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US FDA issues draft guidance on Child-Resistant Packaging, paediatrics calls for immediate adoption

Nandita Vijay, Bengaluru
Saturday, August 12, 2017, 08:00 Hrs  [IST]

US FDA has circulated norms on Child-Resistant Packaging (CRP) in DRUG PRODUCT LABELLING. Paediatricians have appreciated the move and called for its speedy implementation. The guidance is intended to help ensure that such labeling is clear, useful, informative, and to the extent possible, consistent in content and format. The regulator has called to comment on these norms before October this year.

The  guidance is intended to assist pharma industry that chooses to include CRP statements in their labeling. It provides  information to be included to support CRP statements for new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologic license applications (BLAs), and supplements. In addition for non prescription drug products and those that are marketed under the Over-the-Counter (OTC) Drug Review.

One of the most popular trends in the pharma packaging currently is the ‘Child Resistant Closure Caps’. Keeping in mind the increase in demand for the PET bottles, companies are making an effort to move from their neck finish to a child resistant and squeeze loc enabled finish, said Vimal Kedia, managing director, Manjushree Technopack.

According to junior doctors at the Indira Gandhi Institute of Child Health, Bengaluru, CRP is a critical public health safety aspect. There are scores of children being rushed to hospitals for having consumed drugs mistaking it for a confectionary.

“A child resistant package usually requires a special knack to open it. It is complicated for most children to open the lid. For example, users might have to push or squeeze a lid at the same time to unlock the bottle.  It is also possible to make non-re-closable packs, such as blister packs, child resistant by using very strong material or covers that have to be peeled off. The parents should be counseled to keep the medicines out of sight and reach of children, preferably in a locked cupboards which children cannot access it. All brands should have warning labels as a caution to parents, said Dr Radhakrishna Hegde S, Senior Paediatric Consultant Apollo Hospitals, Bannerghatta Road, Bengaluru.  

The guidance is recognized by public health experts as only one component of preventing these events. Public health campaigns emphasize the need for consumer education on safe storage practices for medications. When medications are stored in reach and sight of children, these kids are able to gain access to and this defeat CRC in some instances, thereby reducing the effectiveness of the packaging measure. Therefore, FDA advocates that all drugs, irrespective of the type of packaging, be stored safely out of reach and sight of children to further the overall public health efforts to address this safety issue.

FDA regulates certain aspects of drug products’ container closure systems related to safety and efficacy. But it does not include evaluation of testing reports to determine whether a product meets the applicable standards for special packaging as set forth in the Poison Prevention Packaging Act (PPPA) to protect children from unintentional exposure to household substances including food, drugs, and cosmetics.


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