Though the government is encouraging pharma companies to explore less accessed zones across India, it also expects companies to adhere to stringent environmental guidelines. Are pharma companies ready to take up the challenge? By Usha Sharma
The Government of India is aggressively working towards creating a healthy business environment for attracting domestic as well as foreign investors to India. It is also closely working with state authorities to improve the quality of and access to medicines for its citizens. Pharmaceutical companies are being encouraged to increase their business reach to less accessed zones like the North Eastern region of the country and offer better healthcare services to the population.
The government feels that there are several locations across India that can be leveraged and turned into pharma manufacturing hubs/clusters. To achieve this, plans are afoot to introduce new schemes/ programmes whereby the pharma industry is being motivated to take part in such initiatives/ programmes. Today, small and medium sized pharma companies face several challenges like logistics, financial burden etc due to strict environmental guidelines. To help them overcome these challenges, these companies should participate in various programmes/ initiatives run by the government.
These issues are not only restricted to SMEs. Big pharma companies also face similar challenges, particularly while setting up facilities in remote locations.
SV Veerramani, National President, IDMA, while informing about the regulatory requirements which pharma companies need to adhere to for environment safety measures before setting up a manufacturing facility says, “Before setting up any manufacturing facility, pharma companies need to get clearance from the government for environmental issues and safety measures. Today, it has become mandatory to get the clearance from the Ministry of Environment & Forests before setting up any pharma plant.”
Aparna Thomas, Senior Director – Communications and CSR (India & South Asia), Sanofi says, “Safeguarding the environment has now become a greater responsibility for all companies. We are conscious of this and take a number of measures to ensure that we are not only compliant with current regulations, but have also taken adequate steps to run environmental-friendly operations.”
While mentioning about the environment-friendly steps taken by Sanofi, Thomas says, “At Sanofi, we have adopted the concept of recycling, reprocessing and recovery. Our manufacturing facilities are eco-friendly and undertake the following action: waste water management, zero liquid discharge, recycling of treated waste water to conserve and reuse water, minimise air emissions, proper scrubbing, dust collector systems to protect the air from pollution, waste management (hazardous and non-hazardous) and disposal via incineration with heat recovery programme (eg. power generation, water heating, etc.). In addition, we have rigorous inspection and maintenance procedures in place.”
Despite Indian pharma companies adhering to several guidelines in order to conserve the environment, still its image has been blurred in the global pharma arena on the quality front. In terms of sustainability, India has not fared well. And when the government is encouraging the industry to develop pharma zones/ park, it is also important to know what industry expects in terms of support from the government.
Thomas adds, “While the government is encouraging the industry to develop pharma zones, the industry would definitely welcome the following changes like common infrastructure for waste water treatment, water supply, power generation, more solar power plants and wind power generation, incineration facilities with heat recovery programme, ‘industrial banks’ for various types of waste, ie. one company’s waste may be utilised as raw material for some other company, tax benefits on waste water treatment expenditure and single window clearance for manufacturing facility, simplification in license issuance procedures.”
Veerramani informs, “Whenever the government is helping to set up a Pharma Park, we request a common effluent treatment plant, which can be used by all the units in the park. With this, the individual investments and expenses from various units can be avoided. At the same time, a common effluent treatment plant can take up the responsibility for the effluent treatment of the entire park, effectively.”
This can be a corrective measure, as pharma industry also produces a lot of chemical waste. Replying to a query on whether the industry produces maximum chemical waste, Veerramani elaborates, “Many times while providing environmental clearance, the department considers pharma sector at par with large chemical industry and cement industries. This is not true. The pharmaceutical bulk drugs (APIs) have chemical waste, but since they are producing in kilograms, it is not comparable to cement plants, which produce in tonnes. Hence, effluents from the pharma industry is comparatively less than other sectors. In case of pharma formulation sector, it is much less than the API sector.”
Thomas agrees and says, “Every industry that deals with chemicals produces chemical waste. Thus, there is a limited scope for recycling and reusing chemical waste.”
She suggests, “We can overcome this challenges primarily by conducting research and development for all processes and products, to optimise the manufacturing process to increase yield and reduce waste generation. In addition, by adopting the concept of 3Rs – Recycling, Reprocessing and Recovery, industries can overcome the challenge of dealing with chemical waste to a good extent.”
The pharma industry generates waste water mainly through washing of equipment, or as part of the inherent ongoing processes. Even though waste water may be discharged in small volumes, it is highly polluted owing to its highly toxic organic content. It is, therefore, critical that industry ensures that this waste water is managed in a most eco-friendly way.
Another challenge being faced by the pharma industry is waste water management. Thomas feels, “As a pharma company, we need to understand the composition of our waste water if we are to find ways to effectively treat it. Some waste products are not treatable by traditional methods and so the need to implement and install special treatments and techniques to treat such waste becomes imperative.”
DG Shah, Secretary General, Indian Pharmaceutical Alliance (IPA) says, “The active pharmaceutical ingredient (API) is a polluting industry and subjected to stringent norms by the authorities. The waste water management is critical. The effluent treatment plants installed by many companies ensure that the waste water is treated before discharge.”
Informing about Sanofi’s waste water management activities, Thomas says, “In addition to the processes, we use waste water management, such as the zero liquid discharge. We also use innovative technologies like membrane filtration and thermal evaporation/ crystallisation to treat, recycle, and reuse waste water.”
Many pharma companies do have pollution control systems in place. Veerramani informs, “Many of the API plants already have a green belt around the industry. Besides, by establishing a sound effluent treatment plants systems, the pharma sector can definitely be a clean industry without affecting the environment.”
Sanofi has already commenced several activities on this front. Thomas shares, “There are several such measures that pharma companies are and should undertake towards a clean and green industry. At Sanofi, we have been successful in implementing initiatives at our production sites that have given us excellent result.”
She continues, “We also strongly support the use of renewable energy to reduce carbon footprint. In fact, Sanofi is amongst the few healthcare companies that explores the use of renewable energy sources for our manufacturing operations. At Sanofi’s Ankleshwar manufacturing site, we have installed windmills to generate renewable power, for captive consumption. Our Goa manufacturing site utilises biomass from agro waste, to generate energy. The biomass project helped create employment for local villagers and reduce the site’s steam cost as well as its dependence on fossil fuel.
Thus pharma companies in India do seem to be on the right path, but will need a helping hand from the government as well.