With the ban on plastic and PET containers impending, the industry has raised concern over the step that would hamper the transportation of medicines more than the impact on the profitability.
The Drugs Technical Advisory Board (DTAB) had recommended the phasing out of the use of plastic and PET (Polyethylene Terephthalate) containers for liquid formulations from the market on a gradual base, in line with the recommendations of an expert panel. It has also suggested six months time to the pharmaceutical manufacturers for transition.
In a representation to the health ministry, the Federation Of Pharma Entrepreneurs (FOPE) said the recommendation had disturbed the industry and claimed that PET was well established and widely accepted as pharma packaging worldwide, including the developed markets like the USA, USA, UK, Europe and Japan.
“Globally various institutes, laboratories and authorities have already given their clearance for PET as suitable packaging for food and drugs. International LifeSciences Institute (ILSI, Europe) has mentioned that PET and its components have no links with any of the reported endocrine disruptors” said the representation.
The term “phthalates” refers to the diesters of 1,2-benzenedicarboxylic acid, better known as phthalic acid. The plastics industry emphasizes the distinction between PET and phthalates. These are chemically dissimilar, PET is not considered an orthophthalate, nor does PET require the use of phthalates. Hence question of presence of phalates/plasticizers does not arise in case of PET, according to FOPE.
The industry asserts that PET bottles are not a source of endocrine disruptors (e.g. American Chemistry Council 2009). USEPA-United States Environment Protection Agency, under their project EDSP-Endocrine Disruptors Screening and Testing Programme, listed 10000 chemicals out of 85000 chemicals, which fall in list for disrupting Endocrine. PET does fall in the list, hence is not the cause of Endocrine disruptor, the association pointed out.
PET containers are lighter and non-fragile compared to Glass containers. This reduces the overall Packaging requirement and Gross weight of the products reducing fuel consumption (reduction in Green House gases) during transportation of the product as well as post-consumer containers, it said.