Despite serious objections from the packaging industry, the Union health ministry decided to go ahead with its decision to ban the use of polyethylene terephthalate (PET) containers in pharmaceutical industry. The draft notification says that no manufacturer shall use the PET or plastic containers in liquid oral formulations for primary packaging of drug formulations for paediatric use, geriatric use and for use in pregnant and women of reproductive age group. The pharma companies have been given a transition period of 6 months after the final publication of the order in the official gazette to switch over to alternate packaging medium. 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. The issue of health hazards due to use of PET bottles in pharmaceuticals industry was brought up by a public interest group, Him Jagriti from Uttarakhand, in a representation to the health ministry last year. The NGO sought a blanket ban on the use of 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 disrupters. Some environmentalists, quoting recent scientific studies, point out that chemical elements in PET bottles can react with chemical components in drugs and may cause leaching in different temperature conditions existing in India.
Pharmaceuticals industry in India has been using PET bottles for packaging mainly liquid products for the last 30 years without facing any objections from health activists and patient community. And no instances of fatality or health hazards have been reported from patients following consumption of medicines packed in PET. Apart from pharmaceuticals industry, PET containers are being widely used for packaging drinking water, edible oils, milk, spices, honey, pickles, ketchup and confectioneries in the country. In view of the growing demand from these industries, the PET raw material industry is planning to expand its capacity from 1.2 million tonnes to 3 million tones soon. For the user industries, PET containers for packaging gives a great cost advantage over the glass bottles. In a situation like this, a ban on the use of PET containers in a major industry like pharmaceuticals is certainly going to be objected. For the pharmaceutical industry switching over to glass bottles certainly lead to some increased costs and transportation issues. Pharma industry bodies have, therefore, approached the health ministry last year objecting to the ban on PET containers on the ground that usage of PET containers is a well established packaging option and is widely accepted practice in developed markets like the USA, UK, Europe and Japan. Use of PET containers for packing medicines in developed countries may not be that harmful because of the temperate climate and advanced storage conditions there. That is not the case in India and a large percentage of medical shops do not have air conditioned premises exposing medicines to extreme heat conditions during summer. The government has to, therefore, take a balanced view in this matter considering industry’s stand on cost escalation and also the patient welfare.