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Monday, October 13, 2014

Mr.Nilesh Gandhi imminent Pharma Regulatory Author and Drug Inspector

Mr. Nilesh Gandhi an imminent Drug Regulatory author and a drug inspector with Food and Drug Administration, Maharashtra, India

Mr.Nilesh Gandhi

















Nilesh Mohanlal Gandhi
Drugs Inspector,
Food and Drug Administration, Maharashtra



Mr. Nilesh Gandhi has co-authored a book with Shri. S. W. Deshpande on Commentary on ‘The Drugs and Cosmetics Act, 1940 and Rules 1945’. Seven editions of this book are well received by the Industry, regulatory officers and the legal practitioners in India.

A Pharmacy Grduate (B.Pharm.) from Shivaji University securing First class in 1988. Done LLB from Pune University. Excelled in the Post Graduate Certificate Course in Intellectual Property Rights (IPR) from IES, Mumbai. His quest for acquiring knowledge promoted him to obtain a Diploma in Computer Application and has also excelled in one year training program on Good Management Practices.

Impressed by the knowledge and aptitude during the interview, Magnachem Pharmaceuticals Pvt. Ltd., offered the job even prior to the results from the University. Mr. Nilesh Gandhi Contributed and acquired knowledge in different areas of formulations such as Tablets, Capsules, Liquid Orals and Ointments. Shared the knowledge and was affiliated with different companies such as USV Ltd., Elder Pharmaceuticals Ltd. He was instrumental in the development and adoption of the latest standards and technology in the manufacturing procedures and systems making at par with the cGMP.

Mr. Nilesh Gandhi was selected by the Maharashtra Public Service Commission and nominated for the position of the Drugs Inspector in the Food and Drugs Administration, Maharashtra of the Government of Maharashtra. He joined the department in 1992 and his first posting was at Pune, thereafter has served at Thane, Greater Mumbai and Intelligence branch, Raigad, Ahmednagar and Head Quarters.

Mr. Nilesh Gandhi’s experience of over 4 years and persistent efforts in the area of manufacturing and about 22 years in the regulatory has helped many companies to understand the legal requirements as well as concepts of SOPs, master formulae, inspections of laboratories and validation of various production and quality control processes. Through his skills and commitment, he has created place for him in the organization as a rated, strict and fair regulatory officer.   


Mr. Nilesh Gandhi, during his tenure at Pune, Thane, Intelligence branch, Raigad and Ahmednagar has unearthed various cases of adulterated, spurious drugs. His inputs about the Intellectual Property Rights have given clarity to the department in dealing the cases related to the brand imitations. His legal understanding and vigorous pursuance has enabled in withdrawal of exemption given to the Bathing Bars from definition of cosmetics.    

Mr. Nilesh Gandhi was presented the first Best Drugs Inspector’s award in Nov 2001 by All India Drugs Control Officers’ Confederation for his outstanding and sincere contribution to the Drugs Control Organisation.

Mr. Nilesh Gandhi was presented the Award as FDA Person of the Year 2006-2007 by 54th Indian Pharmaceutical Congress Trust, Pune.

Mr. Nilesh Gandhi holds various professional memberships which includes Indian Pharmaceutical Association, Indian Pharmaceutical Graduates Association.

Mr. Nilesh Gandhi has active leadership in Drugs Inspector Welfare Association and is Treasurer of All India Drugs Control Officers’ Confederation.

Mr. Nilesh Gandhi, because of his recognized expertise was specially invited to impart the induction training for the batch of above 40 newly recruited Drugs Inspectors for the State of Bihar.

Mr. Nilesh Gandhi due to his proficiency in computers he could develop and enabled FDA Maharashtra to launch a paperless application for online certification on WHO GMP Guidelines. 

If you have any question about regulatory guidelines you may write an email to him at Email: nilgandhi[@]rediffmail.com, dargandhi[@]gmail.com or leave a comment which will be answered by him.


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