Due to the rise of counterfeit medications, anti-cancer drugs may soon need to have QR codes and track-and-trace systems mandated. The drug regulatory agency CDSCO is reviewing a proposal from the expert panel DTAB to introduce a ‘track and trace mechanism’ for oncology products through the use of bar codes or QR codes.
India currently operates a system in which the most popular 300 medication brands, such as Shelcal, Calpol, Dolo, Allegra and Meftal Spas, are equipped with QR or bar codes for authentication purposes. The 2023 initiative targeted the removal of low-quality and fake medicines from the system.
As per the meeting minutes of DTAB reviewed , the experts were informed about the rising occurrences of counterfeit oncology medications. The minutes talk about a situation in New Delhi where dishonest criminals, working with hospital pharmacies, were discovered filling used vials of costly anti-cancer drugs with fake medications. The counterfeit medicines were combined with authentic supplies and distributed to innocent cancer patients, endangering their lives. The committee talked about the incident where Delhi Police confiscated over 140 vials of counterfeit chemotherapy drugs worth approximately Rs 4 crore.
The specialists suggested that the anti-cancer medications should be released with strict guidelines requiring “mandatory QR codes and robust track and trace systems on each vial and strip of medication sold in India.” The minutes stated that DTAB discussed the issue and approved the suggested change to encompass all anti-cancer drugs in Schedule H2 of Drugs Rules, 1945.
The committee suggested that Schedule H2 of Drugs Rules, 1945 should be updated to require all anti-cancer drugs to have a bar code or quick response code on their labels. According to Schedule H2, the pharmacist must retain a duplicate of the prescription in order to dispense the medication, thus ensuring evidence of providing the drug. This responsibility falls on the retailer to ensure the authenticity of the dispensed medication.
The significance of the action remains high due to the rising occurrences of fake cancer drug sales, with multiple schemes being uncovered by state law enforcement. Oncologists are calling for a reliable system to guarantee flawless drug delivery with zero errors.
Dr. Gaurav Dixit, who is in charge of the haemato-oncology unit at Artemis Hospital in Gurugram, believes that the initiative is extremely beneficial because fake drugs can not only be expensive for cancer patients, but also endanger their lives.
Treating cancer can be costly, with some medications costing lakhs for just one dose. Therefore, these medications are vulnerable,” Dixit stated, pointing out that “there are actually some drugs not found in India, and patients find ways to purchase them independently. Nonetheless, there is no means to verify the authenticity of the medications obtained.
He mentioned that oncologists struggle to understand why certain medications do not have the intended impact on patients, even after showing positive outcomes in clinical trials and other research. Multiple factors could explain why the drug has not produced the expected outcomes, with one of these potential reasons being the drug’s authenticity. Therefore, it is imperative for the government to address the problem of counterfeit drugs.
Likewise, Dr Satya Prakash Yadav, who heads pediatric haematology-oncology and bone marrow transplant at Medanta Hospital, emphasized the critical importance of precision when manufacturing medications for patients.
We cannot make concessions in terms of quality and once it reaches the patient, it cannot be altered by anyone. Yadav stressed the importance of having a flawless system to ensure no errors in drug production and distribution.