The move – detailed in the official Gazette of India on September 29 – will prohibit the use of polyethylene terephthalate, or PET, in liquid oral formulations for primary packaging of drug formulations and impose penalties on manufacturers that contravene the ban.
Stakeholders have until November 13 – or 45 days from the original announcement – to lodge comments with India’s Ministry of Health and Family Welfare according to the Government, which said any objections or suggestions received “shall be taken into consideration.”
If no convincing objections are raised the ban will “come into force after a period of one hundred and eighty days from the date of its final publication in the Official Gazette.”
Ajay Jugran, a spokesman for NGO Him Jagriti, told in-Pharmatechnologist.com the plan signalled “the Government's initial approach to insulate vulnerable sections of the society from the risks associated with plastic packaging used in the Pharma sector has been issued."
He added that: “In response to the said notification, we will send our suggestions to the designated person within the 45 day deadline.”
Dehradun, Uttarakhand-based Him Jagriti has campaigned for a ban on PET bottles arguing that they release harmful chemicals that can contaminate the pharmaceutical products they contain, particularly at high temperatures.
Is proposed ban on PET sound?
Use of PET packaging for pharmaceutical formulations has been a subject of discussion in India for some time, but the debate really took off in November when the Central Drugs Standard Control Organization’s (CDSCO) technical advisory board recommended a ban.
The following month the Indian Drug Manufacturers Association (IDMA) called the recommendation “unjust” and based on neither “robust scientific facts nor on established global practices.”
The IDMA cited data from a number of international agencies to support its argument, including the US Environmental Protection Agency (EPA) which it said had concluded “PET is not an endocrine disruptor” and included glass on a list of chemicals potentially capable of causing such damage.
The industry group also cited data from the Industrial Toxicology Research Centre (ITRC) – a for-profit lab that claims affiliations with the Government and international agencies like the US FDA – which it said showed that the level of leaching from PET and glass bottles was comparable.
Petcore Europe, the European trade association for PET which also commented on the recommendation in December, told us that: “The proposed prohibition of PET containers for primary packaging of certain drug formulations is not accredited by any scientific evidence."
The organisation went on to say that: “PET is approved as safe for use in food & drugs packaging worldwide such as in Europe, USA and Japan,” adding that “we therefore believe that this ban makes no sense for PET and we will respond accordingly.”
The announcement of the PET ban in the Gazette of India does not include any scientific data and the Indian Government did not respond to a request for either confirmation or more details.