On Sep 29th 2014, India’s Ministry of Health and Family Welfare (MHFW) published draft rules called “Prohibition of use of polyethylene terephthalate or plastic containers for primary packaging of drug formulations for use in certain cases rules, 2014” in Indian Gazette. The rules proposed to bring to an end the use of polyethylene terephthalate (PET). PET is commonly used in containers for liquid oral drugs. The draft applies to PET in containers for liquid oral drugs taken by children, the elderly, pregnant women and women of reproductive age.
This draft was drawn up on recommendation by India’s Drugs Technical Advisory Board. It is now open for public comment for 45 days. Industry is insisting that PET has already been put through rigorous testing before being used in food and pharmaceutical packages and has a history of safe use dating back to the 1980’s. MHFW will certainly receive a lot of feedback from the industry, whose lobbying pressure will be an important factor for MHFW to consider.
According to the draft, manufactures that fail to follow the restrictions will be financially penalized in line with the Drugs and Cosmetics Act. The draft will go into effect 180 days after its final publication in the Official Gazette.
