‘’Govt is taking steps to introduce braille script for pharma packaging’’

What is the population of blind persons globally and in India?

Ajit Singh

Worldwide, the visual impaired population is 285 million as per statistics available. Of these, 39 million are blind and 246 million have weak vision. Nearly 90 per cent of the visually impaired live in developing countries. India accounts for a staggering 20 per cent of the world’s blind population, which is approximately 7.8 million.

Why is Braille script essential for pharmaceutical packaging?

Packaging is an essential source of information on the content besides serving the purpose of brand recognition and anti-counterfeiting. Information such as name, strength, quantity, directions of use, cautionary statements, storage instructions, date of dispensing, period of use, etc., are important. Realising the need to get this information in the hands of over 39 million visually impaired (totally blind) people across the world, the European Union (EU) issued a directive in 2005 for pharmaceutical and packaging companies. The legislation (Article 56(a) of council directive 2001/83/EC) requires that the product name, strength and dosage appear in braille on all pharma packaging. ACG adds another dimension to this by adding the expiry date of the product on the pack, which is absolutely critical.

What made the pharma companies adopt Braille script and which issues need to be addressed before implementing it?

The EU regulation has been the guiding factor for pharma companies to introduce Braille for “any medical product for human use.” The directive defines this as “any substance or combination of substances presented as having properties for treating or preventing disease in human beings.” This regulation has since led the way, with other countries quickly following suit. All EU legislation relating to pharma products is covered under the EEA Agreement and so the EEA areas (Iceland, Liechtenstein and Norway) have also implemented this directive. Even countries like Brazil, the US and Canada have implemented a mandate for braille labelling on all pharma packaging. The challenges for braille on pharma packaging are three-fold. Firstly, there is an additional cost in upgrading the packaging machinery and be Braille compliant. Secondly, the Braille dots need to be high enough to be easily read, but not too high that it perforates the packaging. Also, the manufacturer must ensure that Braille dots are not malformed or missing, while ensuring accurate spacing. And lastly, quality control is extremely critical in Braille pharma packaging; for one misplaced dot could lead to costly lawsuits, high product recalls and tarnish brand image.

What are the measured being implemented to deploy braille at your company?

The R&D team at ACG and SciTech Centre is in constant search for new ideas and concepts. Currently, ACG Pampac – a member company that produces efficient, customised and cost-effective blister packing, cartoning machines and packaging solutions is developing a new additional feature on cartoning machines. This will help emboss product expiry dates in braille script along with normal embossing. It appears that this feature will be the first to help print expiry dates in braille type.

For which therapeutic area, does Braille script require much attention and why?

All are important when it’s a matter of health and safety. Marburg Medium should be used as the preferred braille font for pharma packaging, as recommended by the European Commission and other agencies worldwide. Also, specifying dot diameter, dot spacing, character and line spacing makes it easier for manufacturers of vision inspection systems to develop readers that automatically interpret the dots.

Is this technology cost effective?

Braille-compliant features call for pharma companies to upgrade their packaging lines. There are modifications that need to be made on cartoning machines, but optimally-priced solutions are available in India. An important aspect that may require attention is to ensure that each blister is in a unit carton. Loose blisters are sold in India and adding Braille on blisters is a challenge. However, if unit cartons for every product are mandated, then it is an achievable goal.

In India, how many pharma companies are offering this service?

There are very few pharma companies that offer Braille on its packaging.

In India, few pharma companies are adopting this technology. If at all, they are doing so mainly for exports, why is it so?

Yes, there are very few pharma companies that are looking at adopting this technology. Braille on pharma packaging is not a government mandate. The export markets like EU and North America have braille-compliant pharma packaging, in line with EU mandate (2005) and Can-Am Braille (2009) respectively.

What are the government initiatives taken to promote and enhance this technology?

The Indian government is taking many gradual steps towards introducing Braille script on pharma packaging through government and non-government bodies. But since Braille script on pharma packaging is not a mandate in India, the technology advancement in this sector has been minimal.

What are the issues while implementing this technology and what solutions do you recommend?

Currently, there are many issues that plague pharma companies while implementing Braille on packaging. To begin with, there are very few blind people who can actually read braille. Despite this, pharma companies that go ahead and implement this technology find it difficult because each European country has its own Braille code. However, there are occasions when the Braille translation can be used in more than one country. An increasing number of government and non-government organisations around the world are working towards making blind people literate in Braille. They are also working towards implementing and adopting a unified system of braille. In addition, many companies are choosing to use a standard font for artwork and then asking their manufacturers to meet the Marburg Medium specification.

What is your forecast on this technology in India?

Necessity is the mother of all invention. Although the Braille script technology is gaining widespread usage in developed countries, it still remains to be seen how it will develop in a high vision-impaired population country like India. We also have to wait for some mandate for Braille on pharma packaging. Once there is a directive from the government, the technology will develop further, making it easily accessible and cost effective.

As mentioned earlier, the Indian government can set a global example by leading the introduction of expiry dates in Braille, something that is not mandated anywhere else in the world.

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