Fight against counterfeit medicines: digital is the key

By Dr. Gajendra Singh

Medicines are important for us to cure illnesses. These can be prescription supplements or dietary supplements. They help prevent, treat disease and improve health. With the growing threat of counterfeit medicines prevalent around the world, ensuring authenticity is becoming the need of the hour. Nearly 10.5% of medicines sold worldwide are falsified, which has a negative impact on public health, pharmaceutical companies and a company’s reputation.

India’s date with fake and falsified drugs is no different. While India stands as one of the biggest market leaders, supplying and exporting generic drugs worth millions every year, the fake drug trade is tarnishing its image.

As the demand for drugs has increased during the COVID-19 pandemic, online pharmacies have largely benefited, leading to increased investment in this sector. However, the trade in fake drugs and essential medical products also increased during this period. Reports of fake vials of drugs like remdesivir have made headlines around the world. Even though counterfeiting is a major challenge for any industry, the sale of substandard and falsified medicines (SFFCs) has a greater impact as it affects human lives.

Challenges Facing the Healthcare Ecosystem

The sale of fake medicines that typically contain substandard or toxic active ingredients can negatively impact health outcomes and lead to morbidity and mortality. India-specific challenges that need to be addressed include the distribution of over-the-counter drugs (often without a valid prescription), the lack of insurance, and the enforcement of consistent investigations against manufacturers of fake drugs.

The Drug Controller General of India (DCGI) must work closely with the pharmaceutical companies and state authorities to eliminate the problem by following standard and defined protocols. When a complaint is filed and an investigation is conducted, the DCGI guideline labels the drug as “Not Standard Grade”, without specifying whether it is a substandard formulation or a bogus formulation. or falsified. Strict measures must be taken to punish those who manufacture and sell falsified or counterfeit medicines in the name of the original pharmaceutical company, which has no knowledge of them.

Moreover, the lack of quality control infrastructure makes it doubly difficult for authorities to impose strict oversight on the threat of counterfeiting in the pharmaceutical sector. Additionally, low consumer awareness and supply chain imbalances add to the burden. However, with the growing demand to put patient needs first, these infrastructural gaps need to be addressed and improved where possible.

Benefits of digital technology for safe access to medicines

As fake drugs pose dangers to India’s healthcare system and public health, corrective actions are being taken to revise manufacturing and supply chain discrepancies. The adoption of digital technology has been one of the measures taken to combat the sale of fake medicines. It also helps the industry to modernize and phase out SFFC drugs.

Digital track and trace technology can reinforce product authenticity and stop blatant copying. Advances in technology can also help businesses adopt features like serialization and unique packaging with scannable barcodes that can help with more consumer-focused content and better awareness of what to look for. These can also allow consumers to authenticate a product simply by using their phone.

In 2019, the Central Drugs Standard Control Organization (CDSCO) introduced a bill establishing a uniform QR code on drug packaging for ethical compliance and industry-wide quality control. Recently, the Department of Health released a bill titled “Drug, Medical Devices, and Cosmetics Bill-2022” which addresses potential shortcomings in the sale of drugs through online pharmacies. Since January 2023, the government has mandated the use of barcodes/QR codes on Active Pharmaceutical Ingredients (APIs), raw materials and packaging materials for brands available in the country.

The fight against pharmaceutical counterfeiting is also essential to reduce manufacturing losses and ensure patient safety. The pharmaceutical industry and government must act together to establish uniform testing mechanisms and regulatory frameworks and enable punitive actions against fraudulent retailers and agencies. Higher authorities, including CDSCO, the Department of Health and Family Welfare, and the Department of Trade and Industry, should also actively promote programs that encourage consumer awareness and empower pharmaceutical companies.

(The author is a public health expert. The opinions expressed are personal and do not reflect the official position or policy of

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