What's in a label?

Manjusha Morgaonkar discusses the important aspects of labelling in pharma packaging and where is it lagging behind

The labelling woes of the pharma industry are not new, although of late, they have gained prominence as the industry has come under increasing public scrutiny. Today, consumers/patients are more educated, and thus, they want to know more about the medicines they consume. With the shift to self-prescription, most patients rely on the label to give them this information.

There has been considerable progress in labelling techniques and technologies over the years, but at least in India, realities often fall short of industry expectations. Thus, labelling remains a sensitive issue in the industry as pharmacos find it difficult (some would say impossible) to balance rules and regulations with space, material and technology constraints.

Labelling technologies and techniques

According to Ravindra Wagh, Assistant General Manager, Finished Products, Intas Biopharmaceuticals Limited (IBPL), there are three most frequently used technologies in the pharma industry, but each have drawbacks, which result in poor readability. The first technique is the gum applicator cum sticking machine, which involves loading cut paper labels into the label magazine, from where each label is removed using vacuum, gets a coat of gum acacia paste on the non-printed side and then applied to the packaging unit/glass container. The main drawback of this technology is that sticking depends on proper preparation of the gum paste. The second technique—sticker labels—avoids this drawback and has become the technology of choice as it gives a good look to the final product. This machine involves the fixing of the sticker label roll on the machine followed by removal of the label from the silicone back paper and its sticking to the container.

The third technology, the white line concept, according to Wagh, is yet to enter India. This technology involves loading of a white roll on the machine followed by online multi-coloured printing. The label is then warmed to make it self-adhesive and subsequently stuck on the container. Thus, the pharma company does not need to keep an inventory of labels in the warehouse. Pradeep Dhargalkar, Senior Manager, Packaging Development, Unichem Laboratories says, "Pharma labels are mostly printed on UV flexo machines worldwide. Some of these machine manufacturers are Mark Andy, Gidue, Gallus, Nilpeter, etc. These printed labels are stuck on to ampoules, vials, glass and HDPE containers, via imported labelling lines like CVC, pack leader or indigenously by Abma or Maharshi Udyog Machines in India." Wagh lists some common complaints of the pharma industry, such as over printing of labels with manufacturing and expiry dates, batch and packing lot numbers. These details along with others are required to be accommodated in very limited space, and therefore, readability becomes very poor. At the same time, use of rubber stamps/stereos lead to smudgy printing. Secondly, over printing sticker labels require special inks and thinners and only correct mixing determines proper over printing quality. Often ink quality is inconsistent, leading to heavy rejections. On exposure to cold or hot conditions, the printed matter on labels vanishes/fades out and labels may peel off at corners. Such labels require special plastic coating to reduce this problem. This technology requires a label-counting machine with rolling and de-rolling arrangements.

Wagh also points out that labels incorporating RFID elements is a popular technique to overcome the counterfeit problem as this is a very costly technology for low cost products and is very difficult to implement, thus discouraging the counterfeiter. The labels with built in holograms and UV visible marks will be of great help to overcome the problem of spurious labels, adds Wagh. Labels can also have unique 2D code, or hidden features like watermark and coin reactive inks, says Dhargalkar.

Dr Anantha Narayana, a well-known pharmacist, points out that the technology used depends on the product, packs and the type of surface of the containers used for packing pharma products. "Some of the newer technologies coming up use fluorescent inks for highlighting specific portions of labels like expiry dates. Some techniques like holograms are under consideration for important drugs. These techniques, however, add to the cost," he says.

Labelling laws

According to an official of the Maharashtra Food and Drug Administration, "Under the Central Government's Drugs and Magic Remedies (Objectionable Advertisem-ents Act) 1954, if any company does not follow the rules given under provision, they will be advised to follow them. If in case they do not do so, they are told to rectify it, and after this if they cross their limits, they are eligible for action against them under this Act."

The labelling of pharma products—medicines—are regulated by the Drugs and Cosmetics Act 1940 and D&C Rules 1945, as well as Packaging Commodities Regulation Order (PCRO) rules under Essential Commodities Act. As per these rules, a number of details need to be printed on the label including the name of drug (the point size of the generic name should be larger than the brand name, according to Narayana), composition, manufacturer's name and address, batch number, date of manufacturing and expiry, maximum retail price (MRP), indications, dose, storage conditions, etc.

Narayana points out that industry is also cautious in not giving too much information on labels. Doctors may decide against the use of a particular drug for certain patients due to listed contraindications. Also, information on dose and directions for use may encou-rage self-medication. Hence, the industry generally resorts to the phrase "Use as directed by the physician" to cover these requirements. In special cases, Narayana says that industry has also adopted pictorial labelling, especially to provide directions for use. This is particularly seen with inhalers, eye ointments, eye drops and ear drops, chewable tablets, vaginal tablets, dispersible tablets, etc. Though not required under law, the industry provides 'package inserts' for educating consumers/patients for proper use of drugs, he adds.

Unit dose vs bulk

Compared to Western countries, where does India stand on labelling techniques? According to Wagh, Western countries are very advanced in labelling techniques. Most companies have introduced RFID technology, which so far is not commonly used in India. Many companies have started using the double labelling technique, so that the first label can remain attached to the container while the other is removed and stuck to the patient's treatment document. In some Western countries, companies have preferred to print details directly on the glass or any other container, which is not so popular in the Indian pharma industry. The product details are printed directly on the shippers on line rather than pasting labels on the product packs. Dhargalkar says, "India has all the capabilities in terms of labelling technology as renowned Indian and MNC pharmacos are getting their labels developed from Indian converters like Webtech, Unique Fix 'O' Form, Letra-graphics, Mudrika, and many more." Company like Unique Fix 'O' Form has a patent on 'literature affixed within the labels', he adds.

Narayana opines that India is not much far behind on this front. He says, "We are at par on labelling with respect to technologies and Indian pharma industry is constantly upgrading its technologies in this area. Moreover, allied and engineering industries in India are actually at the forefront of manufacturing many packaging and labelling machines and export a lot of machines."

Even so, Narayana reasons that we should not compare label contents of pharma products marketed in India to those marketed in Western countries. This is because at the time of Independence and enactment of the Drugs and Cosmetics Act, Indian government, keeping Indian consumers and their literacy levels in mind, adopted "unit dose packaging" as a means for marketing drugs in India. This meant that drugs need to be packed in a way that each unit contains the daily dose and is sold as such to the patient directly.

In contrast, in Western countries, the drugs are generally packed in bulk and it is the duty of the pharmacist, based on the physician's prescription, to dispense the required quantities of each medicine into separate bottles and label them with specific patient information. In such a system, the pharmacist can give a lot of information on the medicines to patients, and charges dispensing fees for the same, which is not the case in India, Narayana notes.

Lacunae and industry expectations

According to Wagh, "We are lagging behind in paper technology for giving consistency in the shade of the paper colour. Because of this, the finished printed matter varies in shades leading to rejections. The spread of the gum becomes non-uniform and many times adhesives used are non-compatible with siliconised surfaces. Cleaning of the external surface before labelling becomes necessary which is a very big problem in the pharma industry." Wagh further says, addition of chemicals like ammonium trifluoride leads to discolouration in some labels on standing but without such addition, formation of the bond with the surface becomes very difficult.

Narayana says that pharma companies feel that too much information needs to be given on medicine labels in our country. (In Western countries, this information is customised and dispensed at the pharmacist level.) The industry has serious problems in doing so as space available on labels is always limited. A solution would be to put extra information required on leaflet inserts with each pack but industry is not able to do this consistently as it adds to cost, as well as creating a logistics problem and slowing down operations.

It may also be difficult to ensure that each pack has leaflets, besides the fear that the leaflet could be misused. Companies can also be accused of promoting self-medication due to information being provided on usages, doses etc. According to Dhargalkar, "India is a fast developing country as far as labelling technique is concerned. All pharmacos cannot afford to have imported machineries like CVC or pack leader (which are mostly used for US ANDA products). Moreover, involvement of extra manpower and money makes the mysterious world of pharma labelling tougher." In addition to this, the raw material paper (Fasson) required for printing roll form label is also imported from Avery Dennison who exclusively supplies pressure sensitive labels in America, Europe and Asia Pacific regions, he adds.

Thus, it looks like the Indian pharma industry will have to continue to grapple with regulatory requirements and available technologies. However, given the fact that the allied sector is exporting all over the world, one hopes that it will not be very long before hi-tech international labelling solutions make their presence felt and seen in India as well.

manjusha.morgaonkar@expressindia.com