Pharmaceutical packaging, over the period, has evolved with number of innovative concepts, which proved to be the need of the hour. These innovations were always been by-products of the most crucial problems that the user industry passed through at each level of its evolution. The new packaging models in the pharmaceutical industry such as blister technology, PET bottles, alu-alu and currently the security packaging and even holograms, have emerged as systems which can eliminate one or other menace the drug industry faced over the period.
Today, when the cost reduction is the buzzword in order to optimize the economy scales of drug manufacturing sector along with sustaining growth in the highly competitive market place, the industry awaits the innovators to come out with fresh ideas to take them along with the time.
As global regulatory requirements keep updating its quality standards and now even the packaging material and system are also being considered for Drug Master File (DMF) mandates, the global pharma packaging sector is all set to have a higher level of research and development activities to cop with the scenario.
Looking at all these new generation requirements, the concept of using drug specific packaging material comes to the fore at present.This innovation claims to have multiple advantages that not only helps creating optimum level of product safety and stability but also to control the packaging cost by identifying the appropriate packaging material for the molecules, which would help avoid over spending on packaging for certain drugs and ensuring protection and stability to some others.
In this context, pharma packaging segment all around the globe is taking a leap towards developing the most cost-effective packaging system. Here the much talked about idea of drug specific packaging material gets emerged. The new generation packaging industry has taken a step further to categorize the existing 400 molecules in the pharmacopoeia on the basis of the required packaging material, which would be cost-effective and ethically proper.
However, according to experts in the area of pharma packaging, the present scenario in India reveals a very rudimentary picture or says the industry is still in a very nascent stage. The formulations in India are excellent but they don''t get qualitative packaging. Presently, the launch of new products has lead to emulating the design and aesthetics of foreign packaging irrespective of drug formulations. There is absence of research in packaging to suit the requirements of a medicine. It is necessary that packaging should be done as per the nature of any drug but to cut costs the drug manufacturers compromise on quality and other parameters.
They appeals to the industry that the manufacturers should know that research in packaging has now evolved and cost effective solutions would cut down their cost by at least 25 to 30 per cent. Using right kind of packaging material would ensure the safety of the end user, too.
Another important factor today is the consumers'' awareness about the quality, quantity, genuinity and also the visual appeal of the products. The manufacturers must fully ensure that the correct quality and quantity of product reaches the hands of the consumer. Rarely would the consumer''s complaint about the visual appeal / graphics of the products but in case the product or packaging is not intact or complete - the situation is alarming as the manufacturers can lose the market instantly.
The products like tablets / hard capsules / soft capsules - after passing through the stringent manufacturing processes needs a final quality check just before it is packaged. These checks are subjected to the contamination, cosmetic, weight and dimensional detailing and are a must before the products are subjected to the various packaging options and subsequent machines employed viz. counting machines, blister packing machines, printing machines etc.
In India, the Drug Price Control Order (DPCO) and the maximum allowable packaging expenditure is still another serious concern of the industry while considering the newer options. It may be recalled that the pharmaceutical industry in the country has taken serious objection to the draft of a new set of norms for the maximum allowable costs on pharmaceutical packaging materials (PMs) prepared by the National Institute of Pharmaceutical Education & Research (NIPER) as the norms specified in the draft is purely theoretical and not pragmatic.
Indian Drug Manufacturers'' Association (IDMA), which represents the largest industry group, has however urged the National Pharmaceutical Pri-cing Authority (NPPA) to organize an open meeting involving the industry and the Institute to discuss the realities before framing the policy.
The draft policy, which was sent to the industry associations for their views and suggestions by the NPPA recently, was prepared by NIPER after the NPPA undertook a thorough study of the material costs for packaging. The study was claimed to be very exhaustive and addressing the new trends in sourcing and consumption of packaging materials by the drugs industry.
However, industry sources said that in today''s competitive pharmaceutical market where packaging is one of the decisive factors for the success of a product both in the domestic and the international market, it would be insensible for the companies to follow these rules for using cheaper and outdated packaging materials.
"Moreover, in the drug market, the safety and efficacy are major concerns. Thus, selling drug products in updated technology packing is not only essential but a safeguard from duplication and spurious drug menace also," the industry cautions.
On the contrary, the government with the new set of norms is understood to have decided against conceding higher costs for "fancy packaging" and go strictly by the information it has, irrespective of the demand for flexibility by the industry. It is learnt that for different types of drugs and dosage forms, the permissible packaging materials costs will be in the range of 10-25 per cent of the total manufacturing cost of the drug. There will be higher ceilings on packaging material costs for certain products like injections on ampoules.
Packaging materials (PM) cost is a major component of pharmaceutical production process, as important as the raw materials conversion costs (CC) (of drugs) and more significant than the packaging charges (PCs). The National Pharmaceutical Pricing Authority (NPPA) had first notified the CC and PC norms in July 1999 and these norms were re-notified in July 2000 with no major change. The costing formula in Para 7 of the Drug Price Control Order (DPCO) takes into account cost components likes (drug) material cost, conversion cost, packaging material cost and permits a 100 per cent ex-factory cost which includes manufacture''s margin and trade margins.
Of this, the costing of packaging materials has not yet been standardized and published, although the government says that the costing is now done as per internal norms sticking to the international standards. While the PC norms notified earlier are principally about the expenses incurred on bulk transportation of medicines, packaging materials norms are about the costs involved in purchase and use of packing materials. However, with the government firm on its stance, the controversy over lack of incentive to superior packaging of drugs is likely to be more intense.
Drug industry circles point out that different companies use different packing materials and adhere to different standards for the same formulation, resulting in considerable disparities in cost of packaging among them. NPPA should hence notify permissible cost close to the industry average, they say. "Although it is desirable for the regulator to accept the mean, we find that in most of the cases, the NPPA ceilings on cost of packaging is on the lower side, and in some cases equivalent to the lowest in the industry," says experts.
Many in the drug industry apparently believe that the government''s current perspectives on the packaging material have become a disincentive to companies adopting superior packaging standards. They point out that by raising the level of packing standards, the threat of spurious drug rackets could be minimized as it would be difficult for the spurious drug makers to mimic the latest technology packaging that are somewhat copy-proof and pilfer-deterrent.
New trends in packaging have necessitated a through re-appraisal of the materials costs in the changing scenario. Twin packing (one pack of medicine along with the liquid for injection on an ampoule), pouch packs for orals and "alu alu" are among the latest packaging adoptions in the Indian drug industry. Among packing materials, the use of aluminum is on the increase, with the growing awareness of the hazard of poly vinyl chloride (PVC) and poly vinyl dichloride (PVDC) that are still widely in use. While roughly strips and blisters cover 65 per cent of tablets and capsules, there are other modes of packaging like bottles used by a significant segment of the industry. Since materials like PVC and PVDC creates humidity problems, there is a gradual shift to aluminum packaging in the industry. In the case of syrups, tonics and suspensions, bottles are mostly in use. As plastic bottles poses the problem of reaction with the active ingredients, glass bottles are recommended by regulatory authorities for liquid preparations. However, the newly emerging concepts would again change the industry perceptions to yet another world of standardization.