The Indian pharma industry has grown leaps and bounds, addressing the world’s medical needs. Currently, the third largest pharma leader globally, India supplies generic and low-cost drugs across the world. Accelerated investments in medical manufacturing and generic drug supply have also contributed significantly to the nation’s economic growth. Though we have become the ‘pharmacy of the world,’ spurious and Not of Standard Quality (NSQ) is still an issue to deal with in the pharma sector.
Often termed the ‘Crime of the 21st Century,’ counterfeiting or fake medicines found in the supply chain is a global menace and affects every economy in the world. India’s economy suffers to the tune of Rs 1 trillion every year due to this menace. The ramifications of the use and supply of dubious medicines and medical devices have harmful health effects and deter the achievement of sustainable development goals with respect to providing quality care. India must, therefore, take urgent steps to resolve this crisis.
Drug counterfeiting on the rise
Counterfeiting can apply to both branded pharmaceuticals and their less expensive generic counterparts. Falsified drugs aim to match the original brand in looks to a large extent, but contain poor (or toxic) doses of the prescribed medications’ active ingredient and other chemicals, which pose significant harm upon consumption. Most Spurious/Falsely-labelled/Falsified/Counterfeit (SFFC) medicines are cheaper and easily available (even without a prescription), making them a preferred option for several innocent and most vulnerable patients.
The toxicity of the ingredients from spurious drugs has been linked to mass poisoning, organ damage, poor efficacy and even linked to infant mortality. The trade of spurious drugs is also said to be a major driver of anti-microbial resistance, which is a rising threat.
The problems of drug shortages and high demands encountered during the pandemic have increased the sale of fake drugs, due to lack of robust surveillance mechanism and consumer awareness. Multiple stakeholders such as the Drugs Controller General of India (DCGI), the state drug control authorities and the pharma industry need to work together to tackle this growing menace. In India, when a complaint about a drug is raised, the regulatory authority seizes the sample and sends it for quality check. Based on the results, the Drugs Controller General of India (DCGI) releases a directive without any consultation with the other stakeholders. The labelling of the drug as ‘Not of standard quality’ makes it difficult to differentiate if the sample was substandard (low percentage of API) or fake/spurious.
The reputation of the authentic pharma company is often besmirched due to this lack of clarification. It is important that stringent punitive action be taken against the seller of the falsified or fake drug after due investigation.
Moreover, since India is not a tightly regulated market, it augments the problems and allows fake sellers to gain access to the market trade. Long and convoluted supply chains marred by loopholes also compound the risk. With counterfeiters adopting more sophisticated techniques to hoodwink customers, it becomes easy for them to distribute the drugs through unregulated conventional channels and poor regulatory oversights.
How can the industry combat the counterfeiting menace?
Counterfeiting in the pharma industry poses significant challenges not just to public health and global image, but also wastes the income of the consumer. It also leads to a loss of trust in drugs, healthcare providers and healthcare ecosystems as a whole. Rampant sales and availability of fake drugs can also negatively impact innovation and growth vital for global pharma expansion. It can also lead to poor incentivisation needed for research and development, in addition to employment loss.
To prevent economic losses, stakeholders and policymakers have to enact laws focussing on regulation and ensuring compliance. Large pharma conglomerates must play the role of enablers in expanding enforcement, vigil and improving consumer awareness by empowering consumers to differentiate between genuine and fake products education. With an onus on improving our global position, regulatory adherence is necessary to break the trade cycle of criminal-minded counterfeiters.
The use of anti-counterfeit technologies is also becoming popular worldwide and is being adopted in India too. These technologies are being applied in the primary areas of anti-counterfeiting, anti-tampering and tracking and tracing. These can prevent copying, catch the culprits, and help consumers identify genuine products from fake ones. There is also an immediate need for manufacturers and distributors to plug the holes existing across the supply chain and use mechanisms which facilitate verification of drug quality in a user-friendly manner. Developing stronger regulations can govern product discrepancies when they change hands and weed out potential counterfeits in the interest of public health and the economy.