PET packaging: the pharma industry’s Maggi moment

Call it the Maggi moment in the pharmaceuticals sector. At a time when the government has set up a high-level committee to look into a ban on the use of polyethylene terephthalate (PET), a kind of plastic, in pharmaceutical packaging, both manufacturers and environmentalists are duking it out over the quality of tests that the government is basing its decision on.

The committee was set up last month after a government-authorized agency tested some PET bottles and found high levels of toxic materials. However, industry representatives have alleged that the government has only conducted one test on a sample of five bottles and that’s not enough for a ban.

The saga goes back to early 2013 when Him Jagriti, an Uttarakhand-based non-governmental organization (NGO) that works in the health sector, approached the ministry of health seeking a ban on the use of PET for pharmaceutical packaging. The government entrusted the Drugs Technical Advisory Board (DTAB), the highest decision-making body under the ministry on technical matters, to take a call.

In a meeting held in August, DTAB discussed a test conducted by the All India Institute of Hygiene and Public Health (AIIHPH), which is affiliated to the health ministry. According to the minutes of the meeting, AIIHPH got five different pharmaceutical preparations packaged in PET bottles tested at the National Test House in Kolkata, which is under the ministry of consumer affairs.

The tests revealed that the levels of toxic chemicals were higher than safety limits. The DTAB minutes state that antimony, chromium, lead and diethylhexyl phthalate were present at room temperature in all five samples. Mint has reviewed a copy of the minutes of the meeting.

In November 2013, DTAB recommended a phasing out of PET bottles for pharma packaging over a period of six months. In the first phase, it suggested there should be a ban on the use of PET to package liquid oral formulations for paediatric and geriatric use, as well as for drugs used by pregnant women.

However, following strong resistance from PET manufacturers, a draft notification by the ministry of health prohibiting the use of PET for packaging was put on hold in September 2014.

This prompted Him Jagriti and a handful of other NGOs to approach the National Green Tribunal, seeking a blanket ban on the use of PET bottles. An order is expected soon.

“We got tests conducted at reputed government labs like the Indian Institute of Toxicology and Research, Lucknow, and our findings are similar to those of AIIHPH,” said Ajay Jugran, president of Him Jagriti.

“The reports are authentic... tests have also shown that there is heavy leaching of heavy metals and phthalates from PET bottles into their contents,” he added.

Pointing to the health risks—cancer, diabetes, endocrine damage, kidney damage, reproductive diseases and obesity - of heavy metals and phthalates, Jugran said, “We are very concerned that despite multiple test reports confirming leaching of harmful elements from PET bottles into their pharma contents. The government is just dilly-dallying on this serious public health matter by setting up committee after committee to examine the same matter again and again.”

His NGO is demanding an immediate ban on the use of PET bottles for liquid pharma medication consumed by children and women of reproductive age. “If required, let further tests and research be conducted before a wider ban or stricter regulation,” he said

PET manufacturers are not buying his argument.

Suresh Singhal, general secretary of the PET Container Manufacturers Association, an industry lobby group, likens the situation to the ban on Maggi noodles by the Food Safety and Standards Authority of India, only for the order to be lifted by the Bombay high court, subject to retesting and clearance of the product by government-approved laboratories.

“We have sufficient data to counter the claim that toxic substances were seen in medicine packaging at room temperature. Why are they considering only the results from National Test House? We have also conducted similar tests at Delhi-based Shriram Institute and it concluded that PET is completely safe. Since there is a question, they should conduct tests in an acclaimed foreign lab,” he added. Singhal’s packaging company Himalayan Group counts major pharma companies such as Cipla Ltd and Alembic among its clients.

The Indian Drug Manufacturers’ Association (IDMA), an industry lobby group, has also joined the debate. It argues that in India only virgin, and not recycled PET, is used for drug packaging. In a representation to the government, IDMA submitted that PET is not even among the 10,000 items listed by the US Environment Protection Agency as part of its Endocrine Disruptors Screening and Testing Program.

Some believe that a bit of tweaking could be done with the grade of PET products used to package pharmaceuticals in India. “There are international guidelines on PET packaging and if there is a concern regarding the grade of PET in India, we should follow these international guidelines. More tests are needed before taking a final decision,” said Nishant V. Berlia, chairman of the health committee of the PHD Chamber of Commerce and Industry, an industry lobby group.

The largest producers of PET in India include Reliance Industries Ltd, Dhunseri Petrochem Ltd and JBF Industries Ltd.

If a ban on PET does take effect, the immediate beneficiary will be the glass industry.

Arun Kumar Dukkipati, senior vice-president of lobby group All India Glass Manufacturers’ Federation, said, “For PET, leaching characteristics will be higher. If glass is used as an alternative, it will require five or six times of glass per tonne of PET. If a ban on PET for pharma comes into effect, glass manufacturers will see an increase of 25-30% in business.”

Source: http://www.livemint.com/Industry/F1AVaiglWbGnTFIt8QGFtN/PET-packaging-the-pharma-industrys-Maggi-moment.html