APIs are critical components that make drug formulations potent against diseases. Good quality of APIs is critical to the manufacturing of safe and effective drugs. The supply chain with respect to its security and integrity in proper storage condition plays a very important role to enhance quality supply of APIs. It has been a challenge to ensure the integrity of the API throughout the supply chain from the point of origin to destination. There are serious concerns over malicious activities in API, as well as the excipient business like refilling, relabeling, converting food grade or other similar grade materials to pharma grade by changing labels.
Raw materials are usually supplied in bulk and its authenticity definitely affects the quality of the final product. Once the barcoding regulation is implemented, the misuse of brand names and sale of counterfeit medicines will be eradicated.
Barcoding of the API packages is a welcome move by DCG(I)to have stringent control over the traceability of material across the supply chain. They may include barcodes, QR code or RFID. Barcoding is having several benefits considering its industrial use. However, this discussion is all about the recommendation of the DCG(I) having barcoding control of API packs. Like any other control, this too has its own pros and cons as mentioned below.
Merits
- Barcoding ensures complete traceability of the product by giving idea about the content, type, manufacturer, manufacturing date, shelf life, pricing, etc. It will help to determine whether the supplies are coming from the registered company, especially while dealing with companies in other countries from where raw materials are sourced.
- Any mishap done with labeling of the material can be easily identified to protect the interest of the producer and end user. Any kind of tinkering done with the label of the material can be traced and investigated at a faster pace.
- Being a machine readable mechanism, it is difficult to tamper and duplicate and this eliminates the possibility of human error. The occurrence of errors from manually entered data is significantly higher than that of barcodes.
- This will improve customer satisfaction by giving confidence about the integrity of the API. A mutual understanding between the supplier and customer will provide higher level of assurance for its usage for pharmaceutical drugs.
- It will improve the communication between supplier and customer by sharing information about the material being supplied.
- A barcode scan is fast and reliable, and takes less time than entering data manually. A barcoding integrated with GPS enabled device can also track the movement of the product pack from point to point.
Demerits
- Barcoding is limited to tracing and tracking of the material. Illegal activities like repacking, refilling, etc, cannot be ruled out by this, which is prime focus of DCG(I). Still there will be possibility of finding the content of the pack different from the content mentioned on the label. So, the risk of spurious drugs will be always there.
- Barcoding system cannot prevent unethical manufacturers who illegally repack and resell expired material with authentic barcoded labels. These APIs will be again be put into the market. APIs are generally packed in polyethylene bags as primary package, followed by fiber or high density polyethylene drums as secondary package. This type of packaging makes it easy for miscreant to get involved in such unethical practices for commercial gains. This way, the risk of spurious drugs looms big on API industry.
- It is susceptible to environmental damage. Dirty and damaged barcode cannot be read by scanner, leading deficient tracking of the packs. In this case there is no way to scan the product. So, manual entries will need to be made on labels.
- Barcodes became commercially successful when they were used to automate at point of sale checkout systems. They are directly applied on the packaging of ready-to-use products. On the contrary, APIs are meant for further manufacturing of finished dosage forms. They are packed in bulk packaging like drums, depending upon their volume and demand. The volume makes this system a challenging task.
- Pricing of the APIs varies depending upon different types of customers and the target market. So, having barcode with uniform pricing is not possible. However, it can be handled through customisation while designing a barcode.
Though it may not eliminate the risk of spurious drugs, it will definitely minimise the risk. It will give improved degree of assurance for the API supply chain. In a nutshell, barcoding is a step towards strengthening the supply chain of API industry and industry shall welcome this move by DCG(I) wholeheartedly.