In what could be a major relief to Indian pharmaceutical companies, a committee of experts on Monday deemed PET bottles safe for packaging pharmaceutical formulations.
In what could be a major relief to Indian pharmaceutical companies, a committee of experts on Monday deemed PET bottles safe for packaging pharmaceutical formulations. The pharma companies were earlier asked to phase out the use of plastic containers in liquid oral formulations meant for paediatric formulations, geriatrics, women in reproductive age group and pregnant women. However, the experts cautioned about the treated soda-lime glass and regular soda-lime glasses, citing they are “suitable to leaching”.
Stating that there was “no conclusive, reproducible evidence to suggest that use of polyethylene terephthalate (PET) or additive used with it such as antimony for pharmaceutical packaging may leach substances beyond limits that pose threat to human health, the committee of experts, in their submission to the National Green Tribunal, however said that “treated sodalime glass and regular soda-lime glasses are suitable to leaching”.
According to the report by experts, “Treated soda-lime glass is characterised by high hydraulic resistance and is more suitable to leaching than borosilicate glass.” It further said that regular soda-lime glass untreated with moderate hydraulic resistance is more leachable oxide than treated soda-lime glass.
The ministry of health and family welfare (MoHFW) had earlier in 2014 proposed a ban on pl-astic containers for oral formulation after the an experts committee and Drug Technical Advisory Board, a statutory board, considered the issue, following a representation from NGO Him Jagriti that raised concerns abo-ut the harmful effects of PET in packaging of pha-rmaceutical products.
Later, the pharmaceutical firmss approached the NGT that directed the MoHFW to constitute an expert panel to study the science behind the issue.
Thereafter, the expert committee was constituted under the chairmanship of former secretary (department of biotechnology) M.K. Bhan to assess the health and environmental impact on the use of PET or plastic container for primary packaging of drug formulations.
The committee in their report submitted on Wednesday said, “Within a robust regulatory system and process with clearly defined standards and requirements, the use of PET as a packaging material for pharmaceuticals can be practised with assurance of safety. PET does not require use of phthalates or any plasticisers in the manufacturing process.”
This findings are expected to come as a major relief to the Rs. 4,000 crore Indian PET packaging industry. Of the 600,000 tonnes of PET production, the pharmaceutical industry uses around 16 percent, accounting for around 100,000 tonnes every year.
Further, the committee also noted that National Test House and Indian Institute of Toxicological Research (IITR), labs that conducted tests on PET bottles, have not consistently used rigorous methods for all estimations, reporting of results and choice of standards.“The committee requested Him Jagriti to provide additional information in the test reports which requires clarification and Him Jagruti did provided a response but the core concerns raised by the experts remained unanswered making it difficult to arrive at reliable conclusion in either direction.The committee noted “common features of the submitted reports are inadequate reference value for interpreting results.”
The committee also recommended establishing better standards, regulatory requirement strategies for the country. It has also stressed strengthening of regulatory guidelines by prescribing specific methods for disposal of pharmaceutical packaging wastes. In an effort to address public concerns and strengthening of regulation for packaging and waste management, the committee has recommended a series of additional tests. It however is clear that “this tests have been requested to assure public concerns and not because of any doubt in the committee about the scientific basis of safety of PET packaging,” the report further added.
