The Future of Green Chemistry in API Production

Ashok Kumar, President, Centre for Research and Development at Ipca Laboratories Limited, engages in an exclusive interaction with India Pharma Outlook, wherein he discussed how green chemistry is revolutionizing API production in India. In order to lessen their impact on the environment, he talked about the use of eco-friendly techniques like solvent-free synthesis and sophisticated solvent recovery technologies. While issues like exorbitant prices still exist, Ashok pointed out that advancements in continuous flow procedures and green solvents are opening the door to a more sustainable pharmaceutical sector.

How is green chemistry transforming API manufacturing in India, and what role do sustainability initiatives and innovations like solvent-free synthesis play in driving this change?

Green chemistry methods are transforming API production in India by uniting efficient methods with sustainable standards of environmental care. The current industrial movement focuses on three key areas of energy management which include implementing operational efficiency improvements alongside renewable energy transitions as well as reducing dependency on coal-based power supply. The implementation of advanced solvent recovery technologies for pollution control lets factories reduce their emissions and waste output better, while specific measures decrease both CO2 emissions from fossil fuels and CH4 emissions from waste management.

Production methods drive this transformation because companies choose continuous flow systems and employ green solvents and sustainable catalysts to reach higher sustainability. The acceptance of solvent-free synthesis methods has grown substantially because they lower both chemical waste pollution and environmental dangers. The transformation in pharmaceutical industry functions stems from pharmaceutical companies as well as chemical manufacturers, such as Tata Chemicals, Pidilite, Godrej Industries, BASF, and DuPont.

The Indian API sector welcomes green chemistry to maintain global environmental standards as it drives sustainable development as well as pharmaceutical industry leadership.

What factors are driving the adoption of green chemistry in India’s API manufacturing?

India’s API manufacturing sector has shifted to green chemistry because of government support together with strong ESG regulatory requirements and international environmental commitments and increasing public awareness of sustainability. The Ministry of Chemicals & Fertilizers launched environmental impact reduction programs alongside ESG principles and Business Responsibility and Sustainability Reporting (BRSR) which SEBI established as mandatory through their 2023 regulations.

The implementation of the EU Green Deal as an export standards framework is pushing the pharmaceutical companies in India toward adopting environmentally sustainable business practices because the EU plans to reach net-zero emissions by 2050. A high environmental factor in the industry (E-factor) leads to considerable waste in each unit of production thus sparking scientific research and manufacturing development to create greener approaches. These drivers work together to create sustainable standards in India’s pharmaceutical sector while making it competitive globally.

What are the barriers to adopting green chemistry in India’s API manufacturing?

As India’s API manufacturers attempt to implement green chemistry there are fundamental obstacles from the high financial requirements of green technologies that limit available resources. The API industry faces financial restrictions for sustainability investments because the sector operates under price-sensitive rules and conducts its business under government-imposed price regulations. The obstacles create problems between achieving environmental targets and financial sustainability which hinders large-scale adoption of green practices.

What are the emerging green technologies in solvent use for pharmaceutical manufacturing?

The pharmaceutical manufacturing industry uses emerging green technologies to replace conventional solvents by developing sustainable alternatives. The adoption of solvent-free synthesis techniques that incorporate ball milling through mechanochemistry has started to rise; however, scale-up implementation remains difficult to achieve. Aqueous chemistry has become popular through better reaction design and advanced catalyst systems because it uses water as a solvent to create sustainable processes.

Evonik and other companies utilize surfactants through their micellar chemistry to develop water-based reaction environments through micellar formation. The incorporation of hydrotropes like urea and sodium benzoate into water solutions enhances organic compound solubility, which produces faster rates and gentler operating conditions. Deep Eutectic Solvents (DES) comprise compounds that contain hydrogen bond donors and acceptors, which offer environmentally friendly, sustainable solutions instead of conventional cold temperature solvents.

People study Ionic Liquids (ILs) for their customizable properties because these compounds offer non-volatile and non-flammable and non-explosive characteristics while accelerating chemical reactions. Despite their usefulness there are still environmental concerns about these substances because they create potential toxicity in water systems and derive from petroleum.

The pharmaceutical industry can reduce the harm caused by solvents through the implementation of a few alternatives, such as ethyl lactate, supercritical water, and carbon dioxide. However, the widespread adoption of these solvents is hindered by the high cost of operations.

What are the opportunities and challenges of enzymatic chemistry in pharmaceutical manufacturing?

Using enzymes in chemistry provides substantial benefits through achieving catalysis in water as well as operating under mild conditions (with temperature near room temperature and neutral pH values) combined with high chemical selectivity and stereo-chemical selectivity as well as specificity while reducing the number of synthesis steps and allowing green sustainable reusable catalysts due to immobilization methods. Ongoing research is addressing the existing issues related to temperature sensitivity as well as pH and solvent sensitivities. The reduction of enzyme prices coupled with better accessibility in commerce works to solve cost and scalability issues.

How are advanced techniques improving solvent recovery and recycling in pharmaceutical manufacturing?

Traditional solvent recovery methods, using distillation as an example, waste energy along with creating disposal waste. New techniques enhance operational efficiency. Through EU-funded SOLVER the pervaporation (PV) and organic solvent nanofiltration (OSN) membrane technologies achieve 90% solvent return while reducing solvent waste and improving sustainability performance. The SILVER Membrane Technology represents a scalable solution for silver and solvent purification which contributes to improved solvent recovery operations throughout industry facilities.

What advantages does continuous flow chemistry offer the pharmaceutical industry?

Since continuous flow chemistry offers improved yield rates, precise reaction condition capabilities, and increased process efficiency, the pharmaceutical industry embraces it as an advanced method for manufacturing APIs. Small volume operation combined with safer conditions is a feature of this method that suits hazardous azide-type reactions. Real-time quality monitoring makes continuous flow chemistry an advanced method to help pharmaceutical manufacturing industries achieve better scalability with reduced manufacturing risks.

Looking ahead, what breakthroughs could accelerate API sustainability in India over the next decade?

API (Active Pharmaceutical Ingredient) sustainability in India will be determined by three key factors: corporate responsibility, scientific innovation, and emerging technologies. Organizations should prioritize environmentally responsible and socially ethical practices alongside their goal of profitability.

Fermentation techniques have long been used for the commercial production of a wide range of APIs and API intermediates, and they are considered environmentally friendly. Advances in genetic engineering have now made it possible to produce even unnatural products on a commercial scale through fermentation, utilizing genetically engineered bacteria and mammalian cell cultures. The development of biotechnology, coupled with artificial intelligence, is opening new opportunities for creating sustainable methods for producing both small molecules and biologics.

There is a growing need for chemistry research to be overhauled to enable the production of molecules with 100% efficiency under mild conditions, without generating waste. In fact, studying interstellar chemistry, which is known to produce complex chemicals under extremely harsh conditions and low temperatures, could offer valuable lessons.

These recommended advancements will help decrease the Environmental Factor (E-Factor) and transform API production into a cleaner, more sustainable industry, paving the way for a greener future.