Even as the country's Rs 10,000-cr pharma packaging industry is burgeoning with the extensive use of Polyethylene Terephthalate (PET) bottles and plastic bottles in packaging pharma products, the Union Health Ministry appears to have faced with the Hamletian dilemma of 'To be or Not to be', on whether to ban or not the use of PET bottles and plastics for packaging of pharmaceutical products, as there is an outcry from the civil society groups that the use of plastic or PET bottle for primary packaging poses a risk to the public health.

Pharma companies are increasingly preferring plastic and PET bottles over glass containers to package cough syrups, antacids, vitamins as these are shatter proof, light weight and reduce wastage.   The pharma packaging industry in the country is estimated at around Rs 10,000 crore. Of this, plastics and PVC packaging market is pegged at close to Rs 4000 crore.

The issue of banning of PET bottles and plastics for packaging of pharmaceutical products was raised by an NGO named HIM Jagriti, Uttaranchal Welfare Society, Dehradun. It took up the issue with central government and submitted a representation to the health ministry suggesting a complete ban on usages of PET bottles (both coloured and uncoloured) as primary packaging material in pharmaceutical liquid orals, suspensions and dry syrups as it has severe adverse effects on human health due to the presence of endocrine disruptors.

The HIM Jagriti argued with the government that medical and pharmaceutical products, whether consumed orally by or injected into human beings, should not be made available to the consumer in a health threatening packaging.  It has been stated that pharmaceutical liquid orals which were earlier packed in glass bottles are now being packed in PET bottles.  Most of the cough syrups, antacids, vitamins etc. are packed in coloured (Amber) PET bottles. In PET bottles leaching take place under varying storage temperature conditions and the age of packaging. The PET and plastic bottles are composed of rigid plastic and are referred because of their light weight and shatter resistant quality.  Studies have revealed that leaching of plastic leached to contamination of stored product with the chemicals released by its packaging which may be even carcinogenic, the HIM Jagriti told the government.

The NGO asked the government to completely ban plastic and PET bottles in case of at least primary packaging for pharma products citing studies that claim that leaching of plastic leads to contamination of stored products by releasing harmful chemicals from the packages, especially when these products are stored under harsh and variable temperature conditions. The use of PET and plastic bottles for pharma product poses immense risk to public health. Research from published sources show that leaching becomes faster as temperature soars and packaging gets older. There are many scientific studies to prove that leached elements can cause several diseases including cancer, the Him Jagriti warned the government.

The NGO further apprised the government that many chemical additives that give plastic its desirable properties are those very ones which can cause grave adverse impact on human health.  This impact includes direct toxicity for instance in case of lead, cadmium, mercury. Other harmful chemicals that could leach from plastic packaging include carcinogens such as diethylhexyl phthalate.

Acting on the NGO's representation in this regard, the union health ministry decided to leave the issue to Drugs Technical Advisory Board (DTAB), the highest decision making body of the ministry on technical matters.  The issue of banning of PET and plastic bottles for packaging of pharmaceutical products was taken up by the DTAB in its meeting held on May 16 this year. After detailed deliberations, the DTAB authorised Dr. Jagdish Prasad, chairman Director General of Health Services (DGHS), to constitute an Expert Committee for examination and generation of scientific opinion on the issue before the matter is further deliberated in detail.

The government will soon constitute an expert panel to examine if plastic and PET bottles used for packaging pharma products pose a risk to the public health.