Indian pharma industry is critically dependent on imported raw material
The Union Cabinet March 30, 2020 approved a package to promote for bulk drugs parks amid the 21-day lockdown that the Narendra Modi government has invoked to combat the novel coronavirus disease pandemic (COVID-19).
The move is aimed at helping finance common infrastructural facilities and production-linked incentive schemes for the manufacture of key starting materials (KSM), drug intermediates and active pharmaceutical ingredients (APIs).
The Indian pharmaceuticals industry, the third-largest in the world by volume, imports up to 80 per cent of raw materials — mostly from China. Drug security, self-sufficiency and the continuous supply of essential medicines are critical for national security and a healthy population.
In consultation with industry experts on essential APIs, the organic chemistry and chemical engineering scientists of the National Chemical Laboratory (NCL) analysed the structures of chemical intermediates and the state of readiness for employing synthetic routes, which are scaleable and economical.
For three-four drug intermediates, bulk chemicals, research and development are underway and will be fast tracked. For the remaining four-five molecules, the most efficient routes considering atom economy, novel catalysis, flow chemistry, process intensification, plant safety, cost of raw materials, reagents and solvents, and recycling of by-products, and energy management have been designed.
These chemical processes are expected to reduce production costs through continuous flow synthesis, process optimisation and reaction engineering. The NCL is expected to play a role in this.
More than 27 bulk drugs covering different therapeutic classes such as anti-viral, retro-viral, antibiotics, anti-bacterial, anti-fungal, cardiovascular, diabetes, cholesterol lowering, anti-cancer, and pain killers such as paracetamol are synthesised from about 10-12 simpler building blocks or KSMs, drug intermediates. Self-sufficiency in drug supply chain for India means indigenous processes and platform technology to produce these important KSMs.
NCL Director Ashwini Kumar Nangia said he was hopeful of being able to release reports to the government and the chemicals and pharmaceutical industry bodies soon. “The capability and infrastructure for further synthesis of final APIs from the intermediate KSMs largely exists in the country,” he added. (India Science Wire)
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