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The Drugs Technical Advisory Board (DTAB) has refused to take a final call on the issue of banning of packaging of pharmaceutical products in PET/plastic bottles and has asked the government of India for consideration of the findings of All India Institute of Hygiene and Public Health and take further action in the matter.
The issue of banning of packaging of pharmaceutical products in PET/plastic bottles came up for discussion at the 70th meeting of DTAB held on August 18, 2015 at CDSCO, New Delhi. DTAB is the highest authority under the Union health ministry on technical matters.
In the meeting, the chairman raised the issue for the consideration of the DTAB, in the light of the report of Plastic Hazards Committee of the All India Institute of Hygiene and Public Health, Kolkata in respect of testing the level of toxic chemicals in medicines and other formulations sold in PET bottles with respect to the safety limits.
A study was conducted at the All India Institute of Hygiene and Public Health in which samples of five different pharmaceutical preparations packaged in PET bottles were subjected to testing at National Test House, Kolkata. It was found that antimony, chromium, lead and DEHP were present even at room temperature in all five samples. The concentration increased on exposure to higher temperature in the laboratory.
The Plastic Hazards Committee of the All India Institute of Hygiene and Public Health then recommended that the issue of cumulative exposure needed to be addressed through large scale toxicological / toxicokinetic studies.
Earlier, in its 65th meeting on November 25, 2013 it had recommended to phase out the use of PET bottles in pharma packaging. In the first phase, the use of plastic/PET containers in liquid oral formulations for primary packaging of paediatric formulations as well as formulations meant for geriatrics, women in reproductive age group and pregnant women should be phased out and banned. The industry was given an adequate time of six months for smooth switch over.
Accordingly a gazette notification G.S.R. 701(E) dated 29.09.2014 was issued by the government of India for amendment under the Drugs and Cosmetics Rules, 1945 for the purpose. A large number of comments were since received especially from the PET manufacturers associations etc. and the objections and suggestions so received are under consideration of the government of India for the purpose of finalisation.
After detailed deliberations in its meeting on August 18, 2015, the DTAB, however, refused to take a final call on the matter and it recommended that the finding of the committee may be forwarded to the government of India for consideration and taking further action in the matter.
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