With the pharmaceutical industry and polyethylene terephthalate (PET) resin/bottle suppliers 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, experts pinpoint that the ban is unscientific and based on tests carried out under conditions that raise grave doubts on the relevance, repeatability and authenticity of the results.
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.
Experts have argued in favour of PET saying PET fibres are being made for more than 60 years and PET bottles have been made for more than 40 years all over the world. More than 300 million MT already used globally and more than 15 trillion bottles packed and consumed. Further to this, there has been no epidemiologically adverse observation globally on the use of PET and and not a single clinical evidence correlating any ailment in the workforce with PET chemistry. No case has been reported on any occupational hazards faced by the work-force either.
Explains an expert Dr Vijay G Habbu, "PET is the preferred packaging material for liquid pharma products. Reason it does not does not contain phthalates or EDCs. It does not contain Bisphenol A or other Carcinogens and Antimony leaching from PET bottles is much below the permissible limits. Leaching of lead (Pb) is nil, in contrast to finite quantities from glass bottles. Besides this, Estrogenic reactivity is not conclusively attributed to containers (PET or any other). All packaging materials (Glass, PET, Aluminium, tin,Tetrapacks) exhibit leaching that is dependent on temperature, time and pH of contents."
PET bottles comply with Indian and other International Pharmacopeia & standards.All major international pharma companies use PET bottles for packing liquid formulations meant for pediatric, female and geriatric populations.
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.
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).
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.
S Sivaram, CSIR Bhatnagar fellow and former director, National Chemical Laboratories (NCL) 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.”
During May, 2013 and August, 2013, the Dehradun based non-governmental organization (NGO) Him Jagriti 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.
According to an expert Dr S B Rijhwani , 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.
In the light of the ban on use of PET for packaging medicines, the All India Glass Manufacturers’ Federation (AIGMF) had also approached the health ministry to reiterate glass industry’s capabilities for unhindered supplies of glass bottles to the pharmaceutical companies. Overall the glass industry is upbeat about the prospects of glass in pharmaceutical packaging.
While some industry experts voice concern over spike in drug prices due to added logistics and transportation costs with glass bottles as packaging material, glass manufacturers, however, see this as a blessing in disguise and has gone ahead with an assurance to the industry of unhindered supply of glass besides proclaiming the health aspects of glass in healthcare.
According to AIGMF, the misconception created about price increase of drugs due to prohibition of PET packaging shows total disregard for human health especially of women and children. AIGMF has also emphasised that the impact of cost of packaging on the MRP is not so significant that the switch-over from PET to glass should be of any issue to any manufacturer especially considering the huge health advantage women and children enjoy in the long run due to this switch-over.
In a written submission, the AIGMF had assured the Health Ministry ' the availability of glass bottles to the liquid filling pharmaceutical units on priority basis throughout the year'. The industry had invested more than Rs.5000 crore in the last five years to create capacities. This will enable the glass industry to cater to the additional demand from pharma industry.
According to an AIGMF official, an ill-informed campaign was started on the characteristic of glass bottles and on its suitability for primary packaging of pharma products. This campaign started after the government issued a notification on September 29, 2014 seeking suggestion for prohibition of usage of PET for pharmaceutical packaging.
The glass industry in India has a capacity of over 10,000 tonnes of glass per day which will convert to yearly capacity of almost 3.7 million tonnes. If required on an immediate basis, industry has the capacity of over one million tonnes, which is more than sufficient to cater to the requirement. As a matter of fact, the pharmaceutical industry currently uses glass bottles to fill its 40 to 50 per cent requirement. The conversion from glass to PET/plastic packaging started only eight to 10 years back for the sake of convenience, purely commercial benefits and due to lack of awareness. The Drugs Technical Advisory Board (DTAB) had initially considered banning the use of plastic during a meeting held on November 25, 2013. The Indian Drug Manufacturers’ Association (IDMA), in turn, had made a detailed submission on December 20, 2013, asking them to reconsider the recommendation.
The IDMA had also written to the Ministry of Health and Family Welfare and the PMO, slamming the proposed ban on using plastic containers as primary packaging of drugs and formulations in the country. The IDMA, in its letters, quoted the finding of an expert committee set up by DTAB to study the health-related claims noted that, “information provided in the representation of a Dehradun-based non-profit organisation HIM Jagriti, Uttaranchal Welfare Society and according to available literature, is not sufficient enough to establish a definite correlation of causality of plastic container for pharmaceutical products and adverse health effects.”