Profile
Shri. Nilesh Gandhi has a graduate degree in pharmacy and post-graduate degree in law. He has also acquired Diploma of Computer Application, Post Graduate Certificate in IPR – TRIPS and one year program and Good Management Practices specifically conducted for regulatory officers.
After working for four years in pharmaceutical industry in manufacturing of tablets, capsules, ointment and liquid orals, he joined Food and Drug Administration, Maharashtra State as Drugs Inspector in 1992 and was promoted as Assistant Commissioner (Drugs). During his tenure of 26 years in FDA, Maharashtra, he has worked in Intelligence Branch, WHO-GMP certification cell and in Districts with industrial belts like Pune, Thane and Raigad. During his tenure, he has used his experience in pharmaceutical industry and as a regulatory officer to focus on assisting the pharmaceutical industry to enhance compliance of GMP and of various regulatory requirements under drug laws, also as per WHO-GMP guidelines.
During his stint in FDA, he was instrumental in detecting many cases of spurious, adulterated and not of standard quality drugs and has closely worked with other Government agencies. He was always at the forefront of FDA’s initiative and projects such as software development for WHO-GMP certification, software for licensing of sales and manufacturing of drugs and cosmetics, formulating proposal to amend Drugs and Cosmetics (Maharashtra Amendment) Act. He has worked closely with sub-committee formed by Drugs Consultative Committee formed under Chairmanship of Commissioner, FDA, Maharashtra for examining the issue of online sales of medicines.
His contribution and efforts have been recognized by FDA by awarding certificates of appreciation and cash rewards. His excellence in FDA and in other professional activities has been recognized by AIDCOC by awarding Best Drugs Inspector’s Award. He has also been awarded as the Best FDA person of the year 2007 by 54th IPC Trust, Pune. He shares his experience and expertise with regulatory officers and professionals in pharmaceutical industry by making presentations in training programs and seminars organized by the Government and professional organizations.
He has co-authored jointly with Shri. S. W. Deshpande, an Exhaustive Commentary on Drugs and Cosmetics Act, 1940 and Rules, 1945 including Medical Devices Rules, 2017, New Drugs and Clinical Trials Rules, 2019, Cosmetics Rules, 2020, Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules, 1955 and Drugs (Prices) Control Order, 2013. 11th Edition of the publication is extensively useful for regulators, manufacturers, advocates as well as for the academicians. It is used as a reference book in various universities for courses of D. Pharm, B. Pharm and M. Pharm.
After 26 years of fruitful and satisfying service in FDA, Maharashtra, he has opted for voluntary retirement in 2018. Post retirement, he is associated with Pharmalex, a firm providing professional services in the areas of Pharmaceutical Legal, Technical and Regulatory compliances, this includes Label text scrutiny, scrutiny of contract manufacturing agreements, SOPs, preparing draft responses to regulatory offices, drafting appeals, etc. He also conducts audits for technical and regulatory compliances, gap analysis, conducting trainings, assessment of level of cGMP compliance of the pharmaceutical industries and distribution networks. He is taken on board as an expert for cGMP training for manufacturers for access to quality assured medical products by WHO jointly organised with Indian Pharmaceutical Alliance and JSS Academy of Higher Education & Research, Mysuru. He is also invitee as a resource person and expert for various academic programs related to the Pharma field in various educational institutions.