Last Updated on September 2, 2020 by The Health Master
The Department of Pharmaceuticals (DoP) has initiated the method of forming an empowered committee of drug regulatory officials and representatives of pharmaceutical industry to look at varied track & trace technologies and are available out with an authentication mechanism to deal with spurious drug issues.
Dr P D Vaghela, secretary, DoP informed industry representatives about the steps being taken by the department to line up a panel to plan uniform track and trace system at the second meeting of the Forum of Pharma Associations recently. The uniform track and trace mechanism will do away with various drug authentication measures adopted by the health ministry, DoP, commerce ministry, Niti Aayog, informed industry sources.
In fact, the Union commerce ministry has been trying to implement barcoding for exports of medicine since 2011 but it’s yet to be executed smoothly.
Last year, the Central Drugs Standard Control Organisation (CDSCO) had issued a draft notification mandating every active pharmaceutical ingredient (API) manufactured or imported in India shall quick response (QR) code on its label at each level packaging that store data or information readable with software application to facilitate tracking and tracing.
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The DoP in its revised Public Procurement (Preference to form in India), Order, 2017 dated January 14, 2019 had made it mandatory for all medicines procured under public procurement to possess barcode/QR code at primary level packaging from April 1, 2019. Later DoP deferred its implementation till April 1, 2020.
In 2018 CDSCO came out with a trace and track mechanism for top 300 drug brands. The CDSCO’s proposal, cleared by the Drugs Technical advisory board during a gathering in May 2018, was to print a 14-digit number on the labels of the highest 300 pharmaceutical brands identified by it on the idea of moving annual total data obtained from AIOCD AWACS, along side a mobile number of the manufacturer.
Since the numbers would be unique to every strip and bottle sold within the market, a consumer could easily check authenticity of medicine by sending a message to the given number and obtain details of the manufacturer, batch number, expiry data etc. The implementation of barcoding on drug packs was of voluntary nature.
Taking serious note of the spread of counterfeit drugs, Niti Aayog proposed an idea to place the whole drugs inventory made and consumed within the country on blockchain which stops the entry of faux drugs into the availability chain.
Expressing concern over multifarious directions regarding tracing and tracking being issued by various departments, the drug industry demanded implementation of one drug authentication system.
Earlier in July this year a high-level panel, headed by Union health secretary, was found out to figure on a framework to implement unique QR code for drug packs following a gathering of key officials from the health ministry, DoP, commerce ministry, Niti Aayog and Prime Minister’s Office during this regard. The panel was alleged to submit its report in three weeks.
Taking exception to the implementation of QR code to stop the sale of spurious drugs within the domestic market, the pharma industry has appealed to the ministry to guage varied tracking and authentication technologies during a pilot study instead of zeroing in on unique QR code which has limitations of addressing the difficulty .
Said Viranchi Shah, senior vice president of Indian Drug Manufacturers’ Association (IDMA), “Even though the pharmaceutical industry is with the govt in their efforts in using technology for removing the spurious drugs, we reiterated the necessity for implementation of an easy , patient and doctor friendly system that’s efficient (detection of falsified– spurious drugs), affordable (capex and opex) and industry friendly (ease of application and minimum impact on productivity).”
Currently there are various track and trace technologies starting from quick response (QR) code to barcode, SMS based mechanism etc to combat counterfeiting of pharmaceutical products. Each option must be evaluated during a pilot study and consensus be built on use of anybody of the track and trace technologies supported its effectiveness and its adaptability to Indian conditions. The capital investment and adoption of technology on cost of product got to be looked into before its implementation, he said.
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