Counterfeit pharmaceutical drugs are increasing worldwide and have breached the legitimate drug supply chain in both developed (Europe and America) and developing regions and countries (India and South Asia). Since counterfeit medicines pose a massive threat to the global population and the pharmaceutical sector, ensuring the integrity of products is necessary. This is why pharmaceutical companies need an effective and comprehensive solution to combat fake medications.
Mumbai-based Condot Systems offers products and solutions for end-to-end tracking and tracing of products. This starts with serialization, marking, batch coding, variable data printing, and then goes on to transport and vision systems. With these solutions, the company meets the demands of the printing and packaging of food, FMCG, and pharmaceutical products.
According to Kinal Chiniwala, vice president of Operations at Condot Systems, the company designs GS1 track and trace solutions, keeping in mind the pharmaceutical industry’s requirements. The GS1 track and trace solutions comply with each country’s regulations.
Condot has a comprehensive range of variable data print and verification systems for all types of packaging. “We have solutions for coding and marking on porous and non-porous materials with thermal inkjet technology (aqueous, solvent, and UV curable inkjet inks). Our track and trace solutions (hardware and software) are compatible with manual, semi-automatic, or fully-automatic production lines,” says Chiniwala.
Jus printing a QR code is not enough
Since 2011, the Indian government has been trying to introduce technologies such as QR codes for pharma products. These QR codes can help track and trace the supply chain of drugs while minimizing the chances of spurious, sub-standard, and counterfeit drugs reaching patients. In 2019, the Central Drugs Standard Control Organization (CDSCO) issued a draft notification mandating the use of the QR code on the label, at each level of packaging to facilitate tracking and tracing. More recently, the Government set up a committee to fine-tune the modalities and attribute a unique QR code on medicine packs to ensure their authenticity and ease of tracking.
Commenting on this recent development, Chiniwala asserts, “It is a must to keep spurious drugs out of the supply chain, but it will not suffice to print a QR code on the pack merely. There should be a mechanism whereby consumers can find out a drug is spurious before buying or consuming it.”
Serialization demands that pharmaceutical manufacturers invest in advanced technologies, adapt their current processes and systems, and ensure that the entire working line understands the new regulatory environment in which they are functioning. However, observers say that India’s regulations are less demanding and less stringent than the US and Europe.
Chiniwala says that Indian manufacturers focus on buying equipment to comply with current regulations in force. “This is not their fault because the solutions offered to them are also not future-ready.” While she agrees that pharma companies face spurious supply challenges, she suggests a need for stricter government regulations and enforcement. “The Government is only focusing on controlling the price of the drug, but the action on the spurious drug supply chain is still missing.”
Moreover, she is apprehensive of the overall acceptability of serialization, anticounterfeiting, and track and trace solutions. “Market readiness is not there due to the absence of concrete guidelines. As of now, only exporters are following the regulatory framework. The market will take time to stabilize and understand the appropriate selection according to need and future readiness.”
Technology – a game-changer
As many countries are moving towards adopting tighter control over drugs, technology could be a game-changer. According to Chiniwala, rapidly changing regulations pose serious threats to pharmaceutical companies, and only solutions equipped with the latest technology could save them. “Just selecting equipment on the price will not help the market. In such conditions, for every change in rules, their equipment will not be compatible.” She believes that the regulations will keep changing based on newer requirements.
Condot has over 29 different models of track and trace solutions to fit customer needs and production line requirements. The company spends over 30% of its net profit on R&D. “In software, Condot has developed track and trace solutions that comply with the Government regulations and help to ease out the production floor to adopt these,” says Chinwala.
Competing with local pricing
As mentioned above, a challenge in implementing serialization solutions is competing with local pricing. Chiniwala explains, “Since India is a cost-sensitive market, we can easily find suppliers who want to supply quantity without considering the quality.” However, she is hopeful of a change in the current scenario. Both suppliers and buyers understand that there is a better opportunity for quality, saying, “The company is growing with a vision to improve quality and become the first preference in the market.”
Easier to adopt, better productivity with minimum rejection ratios, a wider variety of machines suitable for different products and sizes, future readiness for changing compliances, and minimum requirements of after-sales service, are critical differentiation factors for Condot. Already operating in 38 countries, it aims to expand its business in other jurisdictions.