India Plans Taskforce To Deal With Pharmaceutical Environmental Issues

NEW DELHI - The Indian government will soon constitute a taskforce to assess the impact of drug manufacturing on the environment and find amicable solutions, Department of Pharmaceuticals Secretary Ashok Kumar announced Feb. 12 at an industry seminar in New Delhi.

The taskforce will pick its own objectives from the gamut of pharmaceutical environment issues, targeting those areas that are neglected by industry and regulatory bodies. The members of the taskforce will consist of representatives from Indian research institutes such as the National Institute of Pharmaceutical Education and Research and the Indian Institute of Technology; industry associations including the Bulk Drug Manufacturers Association, the Indian Drug Manufacturers' Association and SME Pharma Industries Confederation; business bodies like the Federation of Indian Chambers of Commerce and Industry; and state pollution boards. While the convenor of the taskforce will be D.N. Mathur, additional deputy industrial advisor to the Department of Pharmaceuticals, it will be co-chaired by Joint Secretary Neelkamal Darbari.

"The taskforce will be the missing link between environmental boards, industry and the government and will take up those issues that are overlooked by existing agencies," Kumar told PharmAsia News.

This taskforce is not a maiden effort by the government to create awareness towards environmental issues. In November last year, the government also constituted an "environment cell" within the Department of Pharmaceuticals to help the drug industry understand and deal with the various environmental hazards arising out of manufacturing active pharmaceutical ingredients. The environment cell is also mandated to collect and compile data on the latest technologies available for effluent treatment and to disseminate the information among pharma units.

Though these efforts are laudable and show the industry's seriousness toward the issue, there has been little or no action at ground level to protect the environment, according to Swedish researcher, Joakim Larsson.

In his research paper, Larsson claimed to have found 21 APIs in a sample taken from a stream that mainly constituted treated waste-water from more than 90 pharmaceutical factories in Patancheru district, one of India's most important pharmaceutical manufacturing hubs, located in the Southern state of Andhra Pradesh.

"The 'treated' water contained exceptionally high levels of various pharmaceutical substances, including several broad-spectrum antibiotics," said Larsson in his paper, which was published in the medical journal Regulatory Toxicology and Pharmacology. "We estimated that the treatment plant released 45 kilograms of the antibiotic ciprofloxacin in one day, which is equivalent to five times the daily consumption in Sweden."

Although the Environment Ministry is already probing the findings of the research paper, the drug manufacturers see this as an attempt to quash India's hopes of emerging as a pharmaceutical manufacturing hub.

India is one of the world's largest producers of generic drugs and exports to country's like Sweden, which has some of the strictest environmental legislation in the world.

"Why should research done in 2006 surface now?" asked Varaprasad from the Andhra Pradesh Pollution Control Board. "This has been done to hurt India's reputation. As long as we continued to produce generics, we weren't attacked but if we get into any value-addition, we will be attacked like this," he added.

His views seem to mirror that of drug manufacturers. "Is it possible to qualitatively identify 21 APIs from a concoction like the one consulted in the research? This remains a big question mark," Bulk Drug Manufacturers Association President M. Narayana Reddy said.

Though the industry may be in damage-control mode, it seems proactive in its future efforts to limit damage to the environment. "We have problems, but we are trying to find solutions," Reddy said. "I ask the government to advise us and we are ready to follow."

The taskforce is one step in that direction. The other may be an environmental code of conduct along the lines of the code of ethics that the Indian pharmaceutical industry already follows. Under the self-disciplinary and self-enforcement code, the industry will take up those issues that need to be addressed but are not covered by any regulation. "We want to involve the industry because it will help enforce the code in unanimity," said Kumar.

- Binny Sabharwal ([email protected])