Plastic bottles are used on a large scale for packaging of liquid products like water, soft drinks, cooking oils, cosmetic products like shampoo, pharmaceutical preparations and many other products. Plastic has become popular because it is lightweight, has superior resistance to breakage and relatively low production and transportation costs besides it provides ease of transportation as compared to glass bottles. Expect for beer and wine the food industry has completely replaced glass with plastic bottles and the pharmaceutical industry is doing exactly the same.
Packaging procedures for pharmaceutical products are followed according to those prescribed in the Product Containers and Closures under Schedule M of the Drugs & Cosmetics Act 1940 and Rules1945. These state that all containers and closures must comply with the pharmacopoeial or any other requirement, suitable sampling methods and sterilization procedures as and when prescribed to assure that containers, closures and other component parts of the drug packages are suitable and are not reactive, additive, absorptive or leachable to an extent that significantly affects the quality of the product.
In view of these guidelines, concerns have been raised about the usage of PET or plastic bottles for the packaging of water, soft drinks, pharmaceutical preparations, etc. A range of chemicals that are used in the manufacture of plastics are toxic. The concerns are justified especially because most hazardous substances used as additives in preparation of PET/plastic bottles are able to migrate or leach into the medium they come in contact with. This is because these substances are not held together with a chemical bond in the plastics.
Therefore a number of global studies have been carried out on how plastics affect the environment and human health. One such study by Thompson, Charles, Frederick and Shanna H Swift measured plastics in the human body through biomonitoring. Biomonitoring is a method used to measure concentrations of environmental contaminants in human tissues. This provides an integrated measure of an organism’s exposure to contaminants from multiple sources. Biomonitoring carried out for the study revealed the presence of Phthalates and BPA, as well as additives in plastics and their metabolites in human populations. Exposure was discovered to be simultaneous and some exposure was because of house dust but Di- (2- ethylhexyl) phthalate (DEHP) was held to come from foodstuffs and to some extent from oral drugs especially for those who have a high daily intake of these drugs. Current safe exposure levels to chemicals are based on traditional toxicological assumptions and so the toxicological effect on children, pregnant women needs further studies. However, there is no doubt that chemicals have an adverse effect on human health, including reproductive abnormalities.
Another study carried out by Emily North and Rolf Halden of Arizona State University “Plastics and Environmental Health” notes that plastic is an ideal material for single use disposable devices because they are cost effective and require little energy to produce and are light weight and biocompatible . “Yet the compounds within the plastic can damage human health. These statics reveal to what extent plastics are used and how they are affecting health and environment.
- On an average 300 million tonnes of plastic are produced around the globe each year. Of this 50% is made of disposal applications like packaging
- Plastics make up 85% of medical equipment. IV bags and tubing alone constitute 25% of hospital waste
- Plastic manufacture uses 331 million barrels of petroleum which is about 4.6% of the annual petroleum consumption in the US. None of this energy is recovered when plastics are disposed of in landfills and very little is recovered when plastic waste is incinerated.
- Recycling plastic poses major logistical difficulties, including effective sorting as it increases costs and the mixing of different plastic streams, which affects post-consumer products.
Because of the presence of plastics and the substances that they release into the environment and the potential interaction of these substances many questions are being asked about the safety of plastics for humans and the environment because
- Detectable levels of bisphenol A (BPA) from plastic has been found in the urine of 95% Americans. However, the US Foods and Drug Administration approve the use of bisphenol A for most food applications. In July 2012 the FDA amended its regulations for use of BPA in baby bottles, Sippy cups and formula packaging.
- Di- (2- ethylhexyl) phthalate (DEHP) often used in Polyvinyl Chloride (PVC) products leaches out easily and has a negative impact the studies point out which include changes to male and female reproductive systems, increased weight around the waist and insulin resistance. Environmental exposure to plastic related chemicals does not occur in isolation but has a cumulative effect.
Plastic may have its advantages but it is also a great threat to the environment and human health and therefore there is an urgent need to regulate its use and re-use and the disposal of plastic. Also since plastic is dependent on the fast depleting petroleum reserve it is no longer considered sustainable. Faced with all these concerns, in April 2015 Dr.Jagdsih Prasad DGHS and the Chairman of the Drugs Advisory Technical Board (DATB) directed the All India Institute of Health and Public Hygiene (AIIH&PH) to conduct a study on leaching of toxics from PET/ plastic bottles used for packaging pharmaceutical preparations, soft drinks, alcohol etc. The All India Institute of Health and Public Hygiene, established in 1932, was the first school of Public Health in the South –East region. Today it works under the aegis of the Directorate of Health Services, Ministry of Health and Family Welfare, Government of India. It is dedicated to teaching, training and research and makes a significant contribution to Public Health. After its study the AIIH&PH came to the conclusion that the use of PET/plastics is not safe and must not be used to package certain drugs.
In the first phase of the study the National Test House Kolkata carried out testing on samples of
- Pharmaceutical preparations like Polybion multivitamin syrup, Benadryl cough syrup, Mucaine gel, Hemfer syrup, Alex Cough syrup.
- The second lot tested was for alcohol products like Asli Nimboo, Asli Santra, Desi Daru, and Pincon Bangla. Dada, twin Tower, Good Evening.
- The third lot consisted of soft drinks like Pepsi, Sprite, 7Up, Mountain Dew and Coca-Cola.
All the samples were randomly collected from various stores in Kolkata. The following chemicals were found to be present in the samples at room temperature and the chemical content increased with increase of temperature at 40ºC and 60 ºC. The increase in lead was noticed in only two samples of pharmaceutical formulations.
In their lifetime humans are exposed to a number of chemicals both harmful and beneficial. Since it is not possible to eliminate exposure to all toxins in the environment; so safe levels of exposure to different toxins have been prescribed which is called the tolerable daily intake (TDI). This is the amount that potentially harmful toxins can be consumed daily over a lifetime without adverse effects on health. Besides this there is also the Guideline Value which under certain assumptions is permissible lifetime consumption of the substance. However even the accredited agencies revise the safe levels which puts a question mark on the way safe levels are prescribed by them. According to the WHO there is no safe level of exposure to lead and so even small amounts of lead in the contents is not safe. These limitations make it difficult to consider what exactly a safe level is. Scientific studies have clearly pointed out that the safe levels of lead for adults, children and pregnant women are different. A study carried out in the USA pointed to the fact that exposure to critically ill neonates to DEHP was a serious concern and that this potential risk required regulatory initiatives including labelling of PVC devices.
The Drug Manufacturers ‘Associations have objections to banning the PET bottles as they feel that
- The proposal of banning the PET bottles is not based on scientific study
- It is against global practices
- The Indian pharmaceutical industry is following packaging standards as prescribed so far.
However, in view of the new evidence now available from AIIH&PH, the drug manufactures are legally bound to follow the new guidelines of prohibiting use of PET/plastic bottles for certain category of drug formulations like those for children, pregnant women etc. Since this new evidence has come to light so the global practice is also subject to change. As already stated, since determining the safe levels is difficult it does not mean the present prescribed levels are safe or unsafe. Various other studies, already carried out, indicate the harmful effects of even a small amount of toxins.
AIIH & PH has made the following recommendations
- Every pharmaceutical liquid or semiliquid oral product must be accompanied by a Toxin Migration Report from an accredited agency at different temperatures. Incubation must be at one fourth, half and at three forth life of the product
- Liquid drug formulations should be made available alternatively in glass bottles of prescribed standards.
- They have also recommended that drug manufacturers earmark at least five percent of their profits for research in green plastic or alternative to plastic and to carry out research in healthy packaging