With the Health Ministry issuing a notification which dissuades manufacturers from using Polyethylene Terephthalate (PET) containers as primary packaging in liquid oral formulations for paediatric, geriatric and reproductive healthcare use, glass bottles seems to have got a thumbs up from the government.
However, even as the industry has opposed the ban and approached the government on the rationale for its withdrawal, Union health ministry officials inform that the matter is under scrutiny and decision on the same will not be taken in haste.
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. 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.
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.”
With a total pharmaceutical-specific market of one lakh metric tonne or Rs. 2,500 crore, the plastic industry is up in arms against the proposal, saying there is no precedence for such a move.
PET bottles are being used widely in packaging of oral liquids and tablets globally including the US, Europe and Japan. All the leading pharmacopoeias of the world like the United States, British, Japanese, Indian etc approve the use of PET bottles as safe in packaging of pharmaceutical products. According to an industry official, PET bottles widely used for pharma products in many countries are tested as per global standards. Bottles made from PET plastic are used for packaging medicines for paediatric, geriatrics and pregnant women by the world’s biggest and best pharmaceutical companies.
It is pertinent to note here that various governments around the world, including Government of India, have approved PET for packaging of drug formulations for more than 30 years now, and till date no single case of any adverse events have been reported from anywhere. In view of the growing demand from various industries, the PET raw material industry is planning to expand its capacity from 1.2 million tonnes to 3 million tonnes soon.
There is an added danger of injury due to breakage of the glass bottle by the consumer, especially children and old persons. Also, mono-cartons will be required for each glass bottle thus adding to the costs, all these leading to an estimated 25 to 30 per cent cost increase per bottle, which will in turn increase the cost of medicines that are supplied in glass bottles.
"Due to increased demand for glass bottles, the prices of glass bottles will shoot up as demand will be more than supply, which will lead to further shortages as small and medium pharma firms may not be able to purchase glass bottles at increased prices," said IDMA in its representation to the health ministry.
Using glass will increase the cost of medicines. As one lakh metric tonnes of PET used in pharmaceuticals market will have to be replaced by nine lakh metric tonnes of glass per year, may lead to shortage of liquid medicines because of shortage of glass containers. Transportation will also go up by 50 per cent as only 90,000 glass bottles can be transported in a container compared to 1.5 lakh PET bottles.
Due to increased demand for glass bottles, the prices of glass bottles will shoot up as demand will be more than supply, which will lead to further shortages as small and medium pharma firms may not be able to purchase glass bottles at increased prices.
Direct cost increase on one to one basis between glass bottles and plastic bottles will be between 10 and 15 per cent. Further cost of outer packaging would go up by 20 per cent minimum due to need of thicker cartons to avoid breakages in transit. Other big cost increases would be on account of lesser loadability of heavier glass packaging and due to increased down time on filling line breakages and these range from 15 per cent to 30 per cent, with maximum disadvantages for supplies to remote and hilly areas,says some of the plastic convertors manufacturers.
According to Suresh Kamath, president, Goa Pharmaceutical Manufacturer's Association (GPMA ), decision to ban PET will be a huge set back to the Indian government’s policy of ‘make in India’ besides badly affecting exports of oral liquids to other countries, which will jeopardise healthy investment climate.
“Glass bottles are costlier which will further push up the prices of medicines. It is important to note that PET has enabled the Indian pharma industry to develop healthy exports of their products around the world. This notification will have disastrous impact of on Indian industry. We fear that if this notification goes unchallenged, hundreds of units will be closed and NPA will rise,”he informed.
Pharma packaging majors have objected to the Union government's decision saying that the notification issued by the government is driven by public interest groups with vested interests.
According to a section of pharma packaging players, including the Bengaluru based Manjushree Technopack, PET has undergone stringent tests before it could be approved for use in pharma and food packaging since 1982. It is only in 2014 after a gap of 32 years that the government has raised objections to its use asserting that PET properties are harmful.
“The reality is that PET has passed all migration tests. It adheres to every global regulatory norm: These are US FDA CFR 21, European Union guidelines of 10/2011 and Bureau of Indian Standards : BIS 12252-1987. Backed by such stringent compliances, PET was certified for use in drugs and foods covering biscuits to beverages, Rajat Kedia, director, Manjushree Technopak .
There has been no instance of fatality or health hazards reported from patients and consumers following consumption of medicines packed in PET. The government effected the ban with misinformation as PET evaluated for its safety and convenience. Traditionally drugs and foods were packed in glass but this was replaced a decade ago with PET because of ‘leeching’ that resulted in fatality, he added.
Efforts to ban PET bottles for pharma is an ongoing affair for a section of vested interest people. There were public interest litigations(PILs) in several High Courts. Various state governments put forth their views before the judiciary advocated that arguments against PET packs were baseless. This itself is the proof on the safety of PET, he said.
It high time, that the Union government calls for an open discussion with PET packaging industry experts to comprehend the facts and do away with the ban because of the ample scientific backing of high quality and safety parameters of polyethylene terephthalate, said Kedia adding that government research centres like the DFRL, CFTRI and IITs have researched on PET safety extensively.
In the wake of the ban which is effective in six months, glass would be option for drugs and foods. Although PET is environmentally-friendly over glass which is also known to chip during package. There are several instances of glass pieces present in products sold at pharmacies.
In addition, the implication of costing is huge as companies will now need to change the packaging lines to pack drugs in glassware. Moreover, only a handful of glass manufacturers can cater to pharmaceutical needs and this would spring up a monopolistic market. Therefore, it would only be prudent for the government to cancel the notification on PET based on the rigorous tests undertaken globally and in India on its safety, said Kedia.
GPMA had stressed that this decision is unfair and discriminatory, especially since the ban as mentioned in the notification is neither based on any substantive objective data, nor any tests or pharma compliance requirements.
This move has taken many by surprise as it comes despite severe objections from the industry. Interestingly, this especially comes in the time when major industry associations like Indian Drug Manufacturers Association (IDMA), All India Plastic Manufactures Association (AIPMA), Federation of Pharma Entrepreneurs (FOPE), Organisation of Plastic Processors of India (OPPI), Organisation of Pharmaceutical Producers of India (OPPI) etc. had already made strong representation to DTAB, DGHS, MoH against the plan.
The health ministry’s decision to ban PET bottles is based on the recommendations of the Drugs Technical Advisory Board in line with the concerns expressed by an expert panel headed by Dr Y K Gupta. The issue of health hazards due to use of PET bottles in pharmaceuticals industry was brought up by a public interest group, Him Jagriti from Uttarakhand, in a representation to the health ministry last year. The NGO sought a blanket ban on the use of PET bottles as primary packaging material in pharmaceutical liquid orals, suspensions and dry syrups with immediate effect as such materials can cause severe adverse effects on humans due to the presence of endocrine disrupters. Some environmentalists, quoting recent scientific studies, point out that chemical elements in PET bottles can react with chemical components in drugs and may cause leaching in different temperature conditions existing in India.
For the user industries, PET containers for packaging gives a great cost advantage over the glass bottles. As switching over to glass bottles certainly lead to some increased costs and transportation issues, pharma industry bodies have approached the health ministry last year objecting to the ban on PET containers on the ground that usage of PET containers is a well established packaging option and is widely accepted practice in developed markets like the USA, UK, Europe and Japan.
Use of PET containers for packing medicines in developed countries may not be that harmful because of the temperate climate and advanced storage conditions there. That is not the case in India and a large percentage of medical shops do not have air conditioned premises exposing medicines to extreme heat conditions during summer. The government should therefore take a balanced view in this matter considering industry’s stand on cost escalation and also the patient welfare, opine experts.