New Delhi: State-run National Institute of Nutrition (NIN) will assess the health impact of the use of polyethylene terephthalate (PET) or plastic bottles to package medicines, based on which the health ministry will take a decision.
The study will help settle an issue that has been lingering for more than four years, government officials said.
The government’s top research institute—the Indian Council of Medical Research (ICMR), under the ministry of health—has tasked Hyderabad-based NIN to conduct the study to ascertain the safety of PET bottles for packaging pharmaceuticals. “A study is being planned by one of ICMR’s Institute. Draft protocol is being reviewed by expert committee,” ICMR told the ministry in a letter in September.
“The matter was examined and it was decided to ask ICMR to expedite it. Considering the sensitivity of the issue, we have asked the ICMR to get the test conducted in at least three laboratories in order to satisfy all the parties involved. To start with, NIN has been shortlisted. The idea is to come to the conclusion on this long-debated issue,” said a government official who declined to be named.
In 2013, Him Jagriti, an Uttarakhand-based non-governmental organization (NGO) that works in the health sector, had approached the ministry of health seeking a ban on the use of PET for pharmaceutical packaging. The matter went to the government’s highest decision-making body on technical matters—the Drugs Technical Advisory (DTAB)—which, based on tests conducted by the All India Institute of Hygiene and Public Health, revealed that levels of toxic chemicals were higher than safe limits. “The reports also revealed heavy leaching of heavy metals and phthalates from PET bottles into the contents,” said another official, requesting anonymity.
Following the report, the DTAB recommended that PET and plastic packaging be banned for pharmaceutical products catering to children and pregnant women. It said suggested the phasing out of PET bottles for pharma packaging. In the first phase, it was suggested that there should be a ban on the use of PET to package liquid oral formulations for paediatric and geriatric use, and for drugs used by pregnant women. A draft notification to this effect was put up. However, due to strong resistance from PET manufacturers, the draft notification was put on hold in September 2014.
At that time, the government also set up a high-level committee to look into the matter under M.K. Bhan, a former secretary in the department of biotechnology. 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.
The Bhan panel told the tribunal there was no conclusive evidence to suggest that use of PET or additives like antimony for pharmaceutical packaging may leach out substances beyond limits and pose a threat to human health.
“The NGT favoured the PET bottle industry and now the case pertaining to its safety is with the health ministry,” said Suresh Singhal, general secretary of the PET Container Manufacturers Association, an industry lobby group.
Singhal’s packaging company Himalayan Group counts major pharma companies such as Cipla Ltd, Sun Pharmaceutical Industries Ltd and Abbott as clients.
PET manufacturers say that their products are absolutely safe. “We are happy that the health ministry has initiated the process. The studies conducted now will nullify the initial study. We, as a PET processor and manufacturer are 100% sure about the safety of our product. If the samples are genuinely tested, the government will know that the worldwide accepted bottles are safe for the pharma industry,” added Singhal.