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 In the wake of rising menace of counterfeit and spurious drugs in the market of Telangana, the new director general of the drugs control administration (DCA), Dr. Shahnawaz Quazim, has issued an advisory to the public alerting them to be vigilant and cautious while purchasing branded drugs, and wanted them to scan the QR code printed on the packaging to verify the authenticity of the medicines.
In the advisory, the DG asks the general public, hospitals, pharmacies and other healthcare stakeholders to verify the QR code/bar code details on the labels of Schedule H2 formulation brands before they are purchased or consumed.
According to the DG, the Government of India, from August 2023 onwards, implemented a vital authentication mechanism as an anti-counterfeiting measure to safeguard public health and ensure the availability of genuine medicines in the market. In this regard, the labelling provisions under the drugs rules, 1945 were amended and a quick response code system introduced on top 300 widely used drug brands produced from August, 1, 2023. The QR codes must contain specific details, including the manufacturing license number, to allow verification of the medication's authenticity.
It is learnt from sources that the department of drugs control aims to curb the menace of counterfeit drugs in the market as the number of counterfeit and spurious drug cases is increasing in Telangana despite severe actions initiated by the state drug regulatory department. The department has informed the consumers (public) to report any suspicious or unverified drug products lacking proper QR code labelling, or those displaying mismatched details to the drug control administration. The QR codes indicating the batch details are mandatorily required only for the 300 formulation brands.
In the advisory, the DCA has given notes for awareness of the people that explain that the spurious or counterfeit drugs are falsified medicines manufactured by anti-social elements by concealing the true identity of the product and made to resemble another drug of a reputed company, especially with a popular brand. This is done intentionally to deceive the public and cash in on the popularity of the original product. Spurious drugs, by their very nature, are difficult to detect as they are often deliberately designed to closely resemble genuine products, sometimes appearing almost visually identical.
“Spurious drugs may contain no active ingredient (commonly referred to as ‘nil’ medicine, often consisting of substances such as chalk, corn starch, or potato starch), or the wrong active ingredient (for example, amoxicillin capsules may contain paracetamol instead of amoxicillin), or an incorrect amount of the correct active ingredient (for instance, amoxicillin capsules 500 mg may contain only 50 mg of amoxicillin). Some spurious drugs are also found to be toxic in nature, containing either fatal levels of the wrong active ingredient or other harmful chemicals. Spurious drugs place the patient’s health at grave risk. These drugs not only fail to cure the disease but, over time, result in disastrous consequences for the patient. They also lead to a loss of confidence in medicines, healthcare providers, and the overall health system”, the DG explains in his statement to the public.
As per the amended provisions of the drug rules, the manufacturers of drug formulation products listed under Schedule H2 (comprising 300 top-selling formulation brands) should mandatorily print or affix the quick response (QR) code on their labels. This QR code must store data readable through a software application to facilitate authentication of the drug product. The stored data or information shall mandatorily include particulars such as unique product identification code, proper and generic name of the drug, brand name, name and address of the manufacturer, batch number, date of manufacturing, date of expiry and manufacturing licence number.
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