PUNE: The Council of Scientific and Industrial Research-National Chemical Laboratory (CSIR-NCL) is developing a fast track research and development (R&D) roadmap for indigenous chemical synthesis of drug intermediates.
According to a press release issued by CSIR-NCL, the purpose is to scale-up the research in this area and also cut on the imports of crucial starting materials/drug intermediates from other countries like China.
NCL is working on molecules that can be key ingredients for making various kinds of drugs as a part of Prime Minister Narendra Modi’s approved special package for the Promotion of Bulk Drugs Parks, announced on March 21.
The national scheme for promotion of bulk drug parks focuses on the reduction of the manufacturing cost of bulk drugs in the country and dependency on other countries for its availability. In line with this, CSIR-NCL has undertaken research work in the area of chemical synthesis of drug intermediates.
A statement released by the laboratory stated that the special package has been approved to finance common infrastructural facilities and production-linked incentive schemes for the manufacture of key starting materials (KSMs)/ drug intermediates and active pharmaceutical ingredients (APIs) in the country, in response to the medical emergency situation which might arise due to coronavirus disease (COVID-19) lockdown for an extended period.
A list of 53 APIs/bulk drugs has been identified-- half of them are based on chemical synthesis on which CSIR-NCL is focussing, stated that official statement.
The Indian pharmaceutical industry is the third-largest by volume. Still, it is critically dependent on imports of raw materials or KSMs, in some cases to over 80 per cent extent, mainly from China. Drug security, self-sufficiency and continuous supply of essential medicines are the need of the hour for national security and a healthy population, read the statement.
More than 27 or so bulk drugs cover different therapeutic classes such as anti-viral, retro-viral, antibiotics, anti-bacterial, anti-fungal, cardiovascular, diabetes, cholesterol-lowering, anti-cancer to simple pain-killers like paracetamol, are synthesised from about 10-12 simpler building blocks or KSMs/ drug intermediates. So, self-sufficiency in the drug supply chain for India means-- indigenous processes and platform technology to produce these critical KSMs, officials stated.
Therefore, in consultation with industry experts and from the list of essential APIs, the organic chemistry and chemical engineering scientists of CSIR-NCL have analysed the structures of chemical intermediates and the state of readiness employing synthetic routes that are scalable and economical, read the statement.
The NCL officials also informed that R&D projects for three-four drug intermediates/ bulk chemicals are ongoing and will be fast-tracked. Remaining four-five molecules, the most efficient routes considering atom economy, novel catalysts, 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 will bring down the cost of production through continuous flow synthesis, process optimisation, and reaction engineering, an area in which CSIR-NCL has prior experience and expertise, stated NCL officials.
Director Ashwini Kumar Nangia said, “CSIR-NCL will be able to release the R&D reports to government bodies, chemicals and pharmaceutical industry soon, as each laboratory-scale process is ready in the next few weeks and months to be taken up for manufacturing by Indian drug companies.”
- The Union Cabinet chaired by the Prime Minister Narendra Modi has approved the following schemes:
- The scheme on the promotion of bulk drug parks for financing common infrastructure facilities in three bulk drug parks with financial implication of Rs 3,000 crore for the next five years.
- Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of critical KSMs/drug intermediates and APIs in the country with financial implications of Rs 6,940 crore for the next eight years.