The Union health ministry has banned the use of polyethylene terephthalate (PET) or plastic containers in liquid oral formulations for primary packaging of drug formulations for paediatric use, geriatric use and for use in case of pregnant women and women of reproductive age group.
In a draft notification (G.S.R. 701(E)), the ministry said, “No manufacturer shall use the polyethylene terephthalate or plastic containers in liquid oral formulations for primary packaging of drug formulations for paediatric use, geriatric use and for use in case of pregnant women and women of reproductive age group”.
However, the manufacturers will get enough time for transition as the notification says, “They shall come into force after a period of one hundred and eighty days from the date of its final publication in the Official Gazette”.
The ministry has banned the PET in exercise of the powers conferred by clause (i) of sub-section (2) of section 33 read with section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), on the recommendation of the Drugs Technical Advisory Board (DTAB).
Earlier, an expert panel headed by Dr Y K Gupta had recommended to the government to phase out the use of plastic and PET containers for liquid formulations from the market in phases. The panel felt that reports of environmental/health hazards because of increasing exposure to endocrine disrupter chemicals known as phthalates etc. were on the rise. Hence the move to phase out PET was taken in the public interest specially considering the precautionary principle that the children, geriatrics, women in reproductive age group and pregnant women should not be exposed to the hazards involved in the packaging of drugs in plastic/PET containers.
In fact, the PET issue was brought up by a public interest group, Him Jagriti from Uttarakhand in a representation to the health ministry some time back. The group sought a ban on PET bottles (both colour and non-colour) as primary packaging material in pharmaceutical liquid orals, suspensions and dry syrups with immediate effect as it has severe adverse effects on human health due to the presence of endocrine disruptors.