Within next six months, cough syrups, antacids or vitamins in plastic or PET (Polyethylene Terephthalate) bottles will be a thing of the past in the country.
Due to the environmental and health hazards posed by plastic leaching, the Union Health Ministry has banned such PET containers in liquid oral formulations for primary packaging of drug formulations for paediatric use, geriatric use and for use in case of pregnant women and women of reproductive age group.
The move follows recommendations by the Drug Technical Advisory Board (DTAB) of the Ministry.
In a draft notification issued recently, Kl Sharma, Joint Secretary (Health) said, “No manufacturer shall use the polyethylene terephthalate or plastic containers in liquid oral formulations for primary packaging of drug formulations for paediatric use, geriatric use and for use in case of pregnant women and women of reproductive age group”.
The manufacturers has been given six months time to switch over to other packaging products such as glass instead of plastic or PET containers for liquid drugs meant for children, elderly, women in reproductive age group and pregnant women. Any manufacturer who contravenes the provisions contained in rule 2 shall be liable to penalty under the provisions of the Drugs and Cosmetics Act, 1940, says the notification.
The DTAB decision was based on a report by a scientific expert panel headed by Dr YK Gupta which had recommended phasing out the use of plastic and PET containers for liquid formulations from the market in phases. The panel felt that reports of environmental/health hazards because of increasing exposure to endocrine disruptor chemicals known as phthalates etc. were on the rise.
It said that children, geriatrics, women in reproductive age group and pregnant women should not be exposed to the hazards involved in drug packaging in plastic containers.
The scientific panel was set up following complaints from a Dehradun-based civil organisation Him Jagriti which had sought a complete ban on plastic and PET bottles as primary packaging material in pharmaceutical liquid orals, suspensions and dry syrups with immediate effect.
The organisation had cited various studies claiming that plastic or PET has severe adverse effects on human health due to the presence of endocrine disruptors. “leaching takes place under varying storage-temperature conditions and can cause several diseases including cancer and physical infirmities.
The DTAB too had noted that temperature rises to 40-45 degree centigrade during summers and exposure of plastic bottles to such a high temperature may result in adverse effect on the drug formulations packed plastic bottles.