Risks of Look-alike, Sound-alike Drugs Highlighted in Indian Healthcare Landscape

LASA drugs, characterized by similar packaging, names, or appearance, pose a significant challenge to medication safety, often leading to medication errors, adverse reactions, and patient harm. In the context of India's vast and diverse pharmaceutical market, where numerous brands and generic formulations coexist, the prevalence of LASA drugs exacerbates these risks, posing formidable challenges for healthcare providers and patients alike.

In India, poor drug regulation is not a recent problem. The Indian drug market is full of look-alike, sound-alike drugs that have not yet caught the attention of the medical community or the media. The viewpoint by Parth Sharma, Association for Socially Applicable Research (ASAR), Pune, Maharashtra, India, and colleagues highlights the problem of LASA drugs and poor prescription practices, proposes solutions for involving all stakeholders in this unaddressed issue which is a huge public health problem in India.

Poorly trained pharmacists, poor regulatory enforcement, and perverse economic incentives have resulted in unchecked and uncontrolled dispensing of drugs in India. Marketing different drugs with deceptively similar brand names remains a significant problem even in cases where the drugs are of standard quality.

Unfortunately, the problem associated with look-alike, sound-alike drugs has not caught the attention of the Indian media yet and there has been very little research within the medical and scientific communities about this issue and its impact, the study stated.

There are instances of two different drugs having the same name but being manufactured and marketed by different entities. For example, (i) brand name ‘Medzol’ is used for both Pantoprazole and Midazolam; (ii) ‘Medzole’ is used for Metronidazole oral suspension, Albendazole tablets and Itraconazole capsules; (iii) ‘Flucor’ is used for both Fluconazole and a combination of Melitracen and Flupentixol; and (iv) ‘Linamac’ is used for both Linagliptin and Lenalidomide.

LASA drugs may lead to significant medication errors and could quite conceivably lead to harm to the patients. Identical brand names contribute the most to such medication errors. The harm could be unnecessary drug effects and side effects to the progression of the disease that was left untreated due to a medication error.

In low-income and middle-income countries (LMIC) like India, the prevalence of untrained pharmacists also makes LASA drugs a significant public health threat.

"After judicial directions, Indian law now requires the drug regulatory body to review a trademark search report to ensure there are no misleading brand names, before granting marketing authorization for a drug," the research team wrote. "The existence of countless misleading brand names shows that Central Drugs Standard Control Organisation (CDSCO), India’s drug regulator, is not doing what it is tasked to do."

The regulator has left it to pharma companies to fight each other in trademark battles to resolve the issue of misleading brand names. The courts have not been consistent in applying clear principles, and often these decisions conflict with the basic principles of trademark law.

As an example, variations of the brand Viagra, like Kamagra and Penagra have been allowed to be used but only after determining that the pills cannot be the same color and shape as the rhomboid-shaped blue Viagra pill, even though the pills are in packaging that does not reveal their color or shape.

The Lancet publication catalyzes action, prompting policymakers, regulatory agencies, and healthcare institutions to prioritize medication safety initiatives and regulatory reforms aimed at curbing the proliferation of LASA drugs in India's pharmaceutical market. By implementing comprehensive risk mitigation strategies and fostering a culture of medication safety, stakeholders can collectively work towards enhancing the quality and integrity of healthcare delivery in India.

As India continues to grapple with the challenges of medication safety in an increasingly complex healthcare landscape, studies like this provide valuable insights and evidence-based recommendations to inform policy development, clinical practice, and patient advocacy efforts, ultimately safeguarding the health and well-being of individuals.

Reference:

Neelakantan, M., Sharma, P., & Kulkarni, A. (2024). Look-alike, sound-alike (LASA) drugs in India. The Lancet Regional Health - Southeast Asia, 26, 100425. https://doi.org/10.1016/j.lansea.2024.100425