Home > Business & Economics > Industry & industrial studies > Manufacturing industries > Chemical industries > Indian Pharmaceutical Regulations: Understand the requirements and ensure compliance
20%
Indian Pharmaceutical Regulations: Understand the requirements and ensure compliance

Indian Pharmaceutical Regulations: Understand the requirements and ensure compliance

          
5
4
3
2
1

International Edition


Premium quality
Premium quality
Bookswagon upholds the quality by delivering untarnished books. Quality, services and satisfaction are everything for us!
Easy Return
Easy return
Not satisfied with this product! Keep it in original condition and packaging to avail easy return policy.
Certified product
Certified product
First impression is the last impression! Address the book’s certification page, ISBN, publisher’s name, copyright page and print quality.
Secure Checkout
Secure checkout
Security at its finest! Login, browse, purchase and pay, every step is safe and secured.
Money back guarantee
Money-back guarantee:
It’s all about customers! For any kind of bad experience with the product, get your actual amount back after returning the product.
On time delivery
On-time delivery
At your doorstep on time! Get this book delivered without any delay.
Quantity:
Add to Wishlist

About the Book

The book covers key Indian pharmaceutical regulations in an easy-to-understand presentation, will be useful for Pharmacy and Life sciences graduates seeking to make a career in Pharmaceutical Industry. The book is also beneficial to key professionals in the pharmaceutical industries including those working in Product development, Quality Assurance, Regulatory Affairs, Finance, Marketing, Sales, senior executives including CEO's who should be familiar with these legislations to ensure compliance. Useful also for start-ups and those entrepreneurs planning to be a part of the Pharmaceutical industry as Manufacturer, Marketer or retail and wholesale medicines business through single or multiple outlets or set up Drug testing laboratories.
The book covers salient features of Drugs and Cosmetics Rules and New Drugs and Clinical trial Rules. Pricing of drugs as prescribed in Drugs price control order is described. Nutraceutical related regulations are also included. It has a chapter on Marketing of drugs which covers the Uniform Code of Pharmaceuticals Marketing Practices . Regulations related to setting up of a Public testing laboratory is also included. The content is as under:
Chapter 1 - Introduction
1.1 Global Pharmaceutical Industry1.2 Global Pharmaceutical Industry1.3Pharmaceutical Regulations1.4Expectations from stakeholders
Chapter 2 - Regulatory Agencies
Chapter 3 - Manufacture of drugs for Examination, Test, or Analysis
3.1 Introduction 3.2 License for examination, test, or analysis of drugs 3.3 Import of drugs for the purpose of examination, test, or analysis 3.4 Labelling of Medicines 3.5 Other labeling requirements 3.6 Standards for Ophthalmic preparations 3.7 Use of letter I.P. on the labels3.8 Packing of drugs 3.9 Use of Package inserts in product packs3.10 Quick Response code on the label of Active Pharmaceutical Ingredients3.11 Diseases which a drug may not purport to prevent or cure3.12 Shelf life of drugs3.13 Stability studies 3.14 Permitted Colours3.15 Standards of drugs 3.16 Schedule V and Vitamin Products3.17 Labels on packs of drugs for export
Chapter 4 - Clinical Trials
4.1 Introduction4.2 constitution of ethics committee for clinical trials 4.3 Clinical trial of new drug or Investigational New Drug4.4 Academic clinical trial4.5 Inspection of clinical trial premises 4.6 Bioavailability or bioequivalence study of new drug or investigational new drug4.7 General Principles and practices of clinical trials (first schedule)4.8 Conduct of clinical trials 4.9 Compensation in case of injury or death in clinical trial or bioavailability or bioequivalence study of new drug or investigational new drug 4.10 Manufacture of new drugs or investigational new drugs for clinicalTrial, bioavailability or bioequivalence study or for examination, testand analysis 4.11Manner of labeling4.12 Import of new drugs and investigational new drugs for clinical trialor bioavailability or bioequivalence study or for Examination, test and analysis4.13 Permission to manufacture unapproved active pharmaceutical ingredient for development of formulation for test or analysis or clinical trial or bioavailability and bioequivalence Study
Chapter 5 - Manufacture of Drug for sale or distribution
Chapter 6 - Import or Manufacture of New drug for sale and distribution
Chapter 7 - New Drug Application - similar biologics
Chapter 8 - Import of drugs for sale or distribution storage, sale and distribution of drugs
Chapter 9 - Storage, sale and distribution of drugs
Chapter 10 - Narcotic and Psychotropic substances
Chapter 11 - Drugs Price Control Order
Chapter 12 Manufacture of Nutraceuticals
Chapter 13 - Marketing of Drugs
Chapter 14 - Public Testing Laboratories


Best Sellers



Product Details
  • ISBN-13: 9798506844297
  • Publisher: Independently Published
  • Binding: Paperback
  • Language: English
  • Returnable: N
  • Sub Title: Understand the requirements and ensure compliance
  • Width: 152 mm
  • ISBN-10: 8506844290
  • Publisher Date: 27 May 2021
  • Height: 229 mm
  • No of Pages: 258
  • Spine Width: 15 mm
  • Weight: 381 gr


Similar Products

How would you rate your experience shopping for books on Bookswagon?

Add Photo
Add Photo

Customer Reviews

REVIEWS           
Click Here To Be The First to Review this Product
Indian Pharmaceutical Regulations: Understand the requirements and ensure compliance
Independently Published -
Indian Pharmaceutical Regulations: Understand the requirements and ensure compliance
Writing guidlines
We want to publish your review, so please:
  • keep your review on the product. Review's that defame author's character will be rejected.
  • Keep your review focused on the product.
  • Avoid writing about customer service. contact us instead if you have issue requiring immediate attention.
  • Refrain from mentioning competitors or the specific price you paid for the product.
  • Do not include any personally identifiable information, such as full names.

Indian Pharmaceutical Regulations: Understand the requirements and ensure compliance

Required fields are marked with *

Review Title*
Review
    Add Photo Add up to 6 photos
    Would you recommend this product to a friend?
    Tag this Book
    Read more
    Does your review contain spoilers?
    What type of reader best describes you?
    I agree to the terms & conditions
    You may receive emails regarding this submission. Any emails will include the ability to opt-out of future communications.

    CUSTOMER RATINGS AND REVIEWS AND QUESTIONS AND ANSWERS TERMS OF USE

    These Terms of Use govern your conduct associated with the Customer Ratings and Reviews and/or Questions and Answers service offered by Bookswagon (the "CRR Service").


    By submitting any content to Bookswagon, you guarantee that:
    • You are the sole author and owner of the intellectual property rights in the content;
    • All "moral rights" that you may have in such content have been voluntarily waived by you;
    • All content that you post is accurate;
    • You are at least 13 years old;
    • Use of the content you supply does not violate these Terms of Use and will not cause injury to any person or entity.
    You further agree that you may not submit any content:
    • That is known by you to be false, inaccurate or misleading;
    • That infringes any third party's copyright, patent, trademark, trade secret or other proprietary rights or rights of publicity or privacy;
    • That violates any law, statute, ordinance or regulation (including, but not limited to, those governing, consumer protection, unfair competition, anti-discrimination or false advertising);
    • That is, or may reasonably be considered to be, defamatory, libelous, hateful, racially or religiously biased or offensive, unlawfully threatening or unlawfully harassing to any individual, partnership or corporation;
    • For which you were compensated or granted any consideration by any unapproved third party;
    • That includes any information that references other websites, addresses, email addresses, contact information or phone numbers;
    • That contains any computer viruses, worms or other potentially damaging computer programs or files.
    You agree to indemnify and hold Bookswagon (and its officers, directors, agents, subsidiaries, joint ventures, employees and third-party service providers, including but not limited to Bazaarvoice, Inc.), harmless from all claims, demands, and damages (actual and consequential) of every kind and nature, known and unknown including reasonable attorneys' fees, arising out of a breach of your representations and warranties set forth above, or your violation of any law or the rights of a third party.


    For any content that you submit, you grant Bookswagon a perpetual, irrevocable, royalty-free, transferable right and license to use, copy, modify, delete in its entirety, adapt, publish, translate, create derivative works from and/or sell, transfer, and/or distribute such content and/or incorporate such content into any form, medium or technology throughout the world without compensation to you. Additionally,  Bookswagon may transfer or share any personal information that you submit with its third-party service providers, including but not limited to Bazaarvoice, Inc. in accordance with  Privacy Policy


    All content that you submit may be used at Bookswagon's sole discretion. Bookswagon reserves the right to change, condense, withhold publication, remove or delete any content on Bookswagon's website that Bookswagon deems, in its sole discretion, to violate the content guidelines or any other provision of these Terms of Use.  Bookswagon does not guarantee that you will have any recourse through Bookswagon to edit or delete any content you have submitted. Ratings and written comments are generally posted within two to four business days. However, Bookswagon reserves the right to remove or to refuse to post any submission to the extent authorized by law. You acknowledge that you, not Bookswagon, are responsible for the contents of your submission. None of the content that you submit shall be subject to any obligation of confidence on the part of Bookswagon, its agents, subsidiaries, affiliates, partners or third party service providers (including but not limited to Bazaarvoice, Inc.)and their respective directors, officers and employees.

    Accept

    New Arrivals



    Inspired by your browsing history


    Your review has been submitted!

    You've already reviewed this product!