Industry Challenges India Proposed Ban on PET Containers for Certain Drugs
The plastics industry and drug manufacturers have challenged India's proposed ban on the use of polyethylene terephthalate (PET) containers for primary drug packaging of liquid oral formulations for pediatric use, geriatric use, and for pregnant women and women of reproductive age. The Indian Ministry of Health and Family Welfare (MHFW) published the proposed rule, "Prohibition of Use of Polyethylene Terephthalate or Plastic containers for primary packaging of drug formulations for use in certain cases Rules, 2014" (Notification G.S.R. 701(E)) on September 29, 2014.
The Society of the Plastics Industry (SPI), the American Chemistry Council, and the Canadian Plastics Industry Association submitted comments pointing out that the proposed rule is based on faulty scientific interpretation of data and a misunderstanding of the components used to manufacture PET. In contrast with the rationale behind the proposed rule, the three organizations noted that PET is not associated with endocrine disruption, and does not contain phthalates.
SPI also noted that the Indian Drugs Technical Advisory Board (DTAB) ignored the recommendation of its own Expert Committee in proposing the Rule. The DTAB Expert Committee met on July 7, 2013, to discuss claims raised in a petition filed by HIM JAGRITI, an Indian non-profit organization focused on health and healthcare issues, recommending the prohibition of the use of PET in pharmaceutical packaging. The DTAB Committee concluded that the information contained in the petition was "not sufficient enough to establish a definite correlation of causality" between plastic containers for pharmaceutical products and adverse health effects.
The Plastic Manufacturers' Association of Rajasthan also explained in comments submitted on the draft notification that glass manufacturers had previously tried unsuccessfully to have PET banned through the courts in several Indian states by "misrepresenting facts" about PET.
In a November 3, 2014 letter to the Prime Minister of India, the Indian Drug Manufacturers' Association stated that a ban on PET containers could lead to severe shortages of liquid medicines, due to an estimated 25% to 30% increase in cost per of glass bottles as compared to PET containers. The Association also pointed out that the use of PET in pharmaceutical containers results in the release of fewer greenhouse gases than glass, making the use of PET a more environmentally-friendly alternative.
The public consultation phase ended in mid-November. Once the comments are reviewed and a final notification is issued, the Rule will become effective 180 days later.