|
The Union health ministry is gearing up to introduce a unique quick response (QR) code for drugs sold in the domestic market to curtail the menace of spurious and substandard drugs in the country. The QR code will help track and trace medication during the entire supply chain and ensure its authenticity.
A high-level panel, headed by Union health secretary, has been set up to work on a framework to implement QR code for drug packs a couple of days back following a meeting of key officials from the health ministry, Department of Pharmaceuticals (DoP), commerce ministry, Niti Aayog and Prime Minister’s Office in this regard. The panel is likely to submit its report in three weeks.
Earlier all these authorities had come out with different models of drug authentication system leading to confusion among drug makers.
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. The Directorate General of Foreign Trade (DGFT) has extended the date of implementation of track and trace system for drug formulations with respect to maintaining the parent-child relationship in packaging levels and its uploading on central portal till October 1, 2020 for both SSI and non-SSI manufactured drugs in view of the coronavirus outbreak and lockdown announced by the government to curtail its spread.
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 QR code on its label at each level packaging that store data or information readable with software application to facilitate tracking and tracing.
The stored data shall include unique product identification code, name of the API, brand name (if any), name and address of the manufacturer, batch number, batch size, date of manufacturing, date of expiry or retesting, serial shipping container code, manufacturing licence number or import licence number and special storage conditions required (if any).
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 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. It uses a highly scalable transparent protocol to assign every manufactured product an asset. The assets are then added to the blockchain and assigned a unique identification number, commonly referred to as hash. The technology then verifies the hashes to find out whether or not the product in question is counterfeit or legitimate.
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.
Commenting on the government’s initiative to introduce track and trace system for drugs sold in the local market, Viranchi Shah, senior vice president, Indian Drugs Manufacturers’ Association (IDMA) said “Similar attempts have been made by the commerce ministry for exported drugs since 2011 but there have been several hurdles in its implementation. The government should ensure that the industry and regulators jointly work out a feasible plan to implement the QR code on the drug pack in the long run.”
Echoing his view, Ashok Kumar Madan, executive director, IDMA said, “Barcoding on exported medicines is yet to be implemented smoothly. The industry has time and again raised difficulty in its implementation. Barcoding has increased the cost of drug exports leading to a decline in competitive advantage of exporters. Drug units require a minimum investment of Rs. 25 crore to Rs. 30 crore to put in place a barcoding mechanism. An assembly line costs Rs. 1.5 crore to Rs. 2 crore. The drug production also gets slowed down. On top of all that several importing countries do not require barcoding on pharma products as they lack mechanism to scan the barcode while several other countries have their own track and trace mechanism. Indian track and trace guidelines can be implemented only after importing countries’ acceptance of these guidelines.”
Over the last few years, various departments have proposed different models of drug authentication which created confusion among drug manufacturers. Last year CDSCO came out with a draft notification introducing QR code for APIs. QR code is hardly effective for APIs sold by vendors in small quantities, he pointed out, adding that Rule 96 of Drugs and Cosmetics Rules, 1945 clearly mentions labeling specifications which include details of products and their manufacturers.
The QR code will put it in machine readable form. Its implementation can be done, once repercussions of COVID-19 pandemic subside, he stated.
Nipun Jain, chairman, Small and Medium Pharma Manufacturers Association (SMPMA) said, “A meeting of stakeholders should be convened to discuss the implementation of QR code on medicine packs. Besides this, the experience of large companies voluntarily implementing QR code on top 300 drug brands should be shared by the drug regulatory body which would offer learning experience to other drug makers especially MSMEs. Funds need to be allocated to pharma MSMEs to help them implement track and trace mechanism.”
|