Following government notification banning PET bottles as primary packaging in liquid oral formulations for paediatric, geriatric and reproductive healthcare use, industry may be able to comply with the notification in six months time in the wider patient interest.

Though experts feel the notification which is based on Drug Technical Advisory Board (DTAB) recommendations is backed by scientific data, medicines packaged in PET bottles continue to be sold in the market despite the notification. President All India Glass Manufacturers' Federation (AIGMF), Alok Taparia, however say that industry is well equipped for the switch over to glass packaging from PET as glass manufacturers industry has the capacity of 10,000 tonnes per day and an investment of Rs.7,500 crore.

Adding to it Vinit Kapur, secretary, AIGMF said, “Glass packaging is completely inert, safe and made from naturally occurring minerals. Glass is again 100 per cent recyclable. The industry shifted to PET packaging solely for commercial benefits as PET is cheaper and unbreakable. The glass industry which has plenty of idle capacity can easily supply to the extra demand."

The notification released on September 29, 2014, clearly said that the draft rules shall be taken into consideration on or after the expiry of a period of forty-five days from the date on which the copies of the Gazette of India containing this notification is made available to the public. It further said that any manufacturer who contravenes the provisions contained in Rule 2 shall be liable to penalty under the provisions of the Drugs and Cosmetics Act, 1940.

As per the scientific data shared by experts, packaging of medicines in PET bottles will lead to adverse health effects in women and children, including preterm birth, low birth weight, congenital defects. There will be 80 per cent increase in miscarriages and asthma and 78 per cent increase in risk of breast cancer cells is due to due to use of plastic bottles to pack liquid medicines.

These were the thoughts shared on the sidelines of the launch of a movement called “Act India which aims at enabling people demand responsible and safe packaging” hosted by Him Jagruti, a not-for-profit independent organisation in association with Medwiz Healthcare Communications Pvt. Ltd.

Dr Mamta S Jain, MD, Medwiz Healthcare said, "This is a great step by the ministry as based on 'safety first approach', keeping in mind both Indian and international evidence which documents direct linkage of leaching of harmful products above permissible rates from the PET bottles."

Pharmaceuticals industry in India has been using PET bottles for packaging mainly liquid products for many years. HIM Jagriti, Uttaranchal Welfare Society Dehradun based non-profit organisation had made a representation before the secretary, ministry of health, directorate general health service and drug controller, wherein it had requested to impose a ban on polyethylene terephthalate (PET) bottles as primary packaging material in pharmaceutical liquid orals, suspensions and dry syrups as it has severe adverse effects on human health due to presence of endocrine disruptors.

HIM Jagriti claimed that in plastic bottles leaching takes place under varying storage temperatures and also when the packaging becomes old, which can, in turn, lead to several diseases including cancer and physical infirmities.

Informed Dr Hemant P Thacker, senior consultant from Breach Candy and Jaslok Hospital, Mumbai, "In this world where plastic is omnipresent, the new legislation by the government banning the use of PET bottles in the dispensing of oral formulations is indeed commendable. 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, preterm birth, low birth weight and congenital defects in the child which could manifest in later life.”

Echoed Dr Jayesh Lele, Hon. Secretary, IMA Maharashtra State Chapter, "While the potential harmful effects of such toxins and chemicals could fill a chapter, it is time for the pharmaceuticals and ancillary industries to take the right cue from this government ordinance and minimise man made medical issues in the vulnerable population."

After a successful representation with the government to enforce the ban and in support of Act India Movement, Ajay Jugran said, “ A study, which was presented at the 24th congress of the European Society for Paediatric Urology in Genoa, Italy, on 26.04.2013, showed there is a growing incidence of genital abnormality among boys possibly because of the increasing exposure to endocrine disruptor chemicals known as phthalates and bisphenol-A."

American Society of Reproductive Medicine and International Federation of Fertility Societies have also requested the government of United States of America for a similar action.

Dr Arbinder K Singal, Paediatric Urologist concludes, “ Globally there has been an increase in male reproductive disorders and in India genital abnormalities in new born babies has seen a threefold increase in the last 40 years. Many investigators link this to sudden increase to chemical exposures in the environment which interfere with the sex hormones during development and sex differentiation which happens during 8-12 weeks of foetal development. Exposure to Endocrine Disruptor Chemicals (EDC’s) during first trimester significantly increases the chances.