Even as the government has proposed a ban on plastic (PET) containers as primary packaging in liquid oral formulations for paediatric, geriatric and reproductive healthcare use, industry has opposed the move saying it is neither based on scientific facts nor on established global practices.
In a recent submission made to the health ministry, IDMA stated that use of PET bottle is considered safe and acceptable on all counts- regulatory, pharmacopoeial, legal, packaging, distribution, logistics and wastage.
PET bottles are being used widely in packaging of oral liquids and tablets globally including the US, Europe and Japan. All the leading pharmacopoeias of the world like the United States, British, Japanese, Indian etc approve the use of PET bottles as safe in packaging of pharmaceutical products.
According to an industry official, it is to be noted that the current gazette is only a draft notification with reference to the usage of PET bottles and there is no ban in place. PET bottles widely used for pharma products in many countries are tested as per global standards. Bottles made from PET plastic are used for packaging medicines for paediatric, geriatrics and pregnant women by the world’s biggest and best pharmaceutical companies.
It is pertinent to note here that various governments around the world, including Government of India, have approved PET for packaging of drug formulations for more than 30 years now, and till date no single case of any adverse events has been reported from anywhere.
There is an added danger of injury due to breakage of the glass bottle by the consumer, especially children and old persons. Also, mono-cartons will be required for each glass bottle thus adding to the costs, all these leading to an estimated 25 to 30 per cent cost increase per bottle, which will in turn increase the cost of medicines that are supplied in glass bottles.
"Due to increased demand for glass bottles, the prices of glass bottles will shoot up as demand will be more than supply, which will lead to further shortages as small and medium pharma firms may not be able to purchase glass bottles at increased prices," said IDMA in its representation to the health ministry.
A draft notification was issued in September 2014 by the health ministry for proposing the ban on PET or plastic containers for primary packaging of drug formulations and a stipulated period of 45 days for objections/ suggestions was also specified.