Dr. Ajmeer Ramkishan

Dr. A. Ramkishan has completed 27 Years of service in Central Drugs Standard Control Organization (CDSCO), Under Union Ministry of Health & Family Welfare, DGHS, Government of India.

He Joined as Drug Inspector in CDSCO, West Zone, Mumbai (1998-2002), served as a Asst. Drug Controller (India)-In charge, CDSCO, Sub Zonal Office at Airport, Ahmadabad (2002 2008); Asst. Drugs Controller (I), CFS Import, JNPT, Navi Mumbai (2008-2009); Asst. Drugs Controller (India), Air Cargo Complex, Ahmedabad (2009-2012); Deputy Drugs Controller (India) In-Charge at Airport, Ahmedabad (2012-2013); Deputy Drugs Controller (India), CDSCO (HQ), FDA Bhawan, New Delhi (2014-2017); Deputy Drugs Controller (India), West Zone Office, Mumbai (2017-2018); Deputy Drugs Controller (India), East Zone office, Kolkata (2018-2022); and currently serving as Deputy Drugs Controller (India), effectively from 12th May 2022 at Zonal Office Hyderabad (Heading Telangana & Andhra Pradesh).

His Responsibilities include Enforcement of Drugs and Cosmetics Act 1940 and rules 1945 there under to ensure quality, safety and efficacy of Drugs, Biological Products (Vaccines, Regenerative medical products, r-DNA Products, Bio-therapeutics, Blood products etc.,) Cosmetics and Medical Devices & Diagnostics. Laying down standards, making amendments, Approval of new drugs, Clinical Trials and monitoring of Import & Export of Drugs and also Inspection of Pharmaceutical units for grant of GMP certificate as per WHO TRS guidelines. Inspection of Pharmaceutical manufacturing units falls under CLAA Scheme like Blood centers, LVPs, Vaccines & r-DNA products and also inspection of Medical devices units and IVD manufacturing facilities.

He Served as a Head-Biological division, CDSCO (HQ) for the period of 2013-2017 at New Delhi and looked after the SEC meetings for Biological products and review of CT protocols/CTD data for approval of Clinical trials, Test License, Market Authorization, Product leaflets information, Evaluation of PSUR and PMS data, Manufacturing license in Form-28D, Import Registration and Import license for r-DNA products, Stem cells, Vaccines & Sera’s including Blood products and also served as Head for Bioavailability/Bioequivalence division & Veterinary division including Administration at CDSCO (HQ), New Delhi.

He also served as an expert Committee member of RCGM, CBBTDEC, SEC, GLP, DCVRN, Indian Pharmacopeia Commission, National AEFI Committee on Vaccines and member in National Haemovigilance program of India. He has received the best appreciation letters from Drugs Controller General (India) CDSCO, Ministry of Health, Government of India for outstanding contribution during the NRA Assessment 2017 (GBT Version 01) and also contributed for achieving favorable judgment to Union of India with respect to simplification Page 1 of 2 of Regulatory pathway for approval of Biosimilars in India based on challenging in the court of law with respect to Biosimilar products.

He has delivered 198 presentations on Regulatory Affairs at various National & International workshops to his credit and also recently nominated as a National Chairman for Regulatory Affairs by Indian Pharmaceutical Association (IPA) to his credit and also for creating awareness and imparting quality education of various regulatory principles published by Government from time to time as a part of capacity building as desired by skill India initiative under the ambitious leadership of Prime Minister of India.

He has received 47 awards few namely Best Drugs Controller officer award, B.V.Patel Gold Medal , Best Drugs Inspector award, M.L.Khorana Best research paper award, FDA person of the year award 2007, NATA Award USA, B.V.patel Memorial Award, M.L.Khorana Memorial Award, Patient excellence of the year Award, Pharma Ratna Award, Best Research paper award by Depart of Biotechnology, Fellowship award from IPA,IPS,TSAS,APAS and honors for his contribution both India and Internationally ; has made several presentations (179 ppts) and holds many professional memberships like DIA,ISPE,IPC,IPS,IPA,AIDCOC. He has served as a National convener in scientific services committee of Indian Pharmaceutical Congress Association (IPCA) and also served as a Expert committee member in Indian Pharmacopoeia Commission, National Haemovigilance Program of India and also r DNA expert committee at National Institute of Biologicals, Noida (UP).

He has obtained two patents (IPR) from Patent office, Govt. of India, and has authored 4 books in Pharmacy competitive examinations including NAPLEX, FPGEE and 48 research publications in various National and International journals to his credit. He holds a Ph.D. in Pharmacology – Gujarat University, Ahmedabad, Gujarat and also served as a Co-opt member in Gujarat State Drugs Advisory Board. He is also currently pursuing his Management of Business Administration (MBA) with specialization in Human Resource Management. He has attended 21 International meetings on behalf of CDSCO, Ministry of Health & Family Welfare, Government of India., namely few like Washington-DC- USA, North Carolina State University-USA, Philadelphia-USA, Colombo-Srilanka, Seoul and Jeju-Republic of South Korea, Bangkok-Thailand, Uppsala-Sweden, Lyon-France, Tianjin city-China, Brasilia Brazil ,Kualalumpur-Malaysia, Svetlogorsk-Russia and Vatican city –Rome-Italy, Geneva Switzerland being organized by WHO /USA-FDA /KFDA /PMDA /MHRA /EMEA /ANVISA /TFDA /MCC /MHRA/EMEA/SIDGP Conference.

Dr. A. Ramkishan’s main Motto is to serve the Humanity especially vulnerable population to promote International Health.