Two panels of the Union Health Ministry are having divergent views on usage of PET (polyethylene terephthalate) for pharmaceutical packaging. While a panel in the Ministry last month told the National Green Tribunal (NGT) that there is no conclusive evidence to suggest its use can pose a threat to human health, the second panel recommended ban on its usage in the sector.
The panel, headed by former secretary of Biotechnology Department MK Bhan, in a report submitted to the NGT in March said that the plastic bottles made of PET are safe for packaging medicines.
“The use of PET as a packaging material for pharmaceuticals can be practised safely especially when the country has a robust regulatory system in place with clearly defined standards and requirements,” the panel report said.
However, the Drug Technical Advisory Board (DTAB), a highest decision making body on drug issues under the Health Ministry in its meeting last month has sought prohibition on use of such containers for packing of liquid oral formulations for paediatric use as well as formulations meant for geriatrics, women in reproductive age and pregnant women following the tests reports of National Test House (NTH), Kolkata.
The debate on safety of PET kicked off following an Uttarakhand-based non-governmental organisation (NGO), Him Jagriti’s allegations that the PET bottles leaked harmful substances, including phthalates and heavy metals into the substances inside, thus posing a great danger to peoples’ health. It has also filed a petition before the NGT urging to restrict the sale of PET containers.
The expert committee was set up by the Ministry to assess the health and environmental impact on the use of PET container for primary packaging of drug formulations, following the direction from NGT.
In September 29, 2014, the Ministry had issued a notification seeking amendment to Drugs and Cosmetics Act, 1940 to impose ban on plastic containers for oral formulation. The notification was issued by the ministry after an experts committee and Drug Technical Advisory Board, a statutory board, deliberated the issue, following the representation from the NGO.
However, Confederation of Indian Pharmaceuticals Industry (CIPI) has opposed the proposed ban claiming that the PET containers are globally used for packing pharmaceutical formulations which are meant for paediatric, female and geriatric population.
“If PET bottles are prohibited, the industry will have no option but to use the glass bottles that leach a very large list of elements into water and leaching is much higher as compared to PET containers," said CIPI President PK Gupta.