Illegal Making of Medical Devices, 45 Units under CDSCO scanner

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Orthopedic implants were manufactured illegally without any regulatory license or approval. The Central Drugs Standard Control Organisation(CDSCO) team has raided 45 medical device facilities across the country for illegally producing orthopedic implants, cracking the whip on manufacturers making high-end life-saving devices without following quality standards and best practices.

The manufacturers are from Delhi, UP, Maharashtra, and Gujarat, as per officials statement. A senior official from CDSCO shared with the media that they issued show cause notices to them and the owner manufacturers have to explain the reason for the violation. Once we get their responses, action will be taken under provisions of the Drugs and Cosmetics Act.

These surprise raids were carried out by 125 officers divided into 37 inspection teams from the Central Drugs Standard Control Organisation. Drug inspectors found “dirty and filthy conditions” for manufacturing, lack of quality management and testing facilities as well as poor quality raw material.

Out of the four raided states, Delhi counted for the highest number of illegal facilities with the central regulatory teams conducting raids at 25 factories, whereas eight facilities were inspected in Maharashtra and six each in Gujarat and UP.

The use of medical devices is a rapidly growing segment in India, and these raids assume significance. Medical devices are particularly for high- end implants like cardiac and orthopedic implants where medical procedures are increasing swiftly despite the high prices of these devices and overall treatment. Presently, the Indian device manufacturing industry is pegged at $7 billion and is projected to reach $50 billion by 2025.

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