The Union health ministry is reported to have decided to ban the use of plastic and PET containers for liquid formulations by the pharmaceutical industry in a phased manner. To start with, PET containers with paediatric preparations, formulations meant for geriatrics, women in reproductive age group and pregnant women will be disallowed. Six months time is going to be given to the manufacturers to comply with the decision. The ministry’s move is in consideration of the precautionary principle that the children, geriatrics, women in reproductive age group and pregnant women should not be exposed to the any hazards involved in the packaging of drugs in plastic and PET containers. The issue of health hazards due to use of PET bottles was brought up by a public interest group, Him Jagriti from Uttarakhand, in a representation to the health ministry. The group sought a blanket ban on PET bottles as primary packaging material in pharmaceutical liquid orals, suspensions and dry syrups with immediate effect as such materials can cause severe adverse effects on humans due to the presence of endocrine disruptors. The health ministry’s decision to ban PET bottles is based on the recommendations of the Drugs Technical Advisory Board in line with the concerns expressed by an expert panel headed by Dr Y K Gupta.
It is known to everyone that the pharma industry has been using only glass bottles as primary packaging material for several years. The switching over to packing in plastic or PET bottles over the years is not based on any scientific studies establishing that use of PET bottles will not cause any harmful effect on the drug formulations and there are no releases of endocrine disruptors due to leaching. And it is a fact that India has wide temperature variations in many regions and several thousands of medical stores in the country have no air conditioned premises. In summer, temperature rises to 40 to 50 degree centigrade and exposure of plastic bottles to such a high temperature may result in adverse effect on the drug formulations packed plastic bottles which may result in increased leachbility. For the pharmaceutical industry switching over to glass bottles might lead to increased costs and transportation issues. In a representation to the health Ministry, the Federation Of Pharma Entrepreneurs raised objection to the proposed phasing out plan on the ground that using PET containers is a well established packaging option and is widely accepted worldwide including in developed markets like the USA, UK, Europe and Japan. It is possible that in developed countries usage of PET bottles for medicine may not be that harmful because of the temperate climate and advanced storage conditions. That is not the case in India. Therefore, the government has to take a stand in the matter in consideration of industry’s position on the cost escalation and also in the interest of patient community.