Law Relating to Drugs and Cosmetics

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Containing
•    Drugs & Cosmetics Act, 1940
•    Drugs & Consmetics Rules, 1945
•    Drugs (Prices Control) Order, 2013
•    List of Drugs approved during January 2006 to march 2016
•   Transplanation of Human Organs and Tissues Rules, 2014
•   Pharmacy Pratice Regulations, 2015
•    List of Schedule H1 Drugs
•    National Pharmaceuticals Pricing Policy, 2012
•    List of Banned Drugs and Combination of Drugs
•    Pharmaceuticals and Patents
•    Guidelines on Registration of Import of Cosmetics and Important Circulars issued by CDSCO 
•    Penal Laws and other Alied Acts, Rules, Notifications etc.
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Description
The present twenty-fifth edition provides the fully amended and updated text of the Drugs and Cosmetics Act. 1940 (as amended by Amending Act 26 of 2008 enforced on August 10, 2009) and the Drugs and Cosmetics Rules, 1945 as amended up to the Second Amendment Rules, 2016, along with case-law notes, allied Acts, Rules, Orders and Notifications. Also recent notifications and Orders have been given to bring the book up to date. This exhaustive work is the most comprehensive and up-to-date manual on the subject.
Fresh new materials covered include:
•   Transplantation of Human Organs and Tissue Rules 2014
•   Pharmacy Practice Regulations, 2015:   
•   Number of Licensed Blood Banks in  India 
•   Pharmacovigilance Programme of India (PvPI);
•   Reporting of Adverse Drug Reactions and Haemovigilance Programme of India (HvPI);
•   List of Drugs approved during January 2006 to March 2016.
•   Transplantation of Human Organand Tissues Act. 1994
•   Transplantation of Human Organ Rules 1995
•    National  List  of approved  Testing Laboratories
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Contents
Appendices

I.  Drugs (Prices Control) Order, 2013
II.  Drug Policy
HI. National Pharmaceuticals Pricing Policy, 2012 (NPPP-2012)
IV.  Pharmaceutical Policy, 2002
V.  Bio-Medical Waste (Management and Handling) Rules, 1998 .  
VI.  Breeding   of and   Experiments   on   Animals   (Control and
       Supervision) Rules, 1998
VII.  Central Opium Rules, 1934
VIII.  Cigarettes and Other Tobacco Products (Prohibition of Advertisement
        and Regulation of Trade and Commerce, Production, Supply and Distribution) Act, 2003
       Cigarettes   and Other Tobacco Products (Prohibition of Advertisement and
        Regulation of Trade and Commerce, Production, Supply and Distribution) Rules, 2004
        Prohibition of Smoking in Public Places Rules, 2008. 
       Cigarettes   and   Other   Tobacco   Products   (Packaging   and Labelling)Rules,2008
       Cigarettes and Other Tobacco Products (Display of Board by
        Educational Institutions) Rules, 2009
IX.  Clinical Establishments (Registration and Regulation) Act, 2010.
      Clinical Establishments (Central Government) Rules, 2012
X.   Clinical Thermometers (Quality Control) Order, 2001 
XL  Cost Accounting Records (Pharmaceutical Industry) Rules, 2011  
XII.  Dangerous Drugs Act, 1930 .  
XIII.  Drugs (Control) Act, 1950.  
XIV.  Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954
        Drugs and Magic Remedies (Objectionable Advertisements) Rules, 1955
XV.  Epidemic Diseases Act, 1897  
XVI. Essential Commodities Act, 1955
        Essential Commodities (Special Provisions) Act, 1981 . 
XVII.  Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002.  
XVIII.  Infant  Milk   Substitutes,   Feeding-Bottles   and  Infant  Foods (Regulation of
           Production, Supply and Distribution) Act, 1992  .
           Infant  Milk  Substitutes,  Feeding-Bottles  and  Infant  Foods (Regulation of
           Production, Supply and Distribution) Rules,1993  
XLX.  Medical Termination of Pregnancy Act, 1971. 
          Medical Termination of Pregnancy Rules, 2003
          Medical Termination of Pregnancy Regulations, 2003.  
XX.  Medicinal and Toilet Preparations (Excise Duties) Act, 1955  
       Medicinal and Toilet Preparations (Excise Duties) Rules, 1956 
XXL  National Institute of Pharmaceutical Education and Research Act, 1998  
XXII.  Opium Act, 1878  
XXIII.  Patents Act, 1970
XXTV.  Pharmacy Act, 1948
XXV.   Poisons Act, 1919
XXVI.  Pre-Conception and Pre-Natal Diagnostic Techniques
          (Prohibition of Sex Selection) Act, 1994.  
           Pre-Conception and Pre-Natal Diagnostic Techniques
          (Prohibition of Sex Selection) Rules, 1996.  
XXVII.  Prevention of Blackmarketing and Maintenance of Supplies of
            Essential Commodities Act, 1980  
XXVIII.  Transplantation of Human Organs and Tissues Act, 1994
             (Transplantation of Human Organs Rules, 1995.  , '
XXIX.   Supreme Court ruling on Price Control on Seven Bulk Drugs
            [Ministry of Chemicals & Fertilizers, Covt, of India v. Cipla   (2003)7SCCl] 
XXX.   Supreme Court judgment on Novartis' Challenge to Patents Act, 1970 [NovartisAGv. Union of India, (2013) 6 SCC I].  
XXXI.  Relevant Provisions of CrPC and IPC .  
XXXII.    Changes made in First Sch. to CrPC, 1973 .  
XXXIII.    Addresses of Central Drug Control Authorities
XXXIV.    Adverse Drug Reactions (ADRs)
XXXV.    Circular regarding printing of MRP of Medicines on labels
XXXVI.    Clarificatory Circular on M.R.P.
XXXVII.    Clinical Trials Registry — India (CTRI).  
XXXVIH. Customs on Import of Cosmetics under the Drugs
               and Cosmetics Act, 1940 and rules made thereunder
XXXLX.  Documents to be submitted for grant of permission to conduct
               bioequivalence studies for export purpose
XL.   Global Clinical Trial — Requirements for Filling Applications
 XLI.  Good Clinical Practice Guidelines for Clinical Trials in India . 
XLII.  Grant of licence in Form- 1 1 to Import Drugs for the purpose of Test and Analysis
XLIII.  Guidelines for Unavailability and Bioequivalence Studies  
XLIV.  Guidelines for Import and Manufacture of Medical Devices.  
XLV.   Guidelines for Patients/Consumers of Drugs and Cosmetics
XL VI. Guidelines for taking action on samples of drugs declared
            spurious or not of standard quality in the light of enhanced
            penalties under the Drugs and Cosmetics (Amendment) Act,
XL VII. Indian Council of Medical Research  
XLVIII. Modalities for grant of WHO - GMP certificate of pharmaceutical product
           by CDSCO, DGHS, Ministry of Health and Family Welfare,
          Govt. of India from 1 October, 2009
XLIX.  National List of Approved Testing Laboratories.  
L.  National Pharmaceutical Pricing Authority
LI. Number of Licensed  Blood  Banks  in the  Country up  to february 2015 
LII.  Provisions of Consumer Protection under Drugs and Cosmetics Act, 1940  and Rules 1945
LIII.    Restricted Items for Imports under EXIM Policy, 2002-2007
LIV. Reward scheme for Whistleblowers in the fight against the menace of spurious
       or fake drugs, cosmetics and medical devices  
LV. Important Circulars   
SUBJECT AND PRODUCT INDEX . 
SHORT CONTENTS
 (CD-Rom)
1.    National Drug Policy on Malaria (2013)
2.    Circulars       
3.    Code of Marketing Practice for Indian Pharmaceutical Industry
4.   Guidelines for Blood Banks
5.    Guidelines for determining quantum of financial compensation to be paid in
       case of clinical trial related injury or death
6.    Guidelines for LV Fluids Distribution, Storage and Administration
7.    Guidelines on Recall and Rapid Alert System for Drugs (Including Biologicals and Vaccines)
8.    List of Drugs approved during January 2006 to October 20 13
9.    List of Equipment Manufacturers in India                           
10.    Major Associations in Pharmaceuticals Industry                          
11.  Manufacturers of Herbal Cosmetics and Eucalyptus Oil in India
12.  Manufacturers of Herbal Formulations in India
13.  Manufacturers of Standardized Herbal Extracts, Phytochemicals and Essential Oils in India
14.  National Blood Policy
15.  Pre-screening Checklist for the submission of Application submitted to CDSCO
16.  Ryan Haight Online Pharmacy Consumer Protection Act of 2003
17.   Sources of Medicinal Herbs in India
18.   World Importers of Herbal Products
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Author Details
Vijay Malik, B.A., LL.B., M.B.A
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