The expert panel set up by the health ministry for examining and generating scientific opinion on the issue of banning of packaging of pharmaceutical products in Polyethylene Terephthalate (PET) bottles and plastic bottles has already submitted its preliminary report that will now be discussed by the Drugs Technical Advisory Board (DTAB).
The panel headed by eminent pharmacologist Dr Y K Gupta, professor and head of the Department of Pharmacology at AIIMS, has submitted its preliminary recommendations and scientific data. But the final report is still awaited. The issue of banning the PET bottles due to public health and environmental hazard will now be taken up by the ministry as per the recommendation of the DTAB.
“This is a very crucial and important issue. The DTAB will take the final call on the matter. We have received the preliminary report, but the investigations and discussions are still continuing for the final report,” Drug Controller General of India (DCGI) Dr G N Singh said, without further disclosing about the recommendations by the panel.
“The matter will be included in the agenda for the next DTAB meeting. Board will then discuss and decide as it is very crucial issue involving technical matters,” he told Pharmabiz.
The issue came up after the HIM Jagriti, Uttaranchal Welfare Society, Dehradun had submitted a representation to the health ministry suggesting complete ban on usages of PET bottles (both coloured and uncoloured) as primary packaging material in pharmaceutical liquid orals, suspensions and dry syrups, claiming that it has severe adverse effects on human health due to the presence of endocrine disruptors.
After detailed deliberations, the DTAB, the highest decision making body of the union health ministry on technical matters, at its meeting on May 16 this year authorised Dr Jagdish Prasad, chairman of DTAB and Director General of Health Services (DGHS), to constitute an expert committee for examination and generation of scientific opinion on the issue before the matter is further deliberated in detail. And the panel was set up.
Though the issue was included again in the agenda for the DTAB meeting in July, the discussion was deferred as the report from the expert panel was pending.
It has been stated that pharmaceutical liquid orals which were earlier packed in glass bottles are now being packed in PET bottles. Most of the cough syrups, antacids, vitamins etc. are packed in coloured (Amber) PET bottles. In PET bottles leaching takes place under varying storage temperature conditions and the age of packaging. The PET and plastic bottles are composed of rigid plastic and are referred because of their light weight and shatter resistant quality. Studies have revealed that leaching of plastic lead to contamination of stored product with the chemicals released by its packaging which may be even carcinogenic, the HIM Jagriti in its representation to the government said.