Prof.Malay Mitra

Shri. Mitra completed his Pharmaceutical education from Jadavpur University, Calcutta in 1974. He worked in the area of pharmaceutical manufacturing in various capacities up to 1982. He joined Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Ministry of Health & Family Welfare, Govt. of India in 1982. He has audited around 1500 institutions till date including China. He was an active member during the formation of Schedule M (GMP, Drugs and Cosmetic Rules, 1945). He was engaged in various workshops on Blood banking at Chandigarh, Lucknow, Delhi and was invited by the Government of Kerala to organize GMP seminars and training workshops in Cochin a number of times for their regulatory staff and manufacturers. More than 200 presentations on various technical topics have been delivered by him in various fora including the Indian Pharmaceutical Congress Association, Indian Pharmacy Graduates Association, Bureau of Indian Standards etc.
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Prof.Arun B.Ramteke

Shri. Arunkumar B. Ramteke retired as a senior drugs regulatory officer (Joint Drugs Controller, India, CDSCO) with 31 years of experience in drug regulatory aspects in the office of the Drugs Controller General of India (DCGI). He has in-depth knowledge of Indian Drugs & Cosmetics Act, Rules and of regulations of Global Drug Regulatory norms. He started his career at Central Research Institute, Kasauli, as Deputy Assistant Director, BSQC Division and faculty for B.Sc. (Microbiology) H.P. University. As Drug Regulator he has extensive experience with new drugs, vaccines and biotech products/pharmaceuticals, medical devices regulatory approvals and development experience. He also has experience in review and evaluation of product dossier for pre-clinical, toxicological, pharmacological, CMC, and quality control, clinical trial data of new drugs, biological and medical devices (INDs, ANDA). He has strong skills in quality assurance management, regulatory oversight of clinical trials, development of SOP and guidelines and involvement in drug rules amendments. As an expert he has attended various national and international training workshops and meetings on drug regulations. He has contributed to preparation and implementation of Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice
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