Pharma packaging majors have objected to the Union government's decision to prohibit the use of polyethylene terephthalate (PET) to package liquid drug formulations. They view the notification issued by the government as one driven by public interest groups with vested interests.

According to a section of pharma packaging players, including the Bengaluru based Manjushree Technopack, PET has undergone stringent tests before it could be approved for use in pharma and food packaging since 1982. It is only in 2014 after a gap of 32 years that the government has raised objections to its use asserting that PET properties are harmful.

“The reality is that PET has passed all migration tests. It adheres to every global regulatory norm: These are US FDA CFR 21, European Union guidelines of 10/2011 and Bureau of Indian Standards : BIS 12252-1987. Backed by such stringent compliances, PET was certified for use in drugs and foods covering biscuits to beverages, Rajat Kedia, director, Manjushree Technopak told Pharmabiz.

There has been no instance of fatality or health hazards reported from patients and consumers following consumption of medicines packed in PET. The government effected the ban with misinformation as PET evaluated for its safety and convenience. Traditionally drugs and foods were packed in glass but this was replaced a decade ago with PET because of ‘leeching’ that resulted in fatality, he added.

Efforts to ban PET bottles for pharma is an ongoing affair for a section of vested interest people. There were public interest litigations(PILs) in several High Courts. Various state governments put forth their views before the judiciary advocated that arguments against PET packs were baseless. This itself is the proof on the safety of PET, he said.

It high time, that the Union government calls for an open discussion with PET packaging industry experts to comprehend the facts and do away with the ban because of the ample scientific backing of high quality and safety parameters of polyethylene terephthalate, said Kedia adding that government research centres like the DFRL, CFTRI and IITs have researched on PET safety extensively.

In the wake of the ban which is effective in six months, glass would be option for drugs and foods. Although PET is environmentally-friendly over glass which is also known to chip during package. There are several instances of glass pieces present in products sold at pharmacies.

In addition, the implication of costing is huge as companies will now need to change the packaging lines to pack drugs in glassware. Moreover, only a handful of glass manufacturers can cater to pharmaceutical needs and this would spring up a monopolistic market. Therefore, it would only be prudent for the government to cancel the notification on PET based on the rigorous tests undertaken globally and in India on its safety, said Kedia.