Supplement to Express Pharma Pulse I 29 April 2004

POST January 2005, a TRlPs and IPR-compliant India will usher our economy to a new era and open its doors to the MNCs who are keen to outsource high quality drugs at low costs. The competi­tion is becoming severe the world over. With m re and more drugs emerging out of the patent umbrella, the growing generic market shall pay richer dividend to countries like India. While the entire process of shift may take a few years, the excitement has already begun to show its irnpact with Indian companies expanding produc­tion lines en masse. Packaging, however, is but one area that has been shockingly neglected by the pharmaceutical industry as a whole. There are many reasons for the industry's lacklusture inter­est in quality packaging. Archaic laws governing the price contro1 regime and lack of awareness being the key aspects. In India, most companies are cost conscious. Besides, the industry also tends to take consumers for granted as branded drugs are driven by prescription sales where a patient is forced to accept whatever is doled out. The Government of India, being one of the largest pro­curer of drugs, is also guilty of allowing medicines to be packed in inferior quality aluminum strips, foils, extrusion covers and sub­standard plastic material.  Lack of standardization in drug packaging industry has in turn promoted counterfeiters in multiplying their businesses and making India’s trade in fake drugs reach astronomical figures.  Counterfeiters are also helped in their cause by the simple fact that nearly half the population of India cannot read or write.  Spurious drugs, aided by poor quality packaging are therefore likely to be this country’s single biggest problem in the coming decade.  Counterfeiting of drugs is not only an economic and social menace; it has also acquired an alarming share of 25 per cent to 30 per cent of india’s total drug business forcing established players in the industry to adopt novel technologies and imaginative packaging systems to safeguard their brand image.

A good quality drug essentially needs to be vacuum packed in a sterile environment failing which it stands the risk of losing its efficacy and safety.  A vast number of drugs are hydroscopic in nature.  Moisture contents, in turn, initiate early degeneration of the drug and can convert a life-saving drug like Methargin used by pregnant women into a life-threatening one.

Ironically, while qualitative packaging plays a crucial role in ensuring that the drugs efficacy is maintained throughout its distribution chain, a vast number of small time manufacturers overlook its vitality.  While the guidelines generally outline the packaging components in terms of physical, chemical and biological characteristics.  More focus need to be on standardization in terms of usage of ingredients such as pigments, plasticisers, glues and ink etc.  Food grade plastic, for example, is a desirable ingredient but is sparingly used due to high costs. 

Like milk and honey, labeling and leaflets form an integral part of the packaging.  While the label outlines brief description of the drug including active ingredients, contents, recognizable side effects, warnings, precautions, methodology of administration, expiry date, batch numbers etc, a leaflet identifies the product together with its active ingredients, pharmaco-therapeutic group, information needed for taking the drug, dosage, special warnings, administration. storage conditions etc.

Innovative packaging

Innovation in packaging and labeling is beginning to play a bigger role in warding off counterfeits.  These include the hologram security, tamperproof seals, advanced colour bar coding systems etc.  Holograms act like a company seal and offer an alert consumer a simple way to identify the fake from the genuine.  Tailored to requirement, it can be embossed on any surface to provide a 3D image.  There is yet a wide gap in its demand and supply as the hologram manufacturers have been found wanting in fully satisfying the industry in terms of costs, utility and mass awareness.  Bar-code is another commonly used tool that helps in inventory management and sales tracking.  The pharmaceutical industry worldwide uses EAN 13 barcode system, which apart from providing the country code also offers basic information.  Code 128 is further used to provide numerical data and covers greater selection of characters required for bulk shipments.  Colour bar-codes are also used to differentiate the pattern/usage of drug. For example, orally consumable drugs are denoted in a standard colour. Most high-risk life-saving drugs, espe­cially those meant for fighting dreaded diseases like cancer, need tem­perature sensitive packaging. It is important for such drugs to follow the medicinal cold chain guidelines in order to safeguard it from tem­perature variance. Established pharma companies carry out stability trials to determine the degrees of temperature abuse that can be toler­ated by the drugs during handling and shipment.

Validation

Select companies provide data on operational qualification (OQ) and performance qualification (PQ). Both OQ and PQ tests monitor the temperatures during test shipments and indicate the variance under different conditions. These protocols then form part of packaging to enhance drug safety during its transition.

Refrigerant choices are commonly adopted to maintain sub-degree temperature. For-example, dry ice, water packs, frozen blankets and gel packs are used and reused to maintain required temperature. Some companies even go to the extent of installing mechanisms whereby odours are eliminated through use of anti-microbial addi­tives in specially designed packs. Pressure sensitive labels are also used very effectively. These labels change colour with rising tem­perature and alert its consumer as and when variance occurs. Some companies offer more than one triggering temperature label that highlights the time lapse in phases.

For the packaging industry to grow effectively and make its mark in India, it would be essential for the government to step in and act as a necessary catalyst. While NPPA indeed has started giving a posi­tive look to innovation, much needs to be done to ensure that a phar­rna company is adequately compensated for initiating customer safe­ty programme. A quality' packing to drug is what a skull is to the brain. Both cease to exist without adequate protection.