Circular Archive

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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