The Paracetamol Breakthrough: India's Leap Toward Smarter Pharma

A pill we pop without a second thought is now at the centre of a quiet revolution. A breakthrough from CSIR-NCL has just rewritten the rules of paracetamol production.

Paracetamol, also known as acetaminophen, is found in nearly every household medicine cabinet. Often taken as a painkiller and fever reducer, it is the most widely used medicine all over the world. Though it is useful for us, its conventional manufacturing has certain adverse impact on the environment. Further, the raw materials used to produce it are classified as 'controlled substances' in India, most of which have to be imported from other countries. As a result, the production cost increases significantly. In a remarkable breakthrough that blends process chemistry with national self-reliance, scientists of National Chemical Laboratory (CSIR-NCL), Pune have discovered a continuous, cheaper, and environmentally friendly process to produce paracetamol.

The problem with the old way

Traditionally, paracetamol is produced in batch mode using two key raw materials: Para-Aminophenol (PAP) and Acetic Anhydride. This is a widespread method that has some limitations. Imagine a wedding caterer making a signature dish. They cook a specific quantity, like curry for 50 people, as one "batch," then repeat the process for remaining guests in multiple batches. Akin to this, paracetamol is traditionally manufactured by “batch” methodology. This batch method can result in inconsistent quality, higher raw material consumption, larger manufacturing footprints, and the generation of wastewater and chemical effluents. Worse still, it often depends on expensive and regulated raw materials like acetic anhydride, which raise both safety and cost concerns.

CSIR-NCL's breakthrough

To tackle such challenges, CSIR-NCL launched a project under the umbrella of "INPROTICS" mission (Innovative Processes and Technologies for Indian Pharmaceuticals and Agrochemical Sector Industries). The aim of this mission was to find smarter, greener, and more scalable solutions for chemical and pharmaceutical industries of India. By 2018-2020, researchers in CSIR-NCL had successfully developed a continuous process (Continuous flow technology) for synthesizing Paracetamol. Imagine replacing the batch manufacturing method with a smooth, uninterrupted manufacturing line, a system where the raw materials flow in and finished medicine flows out, with precision and control at every step. That is what a continuous flow technology offers, a streamlined operation, improved product quality, and greater efficiency. The key to the innovation lies in a multi-functional reactor that enables the continuous reaction of para. amino phenol with readily available, relatively safer and cheaper chemical, Acetic Acid. The lab focused on optimizing every aspect such as temperature, reaction speed, purification methods, and more.

Cleaner, Greener, Smarter Medicine 

The continuous production method for Paracetamol is not only a technical breakthrough but also a major step forward in sustainability. Unlike traditional batch processes, this method offers greater control, that ensures each dose consistently meets strict pharmaceutical standards. It uses significantly less solvent, a liquid that helps chemicals mix and react, much like water helps blend spices and ingredients when cooking a curry. Using less of it means fewer chemical leftovers (called effluents), which leads to lower water pollution and less energy needed for clean-up. The process is designed to be compact, minimizing the physical footprint of manufacturing plants and cutting down on infrastructure costs. By relying on affordable and easily sourced raw materials like acetic acid instead of the hazardous and regulated acetic anhydride, it also reduces manufacturing expenses and regulatory burdens. In short, India now has the ability to produce Paracetamol with the same chemical composition as the traditional batch method, but in a way that is cheaper to make, safer to produce, and significantly better for the environment.

Make in India Product 

CSIR-NCL teamed up with Texol Engineering in Pune to build a pilot plant to validate the continuous Paracetamol production process in real-world conditions and generate commercial-grade sample batches. The pilot plant proved a great success that set the stage for industrial-scale deployment of Paracetamol. In February 2020, Hyderabad-based Satya Deeptha Pharmaceuticals Limited (SDPL) stepped in and collaborated with CSIR-NCL to take the innovation forward. This collective effort led to the creation of a state-of-the-art commercial Paracetamol manufacturing facility in Humnabad, Karnataka. This is the first-of-its-kind in India, officially inaugurated in 2024 and boasts an impressive annual production capacity of 2,800 tons. This success is more than a technological triumph. It is a clear validation of national policies like "Make in India", "Innovate in India", and Import Substitution. It also reflects CSIR's larger mission to align cutting-edge science with everyday needs. In the global context, India is one of the largest consumers and exporters of generic medicines. Technologies like this will help the country to reduce dependency on imports, strengthen pharmaceutical sovereignty, and open doors for similar innovations across other essential drugs.

A Model for the Future 

The CSIR-NCL Paracetamol project is now being praised as a first-of-its-kind success story. This is a kind of project where deep science was translated into industrial transformation in a short timeframe. The model could be applied to other generic drugs that India produces. It also sets a precedent for how public research institutions can work hand-in-hand with industry to deliver impact at scale.

Paracetamol may seem like just another everyday medicine, but behind its simplicity lies a quiet revolution assisted by CSIR. It's a story where cutting-edge science combines with sustainable innovation, and where industrial progress fuels national self-reliance. With this breakthrough, India steps forward to reshaping how medicine is produced. So the next time you take a paracetamol, this would be a gentle reminder that it's not only relieving pain, it may also be a product of smarter, greener, and proudly Indian science.

Dr. Sudip Karmakar 
SCDD, CSIR HQ.