The recent Government move to make QR Codes mandatory on Active Pharmaceutical Ingredients (APIs) is a significant step in making the medicine supply chain more secure. This will lead to assuring the quality of medicines against counterfeiting, according to experts.
The Central Government has mandated QR code on the label of all APIs manufactured or imported in India, at each level packaging to enable tracking and tracing of the pharmaceutical ingredients. The amendment Rule is scheduled to come into force from January 1, 2023.
API refers to any substance or combination of substances used in a medicine intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease.
“Mandating Quick Response (QR) Codes in APIs will help in distinguishing spurious and original medicines and make the ecosystem less vulnerable to substandard and falsified products,” according to Nakul Pasricha, President, Authentication Solution Providers’ Association (ASPA).
This development is a wake- up call in the light of recent seizure made of spurious vaccines in Varanasi, where the accused allegedly filled empty vials with distilled water and passed them off as vaccines. To make COVID-19 rapid antigen test (RAT), the accused used pregnancy strips which looked like RAT test as both pregnancy and RAT are strip-based tests.
The UP Police Special Task Force on February 3, 2021 busted a fake vaccination racket in Varanasi and seized fake Covishield and Zycov-D vaccine vials, Covid -19 testing kits, Remdesivir injections worth Rs 4 crore. Several machines used to manufacture the fake vaccines, kits and injections were also recovered during the raid.
ASPA has 69 plus member companies providing physical and digital authentication solutions. As an industry body of authentication solutions providers, it encourages its members to adopt best practices, standards, and advanced use of technology in providing cost-effective anti-counterfeiting solutions against counterfeiting.
One of the challenges faced today by the enforcement agencies is the absence of anti-tampering, anti-counterfeiting and traceability measures making counterfeiters task quite easy. Apart from it, reasons that are triggering the growth of counterfeit products are inadequate legal framework, weak administration measures, brand and consumer awareness and fragmented distribution channels.
“The ideal solution is to include a mix of physical and digital features in the products by providing authentication and increased digital security to reduce system vulnerability. The approach adopted by European Union; falsified medicine a directive is a good example. It introduced two new safety features that must be present on each individual pack or bottle of medicine: a unique identifier (a 2D barcode containing a unique 20-digit pack number, as well as other data), and a physical anti-tampering device (ATD),” Pasricha explained.
He further added, “Counterfeiters are becoming smarter, and we need to stay one step ahead of them. The loopholes exist in our systems. In many incidents, we have noted that counterfeiters are fooling people simply by replicating the product packaging, while potentially putting inactive or even harmful contents inside the vial/packing. A weak anti-counterfeiting ecosystem and lack of awareness about how to identify fake products in the stakeholders further encourage fraud.”
The Gujarat Food and Drug Control Administration (FDCA) had made several raids in Gujarat on illegal sale of spurious COVID-19 drug favipiravir and remdesivir injections last year which had its network in Maharashtra and Himachal Pradesh.
Raids were conducted by the Gujarat FDCA in Surat, Vadodara and Ahmedabad and it was revealed that the offenders used to mislabel the drug as remdesivir and favipiravir brands of known manufacturing and marketing companies.
“An inter-state nexus of people either working as hospital staff or working in pharma companies were involved in the spurious drug racket with its network in Maharashtra and Himachal Pradesh. The offenders were booked under different sections of Indian Penal Code (IPC) and Drugs Act,” informed Gujarat FDCA Commissioner Dr HG Koshia.