The rotten pill

With technological advancements, pharma companies can also explore new generation anti-counterfeiting technologies. In the last of the series of six articles, Organisation of Pharmaceutical Producers of India (OPPI) reveals more

People can still live with fake handbags and shoes but cannot afford to live with fake medicines. Fake medicines are a growing concern like cough syrup for children that contained a powerful opioid. Antimalarial pills and sometimes antibiotics that were just made of potato and cornstarch. These are, according to the World Health Organization (WHO), just a few examples of poor-quality or fake medicines identified in recent years. In fact, “1 in 10 medical products circulating in low- and middle-income countries is either substandard or falsified.” That includes pills, vaccines and diagnostic kits.

More than anything such substandard and fake medicines may cause harm to patients and fail to treat the diseases for which they were intended. They erode the confidence in medicines and in the health system itself. What is shocking is the WHO estimates that 35 per cent of fake drugs sold all over the world come from India. Other industry observers have said the market in spurious drugs in India could be worth as much as $8 billion (` 50,000 crore, as per current exchange rates)!

Counterfeits are produced in very poor and unhygienic conditions by unqualified personnel and contain unknown impurities and are sometimes contaminated with bacteria. In fact, they can mean that the product concerned is one of the following:

• It does not contain an active chemical at all; instead there is an inert substance like chalk powder (or distilled water instead of an injectable)
• It contains the right chemical but not in the correct dose
• It contains the right chemical in the right dose, but not the correct excipient (additive)
• Mismatch between the label and the medicine inside

Substandard drugs can also enter the market when medicines are purchased through illegal and unregulated internet sites. A complex global supply chain management especially for pharmaceuticals makes it more challenging. With so many points of entry and no robust or secure system in place to track the drug supply chain, the absence of unified and interoperable labelling and identifications standard, improper cold chain management and monitoring, multiple change of hands, including packaging and logistics provider and the absence of a standardised acceptable system heightens the counterfeit medicine issue, putting the patient at risk.

Most drug manufacturers worldwide follow globally accepted mandatory methods like mass serialisation in which machine-readable codes containing a serial number are added to each pack of medicines, enabling the product to be tracked and traced. With technological advancements, pharma companies can also explore new generation anti-counterfeiting technologies, such as the use of forensic markers (chemical, biological and DNA taggants), cloud-based supply chain data repositories, and blockchain technology in supply chains. non-ClonableID from one of the leaders in pharma packaging use nanotechnology-based authentication that is integrated seamlessly into the supply chain.

With blockchain technology companies could look at rebuilding their supply chain management. Blockchains make it possible for ecosystems of business partners like the manufacturer, distributors (3PL), and pharmacist or hospital to share and agree upon key pieces of information on a trusted network. Fully trackable and traceable through serial numbers recorded on the blockchain at every point along the journey of the pill from factory to pharmacy, the blockchain can even document critical details like location and temperature from IoT devices attached to the packages, making the journey visible to all concerned entities, while greatly reducing the possibility of record tampering.

Digital records make for a transparent, secure, decentralised supply chain management that aims to deliver drugs that protect lives. Much like the rotten apple which spoils the basket the rotten pills ruin the reputation of the industry which improves patients’ lives.

Issued in public interest by OPPI