Ours is the first company to get a license under the Risk Class B device in Karnataka as per New Indian Medical Device Rules 2017.
Dear Friends and colleagues,
Here is some good news to share and feel excited about.
As a duly recognized Research and Development company, by the Union Ministry of Science and Technology, New Delhi, Glowtronics embarked on a journey to look for medical devices and components which could be manufactured in our own country, with authorization from the Government.
Well equipped for the challenging task and facilitated by a controlled environment, clean rooms complying with the ISO Class 7 and 8 norms, we began to look for imported devices that were being widely used in India.
After research and development on perfusion sets used during chemotherapy, our in-house design and development team began the activities in 2016. Subsequently, we took the help of the Bangalore-based medical-surgical manufacturer Pradeep Surgicals. They helped us begin our interactions with Karnataka Drug Control Office HQ and CDSCO in 2017.
With close follow-ups and continuous interactions with the officials in Karnataka Drug Control Office and CDSCO New Delhi by our Regulatory and Quality in-charge, we received the test license for our perfusion set called, “Chemo-Perfusion-Set.”
With the test license in hand, we started completing all other mandatory testings and validations to comply with the EN ISO 13485 and CDSCO medical device regulations. Simultaneously, we started our application activities to secure the manufacturing license in 2018 with the help of IT Personnel and PRO of CDSCO Officials in New Delhi.
Being a compact professional company, we chose to apply for the license through the online application system – CDSCOMD Portal introduced by the government and thus supporting the initiatives of the government.
Although the required documents were to be submitted and processed online, we followed up with personal visits to Bangalore, Chennai, and New Delhi to deliver the technical presentation about the device and its end use to ensure required clarifications are promptly cleared to save precious time and move to the next stage. Our team members utilized the opportunity to interact with various officials at different locations and be able to build a network to pursue our application without the need for hiring a consultant.
In February 2018, we received the First manufacturing license for “Chemo Perfusion Set.” According to the Drug Control Department in Karnataka, Glowtronics is the first company to get a license under the Risk Class B device.
As a management philosophy, we aim to develop two new products every year to compete in the global market. Between 2016 and 2018, we developed three new products. We started the activities for test licenses in 2018. In 2020, we received the manufacturing license for Endoscopic Ultrasound Needle, Biopsy Forceps, and Multiple Band Ligator. All these devices fall under the Class B devices.
As a “Make in India Initiative,” Glowtronics now has the manufacturing license for four medical devices under the following categories: Disposable Perfusion Sets, Disposable Hypodermic Needles, Forceps-Endoscopic, and Ligatures that can be sold in the global market.
Activities for test license for two new products and activities to endorse further four devices are also in progress. It gives us a lot of satisfaction that all the departments in Glowtronics have equally contributed to achieving these successes.
We continue to interact with several officials from the Karnataka Drug Control Office including Ms. Vibha L, Ms. Manjula C, Ms. Namaratha, Mr. Bhagoji Khanapure, Mr. Amaresh Tumbagi, Mr. Venkatesh S, Mr. Ramesh P, Mr. Dayanand Kadadevar, Mr. Renuprasad M.U, and officials from CDSCO including Ms. Shanthy Gunasekaran, Dr. V.G. Somani, Dr. S. Eshwar Reddy, Mr.Ravikanth, Mr.Somani and Mr. Ravikanth among others.
We thank all the officials for supporting us in securing the manufacturing license and contributing their part in the Make In India initiative of the Union government.
