities are required. Gilead is expected to provide technology transfer for the manufacturing of API as well as the finished formulation of remdesivir.

Sasmitha Sahu, Pharma Analyst at GlobalData, comments: “The choice of four Indian companies in the first round of remdesivir licensing itself lends weight to the capabilities of the country’s generic pharma industry. All of the four companies are key generic formulation manufacturers with significantly large-scale API production capabilities. Cipla, Hetero and Mylan have a robust presence in the anti-infectives space with well-established supply chain capabilities.

“This will mean increased production and supply chain efficiencies, which will eventually result in the reduction of manufacturing costs to ensure an uninterrupted supply of affordable COVID-19 medicines.”

The remdesivir licensing deal includes all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access but excludes major markets like the US, EU, Japan and China. Gilead’s patent portfolio of remdesivir in more than 70 countries may block generic entry until 2031.

Sahu adds: “With several countries contemplating compulsory licenses to facilitate the generic production of many potential COVID-19 treatments, other generic Indian pharma companies are also likely to be able to manufacture remdesivir. They may also look forward to produce repurposed drugs like favipiravir and lopinavir/ritonavir which are being majorly evaluated in clinical trials across many nations.”

Currently, Strides, Glenmark and Cipla are the three Indian companies which have successfully produced API for favipiravir. IPCA and Zydus-Cadila, the largest producers of HCQ, have already ramped up their API production targets to 20-30 tons per month vs. 2-4 tons prior to COVID-19.

Sahu concludes: “Indian companies have proven in recent times that they were able to quickly scale-up the API production amid COVID-19 outbreak and supply formulations as per global demand. This will further consolidate Indian pharma companies’ position in the global market. In parallel, Indian players will further benefit from the government’s recent package of US$1.3bn to the API industry.

“As the world is slowly returning to normalcy with a phased out exit from lockdown, COVID-19 cases are only likely to increase which in turn will drive the demand for drugs. Indian companies can leverage this opportunity to further improve outreach with COVID-19 generics.”

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