‘Inclusion of green norms in pharma regulations still a distant dream’

HYDERABAD: Environmental pollution due to effluent released illegally by pharmaceutical companies, who sell their drugs in India and to many other countries, has been wrecking environmental havoc in Hyderabad since decades, and also resulting in development on novel Anti Microbial Resistance (AMR) genes in the environment. However, when it comes to regulations, the international agencies unfortunately do not consider environmental performance of the companies they buy their drugs from.

One example is that of the United Kingdom. As per the 2014-15 report by Pharmaceuticals Export Promotion Council (PHARMEXCIL), pharma exports from India to UK stood at 540 million dollars, making UK India’s second largest market. Moreover, about 25 per cent drugs used in the UK are manufactured in India.

However, the Good Manufacturing Practices that the drugs manufacturing companies in India have to fulfil in order to sell their products in the UK do not include environmental practices of a company as one of the criteria that is inspected by inspectors of Medicines and Healthcare products Regulatory Agency that regulates medicines and medical devices in the UK.

When asked by Express about it, Gerald W Heddell, Director, Inspection, Enforcement and Standards, Medicines and Healthcare products Regulatory Agency, UK, said, “Environmental issues are important and we had lengthy discussions, should environmental issues be incorporated more strongly into Good Manufacturing Practices. A particular driver behind it is of course Anti Microbial Resistance. I don’t think there is any clear consensus on it.”

However, he added, “The real concern is if your inspectors are thinking about broader environmental issues, then it may dilute their attention from the primary issue of safety or process of the product. From my perspective there is still a long way to go.”