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The Department of Pharmaceuticals (DoP) has initiated the process of forming an empowered committee of drug regulatory officials and representatives of pharmaceutical industry to examine varied track & trace technologies and come out with an authentication mechanism to address spurious drug issues.
Dr P D Vaghela, secretary, DoP informed industry representatives about the steps being taken by the department to set up a panel to devise 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 drugs since 2011 but it is 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.
The DoP in its revised Public Procurement (Preference to Make in India), Order, 2017 dated January 14, 2019 had made it mandatory for all medicines procured under public procurement to have 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 meeting in May 2018, was to print a 14-digit number on the labels of the top 300 pharmaceutical brands identified by it on the basis of moving annual total data obtained from AIOCD AWACS, along with a mobile number of the manufacturer. Since the numbers would be unique to each strip and bottle sold in the market, a consumer could easily check authenticity of drugs by sending a message to the given number and get 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 a plan to put the entire drugs inventory made and consumed in the country on blockchain which stops the entry of fake drugs into the supply chain.
Expressing concern over multifarious directions regarding tracing and tracking being issued by various departments, the drug industry demanded implementation of a single drug authentication system.
Earlier in July this year a high-level panel, headed by Union health secretary, was set up to work on a framework to implement unique QR code for drug packs following a meeting of key officials from the health ministry, DoP, commerce ministry, Niti Aayog and Prime Minister’s Office in this regard. The panel was supposed to submit its report in three weeks.
Taking exception to the implementation of QR code to prevent the sale of spurious drugs in the domestic market, the pharma industry has appealed to the ministry to evaluate varied tracking and authentication technologies in a pilot study rather than zeroing in on unique QR code which has limitations of addressing the issue.
Said Viranchi Shah, senior vice president of Indian Drug Manufacturers’ Association (IDMA), “Even though the pharmaceutical industry is with the government in their efforts in using technology for weeding out the spurious drugs, we reiterated the need for implementation of a simple, patient and doctor friendly system that is 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 ranging from quick response (QR) code to barcode, SMS based mechanism etc to combat counterfeiting of pharmaceutical products. Each option needs to be evaluated in a pilot study and consensus be built on use of any one of the track and trace technologies based on its effectiveness and its adaptability to Indian conditions. The capital investment and adoption of technology on cost of product need to be looked into before its implementation, he said.
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