27 February 2014 08:48 [Source: ICIS news]
KOLKATA (ICIS)--India likely to keep in abeyance a planned gradual phase-out of polyethylene terephthalate (PET) bottles as containers for liquid oral formulations by the pharmaceutical industry, pending further study, a government official said on Thursday.
The initial plan was to phase out the use of PET bottles and replace them with glass bottles over a six-month period from January 2014, the official said.
The country’s pharmaceutical industry sought further scientific reports on the harm caused by PET packaging, he said.
According to the Goa Pharmaceutical Manufacturers Association (GPMA), the ban on use of PET for packing liquid formulations was not backed by scientific evidence and the packaging material was in extensive use even in highly regulated markets like UK, US and Japan.
India initially ordered the phase-out based on a report submitted by the Drug Technical Advisory Board (DTAB) to the Drug Controller General of India (DGCI), citing possible adverse effect on drug formulations packed in plastic bottles at high temperatures, which is prevalent in the country.
“India has large variation in temperatures rising to 40-45 degree centigrade … and the high temperature may result in increased leachbility [of drug formulations] or percolate and dissolve in solution ,” the DTAB said.
GPMA, in its representations to the government, noted expansion plans for liquid pharmaceutical formulations were held up since the packaging aspect is critical in making the investments.
It added that the proposed switch to glass bottles would be time consuming and entail costs, possibly lead to a shortage of liquid formulations in the market.
The Indian pharmaceutical packaging material industry is valued at around $23bn and is growing at annualized rate of 15%. Packing for beverages and pharmaceuticals account for $1.6bn of the total PET industry, and is forecast to grow to $2.15bn by 2016.
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