Indian pharma and biotech companies complain of frequent harassment by the state pollution control board (SPCB), which they believe not only targets companies unnecessarily but also does not comprehend the production processes of this sector.

Companies complain of frequent and surprise visits by SPCBs, who slap warning letters and accuse them of flouting environmental norms, especially in effluent treatment plants (ETP). “The industry is forced to put up with such inconveniences despite having formal approvals and adhering to every environment and waste management regulation,” says Gurudatta G G, chief executive officer, Estima Pharma Solutions.

“Investments into ETPs, solvent recovery processes, waste management systems are substantial. Yet they constitute a small portion of the total project cost. For instance, if investment on a production plant is Rs. 600 crore, environmental and waste management technologies would cost Rs. 60 crore. Considering the responsibility of safeguarding patients’ health, the industry would not think twice before putting into place the most advanced  solutions,” pointed out another industry chief.

“The big challenge is to make the SPCB comprehend the complexities of manufacturing active pharmaceutical ingredients, formulations, vaccines and biologicals when they allege that there is poor ambient air quality, high noise pollution and foul odour,” says Gurudatta who has provided consultancy to leading pharma companies in India and abroad.

A recent media report alleged that Karnataka State Pollution Control Board (KPCB) had found Biocon’s ETP was not running scientifically, causing odour nuisance.

According to Biocon, it deploys ISO 14001 certified environmental management system. As a zero liquid discharge facility, Biocon recycles its entire effluent at the ETP and all the treated water is used for its utilities.

Dr Kameshwar Rao, Head, EHS, Biocon, says, “Biotech drugs are developed using fermentation process which uses highly bio-degradable ingredients largely made of starch, sugar and edible oil.”

The company clarified that it has a full-fledged ETP and has the most advanced systems installed to control the odour, which is harmless, as reflected through the health of its 6,000 employees at the plant. Biocon is committed to observe global best environment management practices, it incurs Rs. 40 crore annually as the operating cost for the sophisticated Environment Management System (EMS) deployed at its facilities. It has also ensured 49 percent green cover at its facility, which is far above the government norm of 33 per cent.

“We have invested in the latest technologies and have received certifications, awards for compliance to best environment practices,” says Dr. Arun Chandavarkar, CEO & Joint MD, Biocon.

Interestingly, a few weeks ago, KPCB senior officials had visited Biocon and had expressed satisfaction with the company’s compliance and the most advanced EMS.

Commenting on the KPCB’s charge that odour was a nuisance to residential areas surrounding the company’s units, other industry leaders said Biocon had invested in the plots several years ago on approved KIADB land. “But with violation of zoning laws, illegal housing projects have mushroomed in the area. Further, ETP review is a key parameter that international regulators like US FDA and EMA assess during inspections and approvals,” added industry heads. They contended that Biocon, which is known for its advanced biologicals for cancer and psoriasis marketed to stringent regulated markets, would not flout basic environmental and waste management norms.

Raghurama Bhandary, Karnataka drugs controller said that during his audits, companies in the state are largely compliant to pollution norms.

Refuting the charges by the industry, Dr. Vaman Acharya, chairman, KPCB told Pharmabiz that in Karnataka, formulation and Ayurveda industry had no serious issues but it was the bulk drug sector particularly in Bidar and Gulbarga that flouted all norms and closure orders were issued. Now the industries in the region were coming back with compliances and we are auditing the same.