India: PET OK in packaging, but phthalate excipient use should be minimized

The conclusion – which was presented in a report this month​ – follows years of debate prompted by a 2014 Ministry of Health and Family Welfare plan to ban​ PET in packaging for liquid drug formulations for children, the elderly and women of reproductive age.

The proposed ban – which followed concerns about PET safety raised by NGO Him Jagriti – provoked considerable reaction among Indian drug firms and container manufacturers. The Government responded by setting up the review committee.

The Committee found no “conclusive, reproducible evidence to suggest that use of PET or the additive used with it, such as antimony, for pharmaceutical packaging may leach substance(s) beyond limits that pose threat to human health​.”

It added that: “Within a robust regulatory system and process with clearly defined standards and requirements, the use of PET as packaging materials for pharmaceuticals can be practiced with assurance of safety​.”

Phthalates​

The committee also looked at the safety of a separate group of chemicals called phthalates, which are used to soften plastics in packaging manufacture.

Various studies have linked phthalates to endocrine disruption of animal laboratory animals with three specific chemicals - diethylhexyl phthalate (DEHP), dibutylphthalate​ (DBP) and diethylphthalate​ (DEP) – being the biggest source of concern.

Committee members suggested use of DEHP, DBP and DEP in packaging should be closely monitored and that further research is needed. They were less equivocal about use of their use as excipients.

“Regulatory standards and requirements should be upgraded to minimize their [Phthalates'] use and to provide more stringent norms for the circumstances where their use is in escapable, including permissible daily limits, in line with international regulatory guidelines​.”