Circular Archive

Pharma Court Cases

Bombay High Court Aurangabad Bench Order dated 01.09.2026 - Writ Petition No. 11482 of 2026 - Indira IVF Hospital Ltd Medical Store vs State of Maharashtra & Ors.

01 September, 2026

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Pharma Court Cases

Bombay High Court Order - Writ Petition No. 11376 of 2026 - Cipla Pharma and Life Sciences Limited vs State of Maharashtra & Ors. - 2026:BHC-AS:35489-DB

29 August, 2026

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MHOFW

Gazette of India Notification No. 4415 dated 19.08.2026 - MoHFW - Extraordinary Part II Section 3 Sub-section (ii)

19 August, 2026

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MHOFW

Gazette of India Notification No. 679 dated 19.08.2026 - GSR 745(E) - Ministry of Health and Family Welfare (MoHFW)

19 August, 2026

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Government Notifications

Rajya Sabha Unstarred Q No.2678 - Pharma Manufacturing Units Inspected by CDSCO - Answered on 11.08.2026

11 August, 2026

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Government Notifications

Rajya Sabha Unstarred Q No.2648 - Fake & Sub-Standard Quality Medicines - Answered on 11.08.2026

11 August, 2026

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DGFT

DGFT Trade Notice No.19/2026-27 - Advisory against 2 Bhutanese Firms - 11.08.2026

11 August, 2026

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CDSCO

CDSCO Circular F.No.ND-11011(13)/2/2026 - Clarification on Import & Market Permission for New Drugs with Phase III GCT - 10.08.2026

10 August, 2026

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CDSCO

CDSCO Enforcement Letter F.No.ENFORC-12016(11)/2/2026 - Enclomiphene Unapproved Drug - 10.08.2026

10 August, 2026

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Pharma Court Cases

Dabur India Ltd vs UOI - Delhi HC W.P.11282/2026 - 2026

07 August, 2026

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Government Notifications

Gazette of India Extraordinary No.649 - MoHFW Draft Amendment Rules 1945 - 07.08.2026

07 August, 2026

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CDSCO

Quarterly Meeting with Stakeholders on CDSCO Regulatory Framework

06 August, 2026

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Government Notifications

Gazette of India Extraordinary No. 642 - Dated 05.08.2026 - PART II Sec 3(i)

05 August, 2026

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CDSCO

Guidance Document on Import & Registration of Drugs - Doc No. IMP/REG/200711

04 August, 2026

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Pharma Court Cases

Sushil Khanna vs Union of India | HP HC | Cr.MMO 187/2026

03 August, 2026

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Pharma Court Cases

Bombay HC Nagpur - Cr.WP 967/2024 - Oscar Remedies Vs State of Maharashtra

30 July, 2026

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Pharma Court Cases

P&H HC Chandigarh - CRM-M-24317-2026 - Ankit Aggarwal Vs State of Haryana - Decided 29.07.2026

29 July, 2026

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Government Notifications

MSME Development Amendment Bill 2026 - Rajya Sabha Bill No. LXXII

28 July, 2026

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Pharma Court Cases

Allahabad HC - Habeas Corpus Writ Petition 739/2026

23 July, 2026

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CDSCO

Vigilance on imported cosmetics products

22 July, 2026

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FOPE

FOPE Webinar Presentation on Labeling and Packaging Provisions of Drugs

21 July, 2026

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Pharma Court Cases

Innova Captab & Ors Vs State - Criminal Petition Quashing - Tripura HC 2025

20 July, 2026

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DGFT

Procedures for Export of Drugs & Pharmaceuticals - JNCH Public Notice 88/2026

20 July, 2026

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NPPA

Clarifications on filing of Form-IA for New Drugs - DPCO Amendment Order 2026

16 July, 2026

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CDSCO

CDSCO Office Order F.No Admin-11011/1/2026-eoffice dated 15.07.2026 - Posting of Dr. G.S. Pradhan as Addl DG (GSP) for CDSCO matters

15 July, 2026

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Pharma Court Cases

ZEE LABORATORY Versus UNION OF INDIA

13 July, 2026

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DGFT

Prohibition on Import of Goods Produced

13 July, 2026

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Pharma Court Cases

Himachal Pradesh HC - Cr.MMO 1336 & 472/2024 - M/s Crystal Pharmaceuticals Vs State of HP

10 July, 2026

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CDSCO

FDC Approval - Liquor Bismuth Ammonium Citrate + Belladonna + Menthol + Thymol Oral Liquid

08 July, 2026

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NPPA

Retail Price fixation of Scheduled Formulations under DPCO 2013

08 July, 2026

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NPPA

Implementation of Review Order under DPCO 2013 - Revised Ceiling Price with WPI impact @0.64950% for year 2026

08 July, 2026

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NPPA

Addendum - S.O. 3714(E) - Ceiling Price Ringer Lactate - M/s Sachin Parenteral Pvt Ltd - 08.07.2026

08 July, 2026

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NPPA

NPPA Addendum - S.O. 3713(E) - 08.07.2026 - Ceiling Price of IV Fluids

08 July, 2026

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Government Notifications

Gazette of India Extraordinary - 08.07.2026 - No.3549 - CG-DL-E-09072026-274309

08 July, 2026

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Pharma Court Cases

P&H HC Order - Theramax Laboratories vs State of Punjab - CRM-M-28121-2023

07 July, 2026

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CDSCO

Proposal on Brand Name Extensions - Comments Invited

06 July, 2026

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FOPE Newsletter

FOPE Newsletter – June 2026

01 July, 2026

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Ministry of Finance

Public Notice - CBN Services Integrated with ICEGATE Portal

01 July, 2026

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MHOFW

Seeking Comments/Suggestions on Draft NPC Bill, 2026

01 July, 2026

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NPPA

Drugs (Price Control) Amendment Order, 2026

30 June, 2026

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CDSCO

Regulation of Formulation Intermediates - F.No.ND-11012(17)/1/2026 - 24.06.2026

24 June, 2026

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CDSCO

Submission of Post Approval Changes via SUGAM Portal

24 June, 2026

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CDSCO

Regulation of Formulation intermediates such as Directly Compressible granules, Taste masked granules, Modified release granules / Pellets

24 June, 2026

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NPPA

NPPA OM - Integration of Pharma Jan Samadhan Portal with Pharma Sahi Daam Portal - 23.06.2026

23 June, 2026

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Government Notifications

Gazette of India - Extraordinary - No.455 - MoHFW Notification - 22.06.2026

22 June, 2026

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NPPA

Revised sheet based on review order dated 21.03.2023 - Paracetamol + Phenylephrine + Caffeine + Ammonium Chloride price revision

22 June, 2026

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MHOFW

Gazette Notification No. 3286(E) dated 22.06.2026 - Amendment to Jan Vishwas Act 2026 for Drugs & Cosmetics Act

22 June, 2026

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MHOFW

Gazette No. 445 dated 18.06.2026 - Drugs Rules 1945 Amendment Draft

18 June, 2026

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FOPE Secretariat

Webinar PPT on Power and Procedures of Inspectors

18 June, 2026

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FOPE

FOPE Webinar Presentation on Power and Procedures of Inspectors

16 June, 2026

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CDSCO

Implementation of Pharmacovigilance (PV) System as per the requirement of Schedule M of Drugs & Cosmetics Act 1940 and the Rules made there under

16 June, 2026

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MHOFW

Gazette No. 2962 dated 15.06.2026 - Ministry of Health & Family Welfare Notification

15 June, 2026

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CDSCO

Constitution of Consultancy Committee of Key Stakeholders for Advice on Suo-Motu Disclosure under Section 4 of the RTI Act, 2005 in CDSCO

15 June, 2026

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NPPA

Gazette Notification No. S.O. 3006(E) Issued by Ministry of Chemicals & Fertilizers

11 June, 2026

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CDSCO

Submission of Compliance for lmported/manufactured Hair Color Cosmetics Products as per Cosmetics Rules, 2020 and applicable BIS Standards.

10 June, 2026

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MHOFW

G.S.R. 477(E) dated 09.06.2026 - Drugs (Fifth Amendment) Rules, 2026 for Schedule K

09 June, 2026

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NPPA

1Aform11tion n,ganlin

05 June, 2026

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CDSCO

Prohibits to Import, manufacture, sale, distribution and use in any food producing animal rearing s ystem of drug formulations containing "Chloramphenicol or Nitrofurans drugs with imediate effect.

03 June, 2026

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CDSCO

Implementation of Pharmacovigilance (PV) System as per the requirement of Schedule M of Drugs & Cosmetics Act 1940 and the Rules made there under.

03 June, 2026

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DGFT

Amendments in Para 2.88 of Handbook of Procedures

02 June, 2026

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DGFT

Amendment of Appendix 2B [List of Agencies Authorised to issue Certificate of Origin (Preferential)] of Foreign Trade Policy, 2023

02 June, 2026

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DGFT

Fixation of Six New Standard Input Output Norms (SIONs) at SION No. A-3702, A-3703, A-3704, A-3705, A-3706 & A-3707 under "Chemical and Allied Product" (Product Code-'A').

01 June, 2026

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NPPA

Gazette Notification No. S.O. 2680(E) 27.05.2026 - Ceiling Price Fixation Gazette

27 May, 2026

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Government Notifications

Draft Revisions for Comments - Indian Pharmacopoeia

18 May, 2026

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CDSCO

Circular FDC/35/2026-eoffice dated 18.03.2026 - Detection of Unapproved FDCs in SUGAM lab testing data

18 March, 2026

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CDSCO

Guidance document on dossier based licensing of Drugs for uniform product licensing in the country

17 March, 2026

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CDSCO

Order Admin-33011(11)/2/2025-eoffice dated 13.03.2026 - Transfer/posting of officers in public interest

13 March, 2026

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CDSCO

Transfer of certain functions and delegation of powers to the zonal offices of CDSCO under Rule 22 of the Drugs and Cosmetics Rules, 1945

13 March, 2026

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MHOFW

Draft Notification reg PAC for amendment in Drugs Rules

11 March, 2026

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CDSCO

Online Applications for grant of license in Form 28-D/28-DA for r-DNA products

10 March, 2026

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CDSCO

Online Applications for Post Approval Changes (PAC) w.r.t Marketing Authorization (MA) for r-DNA products

09 March, 2026

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CDSCO

Disposal/Rejection of Long-Pending Applications on Sugam Portal Awaiting Query Response.

16 January, 2026

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FOPE Newsletter

FOPE NEWSLETTER 59

18 November, 2025

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CDSCO

Post Approval changes for clinical trials (Form CT-06) for CGTP through SUGAM Online Portal

29 October, 2025

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FOPE Newsletter

FOPE NEWSLETTER 57

24 October, 2025

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CDSCO

Withdrawal of Covid-19 indication of Baricitinib Tablets 2mg & 4mg

23 October, 2025

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DGFT

Amendment in Import Policy Condition of Sulfadiazine API covered under Chapter 29 of ITC HS 2022 ScheduleI Import Policy regarding

15 October, 2025

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CDSCO

Notice for inviting comment to ensure a level playing field in new drug approval in India

08 October, 2025

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CDSCO

Mapping of ICEGATE with CDSCO-Notified Ports

07 October, 2025

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CDSCO

Strict compliance with the Drugs Rules 1945 for testing of raw materials and finished formulations

07 October, 2025

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CDSCO

Clarification for grant of permission for combipack product of lyophilised dry powder for injection /I.V infusion and diluents for reconstitution such as sterile water for injection / sodium Chloride Injection

29 September, 2025

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CDSCO

Circular Internal time-lines Procedures for RTI Appeals

22 September, 2025

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FOPE Newsletter

FOPE NEWSLETTER 55

19 September, 2025

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CDSCO

ICMR-CDSCO Standard Performance Evaluation Protocols

17 September, 2025

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CDSCO

Clarification for regulatory pathway for Cocrystals

15 September, 2025

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CDSCO

Corrigendum to the letter dated 11.04.2025 on manufacturing and marketing of unapproved FDCs

10 September, 2025

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CDSCO

Inviting comments on consideration of the proposal regarding problem faced by the blind or visually impaired people to read medicines tablets/capsules strips

09 September, 2025

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FOPE Secretariat

Online Webinar on "Navigating GST Reduction on Pharma-DPCO & Market Perspective"

08 September, 2025

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CDSCO

Acceptance of the IBSC approval for seeking permission to manufacture test items for examination, test and analysis through form CT-10 as per the recommendation of the 314th RCGM meeting, dated 09.07.2025

03 September, 2025

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NPPA

NPPA has fixed retail prices of 42 formulations under Drugs (Prices Control) Order, 2013 based on the decision of 136th Authority meeting dated 28.8.2025

01 September, 2025

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CDSCO

Availability of Not Standard Quality (NSQ) Alert on New Link in CDSCO Website

28 August, 2025

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MHOFW

Draft Notification for application of unapproved drugs for conduct of BA/BE studies for export purpose under NDCT Rules 2019

27 August, 2025

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MHOFW

Central Health Service (Amendment) Rules 2025

25 August, 2025

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MHOFW

Notification for amendment in Rule 96 (7) of the Drugs Rules, 1945.

20 August, 2025

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CDSCO

Income Tax Circular regarding Tax regime and Savings dated 19.08.2025

19 August, 2025

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CDSCO

Inviting comments on standard IVD evaluation protocol drafted by ICMR and CDSCO 3

12 August, 2025

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CDSCO

Circular for New online Dual Use System on SUGAM Portal

01 August, 2025

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MHOFW

Notification for Amendment in Cosmetics Rules, 2020

29 July, 2025

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CDSCO

Visitors management FDA Bhawan

25 July, 2025

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CDSCO

Circulars regarding CDSCO Visitor Online System

24 July, 2025

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CDSCO

Revised Export NOC Guidance document for Manufacture of Unapproved / Approved New Drugs along with Annexures

17 July, 2025

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DGFT

Anti-dumping investigation concerning imports of "Linear Alkyl Benzene" (LAB) originating in or exported from Iran and Qatar.

15 July, 2025

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CDSCO

Extension of timeline for grant of WHO GMP COPP through ONDLS portal

15 July, 2025

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CDSCO

Circular regarding online Sugam portal for CT-04 applications of CELL & GENE THERAPEUTICS PRODUCTS through SUGAM Online Portal System

09 July, 2025

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DGFT

Fixation of new Standard Input Output Norms (SIONs) at SION (A 3687, A 3688 and A 3689 under Chemical and Allied Product (Product Code A)

08 July, 2025

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FOPE Newsletter

FOPE Newsletter 50

08 July, 2025

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NPPA

Fixation of separate Ceiling price under Para 11(3) for Paracetamol + Phenylephrine Sachet for M/s GlaxoSmithKline Pharmaceuticals Ltd. based on the decision of 134th Authority meeting dated 26.6.2025

04 July, 2025

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NPPA

NPPA has fixed retail prices of 71 formulations under Drugs (Prices Control) Order, 2013 based on the decision of 134th Authority meeting dated 26.6.2025

04 July, 2025

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FOPE Newsletter

FOPE Newsletter 48

08 June, 2025

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MHOFW

In exercise of the powers conferred by Sub section 1 of Section 43 of the Food Safety and Standards Act

04 June, 2025

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CDSCO

CDSCO updated list of laboratories to conduct Performance evaluation of IVDs dated 04.06.2025

04 June, 2025

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IPC

Clarification on impurity limits published in the Indian Pharmacopoeia (IP)-reg

30 May, 2025

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CDSCO

G.S.R. 345(E)_Draft notification for amendment in certain Drugs Rules (Related to Rule 121A Test for Pyrogen, Footnote of Schedule H, condition of license under Form 20B, 20BB, 21B, 21BB, inclusion of name of competent person in Form 20G)

28 May, 2025

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CDSCO

Office Memorandum regarding Clarification of Comprehensive permission for products imported for overprinting/stickering/stamping as per Rule 104A of Drugs and Cosmetics Rules 1945

26 May, 2025

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CDSCO

Guidance document on disposal of expired/ unused drugs

26 May, 2025

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CDSCO

Revised Export NOC Guidance document for Manufacture of Unapproved / Approved New Drugs along with revised Annexures

07 May, 2025

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CDSCO

CDSCO Notice regarding PRO Schedule

30 April, 2025

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CDSCO

Circular regarding introduction of Tooltips for legal forms in SUGAM and Medical Device Online Portals to Assist Stakeholders.

28 April, 2025

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CDSCO

Minutes of the 92nd meeting of the Drugs Technical Advisory Board (DTAB) held on 24.04.2025 through Hybrid mode.

28 April, 2025

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PULSE Series - Revised Schedule M

Revised Schedule M from the subject matter expert

27 April, 2025

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CDSCO

Notification on Drugs and Cosmetics Compounding of offences Rules

24 April, 2025

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IPC

Change in Monograph Titles and Synonyms in the Indian Pharmacopoeia - reg.

23 April, 2025

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FOPE

Our National President Mr Harish K. Jain invited to 'Pharma Ratna Universe 2025 Celebration' on 20th April, 2025 at Ahmedabad.

20 April, 2025

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FOPE Newsletter

FOPE NEWSLETTER 45

17 April, 2025

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CDSCO

Notification regarding Restriction of the Fixed Dose Combination of Chlorpheniramine Maleate and Phenylephrine Hydrochloride.

15 April, 2025

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CDSCO

CDSCO Notification dated 09.03.2025 Provision for auto-generated MSC and NCC for licenced medical device - reg.

09 April, 2025

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CDSCO

Office Circular regarding Transfer of Drugs (API/Formulations) from special Economic Zone (SEZ) to Domestic Area (DTA).

08 April, 2025

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CDSCO

OM dt 07.03.2025 regarding Grant of mfg. lic for human vaccines through ONDLS portal

07 April, 2025

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CDSCO

Office order regarding transfer of the CDSCO officers

07 April, 2025

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PULSE Series - Revised Schedule M

Session-18 of PULSE Series - Revised Schedule-M

06 April, 2025

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FOPE Newsletter

FOPE NEWSLETTER 44

04 April, 2025

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Ministry of Finance

CBIC Notification No. 21-2025 dt 03.04.2025 reg. Post export Conversation of export.

03 April, 2025

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Ministry of Finance

CBIC Circular No. 11-2025 Implementations of the export entry.

03 April, 2025

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CDSCO

Office order regarding a new Division titled "Co-ordination Division" created within CDSCO(HQ)

02 April, 2025

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NPPA

NPPA notification dated 27.03.3025 issued for revision in ceiling prices for 152 scheduled formulations based on WPI factor of 1.74028, effective from 1st April, 2025.

27 March, 2025

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NPPA

NPPA notification dated 27th March, 2025 issued for revision in ceiling prices for 748 scheduled formulations based on WPI factor of 1.74028, effective from 1st April, 2025.

27 March, 2025

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NPPA

Notification issued by NPPA for revising ceiling prices of other IV fluids of 6 formulations based WPI index 1.74028% with effect from 01.04.2025

27 March, 2025

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NPPA

Office Memorandum regarding Movement in Wholesale Price Index (WPI) for the preceding calendar year 2024 over the year 2023

26 March, 2025

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FOPE

Invitation-PharmaTech & LabTech Expo-Panel discussion on revised Schedule M on 10 April 2025

26 March, 2025

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CDSCO

Ref. G.S.R 127(E) dt. 11.02.2025. CDSCO now issued a circular outlining an online system for submission of applications via ONDLS portal. With 3 months extension, the deadline for submission is 10.05.2025

24 March, 2025

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Pharma Court Cases

Drugs & Cosmetics Act: Rajasthan HC Rules Failed Dissolution Test as Minor Defect, Quashes Prosecution S.B. Criminal Misc(Pet.) No. 6621/2023 & Ors.

21 March, 2025

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Pharma News

ET_HEALTHWORLD_NEWS_20.03.2025

21 March, 2025

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Pharma News

PHARMA_NEWS_CLIPPINGS_20_MARCH_2025

21 March, 2025

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FOPE Secretariat

FOPE Annual Membership Renewal Due For Year 2025-26 w.e.f April

18 March, 2025

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PULSE Series - Revised Schedule M

Session 17 (Hand-on Workshop): Gap Analysis & Implementation Plan for Revised Schedule M

16 March, 2025

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PULSE Series - Revised Schedule M

Revised Schedule M Compliance: The Clock is Ticking

16 March, 2025

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PULSE Series - Revised Schedule M

Revised Schedule M - GAP ANALYSIS & IMPLEMENTATION PLAN Session - 17

16 March, 2025

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PULSE Series - Revised Schedule M

Revised Schedule M Compliance & Extension | Session on Gap Analysis

16 March, 2025

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IPC

Monthly Drug Safety Alerts dated 12.03.2025

12 March, 2025

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IPC

Newsletter 2024 ( Volume- 2 )

12 March, 2025

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IPC

Newsletter 2024 ( Volume-1 )

12 March, 2025

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DGFT

Final findings in the anti-dumping investigation concerning imports of “Vitamin-A Palmitate” originating in or exported from China PR, European Union and Switzerland dated 10.03.2025

12 March, 2025

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FOPE Newsletter

FOPE Newsletter 43

11 March, 2025

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CDSCO

Export NOC Guidance and User Manual dated 07.03.2025

07 March, 2025

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NPPA

Submissions of Form-I (Application for retail price fixation of new drugs) through IPDMS only dated 06.03.2025

06 March, 2025

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NPPA

Retail Pricing Notification dated 05.03.2025

05 March, 2025

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DGFT

Metronidazole Notification dated 03.03.2025

03 March, 2025

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IPC

Proposal to Change Titles of IP Monographs published on 17.02.2025

03 March, 2025

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DGFT

Fixation of SION No. A-3684 under Chemical & Allied Product

03 March, 2025

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NPPA

Reduction in the Maximum Retail Price (MRP) on account of reduction/exemption from Custom duty dated 17.02.2025

03 March, 2025

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CDSCO

Gastro Resistant Tablets/Capsules, Delayed Release Tablets/Capsules as "New Drugs" as per Rule 2, (1)(w) of the New Drugs and Clinical Trials Rules, 2019-Reg.

24 February, 2025

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CDSCO

Evaluation of certain pre 1988 permitted Fixed Dose Combinations (FDCs) de novo for manufacture for sale in the country without due approval from Central Licensing Authority-regarding.

24 February, 2025

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Government Notifications

Immediate withdrawal of the permission to manufacture all combinations of Tapentadol and all combinations of Caresoprodol

21 February, 2025

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PULSE Series - Revised Schedule M

Session-16 of PULSE Series - Revised Schedule-M

21 December, 2024

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Government Notifications

Letter No 7-5/2025/Misc-002 dated 21.02.2025 from CDSCO(HQ), New Delhi

10 December, 2024

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FOPE Newsletter

FOPE NEWSLETTER 42

02 December, 2024

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Pharma Court Cases

Bombay HC Aurangabad - Cr.WP 912/2022 - Shree Umiya Surgical Pvt Ltd Vs State of Maharashtra - FDA Nanded

23 March, 2023

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