Child resistant packaging, Definitely not child’s play!
Children are naturally attracted to brightly coloured medication and it only takes a second to pop a pill, but this innocent act could lead to tragedy. Child resistant packaging is one optimum solution to this situation. Usha Sharma traces a new trend in the industry.
Pharma industry needs reliable and speedy packaging solutions that can deliver a combination of product protection, quality, tamper evidence, patient comfort and security requirements. Meeting all these challenges child-resistant (CR) packaging, is designed or constructed to be significantly difficult for children under five years of age to open within a reasonable time but not difficult for normal adults. Such packaging is called child-resistant, rather than childproof, because some children will be able to open it. US and Korean regulatory bodies have already enforced CR packaging guidelines for all pharma products, while efforts are on in the European Union (EU) to develop unified standards across the EU countries .
Avinash Mandale, Global Chief, Marketing Officer Bilcare explains CR packaging’s vital need saying, “CR packaging is essential from the children’s safety angle. Every pharma product needs to be CR packed because it can prevent a child from accidental consumption or misuse of the medicine. For example; if the patient is suffering from diabetes there are chances that his son/daughter may accidentally consume diabetes pills and their sugar level may go down which can lead to a fatal situation.”
In India few leading pharma companies like; Ranbaxy, Cipla, Dr Reddy’s Laboratories, Lupin, USV Wockhardt, Ipca Laboratories, Aurobindo, Strides Arcolab, Indoco Remedies etc, are already using CR packaging but it is mainly meant for generic export markets.
Giving the rationale for the increasing need for CR packaging, Ranjit Shahani, Vice Chairman and Managing Director, Novartis India, reasons that, “CR caps are mandatory for most products in US. Generic players in India, into export to US have to use CR caps with high density polyethylene (HDPE) containers and as US generic drugs markets have shown very good growth compared to other branded drugs, the potential is very vast.”
CP packaging is often available in the form of Ecobliss wallet packs with dose guard labels, CR caps and closures, few customised and tailor-made packs and so on. Normally, the standard CR pill boxes remind the patient to take the medicine at right time. However, the usage of such pill boxes is limited as the medication is transferred from the primary pack to such pill boxes as per the requirement. While designing a CR pack to suit requirements, the challenge lies in commercial production of high volumes at high speeds. Presently, the most common CR packaging available is known as ‘push through’, which needs higher effort to take out the medicine and thus a child would most probably give up after a few attempts. Conventionally, foil available in the market is peelable foil. In a ‘peel and push packaging’ the tablets need to be pushed. However, these two foils are not senior friendly either.The lidding material has a peelable coating and is sealed to the blister using heat and pressure. The packaging and its contents can then be sterilised. Lidding material can be die- cut in any shape required. These materials are compatible with common sterilisation methods such as ethylene oxide (ETO), gamma ray sterilisation, beta ray sterilisation and steam sterilisation. Stressing on the uses of CR foils, Debdeep Bhattacharya, Director, Ess Dee Aluminium says, “CR lidding means safety, security and convenience in preventing children from gaining access to medication. As regulations come into effect, it is important to increase the barriers for children, while simultaneously allowing easy access for seniors.”
In the USA, CR packaging is result of the Poison Prevention Act (PPA) passed by the US Congress in 1970. The purpose of the law is to decrease the opportunity of children to gain access to substances, resulting in accidental poisoning. In addition, the PPA extends to all states or localities in the USA and is the one standard applied for all applicable products. The European standard only covers packages containing paracetamol, aspirin and medicines which containing 24 mg of iron.
Commenting on CR packaging regulation Bhattacharya says, “US and European testing methodologies are not very different but there are substantial differences in the additional requirements and criteria. US drugs need to be labelled CR, including determination that if ingested by a child, the drug toxicity level would not cause harm or injury. This is not a consideration in determining the type of package used in Europe.”
He further highlights that, “In the US, protocol testing methods were developed primarily to address cap-and-vial closures as this was the preferred packaging format in the 1970s with unit dose formats being virtually non-existent. Today, there is a significant bias towards unit dose formats such a blister and strip packaging. During the protocol development era, it has been estimated that blister use and unit of use packaging formats represented less than 20 per cent of US drug packaging.”
Highlighting global CR packaging trends, AVPS Chakravarthi, Managing Director, Ecobliss India says, “Currently legislation exists for commercial products in Europe for UK, Germany and Italy and the Netherlands. The US is the biggest market with extensive legislation and potential litigation. On the clinical trial front all US trials have to use trial samples with CR packaging, but there is no requirement elsewhere in the world.”Commenting on mandatory guideline of CR packaging in India, Mandale says that, “The US and Korea regulatory body has already made it a compulsion and very soon other regions will follow. In India, I assume that it will take some more time to come in force. It would be better if pharma industry does follow the guideline; but I am assuming that it will take some more time to come as an Act and become a regulatory compulsion on each pharma company. Whereas, in the European market regulatory body’s discussions are on going.”
“If Government is looking from safety point of view of child by preventing accidental use of tablets, then it must be mandatory. It should make it mandatory in India as well, for all formulations harmful for children,” says Bharat Mehta, Managing Director, Super Label Manufacturing.
CR market is growing with more and more companies developing packaging solutions. As arthritic patients find bottles difficult to open, blister packs with thicker foil or paper/foil laminates are also very difficult for such adult patients to access. Also, these are cumbersome, size limiting and expensive. Ecobliss Pharmaceutical wallets supported by dose guard and dose guard labels applied directly onto the blisters provide the best cost effective compliance solution and it is for blisters which have the advantage of excellent CR and senior friendly access. The regular Alu-Alu or blister packs are the ones mostly in general use. Chakravarthi enlarges the usage of CR and its cost effective ways saying, “The CR packaging needs to be cost effective and should not add too much to the packaging cost while complying with requirement. And it should be feasible at high volumes and high productions speeds as well.”
“Alu-Alu packaging would be confined to a smaller quantity of products and service a niche segment. The need of the hour is to facilitate bulk packaging to reduce costs in the generic market which is being achieved through the use of HDPE containers fitted with CRC caps, observes Eric Souberiran, Business Managing Director, Rexam Pharma Packaging India.
On the cost front, Mehta says, “To change from current mode of packaging to CR packaging, one needs to understand the advantage as against cost. Indian pharma industry is still quite driven by cost. Normally, the price difference between a product using CR packaging a product normal packaging is a reasonably big difference but depending on size and volume of the products.”
“It is a new trend seen in the industry and is emerging differentially. The key reason is to differentiate from other packaging, which is happening in the Indian pharma industry. Indian pharma players are realising that packaging differentiation will make them stand out in the competitive market. And CR packaging will be good for differentiating. I see big pharma giants protecting their brand concealing with CR packaging and these can help the pharma companies to differentiate themselves from their competitor,” analyses Mandale. “The price difference in CR packaging is minor compared to the safety gains.” adds Souberiran. Shahani opines that export oriented Indian pharma companies have implemented CR packaging, but the concept remains underdeveloped in the local markets.
Many Indian pharma companies are currently exporting their generic drugs to the US or those planning will have to essentially look at bulk packaging, while, keeping in mind the US FDA regulations. “In the near future, Indian pharma companies are going to be strong contenders in the US generic market, which would necessitate use of CR caps. This coupled with the fact that the pharma consumer in India will also evolve over a period of time makes it necessary for them to pursue this packaging trend. HDPE containers with CRC caps are a perfect fit to meet the demands of this market. So the trend is very positive and we see more and more companies adopting this packing in future,” avers Souberiran.
Suggesting a user friendly point of view, Mandale comments that, “The existing leading foil should evolve into a new form of design solution, which can be provided as a CR pack. The future trend is that CR packaging should be senior friendly, eco friendly and cost effective as well.”
Chakravarthi sum up the potential when he predicts that, “We see this market (CR) expanding from the US across the world as soon as a cost effective solution is provided.”