|
DTAB asks govt to prohibit use of PET for primary packaging of drug formulations for vulnerable groups
|
|
Ramesh Shankar, Mumbai
May 31 , 2016
|
|
|
The Drugs Technical Advisory Board (DTAB) of the Union health ministry
has once again recommended to the government to prohibit the use of
Polyethylene Terephthalate (PET) or plastic containers in the liquid
oral formulations for primary packaging of drug formulations for
paediatric use, geriatric use and for use of pregnant women and women of
reproductive age group.
The DTAB's latest decision is based on
the study conducted by the All India Institute of Hygiene and Public
Health (AIIH&PH), Kolkata in which samples of five different
pharmaceutical preparations packaged in PET bottles were subjected to
testing at National Test House, Kolkata. In the study, 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 controversial issue
of banning of packaging of pharmaceutical products in PET/plastic
bottles again came up for discussion during the DTAB's 71st meeting held
on May 13, 2016. “DTAB agreed with the findings of AIIH&PH, Kolkata
and also method of tests adopted by the National Test House, Kolkata.
Based on these evidences DTAB after deliberations recommended that
report may be forwarded to the Ministry of Health and Family Welfare for
its consideration and finalization of the draft rules to prohibit the
use of Polyethylene Terephthalate or plastic containers in the liquid
oral formulations for primary packaging of drug formulations for
pediatric use, geriatric use and for use of pregnant women and women of
reproductive age group”, the DTAB in its recommendation said.
Earlier,
the issue also came up for discussion at the 70th meeting of DTAB held
on August 18, 2015 when it refused to take a final call and has asked
the government of India for consideration of the findings of AIIH&PH
and take further action in the matter.
The issue dates back to
2013 when the DT AB in its 65th meeting held on 25.11.2013 recommended
that the use of PET should phased out and banned, in view of reports of
leaching of harmful chemicals from plastic bottles to the contents on
long storage
Accordingly a Gazette notification G.S.R. 701
(E) dated 29.09.2014 was issued by the government for amendment under
the Drugs and Cosmetics Rules, 1945.
However, since a large
number of comments were received by the government on the draft rules
especially from the PET manufacturers, associations, etc. raising
objections the notification, the government constituted a committee
under the chairmanship of Prof M K Bhan to assess the health and
environmental impact of the use of PET for primary packaging of drug
formulations.
Interestingly, the Bhan committee recommended
continued use of PET for pharma packaging as the committee did not find
any conclusive, reproducible evidence to suggest that such use will have
any ill effects on human health. It sought clarifications in respect of
methods of estimation adopted, sample size, etc. by the AIIH&PH.
In
reply, it has been clarified by the AIIH&PH in its report that it
had used Optical Emission Spectrometry, Gas Chromatograpy, Mass
Spectrometry and Atomic Absorption Spectrometer and the sample size
consisted of three bottles of the product of same batch number at three
different temperatures, room temperature, temperature at 40'C, and
temperature at 60'C after incubation of ten days.
In view of all
these reports and clarifications, the matter was again considered in the
71st meeting of the DTAB held on May 13, 2016 and it recommended to ban
the use of PET in the liquid oral formulations for primary packaging of
drug formulations for pediatric use, geriatric use and for use of
pregnant women and women of reproductive age group.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|