Contradicting what the health ministry said in March, the Drugs Technical Advisory Board now recommends banning plastic bottles for medicines.
Plastic or PET (polyethylene terephthalate) bottles contaminate the medicines stored in them, concluded laboratory tests ordered by the health ministry and endorsed by the country’s top statutory authority on standards for medicines, the Drugs Technical Advisory Board (DTAB). Based on the result of the lab tests, the board has recommended banning the bottling of medicines in plastics and PET meant for vulnerable groups, such as children and pregnant women.
These recommendations, made in May 2016, by the statutory panel of experts, stand in complete contrast to what the health ministry told the National Green Tribunal (NGT) in March, discrediting the results of the lab tests as inadequate, based on another report from a committee it formed specifically on the issue, chaired by an ex-secretary M. K. Bhan.
The study, undertaken on the instructions of the health ministry, was conducted by the government’s All India Institute of Hygiene and Public Health (AIIH&PH). It found that four heavy metals – lead, antimony, Di-(2-ethylhexyl)phthalate (known as DEHP) and chromium – had leached into the five liquid medicine formulations that were tested. The leaching occurred even at ambient room temperatures. “To consider a level as safe level amounts to playing with fire [sic],” the institute said.
In the five brands it tested, the research institute found that the leaching of antimony, DEHP and chromium increased with a rise in room temperature. The leaching of lead increased in just three brands as the room temperature rose. On lead, the World Health Organisation (WHO) had concluded that there was no known level of safe exposure.
The lab tests were also carried out on juices, beverages, alcohol and oil packaged in plastic and PET bottles. But the results of these products are not known.
A long debate
Reacting to the preliminary report of the institute in August 2015, the health ministry had formed a temporary high level committee under Bhan. The committee had found faults with the institute’s lab results.
Subsequently, in an ongoing case before the NGT, the health ministry in March tabled only the Bhan committee report, which dissed the government’s internal lab tests report as inadequate. The results of the lab tests were not disclosed before the tribunal. The committee said there was no clear proof of PET bottles contaminating medicines inside them. It also recommended that PET and plastic packaging continue and standards be set for it. It admitted that there were no standards in India for safe plastic packaging, unlike in countries such as the US.
But in May 2016, government’s statutory DTAB experts met, as they do periodically. They endorsed the lab test results of the AIIH&PH. The DTAB recommended to the health ministry to prohibit the use of plastic-bottle packaging for any liquid oral formulations having “pediatric use, geriatric use, use by pregnant women and use by any women of the reproductive age group.” These recommendations were reviewed by Business Standard as were the Bhan committee report and the institute’s lab results.
The government research institute’s special group set up on this issue itself had recommended that at least 20% of any pharmaceutical liquid or semi-liquid oral product should be packaged only in glass bottles. It also said packaging companies should deploy 5% of profits in discovering better alternatives. In its final report, the institute also rebutted Bhan committee’s critique. The rebuttle was accepted by government’s DTAB.
The debate within government on this issue dates back to 2013 when DTAB first recommended that PET and plastic packaging should not be permitted for pharmaceutical products catering to children and other vulnerable groups.
In 2014, the Indian Council for Medical Research concluded that leaching from plastic bottles had been demonstrated in various studies, and these bottles should not be used for packaging drugs meant for the pediatric age group and pregnant women. The ministry said it was going for a ban and asked for comments.
The pharma industry as well as the plastic packaging industry argued against the ban. In April 2015, the ministry asked the AIIH&PH to carry out lab tests. This sequence of events was captured by the DTAB in its internal meeting. Now, the lab test results, confirming leaching, have been endorsed by the DTAB but have not been presented before the NGT.
The story so far
July 2013: India’s top pharma experts authority (Drugs Technical Advisory Board) agreed for the phase-out of PET bottling of medicines.
Sep 2013: Recommended ban of PET and plastics in liquid medicines for children and pregnant women.
March 2014: The Indian Council of Medical Research (ICMR) said studies proved leaching of dangerous chemicals from PET bottles.
May 2014: ICMR recommended PET plastic bottles not be used for vulnerable sections following precautionary principle.
Sept 2014: NDA government’s health ministry pre-notified the ban.
April 2015: Health ministry asked government health body to carry out tests for leaching.
August 2015: AIIH&PH conducted tests on pharmaceutical products, juices, beverages, oils and alcohol packed in PET. Results showed leaching in pharma products. Results of others not disclosed.
August 2015: Ministry created a high-level committee (HLC) under ex-secretary M. K. Bhan to review again.
March 2016: HLC submitted report, said no definitive proof, said lab study unreliable recommends standards but no ban.
March 2016: In on-going case before NGT, the government submitted Bhan committee report dissing lab tests, did not disclose actual results.
April 2016: AIIH&PH finalised report, stood by its findings, recommended restrictions on PET bottling.
May 2016: The government’s top pharma committee endorsed findings of AIIH&PH against conclusions of Bhan committee.