Concept of 'green' chemistry for 'clean' pharma

After numerous Acts and Rules, the current economic situation is forcing managements to re-think their stand on Environmental, Health & Safety (EHS) policies. Suresh Pareek, Managing Director, Ideal Cures, gives the industry's perspective of how pharmaceutical companies can go green

The cost of developing pharmaceutical product is growing dramatically in international market and India is increasingly being seen as a destination to reduce the cost of development by 30 percent - 40 percent. This globalisation seems to be driving the Indian pharma industry towards better Environmental, Health and Safety (EHS) performances. In order to elevate global image, most of the big Indian pharma companies are complying with EHS standards to widen their horizon and attract international players. But what is Green Pharma, Clean Pharma? To understand this concept let us understand the concept of what Green Pharma means.

In the pharma industry it is the chemical process which needs to be properly understood. Therefore it is the Green Chemistry which has to be first understood. Green Chemistry is the use of chemistry for prevention of air and water pollution.

Green Chemistry would mean that the chemical process efficiently utilises raw material, eliminates waste, avoids the use of toxic solvents or recovers for reuse in the design, manufacture and application of chemical processes and products.

One of the important examples which can be given is manufacture of Ranitidine HCl. Newer catalysts have been designed to achieve a Green Process for the production of the Ranitidine HCl. The functional catalysts have been developed jointly by RCHEM, Hyderabad and Professor Mihir K. Chaudhari of Indian Institute of Technology (IIT) Guwahati, thereby reducing the cost of production by 20 percent; a win-win situation for the industry through the adaptation of Green Chemistry tenets.

After a long struggle pharma manufacturers have recognised the economic and environmental value of Green Chemistry. Although various Act and Rules such as -

i. The Environmental (Protection) Act, 1986 and Rules.
ii. The Water (Prevention & Control of Pollution) Act, 1974 and Rules.
iii. The Air (Prevention & Control of Pollution) Act, 1982 and Rules.

have been introduced by the Indian government, these have been followed for compliance and for obtaining licenses rather than realising the importance and value of Green Chemistry. The importance and self realisation has now come to mean economic value also.

For example, consider Process Analytical Technologies (PAT). While those who use PAT understand the efficiency benefits it offers, the companies may not realise that it also offers environmental benefits. PAT is about timely measurement of process with the goal of understanding and controlling pharma processes. For example using PAT for drying operations can reduce energy consumption by 80 percent while eliminating the lion's share of chemical waste and its attendant solvent and waste. Another example of PAT is of changing process of film coating from organic solvent to aqueous coating.

Pharma manufacturers need to follow Green Chemistry principles to achieve significant efficiencies. The US Environmental Protection Agency's principles of Green Chemistry are as under: prevent waste, design safety products, implement less hazardous chemical process, use renewable feedstocks, employ catalysts instead of stoichiometric reagents, avoid chemical derivates, reduce solvent use or use safer solvents and reaction conditions, improve energy efficiency, design biodegradability, analyse in real time to prevent pollution, minimise accidents, recover all elements

Green Chemistry provides a number of benefits including reducing waste, eliminating costly effluent treatment. This gives us safer products, with reduced use of energy and resources, as well as improved competitiveness of chemical manufacturers and their customers.

Pharma companies have to take responsibility for two major issues: energy efficiency and solvent reduction.

Energy efficiency (HVAC, Boilers and Cogeneration), improving energy efficiency should be a strategic goal for any Plant Manager or manufacturing professional working in the pharma industry today. Not only can energy efficiency reduce overall manufacturing cost, it usually reduces environmental emissions, establishing a strong foundation for a corporate green house gas management programme. The government should work and establish an energy performance bench marking tool for pharma plants.

Solvent reduction a good place to start

Solvent reduction is the sweet spot for greening any pharma process. About 80 percent of pharma waste results from solvent use, with the remainder related to reagents and raw materials.

There are many adverse effect of solvent on environment as well as on human health. On the environment side there is risk of fire hazard due to the lower flash point of the solvent. High vapour pressure of the solvent in the air increases the likelihood of breathing of solvent vapours by the people close to it. The solvents are highly toxic and can damage an exposed living organism.

One of the important aspects in the pharma industry for a greener chemistry is replacement of organic solvents with safer available aqueous solvents in tablet coating to protect the environment and health as well as industrial safety.

A large number of companies are now regularly practicing aqueous film coating. However, it is still seen that lots of other companies continue to use huge quantities of organic solvents. The biggest motivation for manufacturer to use organic solvents is the inadequacy of their coating facility for aqueous film coating.

As per the experience in most pharma companies, a great deal of emphasis is given to operations like granulation and compression of tablets but the necessary steps are not taken care of for film coating operation. Even while making a fresh investment in the new coating machine many times the company ends up with a coating machine which fulfills all the apparent demands and works well with organic solvent based coatings but when it comes to aqueous film coating, they find the machine is not fully optimised or may need some modifications.

In the current scenario with serious economic recession, a penny saved is penny earned. The coating set-up needs to be re-looked for identifying the deficiencies in converting to aqueous system. Due to the use of organic solvents, the environment is polluted by increasing the carbon load in atmosphere and also draining out the scarce resources in long run. Conversion of film coating from organic solvents to aqueous coating can save up to 50 percent cost on coating and also reduces the hazards associated with it.

Developing or improving existing chemical products and processes to make them less hazardous to human health and environment is thus very important. Green chemistry is a highly effective approach to pollution prevention because it applies innovative scientific solutions to real world environmental situations.

Increasing incentives to go green

Drug makers are still reluctant to ‘green’ a process in the absence of clear economic incentives. One of the solutions is to teach green principals at the earliest stages of chemistry education and perhaps change the text books of chemistry in schools and colleges. In this connection Green Chemistry Network Centre, Delhi University is playing an important role.

Another step should be setting up of a special department under the concerned ministry in line with Department of Scientific & Industrial Research (DSIR) for recognising and rewarding those industries which are investing money and time towards ‘Green Pharma’.

Similarly the government of India should introduce special incentives under Income Tax Act on the similar lines of section 35 A(B) for deduction on capital and revenue expenditures for the amount spent on implementing the 12 principles of ‘Green Pharma’ as discussed above. This will provide suitable economic incentives and motivation to companies in SEM as well as large sectors to go ahead and make long term investments. The apex bodies can also form special committees to educate and guide industries on the front.

Suresh Pareek is Managing Director, Ideal Cures, He can be reached at pareeksuresh@idealcures.co.in