The Union Ministry of Health is likely to officially ban the use of plastic bottles in packaging liquid medicines, especially for paediatric, geriatric drugs among others, within the next ten to fifteen days, claim sources in the directorate general of health services.
A senior official in the department said, "The matter is under process in the health ministry, and a formal notification is expected within the next ten to fifteen days." He further explained that the Drug Technical Advisory Board (DTAB) has already recommended a ban on use of plastic or PET containers in liquid oral formulations for primary packaging of paediatric formulations and those meant for geriatrics and pregnant women in a phased manner in November.
"However, we had received some representation from the PET container manufacturers, and the matter has been referred to the Indian Council of Medical Research. The ban would indeed be implemented, and a formal notification can come within the next few days," he said.
DTAB is the apex advisory panel on technical matters under the Union Ministry of Health. In November last year, the DTAB had recommended "that in the first phase, the use of plastic / PET containers in liquid oral formulations for primary packaging of paediatric formulations as well as formulations meant for geriatrics, women in reproductive age group and pregnant women should be phased out and banned. However, the pharmaceutical industry may be given an adequate time of six months for smooth switch over."
Earlier, Dehradun based non-profit organisation HIM Jagriti, Uttaranchal Welfare Society had made a representation before the secretary, ministry of health, directorate general health service and drug controller, wherein it had requested to impose a ban on polyethylene terephthalate (PET) bottles as primary packaging material in pharmaceutical liquid orals, suspensions and dry syrups as it has severe adverse effects on human health due to presence of endocrine disruptors, it had claimed. HIM Jagriti had claimed that in plastic bottles leaching takes place under varying storage temperatures and also when the packaging becomes old, which can, in turn, lead to several diseases including cancer and physical infirmities.
The DTAB had noted, "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 leachbility. The harmful effects because of the packaging and leachbility may be further magnified in the case of drug formulations."
Its members had felt that the reports of environmental or health hazards because of increasing exposure to endocrine disrupter chemicals known as phthalates etc. are increasing. "Therefore, it would be in the public interest,specially 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," it had concluded.
