Central Drugs Standard Control Organization

Date

Notifications/ Orders/ Circulars/    Press Release

Accessible at

08 September 2020

Procedure to be followed for regularisation of FDCs declared as rational in respect to 294 FDCs by the DTAB which were licensed to manufacture and market by SLA without prior approval from DCG(I)

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjQ2Ng==

 

03 September 2020

Classification of non-notified medical devices

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjQ1MA==

 

31 August 2020

Submission of notarized/apostilled documents for import of medical device and in-vitro diagnostic kits in view of Covid-19

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjQyOQ==

 

31 August 2020

Requirement of fees for change in address of authorized agent, without change in constitution as post approval change under MDR 2017

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjQzMA==

 

19 August 2020

Submission of notarized/apostilled documents for import and registration of cosmetics in view of Covid 19

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjQyMA==

03 August 2020

Procedure to be followed for subsequent applicant in respect  of FDCs relating to minerals, vitamins and micronutrients declared as rational by Prof Kokate Committtee and approved by DCG

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjM0NA==

27 July 2020

Validity of Existing registration certificate for import of drugs

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjMyOQ==

27 July 2020

Exemption of hand sanitizer from sale license- Section 26 B

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjMzMA==

19 July 2020

Clarification regarding import of diagnostic kits/ reagents for research use only (ROU) for academic research purpose

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjAwNQ==

01 July 2020

Information on Convalescent Plasma in COVID-19

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjA0Mw==

05 June 2020

Compassionate use of new drug

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTk3Mw==

04 June 2020

Guidelines for validation and batch testing of Covid-19 diagnostic kits

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTk3MA==

26 May 2020

Rapid Response Regulatory Framework for COVID-19 vaccine development

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTk1NA==

22 May 2020

Voluntary registration of Personal Protection Equipment (PPE) coveralls at CDSCO and its testing at Labs recognized by Ministry of Textiles

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTk0Mw==

01 May 2020

Extension of validity of WHO GMP/Certificate of Pharmaceutical Product (COPP)

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTg5OA==

30 April 2020

Extension of Validity of BA/BE Study Centres

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTg5Nw==

25 April 2020

PCR Kits approved for testing of Covid-19

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTg4Mg==

23 April 2020

Submission of notarized/apostilled   document for import and registration of medical devices in view of Covid-19

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTg4NQ==

22 April 2020

Amended Clinical Trial protocol version 1.4 by ICMR convalescent plasma protocol v1.4

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTg4NA==

20 April 2020

Submission of notarized/ appoostiled documents for import and registration of cosmetics in view of Covid 19

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTg2OA==

17 April 2020

Clinical trial of convalescent plasma in COVID-19 Patients

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTg2Mw==

16 April 2020

Advisory issued by Ministry of Health and Family Welfare, Govt. of India to spread awareness to general public for the use of Covid-19 medicines

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTg1NQ==

16 April 2020

Office Memorandum on Covid-19 regarding the following of guidelines laid out by the Ministry of Home Affairs

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTg1Ng==

07 April 2020

Granting permission to manufacturers of industrial oxygen to manufacture oxygen for medical use in the light of Covid-19

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTgzNQ==

03 April 2020

Circular Regarding Procedure for lot release of Human Vaccine in view of prevailing Covid-19 Pandemic

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTgxNg==

25 March 2020

Release of consignments of Vaccine and critical IVDs-certain instructions issued

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTc4OA==

24 March 2020

Examples of hand sanitisers/surgical hand disinfectants approved by CDSCO including the WHO formula for reference purposes

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTc4Mg==

23 March 2020

Notice regarding Covid-19 outbreak

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTc4MQ==

19 March 2020

Notice regarding Regulatory pathway for R&D of IVD kit for diagnosis of Covid-19

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTc3MA==

19 March 2020

Notice regarding Measures to contain spread of Covid-19

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTc2OA==

19 March 2020

Notice regarding Regulatory pathway for R&D of Drug or vaccine for Covid-19

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTc2OQ==

Popular Posts

Relaxation in adherence to prescribed timelines issued by SEBI due to COVID-19

State of Karnataka - Closedown update

Further relaxations for compliances under Goods and Services Tax and Customs Laws