Govt to phase out PET/plastic containers for liquid formulations in phases

The Government will phase out the use of plastic and PET containers for liquid formulations from the market in phases, in line with the recommendations of an expert panel, but will give enough time to the pharmaceutical manufacturers for transition.

In the first phase, it is learnt that the PET bottles for liquid oral formulations for primary packaging of paediatric formulations as well as formulations meant for geriatrics, women in reproductive age group and pregnant women will be banned. Six months time will be given to the manufacturers for smooth switch over.

The regulatory authorities, which went into the recommendations by the expert panel headed by Dr Y K Gupta, has felt that reports of environmental/ health hazards because of increasing exposure to endocrine disrupter chemicals known as phthalates etc. were on the rise. Hence the move is taken in the public interest specially considering the precautionary principle that the children, geriatrics, women in reproductive age group and pregnant women should not be exposed to the hazards involved in the packaging of drugs in plastic/PET containers.

The issue of primary packaging materials was brought up by a public interest group, Him Jagriti from Uttarakhand in a representation to the health ministry. The group sought a ban on polyethylene terephthalate (PET) bottles (both colour and non-colour) as primary packaging material in pharmaceutical liquid orals, suspensions and dry syrups with immediate effect as it has severe adverse effects on human health due to the presence of endocrine disruptors.

It was pointed out that leaching takes place under varying storage-temperature conditions and the age of the packaging (leaching becomes faster in hot/warm conditions, and also as the packaging becomes old). The leached elements can cause several diseases including cancer and physical infirmities. Many chemical additives that give plastic products desirable performance properties have grave negative environmental and human health effects, the NGO claimed.

Based on this, the Government constituted the panel which held several rounds of meetings and made its recommendations. “The committee finally concluded that the information provided in the representation of Him Jagriti and according to the available literature, is not sufficient enough to establish a definite correlation of causality of plastic container for pharmaceutical products and adverse health effects. However, this is an important public health concern and needs detailed investigation. Also, absence of evidence may not be considered as evidence of absence of the potential harmful effects of packaging of pharmaceutical products in plastic containers,” the panel said.

“A scientific evidence needs to be generated in a time bound manner through systematic studies as elaborated above, to arrive at answers to the following questions a) The extent of leachbility from plastic container used for packing different drugs formulation, b) The type of toxicants leached, etc. c) Health hazard due to exposure of the leached toxicant. On the basis of the evidence so generated and keeping in view the risk assessment and also environmental hazards, a phasing out plan may then be considered,” it said.

In order to generate scientific evidence on leachbility, common drugs available in plastic bottles samples were sent to Central Institute of Plastic Engineering and Technology (CIPT), Guindy, Chennai and Laboratory for Advanced Research in Polymeric Materials (LARPM), Bhubaneswar. However, these labs have shown their inability to carry out the assessment of leachbility of PET bottles. CISR has now been requested to provide information about the laboratories in the country having facility to test the extent of leachbility from plastic containers used for packing different drug formulations, sources said.

The authorities felt that the pharma industry was earlier using glass bottles only as primary packaging material for pharmaceuticals. The switch over to packing in plastic/PET bottles by the industry is not based on any scientific studies to show that packing of drug formulations in plastic/PET bottles does not have any harmful effect on the drug formulations and there are no releases of endocrine disruptors due to leaching. India has large variation in temperatures. In summer days temperature rises to 40-45 degree centigrade and exposure of plastic bottles to such a high temperature may result in adverse effect on the drug formulations packed plastic bottles and the high temperature may result in increased leachbility. The harmful effects because of the packaging and leachbility may be further magnified in the case of drug formulations, according to the technical advice given to the health ministry.

Demand for pharmaceutical packaging continues to grow

World pharmaceutical packaging demand is projected to increase 6.3% pa to over US$30 bln in 2009, as per another report by Freedonia. The developed countries of Western Europe, USA and Japan will continue to account for over 70% of demand. However, China will provide the strongest growth opportunities based on rapidly expanding pharmaceutical manufacturing capabilities and the phasing-in of an extensive government program designed to upgrade the quality and integrity of nationally produced medicines. Among other major developing economies, India and Brazil will also generate strong gains, although together they will continue to comprise only a relatively small percentage of the total world pharmaceutical packaging market in 2009. The US will remain the largest consumer of pharmaceutical packaging as its advanced drug-producing sector introduces new sophisticated therapies with specialized packaging needs. Growth in West European demand will reflect upgraded government standards requiring unit dose and high barrier packaging for many types of medication. An easing of government-imposed drug price controls will impact favorably on sales of pharmaceutical packaging in Japan, with demand rebounding from the depressed market conditions prevalent over the past decade.

Prefillable inhalers and prefillable syringes will generate the fastest growth opportunities among all pharmaceutical packaging products based on performance advantages in drug delivery. Plastic bottles will sustain the largest share of demand based on low cost, versatility, availability, and ongoing quality and design improvements, Expanding applications in both solid and liquid oral medications will create above average growth opportunities for these containers throughout the world. Pharmaceutical blister packaging will generate strong growth in global demand based on its adaptability to unit dose, clinical trial, compliance, institutional and over-the-counter drugs. The world market for pharmaceutical closures and accessories will grow 5.1% pa to US$9.5 bln in 2009. Child-resistant, senior-friendly and dispensing closures; compliance-enhanced prescription containers; high visibility labels; and tamper-evident accessories will see the fastest gains.

World pharmaceutical packaging demand is forecast to rise 5.9% pa to over US$34 bln in 2011 as per PRMinds. Western Europe, the US, and Japan will absorb nearly three-fourths of this amount due to the presence of the most advanced drug producing sectors. However, China will offer the strongest growth opportunities based on rapidly expanding pharmaceutical manufacturing capabilities and the phasing-in of an extensive government program designed to upgrade the quality and integrity of nationally produced medicines. Among other key developing economies, India and Brazil will become rapid growth markets as drug-producing sectors are upgraded and diversified. The US will remain the largest consumer of pharmaceutical packaging as new sophisticated therapies with specialized packaging needs are introduced.

Growth in West European demand will reflect upgraded government standards requiring unit dose, high barrier and anti-counterfeit packaging for many types of medication. An easing of government-imposed drug price controls, along with greater export market penetration, will impact favorably on sales of pharmaceutical packaging in Japan, as demand rebounds from recent depressed market conditions, especially in generic ethical drugs. Growth in global demand for primary pharmaceutical containers will be paced by prefillable inhalers and prefillable syringes, which will generate the fastest growth opportunities among all pharmaceutical packaging products based on performance advantages in drug delivery and the introduction of new bioengineered medicines. Plastic bottles will sustain the largest share of global demand based on low cost, versatility, availability, and ongoing quality and design improvements.

Expanding applications in both solid and liquid oral medications will create above average growth opportunities for these containers, especially in the US and developing countries. Pharmaceutical blister packaging will exhibit favorable growth in global demand based on adaptability to unit dose, clinical trial, compliance, institutional and over-the-counter drugs. Advances in the changeover features of processing machinery will also benefit growth by making blister packaging more cost-efficient in small volume drug applications. Equipment upgrades, coupled with trends favoring unit dose packaging, will also boost demand for pouches and strip packs. Global market growth for pharmaceutical closures and accessories will be led by child-resistant, senior-friendly and dispensing closures; compliance-enhanced prescription containers; high visibility labels; and tamper-evident and anti-counterfeit accessories.

Demand for these products will benefit from stricter government and industry standards covering the safety, security and ease of use features of drug containers. Sales of dispensing closures will increase favorably as drug makers adapt medication to high value-aded delivery systems. Stepped up efforts by medical groups to improve patient drug compliance will boost the market for high visibility labels as well as that for high value-added prescription containers, such as D-back vials.
Demand for pharmaceutical packaging in the US (including Puerto Rico) will increase 5.5% pa to US$18.4 bln in 2014, as per Freedonia. Recently upgraded regulations and standards that address such issues as barrier protection, infection control, patient drug compliance, drug dispensing errors, and drug diversion and counterfeiting will underlie growth. An increased focus on these issues will boost demand for high value-added containers and accessories, including enhanced barrier plastic bottles, calendar and wallet blister packaging, prefillable syringes and inhalers, track and trace and authentication labels, and unit dose pouches. Demand for primary pharmaceutical containers will increase 5.3% pa through 2014. The fastest growth is anticipated for prefillable syringes and vials, which will expand applications as advances in biotechnology lead to new therapies that must be injected. In spite of below average growth, plastic bottles will remain the most widely used package for oral drugs distributed in bulk and prescription dose volumes to retail and mail order pharmacies. Plastic bottles will also continue to dominate applications in OTC medicines sold in tablet and capsule quantities over 50. Pharmaceutical blister packaging will sustain favorable growth based on its adaptability to unit dose formats with expanded label content, high visibility, and built-in track and trace features. The market for pharmaceutical pouches will expand at a fast pace, spurred by increasing applications in the unit dose packaging of transdermal patches, powders for reconstitution, and topical creams and ointments. Prefillable inhalers will command strong growth opportunities as the number of chronic asthma, allergy and migraine patients treated with inhalation drugs rises. Ongoing improvements in aesthetic and barrier properties will keep tubes a leading primary container for topical medication. Among pharmaceutical packaging accessories, demand for closures will grow 5.5% pa through 2014. Vial stoppers, syringe tips and plastic flip top vial closures will register the fastest growth as injectable bioengineered drugs broaden emergency care and chronic disease indications. Twist and turn child resistant caps will remain the top closures for oral and liquid drug containers, but will lose growth momentum as blister packs and pouches penetrate unit dose applications. Plastic dispensing closures will fare much better among drug makers based on ease of use and convenience in the delivery of liquid medicines and lotions. Due to marketing and security benefits, paperboard boxes will lead sales of secondary pharmaceutical containers. Demand for prescription vials will increase slowly as ethical medicines are adapted to prescription dose bottles and blister packs for direct dispensing. Due to trends toward smaller-sized pharmaceutical shipments, shipping cartons will post faster growth opportunities among drug makers than corrugated shipping boxes. Demand value recorded by pharmaceutical labels will advance rapidly as drug makers change to higher value-added types to meet pedigree regulations for combating drug counterfeiting. Demand for other packaging accessories, including shrink wrap and bands, tamper evident seals, desiccants and packaging materials, will expand with increases in pharmaceutical shipments.

As with most other packaged goods, pharmaceuticals need reliable and speedy packaging solutions that deliver a combination of product protection, quality, tamper evidence, patient comfort and security needs. Constant innovations in the pharmaceuticals such as prefilled syringes, blow fill seal vials, powder applications and others, also have a direct impact on the packaging as per SigPack Systems. Traditionally, the majority of medicines (51%) have been taken orally by tablets or capsules, which are either packed in blister packs (very common in Europe and Asia) or fed into plastic pharmaceutical bottles (especially in the USA). Powders, pastilles and liquids also make up part of the oral medicine intake. However, other methods for taking medicines are now becoming more widely used. These include parenteral or intravenous (29%), inhalation (17%), and transdermal (3%) methods. Oral tablets themselves are also now available in a wide range of different shapes and sizes. These changes have made a big impact on the packaging industry and there is an increasing need to provide tailored, individual packaging solutions, which guarantee the effectiveness of medicines. Due to degradation from environmental factors, such as light and humidity, there is often a direct link between packaging and a remedy’s effectiveness. Packaging of oral medicines generally conforms to requirements for easy dispensing, child resistance but senior-friendliness, but packs must also be identifiable, functional and very often hermetically sealed. However, some innovations provide added benefits in one area but may not conform to the expected standards governing another. For instance, blister packs provide convenience and ensure hygiene. They are ideal for our fast-paced lifestyles and the need to take medication on the go and, as a result, there has been a large increase in their use. However, alongside increased hygiene and convenience, the medicine still has to be child resistant and identifiable. Not many blister packs are child resistant and this goes against recent government proposals to ensure that medicines containing aspirin, paracetamol and iron are supplied in child resistant packaging, to cut the number of accidental poisonings. In fact, the proposed legislation particularly targets blister packs. Some packaging needs are not driven by the need for hygiene, safety or traceability. The increased focus on marketing of pharmaceutical products will become even more important in the future and will drive factors such as the need for flexibility in terms of various pack types and sizes. Other needs are simply driven by costs as pharmaceutical manufacturers face increased cost pressures throughout the entire production and packaging process. As a result, packaging machines have to become more efficient and user friendly, offering flexibility, easy operation, robustness, intelligence and protection from interference. It is a challenge to cover all aspects at once. The ongoing globalization trend with extended competitive landscape in the pharmaceutical industry will lead to smaller batch sizes. If existing packaging equipment is used, this will have a negative effect on productivity, as older machines are often not designed for quick changeovers and flexibility. New packaging lines will have to offer high flexibility while maintaining production levels.