CDSCO Notifies Four Medical Devices Testing Labs In The Country To Ensure Quality

Mumbai, 9 Oct 2019:

With the objective to effectively regulate all medical devices under Drugs and Cosmetics (D&C) Act in a phase wise manner, the Central Drugs Standard Control Organisation (CDSCO) has notified four medical devices testing laboratories (MDTL) for carrying out evaluation of medical devices under the new Medical Devices (MD) Rules 2017 on behalf of manufacturers in the country.

The new MD rules were notified on January 31, 2017 under D&C Act to regulate manufacture, import, sale and distribution of medical devices which were effective from January 1, 2018.

As per Rule 81 of MD Rules, 2017, Sipra Labs Ltd based in Telangana, Hyderabad will carry out test or evaluation of medical devices like Copper -T, Condoms, Sterile Hypodermic Needles, Tubal Rings, Hypodermic Syringes and Blood Bags.

Star Imaging and Path Lab Pvt Ltd based in West Delhi will evaluate Bilirubin (Total and Direct) test, Reagents / Kits, Creatinine Test Reagent/ Kit, Aspartate Amino Transferase (AST/SGOT) test, Alanine Amino Transferase (ALT/SGPT) test, Uric Acid Test reagents/ kits, total Protein test reagents/kits, activated partial thromboplastin time (APTT) test and Prothrombin Time (PT) Test Reagents/ kits.

Alcatec Research Laboratories India Pvt Ltd, Haryana will evaluate Sterilized Surgical Ligatures, Sterilized Disposable Device and Sterilized Surgical Sutures.

Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvanthapuram will evaluate Cardio Vascular Devices (Biological Evaluation as per ISO 10993), Neuroprosthesis (Biological Evaluation as per ISO 10993) and Orthopedic Implants (Biological Evaluation as per ISO 10993), all medical devices and materials (biological evaluation as per ISO 10993) and dental implants (Biological Evaluation as per ISO 10993).

In the meantime, the Union health ministry is planning to upgrade manpower at CDSCO towards effective licensing and enforcement activities to ensure safety, quality and performance of medical devices.

Considering that bringing all medical devices into regulatory control will lead to increase in work load considerably, a total of 754 CDSCO regulatory officers and laboratories staff will be inducted into the existing manpower of 119 regulatory and lab staff at CDSCO before implementation of the second phase.

As per the road map outlined till 2020, the ministry has set out to upgrade CDSCO manpower by creating additional 1,195 new posts, including 64 experts, and additional 4,300 personnel for new laboratories, mobile drug testing labs, e-governance and training.

The regulatory infrastructure including manpower need to be strengthened proportionately for licensing as well as enforcement activities, as per the Drugs Technical Advisory Board (DTAB) report.

DTAB also recommended that 5 laboratories should be set up within a span of five years for testing of various medical devices and in-vitro diagnostics (IVDs) medical device. Pharmabiz