The Health Ministry has predictably stirred a hornet’s nest with its diktat to replace PET with glass packaging for certain formulations. While it is still three months to the cut off date and a lot could happen before then, a review of the issues at stake tries to separate the truth from the hype By Viveka Roychowdhury
By April this year, manufacturers of pharmaceutical products in India will be banned from using polyethylene terephthalate (PET) as a primary packaging material for liquid oral drugs for products meant for paedriatic, geriatric, pregnant women, and women in the reproductive age group.
This is when the six months grace period given by the Ministry of Health and Family Welfare (MHFW), Government of India (GoI), expires and the industry has to fall in line with the Ministry’s notification of October 19 last year, which followed a draft notification (GSR 701(e)) issued on September 29.
Considering that this notification could possibly be a prelude to the complete phasing out of PET as primary packaging in the pharma industry, it is understandable that associations of pharma companies are hoping that the Ministry will see their point of view. PET bottle manufacturers are also obviously hoping for a rethink on this decision.
Is this ban justified considering that materials like milk, water etc still use PET packaging?
To this, Arun Kumar Dukkipati, President, HSIL, the packaging products division of AGI Glaspac points out that packaging medicines in PET has a different connotation from milk packets etc., as medicines are intended to cure diseases and ailments. He sees the Government’s decision as highly pro-active and laudable. His company counts GSK, Pfizer, Ranbaxy, Dr Reddy’s Laboratories, Abbott, Aurobindo Pharma and Reckitt Benckiser as customers and also serves the food, chemical, spirits, and soft drink sectors.
The case against PET
The move against PET has been gaining momemtum from 2013, when 5-6 NGOs filed PILs alleging that PET, when used as primary packaging material for liquid orals, suspensions and dry syrups, had severe adverse effects on human health due to the leaching of endocrine disruptors.
The September 29 notification, issued on the recommendations of the Drugs Technical Advisory Board (DTAB) after a meeting on November 25, 2013, triggered reactions across the spectrum of industry stakeholders ranging from doctors and NGOs hailing the move and representatives of the pharma industry arguing the case for PET.
The NGO which claims to have first raised the issue, HIM Jagriti, Uttaranchal Welfare Society, Dehradun felt vidicated by the October 19 notification. In its representation in 2013 before the Ministry and other officials, the NGO had requested a ban on PET bottles as primary packaging material in pharma liquid orals, suspensions and dry syrups as it claimed that leaching of various chemicals used in the PET/ plastic bottles occurred under varying storage temperatures and also when the packaging becomes old, which can, in turn, lead to several diseases including cancer and physical infirmities.
Emboldened by the Ministry’s decision, they launched a movement in December last year called ‘Act India’ aiming to enable people demand responsible and safe packaging, and to promote the five ‘Rs’: reduce, reuse, recycle, rethink, restrain.
To raise further awareness about the issue and mobilise public opinion, they held a press conference in early December last year, to announce the launch of the Act India movement, where doctors and clinicians spoke about the harmful effects PET use.
Dr Hemant P Thacker, a physician and cardiometabolic specialist and consultant cardiologist at Fortis Hospital, who was one of the clinicians present at the event highlighted the possible long term health impact of such exposure saying, “Besides the fact that such bottles carry the hazard of toxic exposure, the passage of bisphenol A (BPA) and additives like di-ethylhexyl phthalate (DEHP) which gets leeched onto its contents, can lead to significant long term medical consequences. Women (in the reproductive age group) and children consuming this potion out of such bottles could have impaired immune development, loss of pregnancy, pre- term birth, low birth weight and congenital defects in the child which could manifest in later life.”
Dr Arbinder K Singal, a paediatric urologist buttressed this argument by quoting results from a study conducted in India, wherein the results reportedly showed that there was an approximately threefold increase in the incidence of genital abnormalities in Indian new born babies in the last 40 years. According to him, many investigators linked this sudden increase to chemical exposures in the environment which interfere with sex hormones during development and sex differentiation which happens during 8-12 weeks of foetal development. “Exposure to Endocrine Disruptor Chemicals (EDCs) during the first trimester significantly increases the chances. These EDCs, such as phthalates and bisphenol-A are widely used in plastic bottles, vinyl floors, food wraps, medical products, and toys,” he said and recommended that studies in India should be started to collect more data. He also advocated that a possible step would be to institute a ban on production of chemicals which lead to such severe disorders.
The NGO’s concerns, as well as members from the clinical/ medical community, seem to be that since India is a tropical country, storage temperatures are considerably higher than in colder regions across the world. According to Act India, while PET bottles have been tested for permissible levels of phthalates, antimony, acetaldehyde etc, for storage at temperatures of around 20oC, potential endocrine disruptor leaching increases to as high as four times the permissible limit, at higher temperatures, which is definitely of concern in our country where temperatures are considerably higher.
Another factor is that with logistics still a mostly unorganised activity in India, most consignments, even those in the pharma industry, could be left stranded in sub-optimal storage conditions and temperatures, sometimes for as long as 120 days according to Act India release, adding to the possibility and duration of leaching.
HIM Jagriti’s initial submission to the Ministry quotes a study presented at the 24th Congress of the European Society for Paediatric Urology in Genoa, Italy, in April 2013 which showed a growing incidence of genital abnormality among boys possibly because of the increasing exposure to endocrine disruptor chemicals known as phthalates and bisphenol-A. The organisation then got the leaching testing done at Kolkata’s National Test House, which confirmed their fears about the health impact of such leaching of heavy metals and phthalates. The American Society of Reproductive Medicine and International Federation of Fertility Societies have also reportedly requested the US Government for a similar action.
The other side
If HIM Jagriti quoted international studies so is the opposing camp. The Indian Drug Manufacturers’ Association (IDMA) had submitted a detailed representation to DTAB on December 20, 2013, requesting them to reconsider their recommendations, as it was ‘neither based on scientific facts nor on established global practices’. Their submission had refuted each point raised by the NGO, on endocrine disruption, phthalates, migration/ leaching, antimony etc as ‘incorrect and misinformed.’ IDMA’s submission to the DTAB went on provide scientific documentary evidence to support their claim.
IDMA’s submission claims that PET does not appear in the list of 10,000 being studied by the United States Environment Protection Agency (USEPA) as part of an Endocrine Disruptors Screening and testing programme (EDSP).
IDMA’s letter also refers to a report series titled ‘Packaging Materials: PET of food Packaging Applications’ by International Life Sciences Institute, Europe (ILSI) which is affliated to WHO and has a specialised consultative status with the US) which has mentioned that ‘PET and its components have no links with any of the reported endocrine disruptors.’
IDMA has similarly disputed claims on phthalates (on grounds that they are not used in PET bottle manufacturing), migration/ leaching (studies done at Industrial Toxicology Research Centre, Lucknow showed comparable migration with glass as well as PET and much below permissiable limits) and antimony (the IDMA letter quotes the Swiss Federal Office of Public Health, which mentions that risk to consumers from possible migration of antimony from PET bottles is negligible.)
As regards genotoxicity, the IDMA letter states that ILSI, Europe has concluded, after very comprehensive and detailed animal feeding studies, that there is no risk of genotoxicity arising out of use of antimony trioxide in PET.
IDMA has now reinterated these issues through a letter to the MHFW dated November 3, 2014 and in fact, points out that an expert committee set up by the DTAB to study these allegations noted that ‘ information provided in the representation of the NGO and according ot the available literature, is not sufficient enough to establish a definite correlation of causality of plastic container for pharmacuetical products and adverse health effects.’
IDMA’s letter mentions that five such PILs filed by various NGOs were dimissed by the respective high courts (in Allahabad, Chandigarh, Jabalpur, Hyderbad and Bengaluru) citing the fact that PET bottles were already certified by Bureau of Indian Standards (BIS) and were recyclable as well.
Better safe than sorry
Inspite of the voluminous scientific data presented by IDMA, the absence of proof of causality did not deter the DTAB from recommending the ban on PET. The fact that the impact of such exposure may not be evident now but could manifest in the future, probably weighed in on the DTAB to adopt a ‘safe rather than sorry’ stance.
This stance is justified when you consider the regulatory infrastructure in our country. An industry source associated with pharma packaging industry points out that BIS certification cannot be proof that all PET bottles used as primary packaging in the pharma sector are safe as the country does not have sufficient checks and controls and re-cycled polymers could be used. This logic applies to not just PET but other materials used in pharma primary packaging, for example, say in strip packs, or in heat sealed lacquer packs. Pharma companies are thus totally dependent on certifications provided by vendors and its anyone’s guess if these certificates will stand up to scrutiny.
There are clearly economic and practical reasons why pharma manufacturers are opposing this notification. IDMA’s letter points out that while the total pharma market of PET is one lakh metric ton (MT) per year, it will require nine lakh MT of glass annually to replace this, due to the higher weight of glass.
Do the country’s glass packaging players have the capacity to meet this increased demand? The same industry source points out that most major glass packaging companies in this category have prefered to focus on beverages and personal care products, both in domestic and global markets.
Arun Kumar however is quite confident that the glass packaging industry is completely geared up to meet the demand of the pharma industry both in terms of quality and quantity. His point is that glass packaging has always been widely used as primary packaging in the pharma industry and though current use might be slightly less, there was no need for concern on using glass bottles for filling in technical terms.
From the logistics point of view, the IDMA letter quotes from a study, which says that 1.20 lakh PET bottles can be transported in a container versus only 90,000 100 ml glass bottles as the weight of a case of PET bottles is approximately 10 times lower that a case of glass bottles.
It follows that heavier cartons, with less units per conrton, will result in increased transporation and freight costs, increased packaging costs (as mono cartons will be required for each glass bottle). Manufacturers will also have to factor in a minimum of two to three per cent loss due to breakage of glass bottles in transit. IDMA has estimated that there will be a 25-30 per cent cost increase per bottle, which in turn will increase the cost of medicines supplied in glass bottles.
As demand of glass bottles increases, their prices will shoot up, as demand will be more than supply, which will furhter lead to severe shortages as SME pharma companies may not be able to afford purchase of glass bottles at these elevated prices. The IDMA letter has therefore has warned of shortages of liquid medicines due to this notification.
But Arun Kumar estimates that while the cost of medicines will increase by about a per cent or two if this decision is implemented, he opines that this increase is insignificant when compared to the cost the whole healthcare system would have to bear in future due to the ill effects of plastic leaching into the contents in the container.
The packaging industry source goes a step further, calling the high price claim a storm in the teacup, as pharma companies already operate with 35-40 per cent raw material cost (RMC) of which packaging materials account for approximately 20 per cent. Cost increases due to freight and breakages might turn out to have a larger impact rather than material costs.
One of the most compelling reasons to use glass is, of course, the fact that it can be recycled. At the consumer end, IDMA points out that there could be instances of injury due to breakage of the glass bottles during dispensation of medicines. This could be cause for concern, especially since this notification includes formulations for geriatric and paedriatric use.
Most industry spokespersons preferred to comment off the record for this story citing the ‘sensitive nature of the issue’. The Health Ministry is faced with powerful lobby groups on all sides: NGOs, the medical fraternity, and glass packagers on one side, and pharma manufacturers and PET packagers on the other side who seem admanant not to accept the decision as fait accompli.
It is still three months to the cut off date and a lot could happen before then. Whatever the result, it is the patient/ consumer who will be impacted the most in the long run. As Arun Kumar points out, in case the government does not implement its decision of banning PET bottles for packing medicines, the health of a large section of the population could be compromised.