Patient Friendly, Multi-Label Tablet Strips

• The medicine tablet or capsule strip is the most common ‘medical device’ in the world, which unfortunately has not improved for decades!
• The following note explains why the tablet strips in their current form are NOT providing equitable health care to the masses and need to improve
• In large parts of Asia, Africa and Europe, tablets are sold in strips. Often due to regulatory and cost reasons, the printed matter is not easily legible, or in only one language thereby excluding a large percentage of the population - mostly from the economically backward sections of society. For example in India while there are over 20 main languages, the tablet strips are printed only in English! That means at least 50 million people in India alone are excluded from the communication on the tablet strips
• Furthermore there is no space on the strip for capturing individualized directions for usage. This results in patients sometimes consuming the dose at the wrong time of day, or taking a tablet every day when it is to be taken on alternate days, or the wrong combination, or missing the dose completely. Chemists say that majority of patients (including the literate and well heeled) often order medicines in mismatching quantities, due to under or over dosing. The incidence of wrong and missed dosing amongst the weaker sections of society is frighteningly high! 
• The above factors lead to wrong or missed dosage which has a negative impact on patient health and recovery  
• We believe the challenge and opportunity lies in better communication design of the  medicine tablet strip 

• The multi-label tablet strip solves the problem of missed or wrong dosage by providing additional surfaces attached to the tablet strips, to provide and capture information relevant to a specific patient. Apart from adding information in regional languages, tick boxes on when to take the medicine can also be added, making it easier for the patient to take medicines on time
• The manufacturing process by which the label sheets are added to the tablet strips involves adding the label sheet roll to the lidding sheet roll, using a cold sealing process, so that the Heat Sealing Laminate (HSL) layer on the lidding foil is not damaged, and the lidding sheet roll (along with the label sheet roll) can be sealed with the forming foil in the tablet sealing machine. The lidding sheet roll + the label sheet roll is referred to as the Composite Roll
• Importantly, no change whatsoever is required to be made in the tablet sealing machine when the Composite Roll is loaded to be sealed with the Forming Roll
• Post sealing the individual tablet strips are cut as before, resulting in tablet strips with attached label leaves
• Once again, regulatory guidelines which require the regulatory matter to be printed on the primary packaging, and particularly on the Lidding foil, are not deviated from at all.  
• The cost of the additional label sheet is so negligible that for a patient consuming 300 tablets a month (10 tablets a day*30 days), will not cost more than US$ 0.15 per month!

• The Patient Friendly Multi-Label Tablet Strips will be beneficial to ALL tablet strip users, particularly the aged, those who are of weak eyesight, or with cognitive challenges, those who cannot read or understand the technical ‘regulatory’ language, and those who can read or understand only regional languages (e.g in India where the printed matter is in English, but millions of people read and write only in any one of 20 different scripts such as Hindi, Punjabi, Marathi, Bengali, Tamil, Malayalam, etc )
• The additional printing space provided by the attached label sheets will make printed matter available in patient friendly language and format so that the patient is better informed and doses correctly
• Larger font sizes, printed matter in regional languages, patient specific tick boxes on labels attached to each strip will make it easier for patients as well as their care takers to follow dosing instructions correctly

• The problem of illegible printed matter on tablet strips in universal. I (Bipin Deshpande) had got senior officers of the regulator CDSCO (Central Drugs Standard Control Organization under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India) and the National Blind Association of India on a call where the CDSCO authorities agreed that inclusion of basic information such as name and strength of the medicine in Braille would help. While the thought process was not converted to policy, events such as the Covid pandemic with its numerous grey areas has certainly increased the regulators awareness for increased communication access between patients, health authorities and the healthcare community
• The solution prototype is being designed and built with the help of a veteran prototyping expert, Mr Shridhar Karkare, who heads Sigmasun Technologies. He has received commendation letters from the National Chemical Laboratory (NCL https://www.ncl-india.org/ ) for his work
• I have been fortunate to have the support of Eisen Pharmaceuticals (https://www.eisenpharma.com/) who provide me access to their tablet sealing machine to test the Composite Roll made using the 1st prototype
• Funding of USD 40,000 for the prototyping and testing activity is being provided by the Biotechnology Industry Research Assistance Council (BIRAC https://www.birac.nic.in/ ) a Public Sector Enterprise, set up by Department of Biotechnology (DBT), Government of India
• BIRAC is well known in the pharmaceutical community and has provided funding to pharma industry leaders in India such as Serum Institute of India, Biocon, amongst many others
• The solution itself does not interfere with any of the CDSCO labelling guidelines for pharmaceutical products under the Drugs and Cosmetics Act of India
• Finally, apart from regulatory support, the success of the project will depend on solution cost effectiveness, presentation and attractiveness, ease of adoption by pharmaceutical supply chain, go to market strategy, and positive feedback and visible demand from patients and caretakers. I believe all the above factors will be required to make the project a success

Post prototyping, the project vision is to help patients dose correctly across geographies. Manufacturing, marketing, regulatory clearances, distribution, will require local market knowledge and support. Country wise information about pharma packaging regulations, local market supply chain norms, availability of packaging materials, transportation, rules governing import of packaging material, pharma tablet sealing equipment and practices, procedures etc all will require well informed localised inputs

We believe we can help entrepreneurs in other geographies identify partners and experts from in Western India similarly

• The Multi-Label Tablet Strip technology is simple in its objective: i.e improve legibility of printed matter on tablet strips by increasing available printing space, and secondly, customize the tablet strip to each patient to enable more timely dosing
• The patent pending technology allows the pharma manufacturers to use their existing machinery, thereby reducing resistance to change
• The multi-label tablet strip does not interfere with the regulators labelling guidelines
• Lastly, the user i.e. the patient or the caretaker, does not need to be technically savvy to use the multi-label tablet strip technology. Given that the most vulnerable users of tablet strips are patients who are 50 plus, technology change is always a major hurdle

• The patient today has the least say in how tablets are packaged or communicate
• The first target is to give the patient the choice to demand tablet strips in a form which communicate clearly
• The second is to provide senior citizens tablet strips which are simpler to use – every day
• The third is to make patients in India (and other countries where similar language issues exist) who cannot read English, to be more independent and self-reliant in the basic act of taking medicines.
• Last but not least, to convince pharma industry to start using the more patient friendly tablet strip technology, and step up to encourage patients to use the multi-label tablet strip technology

The measures of progress will be:

1. The number of pharma companies using the multi-label technology for any of their tablet strips

2. The number of different medicines that a pharma company sells using the multi-label tablet technology

3. The percentage of tablet strips sold by a pharma company which use the multi-label technology

4. Number of top 10 pharma companies in India who use the multi-label tablet strip technology

5. Percentage of customers who buy multi label tablet strips and customise the strips to their dosage requirements regularly (thru surveys)

6. Percentage of doctors who advise their patients to use multi-label tablet strips (thru surveys)

• The basic assumption is that pharma companies genuinely want to help patients heal faster and lead healthier lives. The multi-label tablet strip technology provides a solution to the problem of wrong / missed dosing, by accommodating regulatory labelling guidelines, not using expensive additional aluminium foil in the solution thereby controlling costs, providing a communication means with patients which does not exist today, and improving their brand recall
• For the patient, receiving a simple tool to help dose on time provides empowerment and independence
• When buyer and seller both work towards a common goal, change comes faster

• The multi-label technology is a simple tablet and capsule packaging technology, which is easily understood by patients with very basic literacy levels. It is this simplicity which will hopefully contribute to its success.
• It will make the tablet strip packaging communication more to the point and make it less confusing for the patient to understand the dosing calendar
• It also follows the line of least resistance: no change in manufacturers machinery, no deviation from regulators labelling guidelines, and very low additional cost for better health

https://youtu.be/moclStEEtcg   44th second in video, or slides 7,8,9

As a non technical founder, I (Bipin Deshpande) focus on my strengths i.e. ideation, business modelling and marketing, and find partners with expertise in design, manufacturing, IP, etc

The project has not yet reached a stage where any specific steps were needed to look at DEI 

Currently we are still at a pre-production stage

The business models that we are exploring are

1. Sell the Composite Roll to vendors who provide the Lidding Roll and Forming Roll to the tablet sealing pharma factories - i.e. make the vendors to the pharma units our agents

2. Sell the Composite Roll and the Forming Rolls to the pharma companies

3. Provide a one stop shop for pharma companies and sell them the multi label tablet strips i.e become a contract manufacturer with a technology edge

Option (1) is the easiest. Option (3) needs substantial capital, but will help to brand the service and by pass intermediary vendors. 

We are still at a prototyping stage 

However, the thought process going forward seems to be inclined towards providing Composite Rolls to the pharma industry thru partners who already have established relationships

This will help expand reach nationally and internationally, while retaining focus on product quality and development

Capital requirements will be funded primarily thru grants initially, and later thru venture capital

Within the next 12 months or less, one or more co-founders with appropriate resources (capital, technical manpower, client base) will probably be needed to increase management bandwidth and scale rapidly

The initial costs and time towards market needs, technical research, IP filing, company formation and first prototype were borne by the founder Bipin Deshpande

A grant for USD 40,000 was sanctioned by the Govt of India in October 2021. Disbursement has started in March 2022. This grant is towards development of a fully functional prototype, which should be ready by December 2022 (inclusive of testing of output on tablet sealing machines)

Provisional patents have been filed in India and PCT. Complete specifications will be filed for India in April 2022, with a request for priority examination, which should happen by September 2022

Production should start by January 2023 on a trial basis. Composite rolls will be supplied to key customers to test market acceptability

For 2023, funding to the tune of USD300,000 will be needed to support manufacturing, customer acquisition, IP expenses, and other operational expenses