New Delhi: Use of polyethylene terephthalate (PET) or plastic containers for packaging drug formulations is safe, a government study concludes, putting to rest the debate on the issue that dates back to 2013.

Earlier last year, the health ministry had asked the government’s research institute, the National Institute of Nutrition (NIN), to carry out a comprehensive study to assess the health impact of PET bottles. This was aimed at helping the Union ministry for health and family welfare to arrive at a well reasoned conclusion on whether or not to ban PET bottles for packaging medicines.

NIN, meant to assess the quality of plastic containers used for pharma formulation as per international guidelines and to estimate leaching of phthalates and heavy metals in the formulations, has not found that PET bottles are “leaching toxins" as anticipated.

In 2013, Him Jagriti, an Uttarakhand-based non-governmental organisation (NGO) that works in the health sector, had approached the ministry of health seeking a ban on the use of PET for pharmaceutical packaging. The matter went to the government’s highest decision-making body on technical matters—the Drugs Technical Advisory (DTAB)—which, based on tests conducted by the All India Institute of Hygiene and Public Health, revealed that levels of toxic chemicals were higher than safe limits. “The reports revealed heavy leaching of heavy metals and phthalates from PET bottles into the contents," said a senior official in the health ministry, requesting anonymity.

Following the report, the DTAB recommended that PET and plastic packaging be banned for pharmaceutical products catering to children and pregnant women. It said suggested the phasing out of PET bottles for pharma packaging. In the first phase, it was suggested that there should be a ban on the use of PET to package liquid oral formulations for paediatric and geriatric use, and for drugs used by pregnant women. A draft notification to this effect was put up.

At that time, the government also set up a high-level committee to look into the matter under M.K. Bhan, former secretary in the department of biotechnology. However, the Bhan panel told the tribunal there was no conclusive evidence to suggest that use of PET or additives like antimony for pharmaceutical packaging may leach out substances beyond limits and pose a threat to human health. This prompted Him Jagriti and a handful of other NGOs to approach the National Green Tribunal, seeking a blanket ban on the use of PET bottles.

Due to strong resistance from PET manufacturers, the draft notification was put on hold in September 2014. “Since then the issue has been lingering. The study settles the issue that has been looming for more than four years," added the official, on condition of anonymity.

Last year in September, government’s top research institute—the Indian Council of Medical Research (ICMR), under the ministry of health—has tasked Hyderabad-based NIN to conduct the study to ascertain the safety of PET bottles for packaging pharmaceuticals. “NIN has favoured the PET bottle industry, concluding that its safe to use them and there was no need to switch over to glass bottles," added another health ministry official.

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