Plastic or PET (polyethylene terephthalate) bottles contaminated the medicines stored in these, 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," the institute said.
In the five brands it tested, the research institute found that the leaching of antimony, Di-(2-ethylhexyl)phthalate (known as 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.
Reacting to the preliminary report of the institute in August 2015, the health ministry had formed a temporary high level committee under a former secretary, M K 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 per cent of any pharmaceutical liquid or semi-liquid oral product should be packaged only in glass bottles. It also said packaging companies should deploy five per cent 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 issues 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 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 National Green Tribunal, which is seized of the matter.
THE STORY SO FAR
July 2013: India's top pharma experts authority (Drugs Technical Advisory Board) agrees for phase out of PET bottling of medicines
Sep 2013: Recommends ban of PET and plastics in liquid medicines for children and pregnant women
March 2014: The Indian Council of Medical Research (ICMR) says studies prove leaching of dangerous chemicals from PET bottles
May 2014: ICMR recommends PET plastic bottles not be used for vulnerable sections following precautionary principle
Sept 2014: NDA govt's health ministry pre-notifies the ban
April 2015: Health ministry asks govt health body to carry out tests for leaching
August 2015: All India Institute of Hygiene and Public Health (AIIH&PH) conducts tests on pharmaceutical products, juices, beverages, oils and alcohol packed in PET. Results show leaching in pharma products. Results of others not disclosed
August 2015: Ministry creates a high level committee (HLC) under ex-secretary M K Bhan to review again
March 2016: HLC submits report, says no definitive proof, says lab study unreliable recommends standards but no ban
March 2016: In on-going case before NGT, govt submits Bhan committee report dissing lab tests does not disclose actual results
April 2016: AIIH&PH finalises report, stands by its findings recommends restrictions on PET bottling
May 2016: Govt's top pharma committee endorses findings of AIIH&PH against conclusions of Bhan Committee