September 1 marked the roll out of field validation studies of Bilcare’s novel nonClonableID technology which got approval under the Council of Scientific and Industrial Research (CSIR) under its New Millennium Indian Technology Leadership Initiative (NMITLI) Scheme last May.
The nonClonableID technology is based on novel aspects of material science and utilises the law of randomness to create unique non-duplicable fingerprints. These fingerprints when processed, digitised and activated can function as unique identification tags.
Speaking to Express Pharma, Dr Praful Naik, Executive Director & Chief Scientific Officer, Bilcare who is the principal investigator for the project, said that, “two leading brands of anti-diabetes and anti-TB medicines from leading MNCs have incorporated the nonClonableID technology into their packaging.”
A total of 50 patients, (25 patients on each disease arm) will be enrolled by the 10 participating doctors. The study is expected to continue over 5-6months and both arms will be monitored by a super specialist.
The aim is to securitise the supply chain in the existing scenario, from the point of origin to the point of sale. The technology allows tracking of the medicines from the manufacturing facility to warehouses, then on to CNF agencies and stockists and finally to the retail level ie. the stockists and chemists.
But what differentiates this technology is that it moves into the patient’s home as well. So the patient can scan the medicine strips, authenticating that the product is genuine. A second improvement over existing track & trace technologies is that it records consumption/non-consumption of doses and also alerts patients that their medicines are getting over allowing them to replenish their medicines in time so that no dose is missed. This attempt to monitor medicine usage and non-compliance was added based on feedback from medical practitioners who were consulted during the planning stages.
For instance, if a patient delays consuming a dose at the prescribed time, he receives a reminder. If the medicine is still not consumed, the second reminder is sent to the patient as well as his doctor and caregiver (generally a family member). This signals a missed dose/non compliance to the doctor who can counsel the patient about the risk of developing drug resistance if the prescribed dosage regimen is not followed and ensure that better compliance is maintained via the caregiver as well.
Thus, Bilcare’s nonClonableID tags are useful not just to crack down on counterfeit medicines but also to reduce non-compliance leading to drug resistance. As Naik speaks of the problem of multi-drug resistant TB plaguing India, as well as the importance of diabetes patients taking their medication at the prescribed times, it is evident why these two disease conditions were chosen for the field validation study.
The scanning device (reader) currently costs around Rs 2000-Rs 2500 and Naik indicates that the price will reduce after commercial launch as more manufacturers start making the device. There is also a chance that the government might subsidise the cost in certain cases.The field validation study is expected to last five to six months, and will involve around 10 doctors (five in each arm) headed by a super specialist who will monitor both arms.
The study size may be small (a total of 50 patients, 25 patients on each disease arm will be enrolled by doctors) but represents almost a year of extensive background work done by CSIR and Bilcare to create a completely scaled up system infrastructure for eventual nationwide implementation. Naik hopes the field validation it will go a long way towards demonstrating the utility of the nonClonableID tags in establishing product accountability through secured traceability from the point of origin to the point of dispensation, authenticity check and establishing e-pedigree as well as improving medication compliance by patients.
EP News Bureau – Mumbai