In September 2014, the union health ministry issued a notification banning the use of PET bottles for packaging of drug formulations for paediatric use, geriatric use and for use in pregnant and women of reproductive age group. The pharma companies, then, were been given a transition period of 6 months for switching 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 expert panel felt that the use of PET bottles for packaging medicines will have serious adverse effects on humans due to presence of endocrine disruptors and leaching which takes place under varying storage and temperature conditions and the age of packaging. Now more than six months have passed after the issue of the notification. No fresh direction has come from the ministry in furtherance of the September notification. And there is no indication on the part of the pharmaceutical industry to comply with the order. The government has admitted that after the issue of the notification, a large number of representations were received from various stakeholders against the proposed ban. Most representations objected to the ban on the ground that sufficient scientific evidence is not available for the harmful effects of the use of PET bottles for packaging medicines.
Thus government seems to have now taken a conciliatory stand against the proposed ban as the objections have come from various quarters over the last six months. The decision to set up a high level committee to review the rationality of the ban may be in the context of these developments. Indian Drugs Manufacturers Association had opposed the ban from the beginning saying that the move is neither based on scientific facts nor on established global practices. There is no doubt that PET has various cost-effective advantages in packaging, distribution and logistics as compared to glass bottles helping industry to keep prices of quality medicines under check. Pharmaceuticals industry has been using PET bottles for packaging mainly liquid products for the last 30 years and there were no serious objections from health activists and patient community all these years. No instances of fatality or health problems have been reported from patients following consumption of medicines packed in PET. Besides PET containers are also being widely used for packaging drinking water, edible oils, milk, spices, honey, pickles, ketchup and confectioneries in the country. Considering all these facts it will be prudent on the part of the government to reexamine the issue of banning the use of PET bottles in pharma industry.
