Decoding the real impact of substandard and counterfeit medications

About Author: Mandeep Singh, Executive Director, Torque Pharmaceuticals gained international experience and insights during his stints with renowned pharmaceutical giants such as Pfizer and Wyeth in United Kingdom. This experience deepened his understanding of multinational operations, he now leverages in his current role where he is a vital contributor for expansion strategies, closely collaborating to enhance manufacturing and management processes.

Medication forms the bedrock of the healthcare sector, providing a ray of hope to countless individuals grappling with a myriad of illnesses. However, the escalating proliferation of counterfeit and substandard drugs, both globally and within India, has cast a long shadow over this foundation. This insidious problem has resulted in significant casualties, the enduring burden of multiple organ failures, and a lifetime of disabilities for many. India, as the world’s third-largest producer of medicines by volume, plays a central role in the pharmaceutical industry. Consequently, the proliferation of substandard or counterfeit drugs not only endangers public health but also obstructs the nation’s economic development.

In the wake of the significant disruption caused by the COVID-19 pandemic in India, the percentage of substandard counterfeit drugs has surged to a staggering 47%. During the pandemic’s peak, the world experienced a severe shortage of medicines, driving up the prices of essential healthcare products and medicines. This desperate situation fueled the emergence of illicit production units. As demand for these products skyrocketed, the legitimate supply fell behind, giving rise to a flourishing counterfeit medicines market. Reports indicate that the Indian counterfeit market reached a staggering Rs. 2.6 trillion in 2020, with the pharmaceutical industry contributing up to 20% of this sum. Shockingly, according to the World Health Organization (WHO), 10.5% of medicines worldwide are either substandard or counterfeit.

Role of consumer awareness

Compounding this issue is the lack of consumer awareness, which inadvertently supports this illicit market. Consumer education plays a vital role in the battle against drug counterfeiting. Taking steps such as purchasing medicines from reputable sources like licensed pharmacies or those accredited by recognized organizations, verifying pharmacy licenses, exercising caution with suspiciously low-priced drugs, and checking for authenticity indicators are all crucial measures to safeguard oneself from counterfeit medicines.

A study conducted by the Central Drugs Standard Control Organisation in 2009 examined 24,780 drug samples collected from 40,000 pharmacies across India. Shockingly, it found that 644 drug samples were similar in appearance, with only 11 being rejected by manufacturers. The latest study in 2017 revealed that one out of every ten medical products in the market was either substandard or fake. These products closely resemble their legitimate counterparts and share the same branding, making them nearly impossible to distinguish with the naked eye. Furthermore, the lack of education in tier 2 and tier 3 cities compounds the problem, creating an environment where counterfeit drugs can be easily sold to unsuspecting consumers, pushing them closer to death or lifelong disabilities.

Government initiatives

Today, the government is actively engaged in raising awareness about counterfeit medicines by implementing stricter policies and enforcing legal actions against counterfeit drug producers. The Central Drugs Standard Control Organization has issued an order mandating the inclusion of barcodes or QR codes on around 300 generic medicines. Under this order, any medicines manufactured on or after August 1 must bear either a barcode or a QR code. These codes will contain crucial information, including the drug’s name, brand name, manufacturer details, batch number, manufacturing and expiry dates, as well as the manufacturing license number. In addition to these efforts, drug manufacturers are continuously using social media and advertisements to educate the public about their products.

A global challenge

Counterfeit medicines pose a significant global challenge. With the global pharmaceutical industry expected to expand from $1.40 trillion in 2021 to an estimated $2.4 trillion by the end of 2029, regulatory authorities must unite. Collaborative efforts between governments, regulatory bodies, manufacturers, pharmaceutical companies, and empowered consumers armed with tools to identify counterfeit medications, can effectively combat the counterfeit medicine market. Together, we can safeguard the integrity of our healthcare system and protect the well-being of patients worldwide.