Use of plastic bottles to pack liquid medicines under review

Drug Technical Advisory Board constitutes expert committee

In what can have serious implications for the pharma packaging industry as well as drugmakers, usage of plastic bottles to pack pharmaceutical liquid orals and suspensions is under scanner at the moment.

The Drug Technical Advisory Board (DTAB), the apex advisory panel on technical matters under the Union ministry of health, has already constituted an expert committee to examine the matter and will take up the matter for discussion in its next meeting likely to be held in the first week of October.

After a Dehradun headquartered non-profit organisation Him Jagriti made a representation to the Centre suggesting a complete ban on usage of Polyethylene Terephthalate (PET) bottles (both coloured and uncoloured) as primary packaging material in pharmaceutical liquid orals, suspensions and dry syrups as it has severe adverse effects on human health due to the presence of endocrine disruptors, a few months back, the DTAB decided to constitute an expert committee under the chairmanship of Y K Gupta, professor and head-of-the-department of pharmacology at the All India Institute of Medical Sciences (AIIMS) to inspect the issue and come up with scientific opinion.

The final report is awaited from the expert committee and the matter is likely to be taken up at DTAB's next meeting. A senior official who was present in the last few meetings of the DTAB informed that while formal date is yet to be announced, the next meeting is likely to be held during the first week of October.

The light weight and the non-brittle characteristic of PET bottles has seen more and more pharmaceutical companies in the recent years to prefer plastic bottles as packaging material over conventional glass bottles.

A senior official in a state drug regulatory body informed, "Usually drug companies conduct independent tests to check the reactivity of a particular chemical or drug with plastic containers, and only after it is found to be non-reactive plastic is chosen as the material for packing. In all cases care should be taken that drugs are packed in material that is inert and non-reactive and does not lead to leaching."

He further added that since the matter has now come up for inspection, there could be a demand for having an independent body for doing the reactivity analysis. "The onus so far was on pharmaceutical companies," said the official.

Him Jagriti had alleged that in PET bottles leaching takes place under varying storage temperature conditions and the age of packaging. Most of the cough syrups, antacids, vitamins etc are packed in coloured PET bottles.