India awaits ban on plastic bottles for packaging liquid medicines

India had proposed a ban on the use of PET and plastic bottles for packaging liquid pharmaceutical formulations, based on the strong recommendation of the Drug Technical Advisory Board (DTAB). The ban was expected to take effect from January 2014, and gradually phase out plastic bottles by July 2014. However, months later, formal notification from the Union Ministry of Health is still pending regarding the official ban of the plastic containers.

Stating concerns regarding the temperature resistance of PET containers to the extreme climate conditions in India, the Drug Technical Advisory Board (DTAB) had asked for a ban on using plastic or PET containers to pack and store liquid oral formulations, especially those for paediatric use, geriatrics and pregnant women. It had initially recommended an immediate ban on PET containers. However, due to resistance from pharmaceutical manufacturers, the proposed ban was amended to a gradual phasing out of plastic bottle within six months.

Towards the end of 2013, DTAB representatives had noted that "The pharma industry was earlier using glass bottles only as primary packaging material for pharmaceuticals. The switch over to packing in plastic / PET bottles by the industry is not based on any scientific studies to show that packing of drug formulations in plastic/PET bottles does not have any harmful effect on the drug formulations and there are no releases of endocrine disruptors due to leaching. India has large variation in temperatures. In summer days temperature rises to 40-45 degree centigrade and exposure of plastic bottles to such a high temperature may result in adverse effect on the drug formulations packed plastic bottles and the high temperature may result in increased leachability. The harmful effects because of the packaging and leachability may be further magnified in the case of drug formulations."

However, these concerns were challenged by the pharmaceutical manufacturers who asked for scientific studies and evidence to support the alleged dangers of PET containers. Further, representatives from India’s large plastics manufacturing industry also appealed the ban. As the proposed ban has not yet been formalized months later, it is likely that the pharmaceutical and plastics industries have prevailed over the Union Ministry of Health to postpone or reconsider the ban.