Forms and Downloads

 

A.  Procedure
  1. Procedure for Registration 
  2. Procedure for Licensing
  3. SOPs for GMP Certificate.(zip)
  4. Guidelines / Standard Operating Procedure for Quota Allocation of Controlled Substances
  5. Guidelines for authorized officers under special SROs for issuance  of NOC or approval for import of drugs under the Drugs Act, 1976 and Rules framed thereunder
  6. Guidelines undertaken for performance of Pharmacovigilance activities

B.  Application Forms

  1. Application Form Grant of a Licence
  2. Application Form for Renewal of a Licence
  3. Form of Warranty
  4. Application for Licence to Manufacture Drug (s) for Experimental Purposes
  5. Application Form for Registration of a Drug for Local Manufacture
  6. Application Form for Registration of an Imported Drug
  7. Application Form for Price Revision of Imported Drugs (Local Repack)
  8. Application Form for Price Revision of IMported Finished Drugs
  9. Application Form for Price Revision of Local Drugs
  10. Application Form for Renewal of Registration of all Kinds of Drugs
  11. cGMP Performa (Schedule B-II)
  12. Statement of Quarterly Production
  13. Documents Required for Approval of Post-Registration Variations

C.  Check Lists 

  1. Check List for Scrutinization of Registration Application / Dossiers
  2. Check List for Allocation of Quota of Controlled Substances

D.  Policy

  1. Policy for Inspection of Manufacturer Abroad (For Imported Drugs) (Dt.Up.05-01-2017)
  2. Policy Guidelines Regarding Reference Regulatory Authorities for Registration of Drugs (Dt.Up.05-01-2017)

E.  Monthly Activities in Drug Licensing Division

  1. Activities in Drug Licensing Division from 01-09-2013 to 06-12-2013
  2. Activities in Drug Licensing Division from 07-12-2013 to 31-12-2013
  3. Activities in Drug Licensing Division from 01-01-2014 to 31-01-2014
  4. Activities in Drug Licensing Division from 01-02-2014 to 28-02-2014
  5. Activities in Drug Licensing Division from 03-03-2014 to 31-03-2014
  6. Activities in Drug Licensing Division from 01-04-2014 to 30-04-2014
  7. Activities in Drug Licensing Division from 01-05-2014 to 31-05-2014
  8. Activities in Drug Licensing Division from 01-06-2014 to 30-06-2014
  9. Activities in Drug Licensing Division from 01-07-2014 to 31-07-2014
  10. Activities in Drug Licensing Division from 01-08-2014 to 31-08-2014
  11. Activities in Drug Licensing Division from 01-09-2014 to 30-09-2014
  12. Activities in Drug Licensing Division from 01-10-2014 to 31-10-2014
  13. Activities in Drug Licensing Division from 01-11-2014 to 30-11-2014
  14. Activities in Drug Licensing Division from 01-12-2014 to 31-12-2014
  15. Activities in Drug Licensing Division from 01-01-2015 to 31-01-2015
  16. Activities in Drug Licensing Division from 01-02-2015 to 28-02-2015
  17. Activities in Drug Licensing Division from 01-03-2015 to 31-03-2015
  18. Activities in Drug Licensing Division from 01-04-2015 to 30-04-2015
  19. Activities in Drug Licensing Division from 01-05-2015 to 31-05-2015
  20. Activities in Drug Licesning Division from 01-06-2015 to 30-06-2015
  21. Activities in Drug Licensing Division from 01-07-2015 to 31-07-2015
  22. Activities in Drug Licensing Division from 01-08-2015 to 31-08-2015
  23. Activities in Drug Licensing Division from 01-09-2015 to 30-09-2015
  24. Activities in Drug Licensing Division from 01-10-2015 to 30-10-2015
  25. Activities in Drug Licensing Division from 01-11-2015 to 30-11-2015
  26. Activities in Drug Licensing Division from 01-12-2015 to 30-12-2015
  27. Activities in Drug Licensing Division from 01-01-2016 to 31-01-2016
  28. Activities in Drug Licensing Division from 01-02-2016 to 29-02-2016
  29. Activities in Drug Licensing Division from 01-03-2016 to 31-03-2016
  30. Activities in Drug Licensing Division from 01-04-2016 to 30-04-2016
  31. Activities in Drug Licensing Division from 01-05-2016 to 31-05-2016
  32. Activities in Drug Licensing Division from 01-06-2016 to 30-06-2016
  33. Activities in Drug Licensing Division from 01-07-2016 to 31-07-2016
  34. Activities in Drug Licensing Division from 01-08-2016 to 31-08-2016
  35. Activities in Drug Licensing Division from 01-09-2016 to 30-09-2016
  36. Activities in Drug Licensing Division from 01-10-2016 to 31-10-2016
  37. Activities in Drug Licensing Division from 01-11-2016 to 30-11-2016

F.  Minutes of meeting of Central Licensing Board

  1. Minutes of 232nd meeting of Central Licensing Board
  2. Minutes of 233rd meeting of Central Licensing Board
  3. Minutes of 234th meeting of Central Licensing Board
  4. Minutes of 235th meeting of Central Licensing Board
  5. Minutes of 236th meeting of Central Licensing Board
  6. Minutes of 237th meeting of Central Licensing Board
  7. Minutes of 238th meeting of Central Licensing Board
  8. Minutes of 239th meeting of Central Licensing Board
  9. Minutes of 240th meeting of Central Licensing Board
  10. Minutes of 241st meeting of Central Licensing Board
  11. Minutes of 242nd meeting of Central Licensing Board
  12. Minutes of 243rd meeting of Central Licensing Board
  13. Minutes of 244th meeting of Central Licensing Board
  14. Minutes of 245th meeting of Central Licensing Board
  15. Minutes of 246th meeting of Central Licensing Board  
  16. Minutes of 247th meeting of Central Licensing Board
  17. Minutes of 248th meeting of Central Licensing Board
  18. Minutes of 249th meeting of Central Licensing Board
  19. Minutes of 250th meeting of Central Licensing Board (dt.27-10-2016)(Dt.Up.11-01-2017)

G.  Minutes of meeting of Drug Regsitration Board

  1. Minutes of 238th meeting of Registration Board 
  2. Minutes of 239th meeting of Registration Board
  3. Minutes of 240th meeting of Registration Board
  4. Minutes of 241st meeting of Registration Board
  5. Minutes of 242nd meeting of Registration Board
  6. Minutes of 243rd meeting of Registration Board
  7. Minutes of 244th meeting of Registration Board
  8. Minutes of 245th meeting of Registration Board
  9. Minutes of 246th meeting of Registration Board
  10. Minutes of 247th meeting of Registration Board
  11. Minutes of 248th meeting of Registration Board
  12. Minutes of 249th meeting of Registration Board
  13. Minutes of 250th meeting of Registration Board
  14. Minutes of 251st meeting of Registration Board
  15. Minutes of 252nd meeting of Registration Board
  16. Minutes of 253rd meeting of Registration Board
  17. Minutes of 254th meeting of Registration Board
  18. Minutes of 255th meeting of Registration Board
  19. Minutes of 256th meeting of Registration Board
  20. Minutes of 257th meeting of Registration Board
  21. Minutes of 258th meeting of Registration Board
  22. Minutes of 259th meeting of Registration Board
  23. Minutes of 260th Meeting of Registration Board
  24. Minutes of 261st Meeting of Registration Board
  25. Minutes of 262nd Meeting of Registration Board
  26. Minutes of 263rd meeting of Registration Board
  27. Minutes of 264th Meeting of Registration Board
  28. Minutes of 265th Meeting of Registration Board
  29. Minutes of 266th Meeting of Registration Board
  30. Minutes of 267th Meeting of Registration Board
  31. Minutes of 268th Meeting of Registration Board

 

H.    Forms, Check lists, Guiding documents and Minutes of Meeting of Health and OTC Division

List of Approved Importers and Manufacturers as entered in the enlistment register till 10th November, 2016 (Dt.Up.11-11-2016) 

 

  List of rejected applications of Manufacturers, importer and contract givers. This list shall be read with list of approved manufacturers, importers or contract givers because some applicants filed fresh application after rejection.  Disclaimers; omission and errors are faults may be reported to Health and OTC Division for corrections. (Dt.Up.24-11-2016) 

  1. 1st meeting of HOTC
  2. 2nd meeting of HOTC
  3. 3rd meeting of HOTC
  4. 4th meeting of HOTC
  5. 5th meeting of HOTC
  6. 6th meeting of HOTC
  7. 7th meeting of HOTC
  8. 8th meeting of HOTC
  9. 9th meeting of HOTC
  10. 10th meeting of HOTC
  11. 11th meeting of HOTC
  12. 12th meeting of HOTC
  13. 13th meeting of HOTC
  14. 1 4th meeting of HOTC
  15. 15th meeting of HOTC
  16. 16th meeting of HOTC

  •  Forms
  1.   Form-I (Manufacturer OR Contract Giver)
  2.   Form-II (Enlistment of Importer)
  • Check list
  1. Check List for Form-3
  2. Check List for Form-4
  3. Check List for Form-5
  4. Import Manufacturer Check List
  5. Local Manufacturer Check List
  6. Inspection Check List
  7. Contract Manufacturing  
  8. Power of Attorney as Agent of Principal Manufacturer

 

  • Guiding documents

  1.   S.R.O.412(I)/2014 (Alternative Medicine)
  2. Ammendment in S.R.O.412(I)/2014 (Alternative Medicine)   This ammendment include   Form 9 for application of GMP Certificate.
  3. Specification monograph and dosage form description
  • Minutes of meeting

  1. Minutes  of 1st Meeting of ECC
  2. Minutes of 2nd Meeting of ECC
  3. Minutes of 3rd Meeting of ECC
  4. Minutes of 4th Meeting of ECC
  5. Minutes of 5th Meeting of ECC
  6. Minutes of 6th Meeting of ECC
  7. Minutes of 7th Meeting of ECC
  8. Minutes of 8th Meeting of ECC
  9. Minutes of 9th Meeting of ECC
  10. Minutes of 10th Meeting of ECC
  11. Minutes of 11th Meeting of ECC
  12. Minutes of 12th Meeting of ECC (held on 27-06-2016)
  13. Minutes of 13th Meeting of ECC (held on 05-08-2016)
  14. Minutes of 14th Meeting of ECC (held on 31-08-2016)  ,,,,,,,,,,,,  Annexures of Minutes of 14th Meeting

 

  I.    Guiding documents and Minutes of Meeting of Medical Devices Division

  • Guiding documents

  1.   Medical Devices Rules, 2015 approved and Notified on 09-03-2015
  2. Guidelines on Good Distribution Practices for Medical Devices 27-12-2016 
  • Minutes of meeting

  1. Minutes  of 1st Meeting of Medical Device Board (MDB) (Dt.up. -01-2017)
  2. Minutes  of 2nd Meeting of Medical Device Board (MDB) (Dt.up. -01-2017)
  3. Minutes  of 3rd Meeting of Medical Device Board (MDB) (Dt.up.05-01-2017)

J.     Minutes of Drug Pricing Committee (DPC)

  1.   Minutes of 18th DPC held on 26.10.2011
  • Guiding documents

  1.   Annual Drug Price Increase Worksheet for the year 2016

Pricing Policy 2015

SRO's

Application Forms