• Frequently Asked Questions
  • 1. WHAT IS THE LEGAL STATUS OF INDIAN PHARMACOPOEIA?

    Indian Pharmacopoeia (usually abbreviated as IP or I.P.) is the official book of standards for drugs in India under the Drugs and Cosmetics Act 1940 and Rules 1945 thereunder.

  • 2. WHAT IS THE EFFECTIVE DATE OF IP 2018?

    The effective date of IP 2018 was 1st January 2018 which has been relaxed till 30th June 2018 for the stakeholders who could not upgrade or change their products for compliance with IP 2018 by the initial effective date.

  • 3. HOW CAN WE PURCHASE IP 2018?

    IP 2018 can be purchased from the office of the Secretary-cum-Scientific Director, Indian Pharmacopoeia Commission, Sector-23, Raj Nagar, Ghaziabad-201002 (U.P.), India or from our authorized distribution network (details on IPC website: www.ipc.gov.in).

  • 4. WHAT IS THE COST OF IP 2018 AND DVD?

    IP 2018 printed set is available along with DVD at the cost of ₹ 50,000 + 5% GST = 52,500/-. However, DVD of IP 2018 may separately be purchased at the cost of ₹ 30,000 + 5% GST = 31,500/-.

  • 5. HOW TO INSTALL AND OPERATE DVD OF IP 2018?

    The DVD of IP 2018 is installed on one system as Single User basis. For the installation of DVD of IP 2018, follow the system operation steps given below:

     

    • ->Insert the DVD of IP 2018 in DVD Player.
    • ->Make sure you have internet connection and it is on (internet required during first run for -registration, subsequently it can be run without internet).
    • ->Disable the Antivirus Software installed on your system and the same may be activated after uploading DVD of IP2018.
    • ->In Windows Explorer go to your DVD Drive.
    • ->Locate the file ‘NDP462-KB3151800’ and double click on it to install Microsoft dot net framework.
    • -Locate the file ‘volumeviewer.exe’ and double click on it to launch it.
    • ->The first time you run it, it’ll open a Product Registration Window.
    • -Ensure that you are registering the software on the system that you’ll be using for referring to IP 2018 as the software will not run on any other system than the one it’s being registered from.
    • ->In case internet is not running, it’ll prompt you for connecting to the internet. Once the connection is established, fill in your registration details:-
    • -Name of User
    • -E-Mail
    • -Name of Organization
    • -Serial Number (This number can be found in a sticker on the DVD)
    • ->Press the Authorize Yellow Button ONCE only and wait for the display message, ‘this will take a while’. If everything has been filled correctly, you should see a success Window open in the right hand side of the screen.
    • ->A Green ‘Registration’ Button will appear on the right hand side of the interface.
    • Press the Button to complete the registration.
    • ->You’ll see a success Box and the IPC Volume Gallery Window will launch.
    • This Window has four large yellow round buttons with ‘Volume 1’; ‘Volume 2’; ‘Volume 3’; ‘Volume 4’ written on them.
    • ->Clicking the buttons will open the respective IP volumes. For eg. Volume 1 button will open Volume 1 of IP 2018 and so on.
    • ->In the below rectangle of the Window, you’ll find two Buttons.
    • ->The first one allows you to print the Volume (You can only print 10 pages or less at one time).
    • ->The second Button is the information button, which will show you your registration information.
    • -> Re-Installation of DVD: The computer system on which the DVD has installed is being Formatted, or Window is corrupted or any other technical fault occurs and the user desired to re-install the DVD, then the DVD will be Re-Installedon the same system only at which it was installed earlier. 

    In case any problem is observed, please provide the full serial number with the numerals prefixed to the serial number with screenshot to our E-Mail ID: ipclab@vsnl.net for resolution of the problem.

  • 6. WHAT IS AMENDMENT LIST?

    Amendment list refers to the corrections/upgradations in the General Chapters andMonographs of IP which are deliberatedby the Experts Committee and approved by the Secretary-cum Scientific Director of IPC for its implementation. The amendment list is released as and when required and becomes effective with immediate effect.

  • 7. WHAT IS ERRATA LIST?

    Errata are considered to be the text erroneously published in the IP or its Addendum that does not accurately reflect the intended requirements as approved by the Expert Committee. The errata are released as and when required and becomes effective with immediate effect.

  • 8. WHAT ARE DRAFT MONOGRAPHS?

    Draft monographs are the monographs drafted in IP format which have not published in the last edition/addenda of IP. After drafting these monographs are displayed on the IPC website for stakeholder’s comments. These may be considered for next edition/addendum after approval from the competent authority.

  • 9. CAN WE USE ALTERNATIVE METHODS FOR ANALYSIS AS A SUBSTITUTE FOR OFFICIAL METHOD PUBLISHED IN IP MONOGRAPH?

    The tests and assays described in IP are the official methods upon which the standards of the Pharmacopoeia are based. Alternative methods of analysis may be used for control purposes, provided that the methods used are shown to give results of equivalent accuracy and enable an unequivocal decision to be made as to whether compliance with the standards of the monographs would be achieved if the official methods were used.

    Automated procedures utilizing the same basic chemistry as the test procedures given in the monograph may also be used to determine compliance. Such alternative or automated procedures must be validated and are subject to approval by the authority competent to authorized manufacturer of substance or product.In the event of doubt or dispute, the methods of analysis of the Pharmacopoeia are alone authoritative and only the result obtained by the procedure given in the IP is conclusive.

  • 10. WHAT IS THE STATUS OF AVAILABILITY OF REFERENCE SUBSTANCES AND IMPURITY STANDARDS AT IPC?

    The lists of IP Reference Substances and Impurity Standards available with IPC are given on IPC website. In case, a reference substance and/or impurity standard is not available with IPC, any other equivalent Pharmacopoeial standard may also be used for the purpose as mentioned in Appendix 5.9 ‘Reference Substances (IPRS)’ of the IP.

  • 11. FROM WHERE WE CAN PROCURE REFERENCE MICROBIAL CULTURES?

    Reference Microbial Cultures may be procured from IMTECH, Chandigarh (www.imtech.res.in) at following address:

    Microbial Type Culture Collection Bank,

    CSIR-Institute of Microbial Technology (IMTECH)

    Sector-39A, Chandigarh-160036

  • 12. HOW ONE CAN PARTICIPATE IN THE WORK OF IPC?

    Interested parties can participate in the following ways:

    Monograph Development: IPC encourages you to submit draft monographs (online through IPC website or offline) along with required documents as per thecheck list for monograph development. Your draft monograph may be the starting point for an official public standard.

    Revision of Existing Monograph: You may propose revisions/upgradations to the existing General Chapters and Monographsinthe current official edition of the IP.

    IPRS Development: You may also donate the candidate material for the development of IPRS.

  • 13. WHAT IS NFI?

    NFI stands for National Formulary of India. It is a Reference document to Healthcare professionals for rational prescribing of medicines.

  • 14. WHO ARE THE HEALTHCARE PROFESSIONALS?

    The healthcare Professionals comprise of Clinicians/Medical Practitioners/Pharmacists/ Nurses and other Paramedics. 

  • 15. WHO ARE THE OTHER USERS OF NFI?

    The other users of NFI may be official involved in supply chain management of medicines, Medical and Pharmaceutical teachers and students etc.

  • 16. WHAT IS THE PURPOSE OF THE NFI?

    The Purpose of NFI is to promote rational and safer use of medicines in the Country. NFI would serve as a guidance document to medical practitioners, pharmacists, nurses, medical and pharmacy students, and other healthcare professionals and stakeholders in healthcare system.

  • 17. HOW IS THE NFI DEVELOPED?

    NFI is developed based on relevant medical and pharmaceutical literature and by following rigorous consultative process with experts involving stakeholders as well.

    The flow diagram of development of NFI is as under-

     

    NFI.PNG

  • 18. HOW MANY MONOGRAPHS IN NFI 2016?

    There are 521 monographs in NFI 2016.

  • 19. HOW IS NFI DIFFERENT FROM OTHER FORMULARIES?

    There are 22 Appendices which are very important, unique & useful to the NFI users and make it different from other formularies.

  • 20. HOW MANY FDC ARE INCLUDED IN NFI?

    There are 33 fixed dose combinations of various therapeutic categories available in the NFI. The scope of fixed dose combinations is expanded, but limited to those falling under the categories of drugs with a view to promote their rational use are incorporated in NFI, Few examples are given below:

    1. 1. Cotrimoxazole (Trimethoprim and Sulphamethoxazole)
    2. 2. Levodopa + Carbidopa
    3. 3. Amoxycillin + Clavulanic acid
    4. 4. Artemether + Lumefantrine
    5. 5. Rifampicin + Isoniazid + Pyrazinamide + Ethambutol
  • 21. WHAT IS THE CRITERIA FOR INCLUSION AND EXCLUSION OF DRUGS IN NFI?

    The Criteria for Inclusion of Drugs in NFI:

    • Drugs in National List of Essential Medicines, India
    • Drugs used in National Health Programmes
    • Drugs listed in Indian Pharmacopoeia
    • Drugs not covered but recommended by panel of experts
    • Any drug (s) considered appropriate by the IPC

    The Criteria for Exclusion of Drugs from NFI:

    • Drugs banned in India
    • Obsolete Drugs
    • Drugs considered inappropritate by IPC
  • 22. IF DRUG NOT INCLUDED IN THE NFI CAN IT BE PRESCRIBED OR NOT?

    Yes, if a drug is not included in NFI, it may be prescribed by the prescriber. NFI is only a reference document for health professionals. Physicians are supposed to use their professional experience, judgment and ethics while prescribing medicines or adopting treatment regimes. Treatment regimes in respect of the diseases and ailments included in this document may also change from time to time and users are advised to adopt the changed regimes.

  • 23. ARE HERBAL AND PHYTOPHARMACEUTICAL DRUGS INCLUDED IN NFI OR NOT?

    Herbal and Phytopharmaceutical drugs Monograph are not included in NFI but few herbal product interactions with drugs are included in NFI.

  • 24. WHAT IF DRUGS BANNED IN INDIA BUT MONOGRAPH PRESENT IN NFI CAN SUCH A DRUG STILL BE PRESCRIBED?

    The use of any drug banned in the country by the authority concerned, the monograph or other content of this document shall stand deleted or modified as the situation may demand.

    Where there is any anomaly between the content of NFI and any other non-statutory Official document exists, the decision of the Government or the implementing authority will prevail.

  • 25. WHAT IS IP GUIDANCE MANUAL?

    IP Guidance Manual is a book published to enable the users of IP to perform the activities relatedto performance of the tests or associated activities prescribed in the IP and also to understand or interpret the requirements of IP for proper compliance to the regulatory requirements. Guidance Manual provides specific features of IP, validation of analytical procedures, procurement, availability and use of IP reference substances, calibration of equipment and glasswares, SOPs and infrastructure requirements for drug testing laboratory. It may be purchased from IPC, Ghaziabad.

  • 26. HOW TO CONTACT IPC?

    You may contact IPC at following address:

    Indian Pharmacopoeia Commission

    (Ministry of Health & Family Welfare, Government of India)

    Sector-23, Raj Nagar, Ghaziabad-201002, U.P., India

    Website: www.ipc.gov.in

    Email: ipclab@vsnl.net

    Phone: +91-120-2783392, 2783400, 2783401

    Fax: +91-120-2783311

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