The pharmaceutical industry is likely to be given an adequate time of six months for the switch over. The decision came in the wake of concerns raised by Him Jagriti, Uttaranchal Welfare Society, Dehradun the use of plastic as primary packaging material in pharmaceutical liquid orals, suspensions and dry syrups can cause severe adverse effects on human health due to the presence of endocrine disruptors.
Their representation to the union health ministry stated, "Leaching takes place under varying storage-temperature conditions and the age of the packaging (leaching becomes faster in hot/warm conditions, and also as the packaging becomes old). The leached elements can cause several diseases including cancer and physical infirmities. Many chemical additives that give plastic products desirable performance properties have grave negative environmental and human health effects." The representation of HIM Jagriti was deliberated by DTAB in May this. They had constituted an expert committee under the chairmanship of Dr YK Gupta, prof & HOD, department of Pharmacology, AIIMS.
The committee had concluded that the information provided in the representation of HIM JAGRITI and according to the available literature, is not sufficient enough to establish a definite correlation of causality of plastic container for pharmaceutical products and adverse health effects. The committee observed that scientific evidence needs to be generated in a time bound manner to find out the extent of leachbility, type of toxicants leached and health hazard due to exposure of the leached toxicant.
The PET Container Manufacturers Associations also represented to the Director General Health Services stating that PET packaging with its inherent strength such as product safety, eco-friendliness and recyclability will continue to be used in food, beverage and pharmaceuticals packaging. The PET is universally safe and environment friendly packaging material. The literature attached to the representation, however, did not address the issues raised by HIM Jagriti.
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," stated the committee.
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