Expressing strong objection to the notification banning plastic containers for primary packaging of formulations, industry wants the government to urgently withdraw the same. Experts warned that failing to do so industry will be forced to approach the court, which in the previous cases have repeatedly rejected public interest litigations (PILs) that have alleged PET not suitable to pack pharmaceuticals.
In a notification issued recently the government banned the use of polyethylene terephthalate (PET) citing it to be inappropriate for use, while replacing it with use of glass bottle. Goa Pharmaceutical Manufacturer's Association (GPMA stressed that this decision is unfair and discriminatory, especially since the ban as mentioned in the notification is neither based on any substantive objective data, nor any tests or pharma compliance requirements.
This move has taken many by surprise as it comes despite severe objections from the industry. Interestingly, this especially comes in the time when major industry associations like Indian Drug Manufacturers Association (IDMA), All India Plastic Manufactures Association (AIPMA), Federation of Pharma Entrepreneurs (FOPE), Organisation of Plastic Processors of India (OPPI), Organsiation of Pharmaceutical Producers of India (OPPI) etc. had already made strong representation to DTAB, DGHS, MoH against the plan.
An industry source pointed out that this notification for the proposed banning was issued without a single hearing or meeting with the stakeholders. In fact, it is understood that DTAB had taken the decision based on the meeting with only one NGO i.e., Him Jagriti (Uttarkhand Welfare Society) and that too in the first week of May 2013.
According to Suresh Kamath, president, GPMA, decision to ban PET will be a huge set back to the Indian government’s policy of ‘make in India’ besides badly affecting exports of oral liquids to other countries, which will jeopardise healthy investment climate.
He informed, “Glass bottles are costlier which will further push up the prices of medicines. It is important to note that PET has enabled the Indian pharma industry to develop healthy exports of their products around the world. This notification will have disastrous impact of on Indian industry. We fear that if this notification goes unchallenged, hundreds of units will be closed and NPA will rise.”
He further pointed out that PET is a globally approved packaging material for pharma, foods and beverages, as PET conforms to pharma formulation packaging regulations as per BIS, US FDA, EU, PIRA, JIS, US pharmacopeia, India pharmacopeia.