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DTAB refuses to take final call on banning PET bottles in pharma packaging, leaves final decision to govt
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Ramesh Shankar, Mumbai
August 29 , 2015
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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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