Six months after the central government first issued the notification on September 29, 2014, banning the use of polyethylene terephthalate (PET), the ban is finally about to be made effective from April. PET bottles carrying suspensions and liquids of medicinal value will henceforth be pushed out of the Indian market. The government had given six months to phase out all such bottles carrying medicines for children, pregnant women and old-age people’s medicines from the market. The move comes after a petition from an Uttarakhand-based NGO, Him Jagriti.

The '4,000-crore PET manufacturing industry is a big employment generator, with the pharmaceutical industry being a major consumer of PET. The steps taken by the government to ban PET will, however, impact the pharmacy industry to the core, as its packaging costs will increase substantially. Therefore, the Indian Pharmaceutical Association has raised strong objections to the prohibition and has requested “immediate intervention of the ministry of health and family welfare to reconsider these rules”.

The association claims the ban would create an acute shortage of medicines in the country, as there may not be adequate glass bottle capacities to cater to the industry. On the other hand, the move is likely to break the backbone of PET product manufacturers.

The apex body of drug regulation, the Drug Technical Advisory Board (DTAB), after the meeting of its expert committee on July 12, 2013, had observed, “The committee finally concluded that the information provided in the representation of Him Jagriti and according to the available literature, is not sufficient enough to establish a definite correlation of causality of plastic containers for pharmaceutical products and adverse health effects. However, this is an important public health concern and needs detailed investigation.”

Also, it added, that “absence of evidence” may not be considered as “evidence of absence” of the potential harmful effects of packaging of pharmaceutical products in plastic containers. Further, it added that the issue needed to be viewed in light of the environmental hazard being posed by the use of plastic containers.

The members said the reports of environmental health hazards, because of increasing exposure to endocrine disrupter chemicals known as phthalates, etc., were increasing. “Therefore, it would be in public interest, especially considering the precautionary principle that children, old people, women in reproductive age group and pregnant women should not be exposed to the hazards involved in the packaging of drugs in plastic PET containers.”

The DTAB after deliberations recommended that in the first phase, the use of plastic/PET containers in liquid oral formulations for primary packaging of paediatric formulations as well as formulations meant for geriatrics, women in reproductive age group and pregnant women should be phased out and banned.

However, considering the problems faced by the pharmaceutical industry with the sudden ban it decided to give “an adequate time of six months for smooth switchover”.

The Indian Pharmaceutical Association and All India Plastics Manufacturers’ Association have strong reservations against the move taken by the government. They say PET is used globally in medical applications for different end-uses, which includes packaging of different pharmaceutical products, such as liquid formulations, blood collection tubes and APET tray for packaging of medical instruments. Not only this, PET, which is basically polyester, has been used as fibre and yarn to make clothing since the 1950s. People have been wearing shirts, trousers and sarees made of PET and moving around in high RH and temperatures in lndia, but there has been no negative impact of this at all.

They further say PET bottles are approved worldwide by global as well as Indian regulatory institutions under different standards focusing on its usage in actual conditions. These include: Food Safety Standards and Authority of India (FSSA), Bureau of Indian Standards (BIS), US Food and Drug Administration (USFDA), United States Pharmacoepia (USP), European Pharmacoepia (EP), Indian Pharmacoepia (IP), etc.

Pharmacopeia standards stipulate guidelines and publish a list of packaging materials approved for pharmaceutical packaging, strictly adhered to by all pharmaceutical companies. They test packaging as per these standards and that is why it is so common to find several liquid medicinal formulations in PET bottles in some of the most health conscious countries like the US, Europe and Japan, among others.

PET bottles are free from hazardous substances like Bisphenol-A, Phthalate Plasticizers, Carcinogens and other Endocrine Disrupting Agents. Recyclable and eco-friendly, a PET bottle is useful even after its use; gets recycled into high-value products. Discarded bottles are recycled to make fibres for carpets, upholstery, pillows, clothing, strap for cotton bales, and paper.

Low fuel consumption, as 30 percent more bottles can be transported in the same truck vis-a-vis other packaging materials. PET also translates in a lower carbon footprint.

Legal battle

Six petitions challenging the use of PET bottles in India have already been dismissed by the high courts of Madhya Pradesh, Karnataka, Andhra Pradesh, Punjab and Haryana and Allahabad before being finally dismissed by the supreme court in October 2013.

Talking on the issue, director general of health services, Dr Jagdish Prasad said, “PET has been found to be carcinogenic, that is why we are banning it, as we cannot put human lives at risk even if it is cheap or easily portable.”

Ajay Jugran, president of Him Jagriti, said, “The DTAB has taken a decision on the findings of the National Test House and Indian Institute of Toxicology Research of Lucknow and the decision has been taken on a scientific basis to save children, pregnant women and old people from slow poisoning from leaching of chemicals.”

pankaj@governancenow.com

(This article appears in the April 1-15, 2015, issue)