Shri. S. W. Deshpande
Former Joint Commissioner, FDA, Maharashtra and Founder Pharmalex, Mumbai.Shri. S. W. Deshpande is a graduate in Pharmacy and Law. Shri. Deshpande has a multifarious personality with marked aptitude for law, Intelligence and Training. He retired from FDA, Maharashtra as the Joint Commissioner after long and outstanding service of 33 years. After his retirement in 2006, he has set up “Pharmalex” offering legal consultation on drug legislations and is legal advisor to the Indian Drugs Manufacturers’ Association, Ayurvedic Drugs Manufacturers’ Association and many leading Indian and Multinational Pharmaceutical companies.
His contribution to the Pharmacy Profession has been recognized by All India Drugs Control Officers’ Confederation by conferring “Life Time Achievement Award” during 58 th IPC at Mumbai, by Central India Pharmacy Promotion and Research Association, Nagpur by presenting “Pharma Excellence Award, 2005” and by Indian Pharmacy Graduates Association by conferring the prestigious K. C. Chatterjee Memorial Award 2005 at 57 th IPC, Hyderabad. In recognition of his service to profession and Drugs Control Officers in India he was elected to prestigious post of President, Indian Pharmaceutical Congress Association and precided over 61 st Indian Pharmaceutical Congress 2009 at Ahmedabad.
He has authored three books on drug legislations namely – A booklet “Case Law on Drugs and Cosmetics Act, 1940”, A Commentary on “Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954” and an Exhaustive commentary on “Drugs and Cosmetics Act, 1950”. He has also contributed in drafting the elaborate amendment proposal to the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 as a member of Sub-committee constituted by the Government of India.
He was instrumental in formation of the Drugs Inspectors Welfare Association (DIWA) as Founder President and was president DIWA for 12 years. He is the founder Secretary General of the All India Drugs Control Officers’ Confederation and was elected as the President in 2004 after serving AIDCOC as the Secretary General from 1995. At present he is the Director General, AIDCOC.
He is gifted teacher, communicator and a trainer, a fact recognized by national and international organizations by inviting him as faculty for seminars and workshops. He loves teaching and regularly shares his thoughts with students of pharmacy, Drugs Control Officers, Professional in Industry, Community Pharmacy and Consumer Organisations.
Shri. Nilesh Gandhi
Former Assistant Commissioner (Drugs), FDA, Maharashtra and Founder Pharm Astute, Mumbai.Shri. Nilesh Gandhi is a graduate in pharmacy and law. He has also acquired Diploma of Computer Application, Post Graduate Certificate in IPR – TRIPS and one year program on 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 was nominated by Maharashtra Public Service Commission in FDA, Maharashtra as Drugs Inspector in 1992 and was promoted as Assistant Commissioner (Drugs). During his tenure of 26 years in FDA, 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. He has extensive experience in audits of pharmaceutical industry to assess level of compliance of GMP as per WHO-GMP Certification guidelines and as per Schedule M under Drugs and Cosmetics Rules, 1945.
He was instrumental in detecting many cases of spurious, adulterated and not of standard quality drugs. He was always at the forefront of FDA’s initiative and projects such as software development for online WHO-GMP certification and licensing of sales and manufacturing of drugs and cosmetics. He has worked closely with sub-committee of 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 and also recognised by AIDCOC by awarding Best Drugs Inspector’s Award and by 54 th IPC Trust, Pune by awarding as the Best FDA person of the year 2007. 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.
After 26 years of fruitful and satisfying service in FDA, Maharashtra, he has opted for voluntary retirement. After his retirement, he is associated with firm Pharmalex(Complete Legal Solution) founded by Shri. S. W. Deshpande. Nilesh Gandhi has started his own legal and technical consultancy firm named ‘Pharm Astute’ for legal solutions and services of technical and regulatory compliance audits, gap analysis, trainings, due diligence to the pharmaceutical industries and distributors. He has been also taken on board as a Consultant by World Health Organisation (WHO) for conducting trainings on GMP in India and ASEAN countries.