STRATEGY
COVID-19
FROM A CHALLENGE TO AN OPPORTUNITY FOR INDIAN PHARMA TO BECOME SELF-RELIANT The COVID-19 pandemic has affected people of more than 200 countries, with more than 4200 thousands people infected and about 300 thousands deaths are confirmed worldwide. There is no specific drug which can cure the disease. Only supportive care is available. Many companies have started clinical trial of existing antiviral drugs against COVID-19. Gilead’s Remdesivir has got approval for treatment of COVID-19 patients. Fujifilm’s Favipiravir is also recommended by Tokyo for treatment of COVID-19. Sharada Prasanna Swain, Associate Professor, Medicinal Chemistry, National Institute of Pharmaceutical Education and Research V Ravichandiran, Director, National Institute of Pharmaceutical Education and Research
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hina and India are the leading players in bulk drugs, and manufacture more than 40 per cent of global bulk drug. China is the largest bulk drug supplier in world, and India is second. As reported by ministry of commerce, India exported drugs formulation and biologicals of 12.9billion USD in 2017-18, which increased to 14.4billion USD in 2018-19 (11.46% increase). At the same time, India also imported bulk drugs/intermediates of 2.9billion USD in 2017-2018, and it increased to 3.5billion USD in 2018-2019 (18.95% increase). Similarly, India imported organic chemicals of 14.2billion USD in 2018-2019, which is 14.66% higher than previous year (12.4billion USD). This signifies that though India is self-reliant on drugs formulation, it is dependent on other countries for many APIs and intermedi-
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P H A RM A F O C U S A S I A
ISSUE 39 - 2020
ates. The import is also increasing each year. The current situation is inhibiting the supply of those intermediates/APIs, which are procured from abroad as there is lock down. This may affect supply of finished dosage forms of those APIs. To avoid these unwanted situations and to get uninterrupted supply of essential medicines, India is planning to become self-dependent. Currently, the key starting materials (KSM) of many drugs are being procured from abroad, as they are available at competitive price. This has led to shut down of many Indian small and medium chemical industries. Indian government has already decided to set up pharma parks in different places in India. The state governments of Punjab and Tamil Nadu are also in the process of setting pharma parks in their respective states. This will act as an incentive
and encourage pharmaceutical industries to manufacture KSM and API in India. This will also be advantageous for fine chemical industries, as huge amount of organic chemicals is being imported every year. The major concern will be competing with foreign companies in cost. The Indian government is preparing a list of 38 essential APIs where India needs to be self-dependent. So, these API should be manufactured in India which also includes production of intermediates and other organic chemicals used for these API syntheses. India has more than 1200 US FDA approved API manufacturing units. There are large talent pools in the field of organic chemistry. There are also international level universities and research institutes which are actively involved in organic chemistry research. Indian bulk drug industries have the expertise of developing process for synthesis of complex molecules. The major concern is to be cost-competitive. The key factors for reduction of cost could be scientific advancement, economic or government support and new strategies for business (industrial symbiosis and cluster manufacturing). The new process development involves different synthetic route scouting, optimisation / fine tuning of process, technology transfer along with manufacturing chemists. Generally, different new synthetic route design and feasibility studies are done by experienced organic chemists. Then comes optimisation of process by process chemists. Parameters like yield, impurity profile and solvent selection are done during this process. Then a team including process chemist, production chemist, and chemical engineers facilitate the technology transfer of new process. Indian companies have excellent expertise and skill in process optimisation and technology transfer. But, scientific knowledge or technological advancement in new synthetic route design is highly essential. This includes development of new scalable synthetic transformation, reactions with high atom economy, new
