Services

Legal services in the matter of the drug laws in India like Drugs and Cosmetics

Technical guidance in the activities where the challenges due to different interpretation of the provisions under the above said Acts and Rules are faced.

Provide legal opinion on issues pertaining to the drug laws and drafting response to the issues raised by regulatory authorities.

Drafting of appeal against the order of licensing authorities

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About Nilesh Gandhi

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 and Good Manufacturing 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 Drugs Administration, Maharashtra State as Drugs Inspector in 1992 and was promoted as Assistant Commissioner [Drugs] in 2015. During his tenure of 26 years in Food and Drugs Administration, Maharashtra State, he has worked in Intelligence Branch, WHO-GMP certification cell and in District 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 Good Manufacturing Practices and of various regulatory requirements under drug laws. He has extensive experience in audits of pharmaceutical industry to assess level of compliance of Good Manufacturing Practices as per WHO-GMP guidelines, Good Manufacturing Practices as per requirements under Schedule M and as per international guidelines. His industrial experience has helped him to guide the pharmaceutical industry in product development, manufacturing the stabilizing of formulations as per cGMP norms.

He was instrumental in detecting many cases of spurious, adulterated and not of standard quality drugs and has closely worked with other agencies such as CBI, NCB, Police and Customs. He was always at the forefront of FDA’s initiative and projects such as software development for WHO-GMP certificate, software for licensing of sales and manufacturing of drugs and cosmetics, formulating proposal to amend Drugs and Cosmetics [Maharashtra Amendment] Act and has worked closely with sub-committee of DCC formed under Chairmanship of Dr. Harshadeep Kamble, IES, 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 has jointly authored an Exhaustive Commentary on Drugs and Cosmetics Act, 1940 and Rules, 1945 including Medical Devices Rules, Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules, 1955 and Drugs (Prices) Control Order, 2013. 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 organization.

After 26 years of fruitful service in FDA, Maharashtra, he has opted for voluntary retirement. After his retirement, he has now associated with PHARM ASTUTE providing complete legal solutions and other services such as training to professionals in pharmaceutical industry, distribution network and community pharmacists, technical audit of pharmaceutical industries and distributors. He has been also 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.

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