About Book
The laws and regulations governing the pharmaceutical industry were adopted to protect the consuming public by attempting to provide drugs of constituent quality, purity, and efficacy. The Food, Drug and Cosmetic Act (the Act) is a living document in that it is amended frequently and interpreted constantly. The act may be imperfect, but careful attention to its provisions plus an effort of good faith by all persons concerned with drug manufacturing can produce the type of product for which the Act and its regulations strives. Even though the applicable laws and regulations may change with regard to specifics, there are, nonetheless, many constant applicable generally. This book serves an overview of the more significant laws, regulations and Acts. This text book describes the Food, Drug and Cosmetic Act, treats briefly regulations bearing on pharmaceutical manufacturing, looks at the structure, powers, and duties of the Food and Drug administration (FDA), describes state and local laws and regulations, and finally, covers the protection of industrial property and product liability.
About Author
1.
Dr. Anasuya Patil. M.Pharm., Ph.D., working as Associate Professor, Department of Pharmaceutics, KLE College of Pharmacy, Bengaluru, Karnataka. She is having more than 20 years of teaching experience and has been guiding many PG and Ph.D scholars in the department of Pharmaceutics. She had worked in formulation development at pharmaceutical industry. She has published several research papers in reputed journals, contributed as author to Pharmaceutical Quality Assurance book and in her credit one Indian Patent.
2.
Dr Nayyar Parvez is working as Professor & HOD in the School of Pharmacy, Sharda University, Greater Noida, Uttar Pradesh. He has 23 years of Teaching & Research Experience at National & International Levels. He has completed his M.Pharm & PhD in Pharmaceutics from Jamia Hamdard, New Delhi. He was awarded GOLD MEDAL in M. Pharm (Pharmaceutics). His Research area is Formulation and Evaluation of Conventional & NDDS using synthetic and natural Polymers, Bioavailability and Bioequivalence studies of conventional and sustained release dosage forms. He was awarded Ranbaxy Research Fellowship also. He has published 65 research papers in National and International journals and presented papers in international and national conferences. He has organized various conferences and workshops. He is a life member of various professional bodies like IPA, IPGA, and ISTE. He has Guided 16 M. Pharm students and 7 Ph.D students are currently enrolled and two students have completed their Ph.D. under his guidance. He has filed 5 patents and 01 patent has been granted. He is actively involved in reviewing research papers and serving as editorial board member for National and international journals.
3.
Dr. Sachinkumar D. Gunjal is presently working at Amrutvahini College of pharmacy, Sangamner. He has completed B. Pharm. from Bharati Vidyapeeth's Poona College of Pharmacy, Erandwane, Pune (Savitribai Phule Pune University) and M. P
