2025-08-28

India’s pharmaceutical sector is one of the world’s largest, valued at over USD 50 billion and ranking third globally by production volume. The industry accounts for nearly 10 percent of global output and exports to more than 200 countries, including highly regulated markets such as the United States, Europe, Japan, and Australia. This scale has cemented India’s reputation as the “pharmacy of the world.”

But rapid growth has brought an equally pressing challenge: pharmaceutical waste. From expired medicines and active pharmaceutical ingredients to solvents and cytotoxic drugs, pharmaceutical waste is a complex and hazardous stream. If not managed properly, it risks contaminating soil and water systems, contributing to antimicrobial resistance, and drawing penalties for non-compliance with India’s strict environmental regulations.

The problem is not confined to pharmaceutical factories alone. Hospitals, diagnostic labs, and research facilities add significantly to the country’s waste load. According to the Press Information Bureau, India generated 651 tonnes per day (TPD) of non-COVID biomedical waste in 2020, along with a staggering 962 TPD of COVID-related waste between May 2020 and March 2022. While India managed to treat more than 91 percent of biomedical waste in 2022, serious gaps remain in segregation, traceability, and compliance.

Recognising the scale of the issue, the Central Pollution Control Board (CPCB) has stepped up oversight. Pharmaceutical waste is regulated under the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016. CPCB audits are designed to ensure industries follow these rules and prevent environmental harm. Inspections cover every aspect of waste management from labeling and storage to transport and disposal, and rely on a “cradle-to-grave” manifest system that tracks hazardous waste until its final treatment at authorised facilities.

Audits are thorough. Inspectors verify records, review manifests, and physically check storage areas to confirm proper segregation and labeling. In some cases, laboratory sampling of effluent or sludge is conducted to detect illegal dumping. Facilities that store hazardous waste for more than 90-180 days without authorisation risk legal action under the Environment Protection Act, 1986. After each audit, CPCB issues a compliance report, and companies are required to submit corrective action plans to close any gaps.

Despite these safeguards, challenges persist. Reports of odour nuisance and emissions from pharmaceutical and chemical industries, especially around Hyderabad, underline the need for stricter enforcement. Data gaps in CPCB’s online hazardous waste inventory portal also make real-time tracking difficult. At the same time, global buyers and regulators are increasingly demanding evidence of sustainable operations. For Indian pharma exporters, environmental compliance is now as critical as financial performance.

Technology offers part of the solution. Digital tracking systems and app-based monitoring can make waste management more transparent and reliable. CPCB has already moved in this direction by digitizing manifests and compliance filings. For pharmaceutical companies, embracing such tools is no longer optional; it is a business imperative.

India’s pharmaceutical sector is a global success story, but one that must be balanced with environmental responsibility. Growth cannot come at the cost of sustainability. As CPCB tightens audits and international markets emphasise ESG commitments, the future of Indian pharma will depend as much on how it manages its waste and accountability of the medicines it produces.

Akshaya Rath brings over 25 years of expertise in Supply chain, B2B marketplaces, E-procurement, and circular economy initiatives. A seasoned professional, he leverages technology and compliance to design transparent and scalable systems that drive industry transformation. His vision is to apply these capabilities to build innovative, environmentally responsible solutions for India’s waste and sustainability landscape.