Effective date of IP-2014 is 01st April, 2014.
Draft Monographs are the monographs drafted in IP format, which are not given in the last edition of Indian Pharmacopoeia. After drafting they are displayed on the website (www.ipc.gov.in) for stakeholders comments. They may be considered for next addendum/edition after approval from the technical experts.
The IPC has started verifying test protocols of certain drugs which have been introduced recently in the Indian market on approval of DCGI office. In the 41st DCC meeting, the members have desired that such test protocols be made available to drug’s testing laboratories/ regulators of the respective states on demands. The list of drugs recently tested is available on our website and their test protocols are available with the IPC secretariat.
Draft Revised Tests means that the existing tests of IP, which are upgraded technically using sophisticated techniques and available on the website (www.ipc.gov.in) for stakeholders comments.
Amendment list refers to the corrections approved by the technical experts committee for implementation.
Draft proposal for amendments are the amendments drafted, which are available on the website (www.ipc.gov.in) for stakeholders comments. The same will be finalized after the technical discussion/deliberation with the technical experts. After finalization, appropriate time would be given to the stakeholders for implementation.
In the 41st meeting of the Drugs Consultative Committee held on 28th October, 2010 at FDA, New Delhi, the issue related to usual strengths indicated in an individual monograph of the IP has been deliberated. The members were of the considered opinion that the usual strengths prescribed in IP 2010 of a drug does not restrict other strengths, approved by the Regulatory Authority, to comply with the standards specified in the Indian Pharmacopoeia and be labelled ‘I.P.’
The lists of reference standards/impurity standards available with IPC are given on our website (www.ipc.gov.in). The reference standards/impurity standards which are not available with IPC, any international standard may also be used for the purpose as mentioned in appendix 5.10 of IP.
IP-2014 can be procured from the office of the Secretary-cum-Scientific Director,IP Commission at IPC Campus, Rajnagar, Sector 23, Ghaziabad – 201 002 (UP),India or from our distribution network (see website:www.ipc.gov.in).
Interested parties can participate in the following ways:
Submit draft monographs.
The Indian Pharmacopoeia encourages you to submit draft monographs. Your draft may be the starting point for an official public standard.
Propose Revisions to Existing General Chapters and Monographs
You can propose revisions to the general chapters and monographs in the current official edition of the Indian Pharmacopoeia.
By email:IPCSecretariat at ipclab[at]vsnl[dot]net
By post:IndianPharmacopoeia Commission
Ministry of Health&FamilyWelfare
Sector-23, Raj Nagar,Ghaziabad(U.P.)-201002,India
Fax : 0120-2783311
NFI stands for National Formulary of India. It is a Reference document to Healthcare professionals for rational prescribing of medicines.
The healthcare Professionals comprise of Clinicians/Medical Practitioners/Pharmacists/ Nurses and other Paramedics.
The other users of NFI may be official involved in supply chain management of medicines, Medical and Pharmaceutical teachers and students etc.
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.
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-
There are 521 monographs in NFI 2016.
There are 22 Appendices which are very important, unique & useful to the NFI users and make it different from other formularies.
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. Cotrimoxazole (Trimethoprim and Sulphamethoxazole)
- 2. Levodopa + Carbidopa
- 3. Amoxycillin + Clavulanic acid
- 4. Artemether + Lumefantrine
- 5. Rifampicin + Isoniazid + Pyrazinamide + Ethambutol
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
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.
Herbal and Phytopharmaceutical drugs Monograph are not included in NFI but few herbal product interactions with drugs are included in NFI.
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.
News & Highlights
- Residential Course On “Phytopharmaceuticals and Herbal Drugs Monograph Drafting, Verification and Validation”
- 1st IPC Interactive Meet on Pharmacopoeia Standards Regulatory and Quality Considerations
- 5th Asia Pacific Pharmacovigilance Training Course
- WALK-IN INTERVIEW for the post of Pharmacopoeial Associate (03)
- Sixth WHO bi-annual Inter-regional seminar for Quality Control Laboratories (QCLs) involved in WHO pre-qualification 23rd – 25th October, 2018 The Lalit Hotel, Barakhamba Rd, New Delhi
- Guidance Document: Materiovigilance Programme of India (version 1.1)
- 7th International Conference of ISPOR India
- Checklist for Monograph Development
- Expression of Interest for Empanelment of Manufacturers for Supply of Pharmaceutical Impurities
- Extension of last date for suggestions/comments on Draft Guidance Document for Medical Devices
- Pharmacovigilance Skill Development Programme
- Celebration of "72th Independence Day" on 15th August, 2018 at Indian Pharmacopoeia Commission, Ghaziabad
- Indian Pharmacopoeia 2018 - Amendments and Erratas
- National Workshop on "Best practices and compliance of Indian Pharmacopoeia's standards for Herbal Drugs and Phytopharmaceuticals" on 18th September, 2018
- National Coordination Centre (NCC)-Materiovigilance Programme of India (MvPI) releases Draft Guidance Document for Medical Devices
- Appointment as Statutory Audit
- National Seminar on "Health Information Resources and Searching Techniques" on 27th July, 2018 at Indian Pharmacopoeia Commission, Ghaziabad
- Interactive session of IPC, Drug Regulators, Industry & Academia at CSIR-NCL, Pune
- Dissolution Test in Albendazole Tablets Monograph for public-stakeholder comments
- IPC extended Analytical Services to Academia, Industry and Stakeholders
- Usual strength
- SOP for Installation of DVD IP 2018
- Extension of Effective Date of Indian Pharmacopoeia 2018
- 11 New Impurities Launched
- Amendment List-001 to IP 2018
- PT Schedule
- 69वाँ गणतंत्र दिवस समारोह
- Proposed Amendment for Blood and Blood Related Products in IP 2014/2018 for Stakeholder Comments
- IP Reference Standards and Impurity Standard Roadmap 2018
- IP Reference Standards and Impurity Standard Roadmap 2018