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Aimed & Regulatory Update

Rajeev Singh Raghuvanshi Appointed As The New Drug Controller General Of India

The DCGI, or Drug Controller General of India, is responsible for ensuring the supply of quality drugs throughout the country and holds the authority to approve new drugs as well as regulate clinical trials. Dr. Raghuvanshi, the new DCGI, has a strong background in the field with over 250 published patents and 25 publications in peer-reviewed journals.

Rajeev Singh Raghuvanshi, former Indian Pharmacopoeia Commission secretary-cum-scientific director has been appointed as the new Drug Controller General of India (DCGI), Central Drugs Standard Control Organization (CDSCO).

Raghuvanshi will supersede Dr PBN Prasad who is holding the said position till February 28. The order which was released on Wednesday stated that Raghuvanshi will continue to be the DGCI till February 28, 2025.

Recently, The Union Public Service Commission (UPSC) has recommended to the government his name as the successor to Dr V G Somani, whose extended tenure will end mid-February, officials said. The recommendation was later approved by the Health Ministry, followed by approval of the Appointments Committee of Cabinet led by Prime Minister Narendra Modi.

“The UPSC on the basis of assessment of bio-data of the eligible officers received…and after holding personal talks with them on January 27 recommend Dr Rajeev Singh Raghuvanshi for appointment to the post of Drug Controller (India) by short term contract basis,” according to the UPSC communication to the Health Ministry.

The DCGI heads the Central Drugs Standard Control Organisation (CDSCO) which is responsible for ensuring quality drugs supply across the country. It also has authority to give approval to new drugs and regulating clinical trials.

Dr Raghuvanshi has 14 granted US patents along with more than 250 published patent cooperation treaties and Indian patents. He has more than 25 publications in peer reviewed journals and has co-authored six chapters in books.

https://www.cnbctv18.com/healthcare/rajeev-singhraghuvanshi-appointed-as-the-new-drug-controller-general-ofindia-16007031.htm ; Feb 22, 2023

DCGI Calls For Medical Devices Testing Laboratories To Register With Its Network Of Laboratories

The Drug Controller General of India (DCGI) has directed the laboratories which have capacity for testing medical devices, with adequate quality accreditation, to submit applications to strengthen the medical devices testing laboratories (MDTLs) network in the country, even as the medical devices are in the phase of entering the licensing regime.

So far it has more than 28 laboratories registered with the office for testing purposes. The DCGI's office is receiving the applications for registration under Medical Devices Rules (MDR), 2017 from various laboratories for testing of different medical devices, said the regulator.

"In order to enhance the testing capacity of medical devices in the country, identification, registration and empanelment of government, private testing laboratory for medical devices testing is under consideration as per the MRD 2017," said a notice issued by V G Somani, DCGI.

In this regard, the DCGI requested the laboratories which have capacity for testing medical device and are accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL), a constituent Board of Quality Council of India, to submit the application in Form MD-39 along with requisite fees and documents through online portal for further necessary action.

http://www.pharmabiz.com/NewsDetails.aspx?aid=155375&sid=1 ; December 27, 2022.

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