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India’s Union Health Ministry has announced the official banning of plastic containers for packaging liquid drugs in the pharmaceutical industry. The ban was proposed earlier this year, and has been formally instituted by the government now. The pharmaceutical manufacturers have been given a transition period of six months to switch from plastic to glass bottles.
According to the recent notification by the health ministry, no manufacturer shall use the polyethylene terephthalate (PET) or plastic containers in liquid oral formulations for primary packaging of drug formulations for paediatric use, geriatric use and for use in pregnant and women of reproductive age.
The ban comes into effect despite considerable resistance from pharmaceutical companies and packaging industries in India. However, the Indian government’s highest decision making body on drugs, the Drug Technical Advisory Board (DTAB), has made strong recommendations regarding the harmful effects of plastic leaching, and accordingly, the health ministry has decided to impose a ban. The DTAB recommendations were in line with the concerns expressed by an expert panel regarding serious issues of health hazards due to PET bottles in pharmaceuticals industry.
Besides the DTAB, several NGOs in India had also sought a ban on the use of PET bottles for pharmaceutical liquid orals, suspensions and dry syrups with immediate effect, due to the possibility of severe adverse effects on humans due to the presence of “endocrine disrupters”.
PET bottles are widely used for packaging liquid formulations in India’s pharmaceuticals industry for the past several decades. With the ban, the pharmaceutical industry will now have to switch to glass bottles.
“The issue was under discussion for long. However, a final decision has been taken and hasbeen communicated to the pharma industry by way of this notification. While, the glass bottles are a bit costly, they are much safer and maintains the efficacy of the medicine,” said a senior official in the health ministry.
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