Cough syrups, antacids or vitamins in plastic and PET (Polyethylene Terephthalate) bottles could soon be a thing of the past. Owing to the environmental and health hazards posed by plastic leaching, the Union Health Ministry’s Drug Technical Advisory Board (DTAB) has recommended a ban on such packaging for liquid formulations by pharma companies.
To begin with, a six-month-period will be given to the drug manufacturing industry to switch over to other packaging products such as glass instead of plastic or PET containers for liquid drugs meant for children, elderly, women in reproductive age group and pregnant women.
The DTAB's decision, which is likely to have a significant impact on the plastic industry’s earnings, is based on the report of a scientific panel that had favoured a ban on plastic/PET bottles after noticing that there has been no study to show that packing of drug formulations in such containers does not have any harmful effect on the drug formulations and that there are no releases of endocrine disruptors due to leaching.
The scientific panel was set up following complaints from a Dehradun-based civil organisation Him Jagriti which had sought a complete ban on plastic and PET bottles as primary packaging material in pharmaceutical liquid orals, suspensions and dry syrups with immediate effect.
The organisation had cited various studies claiming that plastic or PET has severe adverse effects on human health due to the presence of endocrine disruptors. “leaching takes place under varying storage-temperature conditions and can cause several diseases including cancer and physical infirmities.
“Also, many chemical additives that give plastic products desirable performance properties have grave negative environmental and human health effects,” it said. During a meeting held recently, the DTAB members too agreed that since temperature rises to 40-45 degree centigrade during summers 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 members also opined that the reports of environmental / health hazards because of increasing exposure to endocrine disrupter chemicals known as phthalates etc were increasing. “Therefore, it would be in the public interest especially considering the precautionary principle that the children, geriatrics, women in reproductive age group and pregnant women are not exposed to the hazards involved in the packaging of drugs in plastic / PET containers,” said the Board.