 "Govt planning regulatory crackdown on look-alike, sound-alike drug names")
Drug manufacturers may now face strict actions from the drug regulatory authority if they use brand names that are identical in sound or appearance. This measure aims to enhance patient safety and reduce the risks associated with look-alike sound-alike (LASA) drugs, according to a report by The Economic Times.
The news report quoted a source as saying that India has long struggled with the issue of different drugs being marketed under the same brand name. For instance, ‘Olvance’ is the brand name for the antihypertensive drug ‘Olmesartan’, while ‘Oleanz’ is used for the antipsychotic drug ‘Olanzapine’. Similarly, ‘IMOX’ is a brand for amoxicillin tablets for humans, and ‘INIMOX’ refers to a combination of amoxicillin and cloxacillin as an injection for veterinary use.
To ensure patient safety, the Drug Technical Advisory Board (DTAB) in January this year recommended that the manufacturing and marketing of different drugs with the same brand name should be prohibited.
Subsequently, the Director General of Health Services (DGHS), in a letter to the Controller General of Patents, Designs, and Trademarks within the Ministry of Commerce and Industry, requested enhanced scrutiny and oversight of trademarks linked to pharmaceutical products to detect any cases of similarity or confusion.
As quoted by the report, the letter said, “It has come to our attention that various drugs, including those with sound alike and look alike names, are being produced and distributed under identical or similar trademarks. The situation not only creates confusion among healthcare professionals and patients but also increases the likelihood of medication errors, adverse drug reactions and other serious health consequences.”
The letter from DGHS, sent in May, aimed to safeguard pharmaceutical trademarks and uphold public health through more rigorous enforcement of trademark regulations. The DGHS directed the trademarks office to give priority to the matter and promptly enhance trademark regulations about medicines, the report said.
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A source, as quoted by the report, said that the Drugs Consultative Committee (DCC) will discuss the issue and provide recommendations by the end of this month.
‘Poor regulatory enforcement’
In May, an article published by Lancet, titled “Look-alike, sound-alike (LASA) drugs in India”, said, “Poorly trained pharmacists, perverse economic incentives, and poor regulatory enforcement have resulted in uncontrolled and unchecked dispensing of drugs in India.”
The report further said patients who cannot read rely solely on the shape and colour of the medication and its unique packaging for identification. Therefore, drugs that look alike and come in similar packaging create significant challenges for these patients, particularly those with limited educational backgrounds, in correctly administering their medication, the report stated.
“In the case of drugs with identical or similar brand names, there is no way a pharmacist could tell which drug the doctor had prescribed (in general, prescriptions in major parts of India only mention brand names with no mention of diagnosis or treatment protocol). Worse, there is no practical way of working out these ‘duplicates’ for any researcher, doctor, or pharmacist since there is no publicly accessible database that has all the drugs and the associated brands,” the Lancet report said.