The plethora of look-alike, sound-alike drugs are yet to catch the attention of the media or the medical community.
When a renowned academic journal calls out the “poor drug regulation in India” vis-à-vis the plethora of look-alike, sound-alike (LASA) drugs that are yet to catch the attention of the media or the medical community, it is a wake-up call.
Coming hard on the drug regulator, The Lancet Regional Health – Southeast Asia article notes, “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 authorisation for a drug. The very existence of countless misleading brand names shows that India’s drug regulator, Central Drugs Standard Control Organisation (CDSCO), is not doing what it is tasked to do.”
The regulator seems to have left it to pharma companies, the authors argue, to fight each other in trademark battles to resolve the issue of misleading brand names. “Worse, the courts have not been consistent in laying down or applying clear principles, and often these decisions conflict with the basic principles of trademark law.”
As an example, the article cites variations of the brand Viagra, like Penagra and Kamagra have been allowed to be used, “but only after determining that the pills cannot be the same shape and colour as the rhomboid-shaped blue Viagra pill, even though the pills are in packaging that does not reveal their shape or colour”.
The problem associated with LASA 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, notes The Lancer article. “Identical brand names contribute the most to such medication errors. The harm could range from 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, prevalence of untrained pharmacists also makes LASA drugs a significant public health threat,” write the authors.
The Lancet recommends that doctors comply with the guidelines that require them to write in capital letters the International Non-proprietary Names (INN) of the drugs in the prescriptions. After an order by the Odisha High Court, the Odisha government has stressed upon the National Medical Commission’s (NMC) guidelines and directed all doctors in government and private institutes to write legible prescriptions.
Another important point made in the article is about the proliferation of Jan Aushadi Kendras in India, where cheaper single-ingredient drugs are being sold by the government. While this provides a fertile ground to promote generic prescription writing, “the quality of the generic drugs will have to be monitored to gain the trust of the healthcare providers and make generic prescription writing sustainable”.
As a way forward, India needs to ensure that all practising doctors are on the same page when it comes to adhering to prescription practices — guidelines, regulations, and harm of poor prescription practices on the public. That is an important first step in addressing the problem.
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