Indian pharmaceutical companies may soon have to phase out the use of plastic or polyethylene terephthalate (PET) bottles for packaging medicines such as syrups and liquid orals.
The Indian health ministry is considering a ban on the use of such bottles for packaging pharmaceutical products due to concerns of possible adverse effects on health.
Although the government lacks sufficient evidence to confirm a risk to health from the use of plastic bottles, the Drug Technical Advisory Body (DTAB), the top-most advisory body on health-related matters, has suggested that the government must immediately ban the use of such bottles for some specific categories where risks are high, an official said.
Recommendations for immediate action include banning the use of plastic or PET containers in liquid oral formulations for primary packaging of paediatric formulations, geriatric medicines, and medicines for women in the reproductive age group and pregnant women.
Pharmaceutical companies are expected to be given approximately six months to implement the move, according to the DTAB recommendations.
The pharmaceutical industry used to use glass bottles as its main packaging material for pharmaceuticals. However, the industry switched to PET bottles primarily because they are easy to handle in the distribution and retailing process.
However, the DTAB report notes this switchover to packing in plastic or PET bottles by the industry “is not based on any scientific studies” to show such bottles do not have any harmful effect on the drug formulations and there are no releases of endocrine disruptors due to leaching.
One cause of concern in India is the high temperatures experienced throughout the country, and the unknown and adverse effects this could have on drugs packaged in plastic, in terms of increased leachability.