Indian Regulations allow PET for pharma packaging under Drugs & Cosmetics Act (1940), Schedule M, Section 16.10. Stability studies and also under Drugs & Cosmetics Rules (1945), Schedule M, para 11 pharmacopoeial compliance. It is also stipulated for use under Indian Pharmacopoeia in IP 2010, General Chapter 6.2.3 and under Bureau of Indian Standards for use in contact with foodstuffs, pharmaceutical and drinking water.
Several other Indian standards also exist to control and allow PET containers for pharma packing. These were some of the points drawn during a national level seminar on ‘PET Packaging of Pharmaceuticals’ held recently in Mumbai organized by PET division of Reliance Industries Ltd (RIL)- RelPet. This seminar had presentations from RIL, HCA (colorant supplier) and ASB (machinery manufacturer) among others.
The seminar was aimed at addressing various myths and regulatory issues in regard to PET packaging for pharma products. On the occasion Dr S Sivaram, CSIR Bhatnagar fellow and former director, National Chemical Laboratories (NCL) while giving the key note address said, “PET as a packaging material has been in use with us since 1977. It is biologically inert if ingested and not hazardous if inhaled. It is safe for mankind and contains no endocrine disruptors.”
Talking about the regulatory aspects for PET use, Dr Vijay G Habbu from RIL said, “Indian Government has already permitted the use of PET for packaging of pharmaceuticals. international regulations also allow PET for pharma packaging mandated by international regulatory bodies like World Health Organisation (WHO), International Conference on Harmonisation, stability guidelines Q1A-Q1F, International Standardisation Organisation (ISO):ISO 22000:2005: Food Safety Management System (FSMS) for ‘Manufacture and dispatch of polyethylene terephthalate (PET) as raw material for food packaging applications’.”
PET is a widely used thermoplastic used for the primary packaging of liquid oral formulations intended for certain sections of the population (children, elderly, pregnant women and women in the reproductive age group).
Ministry of health and family welfare September 29, 2014 notification that sought to prohibit the use of containers made of polyethylene terephthalate for packaging of liquid oral formulations 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.
Replying to a question in the Lok Sabha recently, 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.
During May, 2013 and August, 2013, a Dehradun based non-governmental organization (NGO) requested that a ban be imposed on the use of polyethylene terephthalate 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.
The pharmaceutical industry and PET resin/bottle suppliers are predictably upset at the notification, and have every reason to be. They pinpoint that the ban is bad in science, and based on tests carried out under conditions that raise grave doubts on the relevance, repeatability and authenticity of the results.
An expert Dr S B Rijhwani explains that the first fundamentally flawed allegation is that PET containers leach harmful chemicals such as bisphenol-A (BPA) and phthalates into the medicines they hold. BPA does not find a place in PET manufacture at any part of the manufacturing chain. It is an important raw material to make polycarbonate resin – but that is a wholly different polymer, and of no relevance to the issue at hand.
“While it is impossible for phthalates to leach out of PET bottles for the simple reason that it is not an ingredient in the bottle. Another bone of contention relates to findings of small amounts of antimony in the leachate. Most likely this has come from the tiny amounts of antimony trioxide used as a catalyst in the polymerization process leading to PET resin,” he added.