Irked over the Drugs Technical Advisory Board (DTAB)'s recommendation to prohibit the use of PET containers for packing of liquid oral formulations, Confederation of Indian Pharmaceutical Industry (CIPI) has urged the Union health ministry to re-examine existing specifications and standards of PET containers in line with the international standards and revise them if needed, rather than banning it.

CIPI, an apex body of the small and medium drug manufacturers, recently submitted a memorandum to the Union ministry in this regard.

DTAB in its 71st meeting held on May 13, 2016 had recommended prohibition on use of PET containers for packing of liquid oral formulations for paediatric use as well as formulations meant for geriatrics, women in reproductive age and pregnant women following the tests reports of National Test House (NTH), Kolkata.

PK Gupta, president of CIPI, contending the DTAB recommendation, said the study should be broad based so that empty PET containers of different manufacturers may be analysed at different storage conditions for presence of toxic substances and also liquid oral formulations being imported for sale and distribution in the country packaged in PET containers shall also be examined.

The matter relating to use of PET bottles is also being examined by National Green Tribunal (NGT) where we are also petitioner. The NGT in its remarks expressed doubts on the test reports of NTH, Kolkata, Gupta said.

He opined even the expert committee constituted by health ministry under the chairmanship of former secretary, department of biotechnology Dr M K Bhan has not found any scientific base favouring the prohibition. However it expressed need to regulate manufacturers of PET containers for packaging of liquid oral drug formulations. This may require a revisit to the existing standards/specifications of PET containers for oral drug formulations.

The expert committee was set up by the ministry to assess the health and environmental impact on the use of PET container for primary packaging of drug formulations, following the direction from NGT.

Several drug manufacturers' associations including CIPI approached NGT after health ministry had on September 29, 2014 issued a notification seeking amendment to Drugs and Cosmetics Act, 1940 to impose ban on plastic containers for oral formulation. The notification was issued by the ministry after an experts committee and Drug Technical Advisory Board, a statutory board, deliberated the issue, following a representation from NGO Him Jagriti which raised concerns over the ill effects of PET in packaging of pharmaceutical products.

PET containers are globally used for packing pharmaceutical formulations which are meant for paediatric, female and geriatric population, said CIPI president.

As per assessment of International Life Sciences Institute (ILSI), Europe, the general toxicity and genotoxicity on PET indicates that material does not pose a threat to the human health and that PET and its components have no links with any reported endocrine disruptors. PET material is not listed as a potential endocrine disruptor in the list of chemicals identified by United States Environment Protection Agency. The studies have shown that use of antimony trioxide as an additive as a catalyst in PET products carries no risks if within the limits as prescribed, he opined.

“If PET bottles are prohibited, the industry will have no option but to use the glass bottles that leach a very large list of elements into water and leaching is much higher as compared to PET containers. Glass bottles are 8 to 10 times heavier and cost 2 to 3 times more than the PET bottles. Glass bottles being fragile will result in higher production losses and being heavier will result in higher transportation cost. The environmental impact due to glass bottles industry will be higher Green House Gases emission and higher energy consumption,” he added.

Further there are a number of drug formulations available in standard dosages form as far as contents of APls are concerned but the dose to be administered is adjusted/reduced if prescribed for paediatric use or meant for geriatrics, women in reproductive age and pregnant women. The proposed prohibition on use of PET containers wilt affect such liquid oral formulations also, he rued.

“Our request is that instead of banning the use of PET containers, the ministry may re-examine the current specifications and standards of PET containers for packaging of liquid oral drug formulation and revise it if it required”, he concluded.