Ban on PET Packaging for Pharmaceuticals - Are we prepared?

Ban on PET Packaging for Pharmaceuticals - Are we prepared?

Ban on PET2 The discussions started during early 2013 when Him Jagriti, an Uttarakhand-based non-governmental organization (NGO) that works in the health sector, approached the ministry of health seeking a ban on the use of PET for pharmaceutical packaging. The government entrusted the Drugs Technical Advisory Board (DTAB), which is the highest decision-making body under the ministry on technical matters, to take a call. In one of the meetings, DTAB discussed a test conducted by the All India Institute of Hygiene and Public Health (AIIHPH), which is affiliated to the health ministry. The tests revealed that the levels of toxic chemicals were higher than safety limits. The DTAB minutes state that antimony, chromium, lead and diethylhexyl phthalate were present at room temperature in all five samples evaluated for pharma preparations packaged in PET bottles. In November 2013, DTAB recommended a phasing out of PET bottles for pharma packaging over a period of six months. In the first phase, it suggested there should be a ban on the use of PET to package liquid oral formulations for paediatric and geriatric use, as well as for drugs used by pregnant women However, following strong resistance from PET manufacturers, a draft notification by the ministry of health prohibiting the use of PET for packaging was put on hold in September 2014 As per Suresh Singhal, general secretary of the PET Container Manufacturers Association, there is sufficient data to counter the claim that toxic substances were seen in medicine packaging at room temperature. There are test results available from Shriram Institute that concluded PET is completely safe Pranay Kumar, Chief Environment Officer, Vasudhaecofriends Projects feels that the industry is not prepared at all to follow the rule. He opines, “Pharma professionals would be well advised to go for elaborate testing for leachables / extractables at various temperatures and chemicals with glass and PET. Plastics have made many revolutions possible, including milk and oil and play a very large role in saving food wastage in a country like ours. Ban on PET3Alternative to PET could be glass but then it has its own challenges like logistics and cost. So what could be a safe way forward on this regulation?    

Packaging is a crucial part of the drug manufacturing and marketing process. While the latest move is likely to have a huge dent on revenues of bottle manufacturers who supply to pharmaceutical companies, it may also have an impact on drug makers as packaging cost and margins on it are determined by the pricing regulator.

Ban on PET1The thought revolves around the impact of this ban - If it does take effect, is our pharma industry prepared to take the blow? Can Cough syrups, antacids or vitamins in plastic and PET (Polyethylene Terephthalate) bottles become a thing of past?   What are your opinions on this? Here is the link to a quick survey where you can share your opinions - https://www.surveymonkey.com/r/ban-on-PET

Comments (11)

  • anon
    Pushpak Agarwal (not verified)

    Damage without preparation already done to the Human being including environment. If you have to see the cost, One should not waste money on medicines. Logistics is a matter of thought & convince only.

    Oct 08, 2015
  • gmillar01's picture
    gmillar01

    I strongly suspect that the "study" is flawed. PET in various grades has been evaluated, validated and used in the West for many years. If there are any serious concerns they would have been flagged up long before now by those with greater experience, especially in markets where serious litigation is common. Surely India has more serious production, validation and compliance issues to be concerned with?

    Oct 08, 2015
  • chhavi221201's picture
    chhavi221201

    Right! PET is being used for feeding bottles, what else do we need to validate on purity?

    Oct 13, 2015
  • hasan01's picture
    hasan01

    Agreed with Gordon Miller.... and sure the validation and compliance issues will not get resolved due to high level of corruption in our countries i.e. India & Pakistan very sad to take my county name too :(

    Oct 09, 2015
  • anon
    d b shetty (not verified)

    PET is the future of packaging. The reason being it can be manufactured from Agricultural waste. So there is a strong lobby against pet world wide from surprisingly the petrochemical industry. If pet is banned it will be unfortunate.

    Oct 09, 2015
  • chhavi221201's picture
    chhavi221201

    Ofcourse. And when we say Glass can substitute PET, this is actually not true. Glass has its own challenges which cannot be ignored

    Oct 13, 2015
  • amitavenkatesh's picture
    amitavenkatesh

    The understanding of testing and transparency in system between Industry and Government is also a concern, the systems are made so complicated that half do not completely understand and the other half manipulate. This seems to be another "Maggi"

    Oct 12, 2015
  • chhavi221201's picture
    chhavi221201

    Exactly. This seems to be the same situation. Just keep banning products / packaging without actually going through the actual reasons

    Oct 13, 2015
  • chhavi221201's picture
    chhavi221201

    It's just that actual test results for products packed vs unpacked needs to analysed before coming to direct conclusions and go ahead banning the product (PET)

    Oct 13, 2015
  • anon
    Hrudayesh (not verified)

    The Pharma Bottles made from PET (Polyester) recycled or used bottles in India should be banned. Only the ones made from Virgin grades should only be used. If recycled PET is used then 5 % max should be mixed with virgin materials and only in case they have used the proper equipment. In India recycling is done on very cheap plants from China which are unable to remove contaminations such as PVC, Glue, sugar etc. and also degrade the material making it not suitable for food or pharma application. Such recyclers should be banned from supplying recycled PET for Bottle applications. Unregulated Pharma companies mostly use 100% recycled materials and because of them all have to suffer. 95% of the soft drinks use only Virgin PET for bottles and at times add a max of 2.5 PET recycled material from regulated plants. Never has there been any issue of contamination. The government should allow use of all recycled bottles only for non food application. World over more and more PET bottles are used for Pharma formulations as it is safe.

    Oct 23, 2015

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