The Drugs Control Administration (DCA) of Telangana has made a significant breakthrough in its ongoing crackdown on illegal medical device operations. On Wednesday, officials conducted a targeted raid on an unlicensed manufacturing unit located in the Serilingampally area of Hyderabad, leading to the seizure of stocks valued at approximately ₹4 lakh.
Illegal Manufacturing of Medical Devices Uncovered
During the inspection, DCA authorities discovered a medical device known as the ‘Patient Monitor (EYVA – Electronic Medical Device)’. This device is designed for monitoring vital human signs, such as heart rate and blood pressure, making it a critical tool in healthcare settings. However, the unit was found to be producing and stocking these devices for sale without obtaining the necessary regulatory approvals.
"We found large quantities of this device that had been manufactured and stocked for sale without the mandatory licence. User manuals and sales invoices linked to the product were also seized as part of the operation," stated an official from the DCA. This seizure highlights the serious nature of the violation, as it involves products that could directly impact patient safety.
Regulatory Violations and Legal Requirements
According to officials, medical devices intended for measuring vital parameters fall under risk classes A or B. Such devices must be manufactured only after securing a medical device manufacturing licence in Form MD-5. The unit in Serilingampally was operating in complete disregard of these essential regulations, posing a potential risk to public health.
The seized product is classified as a medical device under the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017. "As per the rules, such devices must be manufactured strictly under a valid licence and in compliance with the Quality Management System (QMS) requirements prescribed in the Fifth Schedule of the Medical Devices Rules, 2017. Additionally, the devices must meet the prescribed product standards laid down under the rules," explained a statement issued by the DCA.
Implications for Public Health and Safety
The illegal manufacturing of medical devices without proper licences raises significant concerns about product quality and safety. Devices that do not adhere to QMS requirements may be unreliable or even hazardous, potentially leading to incorrect readings or malfunctions in critical healthcare scenarios.
- Risk to patients using unverified devices
- Undermining of regulatory frameworks designed to protect consumers
- Potential for widespread distribution of substandard medical equipment
Future Actions and Legal Proceedings
DCA officials have assured that further action will be taken against those responsible for this illegal activity. The investigation is ongoing, and legal proceedings will be initiated in accordance with the provisions of the Drugs and Cosmetics Act and the Medical Devices Rules. This crackdown serves as a stern warning to other entities operating without proper licences in the medical device sector.
The DCA's proactive measures underscore the importance of stringent regulatory oversight in the healthcare industry. By enforcing compliance, authorities aim to safeguard public health and maintain the integrity of medical devices available in the market.
