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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.

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