A major alert has been issued over drug safety and quality across the country after the regulator flagged 90 samples of Fixed Dose Combination (FDC) drugs as unapproved. These include commonly used medicines such as Paracetamol, multivitamins, folic acid, syrups, and topical creams, raising serious concerns about potential risks to public health.
Preliminary findings indicate that these drugs fall under the category of “new drugs,” which require mandatory approval from the central licensing authority before they can be manufactured or sold. However, indications suggest that these products were being produced and distributed without the necessary clearances. In response, drug controllers across all States and Union Territories have been directed to immediately verify the approval status of these medicines and take appropriate action.
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SUGAM Portal Violations
According to the regulator’s communication, laboratory testing data from the SUGAM portal for the year 2025 revealed a significant number of FDC samples that were found to be unapproved. As per existing rules, no new drug can be introduced into the market without prior approval from the designated authority. The process requires submission of an application along with prescribed fees and compliance with regulatory norms.
Public Health Crisis Feared
Authorities have termed the presence of such unapproved drugs in the supply chain a serious public health concern. These medicines may not only affect treatment outcomes but also carry unknown risks related to safety, efficacy, and side effects. The lack of regulatory approval further complicates accountability in case of adverse outcomes, pointing to gaps in oversight within the pharmaceutical ecosystem.
The directive also calls for immediate investigation and regulatory action against manufacturers, marketers, and other stakeholders involved in the production and distribution of these drugs. States have been instructed to ensure strict monitoring and enforcement to prevent further circulation of unapproved products. Additionally, they have been asked to submit an Action Taken Report (ATR) at the earliest.
Manufacturer Approval Proof
An important aspect highlighted in the directive is the requirement for manufacturers to provide proof if they have already applied for approval under the mandatory provisions governing new drugs. This will help authorities determine whether procedural lapses or regulatory violations have occurred during the approval process.
FDC Safety Risks Highlighted
Experts note that while FDC drugs are widely used in medical practice, their combinations must be scientifically validated for safety and effectiveness. The presence of unapproved combinations in the market can pose significant health risks, particularly if their interactions and side effects have not been adequately studied.
Healthcare professionals also believe that this crackdown could improve transparency and accountability within the pharmaceutical industry. It sends a clear message that non-compliance with regulatory standards will invite strict action. At the same time, experts stress the need to strengthen surveillance mechanisms to detect such violations at an early stage.
Regulatory Framework Test
For now, the issue has been accorded top priority nationwide, with regulatory bodies stepping up monitoring efforts. More drugs could come under scrutiny in the coming days as the investigation progresses. If the allegations are confirmed, stringent action against the companies involved is expected.
Overall, the development serves as a critical test for the country’s drug regulatory framework. Ensuring patient safety and maintaining public trust will depend on swift and decisive enforcement, so that only safe and approved medicines remain available in the market.
About the author – Rehan Khan is a law student and legal journalist with a keen interest in cybercrime, digital fraud, and emerging technology laws. He writes on the intersection of law, cybersecurity, and online safety, focusing on developments that impact individuals and institutions in India.
