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NCL develops superior, cheaper technology for paracetamol; 2 firms sign NDA
This technology could help Indian drug manufacturers compete more effectively against their Chinese counterparts who dominate the global production of paracetamol.
The National Chemical Laboratory (NCL) under the Council of Scientific and Industrial Research (CSIR) has developed a superior and cheaper technology for the manufacture of the widely used drug, paracetamol.
This technology could help Indian drug manufacturers compete more effectively against their Chinese counterparts who dominate the global production of paracetamol.
Estimated to bring down the production cost by 15-20%, the NCL technology will free the manufacturing process from the use of acetic anhydride, said NCL’s principal scientist, Sanjay Kamble.
This process has been developed under CSIR Mission Mode Project called Innovative Processes and Technologies for Indian Pharmaceuticals and Agrochemical Sector Industries (Inprotics).
The usage of multifunctional reactor for reaction and the replacement of acetic anhydride as an acylating agent is the major factor in cost-reduction of the CSIR-NCL Paracetamol Process.
“The conventional process is in batch mode of operation which adds problems such as inconsistent in quality, high footprint of the plant and generates aqueous effluents. CSIR-NCL has recently developed a continuous mini-pilot scale plant for production of paracetamol at its Pune facility; currently pilot plant trials are going on. The CSIR-NCL process required less space as compared to the previous one,” Dr. Kamble said. “This will also help in maintaining consistency of product,” he noted.
“Acetic anhydride is a restricted item. One has to keep minute track of it. It is used in various other things likes drugs. Government inspectors can come and ask about the use of it. Therefore, if the use of aceti anhydride is avoided, it will definitely be beneficial. Or else, the raw material for paracetamol is very cheap,” said Dr Mukund Gurjar, chief scientific officer at Emcure pharmaceuticals.
Used widely in the treatment of flu, common cold and pain management, two pharmaceutical companies have signed a non-disclosure agreement with NCL as an initial step in introducing the drug manufactured by the new process.
NCL has already developed a pilot scale production process at its Pune facility. The technology used to support the process will take up less space as compared to the previous one, Kamble said.
Paracetamol, also known as acetaminophen, is sold by more than 170 brands across India.
