The Centre is set to clamp down on the use of harmful chemicals and energy-intensive processes in the pharmaceutical industry, a sweeping regulatory shift that will alter how medicines are tested and manufactured in its $50 billion drug market.
The Indian Pharmacopoeia Commission (IPC) is crafting new standards for drug making and testing by using green chemistry principles, which are essentially guidelines to reduce or eliminate hazardous substances. The commission is the health ministry's apex body responsible for setting the standards for drug making and testing in India. A key objective is to replace carcinogenic class-1 solvents such as benzene, chloroform and carbon tetrachloride with water or other safer class-3 solvents, two people aware of the matter said on the condition of anonymity.
The commission has started with high-volume categories, one of the two people said. “The IPC has already updated approximately 25 monographs within the IP 2026 edition, focusing on high-volume categories such as anti-cancer, anti-hypertensive, and antibiotic drugs. It is now working on an additional 50 monographs under this 'green' framework to further expand the initiative,” the person said. A monograph outlines the tests a drug must pass to prove its identity, purity, and strength before it can be sold.
The shift towards a Green Pharmacopoeia is expected to have a broad impact on public health by ensuring a cleaner manufacturing cycle. It also assumes significance for global medicine use, given that Indian companies supply 20% of the world's generic medicines and account for 60% of global vaccines. Apart from India, these standards are also followed in 14 more countries -- Afghanistan, Ghana, Nepal, Mauritius, Suriname, Nicaragua, Bhutan, Mozambique, Solomon Islands, Sri Lanka, Nauru, Malawi, Guyana and Fiji.
“The IPC is working on environmental sustainability and eco-friendly standards. If these methods are adopted into the IP, hundreds of manufacturers across India will cumulatively save thousands of litres of hazardous solvents,” the second person said.
The IPC is also utilizing research and innovation to optimize testing processes. By reducing the number of procedural steps and shortening testing times—for instance, achieving results in five hours rather than ten—the commission aims to save significant resources and energy.
“These changes are meticulously evaluated to ensure that drug quality remains uncompromised and results remain reproducible. The initiative also extends to the physical and digital footprints of the commission. The IPC has already moved toward a digital-first IP to reduce paper consumption and is now transitioning its Indian Pharmacopoeia Reference Substances (IPRS) packaging to fully recyclable materials, the second person said, adding the new standards will also limit the flow of discarded toxic chemicals into soil and water.
Queries emailed to a health ministry spokesperson remained unanswered.
The Indian Pharmaceutical Alliance (IPA), which represents 23 leading pharmaceutical companies, welcomed the move. "The IPA has consistently advocated for integrating green chemistry and scientifically validated alternatives to animal testing into regulatory frameworks. To ensure seamless adoption, the implementation of these methodologies must remain science-driven, globally harmonized, and pragmatically phased. This approach will guarantee analytical consistency, reproducibility, and cross-border regulatory acceptance, while upholding the highest standards of drug quality, safety, and efficacy," secretary general Sudarshan Jain said.
“Green pharmacopeial standards are way overdue. Pharma has long carried a heavy environmental cost - toxic solvents, animal testing and energy-intensive processes. India aligning with global green chemistry is structural, not cosmetic,” said Hari Kiran Chereddi, managing director and chief executive officer, at HRV Pharma, a Hyderabad-based drugmaker.
Chereddi further said the industry response will always be divided. “Players treating green chemistry as a compliance overlay will struggle with retooling, but those who built it into day-to-day operations will lead. At HRV, green chemistry is an upstream filter, not an end-of-pipe fix. Every molecule we evaluate is screened for solvent intensity, process steps, and waste profile before it enters our portfolio. The IPC's move only sharpens an existing discipline for us,” he said.
Dr. Sushila Kataria, vice chairman, department of internal medicine, Medanta, Gurugram said, “In medicine, we are trained to weigh benefit against harm, and that responsibility must extend beyond the patient to the broader environment that shapes long-term public health outcomes. The IPC's move toward a Green Pharmacopoeia reflects an important evolution in how we define drug safety. By replacing hazardous solvents such as benzene and chloroform with safer alternatives, reducing reliance on animal testing, and streamlining processes without compromising scientific rigour, this initiative addresses both immediate patient safety and the downstream impact of chemical exposure on water, soil, and communities.”
For a country like India, a major drug maker for the world, this is not merely an environmental shift — it is a public health imperative, Dr. Kataria added. “It signals that quality in healthcare can no longer be viewed in isolation from sustainability. These changes, aligned with global regulatory movements, position India to set a more responsible benchmark for pharmaceutical standards. Over time, such measures will reduce ecological burden and strengthen trust in the healthcare system by embedding sustainability into the very core of drug development and evaluation.”