The Centre has recently mandated that all vaccines, antimicrobials, narcotics and addictive drugs, and anti-cancer drugs carry a bar code or QR code, which can enable the tracking of each vial or blister pack of the medicine. This type of track-and-trace mechanism allows regulators as well as the companies to follow the entire journey of every single unit of the product right from the manufacturing plant to the retail store.This is already applicable for 300 top brands of drugs such as the gastric reflux tablet aciloc and fever medicine such as calpol.The tracking mechanism will be implemented for the new categories of products over the next two years — by July 2027 for vaccines, narcotics, and anticancer drugs and by July 2028 for antimicrobials, according to the recent gazette notification.How does the QR code-based tracking system for medicines work?Manufacturers of all medicines listed under the Schedule H2 of the Drugs Rules are required to affix a unique bar code or QR code on the primary package of the medicine, or in case of dearth of space, on the secondary packaging. A new schedule H2 was created in the Drug Rules, 1945 four years ago when the tracking mechanism was first initiated. This schedule lists the top 300 brands — and now the four new category of products — which have to implement the tracking system.In addition to the unique identification number for the particular blister pack or vial, the QR code or bar code also has to carry the following information: the brand name and generic name of the drug, name and address of the manufacturer, batch number, date of manufacturing, date of expiry, and manufacturing licence number.While most drugs in the market already carry this information on their pack, the QR code based tracking system requires the manufacturers, wholesalers, distributors, and retailers to log these products on specialised track and trace platforms.This essentially reduces the possibility of counterfeiting of drugs — or even dilution — by unscrupulous actors while they are in transit. “This mechanism makes counterfeiting difficult. Some may still use AI to generate codes similar to the original product, but with each unit carrying a unique code, it makes the job very difficult,” said an industry expert, adding, “Even using the original packaging to refill and sell counterfeit drug is not likely to work because once the drug has been registered on the platform, the same number cannot be re-registered.”Story continues below this ad“The enhanced traceability mechanism will facilitate authentication of medicines at various stages of the supply chain and enable improved tracking and verification of drug products. The measure is expected to strengthen regulatory oversight and support efforts to curb the distribution of spurious medicines in the market,” said Union health ministry in a statement.Why is it needed?The main aim of making the journey of the medicines traceable is to prevent counterfeiting. A drug can be counterfeited by either releasing products into the market with no active ingredient or diluting a drug to increase quantities for sale.A track and trace mechanism can help regulators identify whether the spurious drug was manufactured by a company trying to cut costs or was a completely fake product packaged like a known brand. It can also help regulators identify whether a product was contaminated at the source — at the manufacturing plant of a company — or was tampered with.Importantly, the possibility of tracking every single unit also means that regulators and companies know exactly where to find their products in case there is a recall.Story continues below this adThe use of this mechanism for tracking expensive cancer drug is also significant considering there have been instances where used vials have been filled with other medicines and sold to desperate patients. A recent The Indian Express investigation tracked one such ring that counterfeited the cancer immunotherapy drug Keytruda.What did The Indian Express investigation find?The Indian Express investigation found that some unscrupulous players partnered with hospital staff to pilfer empty or used vials of the expensive drug from the cancer units. These vials were then filled with anti-fungal medicine that has similar consistency and sold to patients at a lower cost.While the immunotherapy drug Keytruda has been shown to work wonders for some types of cancers — sometimes dissolving the tumours completely — it remains largely inaccessible in India owing to its high cost.The drug costs around R 2 lakh per cycle, with patients usually administered anywhere between 12 and 17 cycles. Even with patient assistance provided by the company, patients would have to shell out around R 10 lakh for the drug, on top of other costs associated with cancer treatment.What are challenges with implementing the system?Story continues below this adOne of the challenges, an industry expert pointed out, is that if there is a delay in logging the genuine product and the counterfeit gets logged into the system, then the genuine drug might come across as counterfeit.Second is the challenge of cost. Implementing the system would require the companies to put in place mechanisms for generating these unique codes for every packet and a tracking platform allowing these to be logged at every stage. These can be costly.The expert said: “While it may be feasible for companies selling expensive cancer drugs , it is an additional cost that smaller companies making everyday pills may not be able to bear. Considering that many of the drugs in schedule H2 are ‘essential’ and therefore under price control, the government may provide some monetary support or allow the companies to raise the prices slightly as they implement this system.”How does it change regulatory oversight? Another reason for implementing the tracking mechanism is to improve the maturity level of the Indian drug regulator. The World Health Organisation has a benchmark tool for rating the regulators depending on the way drugs are approved, mechanisms for surveillance and testing, and ways of recalling products.Story continues below this adWhen it comes to vaccines, the Indian regulator is already at Maturity Level 3, the second best level as per the WHO benchmarking tool. Making each unit of a vaccine traceable is a step towards achieving the highest level, Maturity Level 4.