The Government will phase out the use of plastic and PET containers for liquid formulations from the market in phases, in line with the recommendations of an expert panel, but will give enough time to the pharmaceutical manufacturers for transition.
In the first phase, it is learnt that the PET bottles for liquid oral formulations for primary packaging of paediatric formulations as well as formulations meant for geriatrics, women in reproductive age group and pregnant women will be banned. Six months time will be given to the manufacturers for smooth switch over.
The regulatory authorities, which went into the recommendations by the expert panel headed by Dr Y K Gupta, has 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 is 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.
The issue of primary packaging materials was brought up by a public interest group, Him Jagriti from Uttarakhand in a representation to the health ministry. The group sought a ban on polyethylene terephthalate (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.
It was pointed out that 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 NGO claimed.
Based on this, the Government constituted the panel which held several rounds of meetings and made its recommendations. “The committee finally 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. However, this is an important public health concern and needs detailed investigation. Also, absence of evidence may not be considered as evidence of absence of the potential harmful effects of packaging of pharmaceutical products in plastic containers,” the panel said.
“A scientific evidence needs to be generated in a time bound manner through systematic studies as elaborated above, to arrive at answers to the following questions a) The extent of leachbility from plastic container used for packing different drugs formulation, b) The type of toxicants leached, etc. c) Health hazard due to exposure of the leached toxicant. On the basis of the evidence so generated and keeping in view the risk assessment and also environmental hazards, a phasing out plan may then be considered,” it said.
In order to generate scientific evidence on leachbility, common drugs available in plastic bottles samples were sent to Central Institute of Plastic Engineering and Technology (CIPT), Guindy, Chennai and Laboratory for Advanced Research in Polymeric Materials (LARPM), Bhubaneswar. However, these labs have shown their inability to carry out the assessment of leachbility of PET bottles. CISR has now been requested to provide information about the laboratories in the country having facility to test the extent of leachbility from plastic containers used for packing different drug formulations, sources said.
The authorities felt that 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, according to the technical advice given to the health ministry.