Pharmaceutical industry wants the government to take immediate steps to clarify its stand on the proposed ban on the use of plastic and PET containers for liquid formulations. The government needs to substantiate with scientific evidence how the use of PET containers for packing liquid formulations will be harmful to the patients so that the industry will not be in a state of confusion.
This demand comes in the wake of growing concern within the industry over the Drugs Technical Advisory Board (DTAB) recommendation to the DCGI on phasing out of the use of plastic and PET (Polyethylene Terephthalate) containers for liquid formulations from the market on a gradual base. Goa Pharmaceutical Manufacturer’s Association (GPMA) pointed out that a lot of projects focused on expansion of oral liquid preparation have been stalled across the country due to the uncertainty and lack of clarity on the use of PET bottles.
They fear that lack of timely intervention from the government in clarifying the matter will affect not only the business but also lead to severe shortage of paediatric preparations, formulations meant for geriatrics, women in reproductive age group and pregnant women which comes in PET containers. According to A K Burman, president, GPMA globally PET is used as a well expected packaging material, even in the regulated markets like US, UK Japan etc. He stressed that industry finds it a little confusing on why India needs to suddenly ban the use of PET especially in the absence of any scientific evidence support the ban.
“Expansion plans largely depend on its packaging aspect, thus the government should come forth with a proper explanation based on scientific data on an urgent basis. So as to ensure that no one suffers due to time lapse. We fear that if this issues is not addressed at the earliest in the long run , the patients may feel the brunt of the same,” he cautioned.