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Even as uncertainty looms large over continuation of Polyethylene Terephthalate (PET) containers for packaging of liquid oral formulations, the government is likely to come out with key findings in one month's time corroborated with a scientific study to ascertain its continued use as a safe packaging material for medicines.
“A group of experts is currently a part of the study which is doing science based evaluation of the issue in the larger patient interest as PET is a widely used thermoplastic used for the primary packaging of liquid oral formulations intended for certain sections of the population like children, elderly, pregnant women and women in the reproductive age group,” informed a senior health ministry official.
Upset at the ministry of health and family welfare September 29, 2014 notification that sought to prohibit the use of containers made of PET for packaging of liquid oral formulations, representations and submissions with scientific and technical evidence have followed about its safe use.
PET has been recommended by various regulatory authorities and Pharmacopoeias and the High Courts and Supreme Court have also dismissed petitions of NGOs due to lack of scientific data against its safety in the recent past.
The notification was issued following ‘findings’ by a Dehradun based NGO Him Jagriti that medicines packed in PET bottles were laced with contaminants that included phthalates and heavy metals. During May, 2013 and August, 2013, the NGO requested that a ban be imposed on the use of PET bottles as primary packaging material in pharmaceutical liquid orals, suspensions and dry syrups.
The NGO claimed that use of PET bottles had severe adverse effects on human health due to presence of endocrine disruptors and leaching which takes place under varying storage and temperature conditions and the age of packaging.
Replying to a question in the Lok Sabha, minister of health and family welfare, Jagat Prakash Nadda also said, "In response to the draft notification, a large number of representations were received from various stakeholders against the proposed ban. Around 292 representations inter alia opposed the ban and stated that sufficient scientific evidence is not available about the alleged ill-effects of the use of PET bottles for packaging medicines.”
Some of these representations also cited studies by various agencies to claim that use of such bottles is safe and is widely used across the world. Four representations supported imposition of ban.
Following Drug Testing Advisory Board (DTAB) recommending banning of PET in pharma at their 65th meeting on November 25, 2013, Indian Drugs Manufacturers Association (IDMA) also submitted a detailed representation with scientific and technical evidence about the safe use of PET. Later the draft notification was published on September 29, 2014 and the industry body again made submissions in detail about its safety and advantages in utility value.
Following these submissions and meetings with the health minister, health secretary and other concerned officials, the proposed ban on PET bottles in pharma industry has been withheld by the ministry.
Follwing this, Indian Drug Manufacturers’ Association (IDMA) also submitted the status note on November 24 for ensuring quality of PET containers including the tests/studies conducted and standards/procedures followed by the industry. Analytical reports and communications between the pharma manufacturer and PET supplier was also provided and also a detailed note on the tests prescribed in the Indian Pharmacopoeia and followed by pharma manufacturers in use of plastic/PET containers for continuation of PET bottles considering their safety and merits.
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