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Last updated on : 29/07/2015
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INTERNATIONAL CELL

 

SR NO Name FileName
1 Office Memorandum- Regarding grant of NOC for manufacture of Unapproved/Approved New Drug/Band Bulk Drug office memorandum-International cell

 

Functions:

  1. Handling of quality failure of drugs exported from India (reviewing of complaints, responding to complaints, appropriate investigation of the complaints, etc)
  2. International Co-operation among Regualtory Agencies.
  3. Exchange of information on product recalls, emergency notifications, not of standard quality drugs, etc.
  4. International collaborations including Memorandum of Understanding (Mou), Joint Working Group (JWG), Statement of Intent (Sol)etc.
  5. Grant of written Confirmation for Export of Active Pharmaceutical Ingredients (API) as per EU directives.
  6. Preparing guidance document related to functions/responsibilities of International Cell.
  7. Handling of visits of International Delegations.

 

Visit of Foreign Delegates

US FDA delegation led by US FDA Commissioner of Food and Drugs Margaret Hamburg visited CDSCO Headquarters on 10th February 2014, along with the following members

  1. Mary Lou Valdez, M.S.M., Associate Commissioner for International programs.
  2. Erica Jefferson, Acting Assistant Commissioner for Media Affairs.
  3. Altaf Lal, Ph.D, Director , FDA India Office.
  4. Albinus D'sa, Ph.D., Deputy Director, FDA India Office.
  5. Solomon Yiman, International Policy Analyst, FDA India Office.
  6. Farhana Khan, International Policy Analyst, FDA India Office.
  7. Peter Baker, Consumer safety Officer, FDA India Office.

Bangladesh delegation led by Additional Secretary, M/o Health & Family Welfare, Bangladesh Mr. A.M. Badrudduja visted CDSCO Headquarters on 26th February 2014.

The delegates group consists the following:

  1. Ms. Niru Shamsun Nahar, Joint Chief (Planning), M/o Health & Family Welfare
  2. Ms. Wahida Ahmed, Director (South Asia), Ministry of Foreign Affairs
  3. Prof. Be-Nazir Ahmed, Director, Disease Control, Directorate General of Health Services
  4. Dr.Syed Abu Jafar Md. Musa, Director, Primary Health Care, Directorate General of Health Services
  5. Ms. Rina Parveen, Director (Planning), Directorate General of Family Planning
  6. Dr. Mohammad Khairul Hasan, Deputy Chief (Health), Ministry of Health and Family Welfare
  7. Mr. A.A Salim Barami, Director, Directorate General of Drug Administration
  8. Professor Dr. Shaheen Akhter, Professor, Department of Pediatric, Bangabandhu Sheikh Mujib Medical University
  9. Ms. Taslima Begum, Director (Nursing Services)
  10. Mr. SK. Md. Shahriar Mosharraf, First Secretary (Political), Bangladesh High Commission, New Delhi.

Russian delegation led by Mr. Mikhail Murashko, Head of Roszdravnadzor visited CDSCO Headquarters on 17th April 2014, along with the following members:

  1. Ms. Alla Trapkova, Deputy Head of Division of State Quality Control of Medical products, Russia.
  2. Ms. Galina Gannochka, Deputy Head of the Department of Drug Quality Control, Russia.
  3. Mr. Maxim U. Rybnikov, Chief Expert, Indian Office of Russian Embassy.

Delegation from the Kingdom of Saudi Arabia led by Dr. Ahmed Hassan Almosilhi, Directorate General of Medical and Pharmaceutical supply, Ministry of Health, Saudi Arabia visited CDSCO Headquarters on 29th April 2014, along with the following members:

  1. Dr. Hamoud Abdul Rahman Alfaiz, Directorate General of Hospitals, Ministry of Health.
  2. Dr. Ibrahim Saleh Almurgin, Directorate General of Health Licensing.
  3. Mr. Mohammed Saeed Al Hamhum, Saudi Health Attache.
  4. Mr. Hamid Ali, Translator.

Prof. John Skerritt, National Manager, Therapeutics goods Administration, Australia had visited CDSCO Headquarters on 13th May 2014 to deliberate with National Regulatory Authorities on Various Issues like Medicines and Medical Device Regulation, Collaboration in inspections etc.















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