As the industry gears up to implement the switch from PET to glass for medicines meant for certain patient categories, the debate on the merits and demerits of both materials continues. Usha Sharma reports
The Central Drugs Standard Control Organization (CDSCO), Director General of Health Services, Ministry of Health and Family Welfare, Government of India is working on a mission to safeguard and enhance public health by assuring safety, efficacy and quality of drugs, cosmetics and medical devices. The government feels that PET packaging will harm pregnant women, child and geriatric populations and to address this issue the Ministry of Health and Family Welfare (MoHFW) had issued a notification banning the use of polyethylene terephthalate (PET) as a primary packaging material for liquid oral drugs on October 19 last year, which followed a draft notification (GSR 701(e)) issued on September 29. By April this year, manufacturers of pharma products in India will be banned from using PET as primary packaging for these specified formulations.
The announcement was welcomed by the glass manufacturers whereas PET manufacturers were disheartened. Realising the industry’s concern, Indian Drug Manufacturers’ Association (IDMA) has made the representation to DTAB on December 20, 2013 to suggesting a rethink about the issue.
Commenting on IDMA’s move, Sanjay Tiwari, Chief Executive Officer, Piramal Glass Ceylon says, “The Government of India should act based on the health advisory from the experts.Already many doctors have raised support for glass due to strong evidence of adverse effects on human health due to plastic/ PET packaging. GoI has issued this pre notification only after seeking opinion from expert committee and ICMR. Any other alternative in favour of PET manufacturers will be seen as taking a step back from their decision.”
A welcome move?
The step initiated by the Government of India to ban the PET bottles indicates that the government is concerned about the health of the Indian population. But a point to be noted is that until few years back most drugs manufactured by pharma companies used glass bottles and later shifted to PET bottles. Why did this shift not raise alarm bells in the government at that time? And if it is mandatory to stop using PET bottles then employees of both pharma companies as well as pharma logistic players need to be well trained and prepared to handle glass bottles, especially while the products are in transit.
To this Tiwari counters, “All these medicines were earlier filled in glass. Even now the pharma industry is using 30 per cent of their current packaging requirement in glass. Of late some of the products have moved to PET packaging, hence there is no need for any training.”
However, Pranay Kumar, Chief Environment Officer, Vasudhaecofriends Projects feels that the industry is not prepared at all to follow the rule. He opines, “Pharma professionals would be well advised to go for elaborate testings for leachates/extractables at various temperatures and a repertoire of chemicals with glass and PET. I don’t think they should bow to NGT or Government with solid scientific evidence, specially with loads of information against the proposition. Plastics have made many revolutions possible, including milk, oil and plays a very large role in saving food in a country like ours. Logistics (weight, breakage, costs) and supply chain would be paralysed for a short time (four-six months) packaging.”
Critics of PET point out that it adds to the plastic waste but as a sustainability activist, Kumar has an answer for this charge. His company Vasudhaecofriends promotes, EcoPure, a range of organic copolymer additives, which accelerates the biodegradation of traditional, oil-based plastic products in a biologically active landfill. (Read his article: Busting the myths around biodegradable plastics, pages 31-35 in this issue). It remains to be seen if technology will be used by the pharma industry because it will obviously add to the cost, but it certainly addresses one of the concerns.
Challenges involved
Logistics play an important role in the pharma supply chain as it connects pharma companies to the end consumers. PET bottles are easy to handle during the transit period whereas glass bottles may require a different set of understanding about glass handling. Commenting on whether logistics players require training to handle and follow glass bottle packaging, Tiwari says, “As far as logistics players are concerned, they are doing transportation for both types and there is no requirement for any specialised transportation for glass.”
With the implementation of glass packaging, it is likely that manufacturing costs will shoot up drastically. Tiwari comments, “The cost escalation in switching over from PET to glass is negligible, keeping in mind the potential harm it can create for our coming generation.”
He explains further, “The additional cost to manufacturers and end consumers will be negligible. Let’s take an example of a 100 ml glass bottle for the pharma industry. It can cost landed to the manufacturing location at Rs 2.0 per PET bottle of 12.5 grams. In glass, a 100 ml bottles can cost at Rs 2.6 per glass bottles of 100 grams weight. If we compare this additional cost of Rs 0.60 per container, the pharma product sold in the market of 100 ml can be any where between Rs 70 to Rs 100.”
Kumar opines and feels, “The manufacturers, sellers all would have many concerns and costs to look into. Many pharma remedies may vanish or would be in short supply for months to come. And there are instances where similar formulation is being packed in glass for exports from India as well as plastic for domestic consumption.”
Market share
Presently, the glass industry has a capacity of 10,000 TPD and currently almost 20~25 per cent capacity is idle, which can be utilised for the pharma industry. Hindusthan National Glass, AGI – Glasspac, Piramal Glass, Empire Industries, Gerreshiemer India, are few of the leading glass manufacturers in India catering to the pharma industry. Apart from them, there are many other glass companies like Haldyn Glass, Sunrise Glass, Canpack which have sufficiently large capacities and cater to other segments like the food & beverage industry.
Glass containers are witnessing a growth of eight~10 per cent year-on-year, however the requirements by pharma industry has declined year on year due to a large shift from glass to PET. It is estimated that 35000 MT of PET Amber is used for the pharmaceutical industry and it is witnessing a growth of eight to 10 per cent year on year. Tiwari emphasises, “The glass industry is fully prepared to cater to any additional requirements of glass containers for pharma usage. We have already received indications from major brands about their desire to shift to glass packing mode and are ready for the same.”
So, how badly hit will the PET manufacturers be if glass packaging in pharma becomes mandatory? Largely all PET manufacturers have the capability to service various sectors like food, beverages, liquor and many others. Tiwari avers, “In terms of the total capacity available in PET container industry, very small portion of the capacity is toward manufacturing containers for the pharma industry and hence again the impact will be very marginal.”
Kumar anticipates that thousands of small companies will be shut down, with lakhs of people unemployed. He says, “Glass also has high pollution associated with manufacturing. The decision was completely ill informed by the government and there is no alternative to plastics packaging. The only other plastic is HDPE for pharma packaging. If NGT is worried about waste, country should look into biodegradable plastics.”
He feels, “The PET industry is not well versed in technologies and they never care to update themselves against challenges like NGOs petitions. Most end consumers like TATAs, Nestle, pharma companies do their time in fire fighting. There is no future or scenario planning. ”
Tiwari concludes, “PET manufacturers have fairly big opportunities in other segments such as food, beverages, liquor which are showing healthy growth rates.”
Thus, while the move has evoked a mixed bag of reactions from the industry, the ramifications of it are yet to be seen.
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