Pharmaceuticals safe in PET packaging: High-level committee

New Delhi : Polyethylene Terephthalate (PET) usage in pharmaceutical packaging does not pose a threat to human health and can be practiced with assurance of safety, said the report of a high-level committee probing the issue.

"There is no conclusive, reproducible evidence to suggest that use of PET or additive used with it such as antimony, for pharmaceutical packaging may leach substances beyond limits that pose threat to human health," said the report submitted to the National Green Tribunal (NGT) on Friday.

The committee was constituted by the health and family welfare ministry to assess the health and environmental impact of PET usage, after NGO Him Jagriti Uttaranchal Welfare Society petitioned NGT that PET usage leaches harmful chemicals like phthalates and heavy metals owing to extreme temperature variations in India.

The NGO sought restriction on the usage of plastic bottle and multi-layered plastic packaging including PET bottles for carbonated soft drinks as well, saying unrestricted use has significant health and environment impact.

But the report said: "Within a robust regulatory system and process with clearly defined standards and requirements, the use of PET as a packaging material for pharmaceuticals can be practiced with assurance of safety."

It said PET does not need the use of phthalates or any plasticisers in its manufacturing process, but however, highlighted that both treated and regular soda-lime glasses are susceptible to leaching.

"Treated soda lime glass is characterised by high hydraulic resistance and is more susceptible to leaching than borosilicate glass. Regular soda-lime glass is untreated soda-lime glass with moderate hydraulic resistance is more leachable oxide than treated soda-lime glass," it said.

But it revealed the lack of consistent rigourous methods in estimations, reporting of results and choice of standards by National Test House and Indian Institute of Toxicological Research (IITR) labs in their PET bottle tests.

The HLC recommended establishing better standards, strengthening of regulatory guidelines and prescribing specific methods for pharmaceutical packaging waste disposal.

Earlier, NGT noted that the Central Pollution Control Board and the Central Drugs Standard Control Organisation (CDSO) have sought a ban on using PET bottles or plastic containers for primary packing in liquid oral formulations.

But two earlier separate tests by international testers SGS and India's Shriram Institute for Industrial Research (SIIR) have not found any traces of harmful leaching in PET containers packaging tested at varied environments.

Pharmaceuticals along with soft drinks constitute about one fourth of India's PET packaging industry which is valued at Rs.4,000 crore.

PET is made from mono ethylene glycol and purified terephatic acid. Of the 600,000 tonnes of PET production, the pharmaceutical industry uses around 16 percent, accounting for around 100,000 tonnes every year.