DC Bhagoji Khanapure Karnatka’s new licensing authority for medical devices & cosmetics

The state government of Karnataka has designated state drugs controller Bhagoji T Khanapure as the new state licensing authority for medical devices and cosmetics. The responsibility to issue licenses for medical devices is to be in adherence to sub-rule (2) of Rule (8) and Rule 3 (zu) of the Medical Devices Rules of 2017 with immediate effect. The task of issuing these licenses for cosmetics is to be as per the amendment made to the Cosmetic Rules 2020, and the same is specified in the Thirteenth Schedule.

The state government of Karnatka’s order has noted that Para XIV under the respective provisions of the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945, is being omitted from para 1 of the notification No HFW 150 IMM 2021 from November 23, 2021, and is as per the amendment introduced to the Cosmetics Rule 2020.

The government order noted that in supersession of its notification No 132 IMM 2018, dated September 20, 2018, it has appointed Khanapure as the state licensing authority.

The onus of issuing the drugs, homeopathy, and blood bank licenses will be on Deepak Gaikwad. Deepak Gaikwad is the former deputy drugs controller, regional office, Belgaum. He was appointed to the State Licensing Authority of Karnataka in November last year. This, the state government of Karnataka, in its order, had at that time, indicated that it was done in adherence to Parts IX and X of the National Drugs and Cosmetics Act.

The state of Karnataka is known for a solid presence in medical devices. Global companies like GE Healthcare, Phillips, Siemens, and Fujifilm vie, and local players like BPL, Axio Biosolutions, Ten3t Healthcare, Comofi Medtech, Technodont, Rx Digi Health Platform, to name a few players present in the market of the state to manufacture critical care and diagnostic equipment within India and global markets. The state is also a hub for medical device innovations. There is a start-up incubation cell at the Centre for Cellular and Molecular Platforms, a department of biotechnology of the union government of India initiative.

Further, the Department of Pharmaceuticals of the union government of India has already drafted the desired policy to catalyze Research and Development (R&D) and innovation in the pharmaceutical and Medtech sectors. Along with the union government of India’s Production Linked Incentive (PLI) scheme is expected to accelerate the pace of manufacturing the medical devices, which mandates the issue of licenses.

In the related area of cosmetics, several companies can undertake contract manufacture for large-scale enterprises, which entails insurance licenses to be sought from the state licensing authority.

In the case of the pharmaceutical sector, the state government of Karnataka is home to about 326 pharma companies. The pharma industry has been certified for its manufacturing practices after intense inspections done by global regulatory authorities like the United States Food and Drug Authority (US FDA), United Kingdom Medicines and Healthcare products Regulatory Agency (UK MHRA), European Medicines Agency (EMA), etc. to name a few. According to global multinationals, these pharma companies of the state are highly reliable and are known for maintaining high standards of quality and sticking to prompt supply timelines. Besides, the state government of Karnataka now accounts for the ten topmost brands of drugs in the country, and that, according to the industry experts, is only made possible because of the stringent and surprise inspections made by a vigilant and proactive state drugs regulatory department of Karnataka which demands a very meticulous implementation of systems of quality assurance and other standards.