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GRANT OF MANUFCATURING LICENCE IN THE FOLLOWING CATEGORIES (DIRECT/LOAN BASIS/REPACKING):

STEP WISE PROCEDURE
Step 1:   Application for Grant of NOC from Concerned State Licensing Authority (SLA) Documents along with application: Project report and forwarding letter from DIC concerned.
Step 2:  Application for Layout approval from Concerned State Licensing Authority along with two copies of original layouts which has to be certified by Concerned Drugs Inspector Manufacturing.
Step 3:  Application to be submitted in the office of State Licensing Authority for grant of licence under above categories:

  1. Form 24, 24 A, 24B (Repacking), 24 C (homeopathy), 24-D (Ayurvedic and Unani Drugs), 24 E (ayurvedic Loan basis) 27, 27 A, 27-B, 27 C (Blood Bank) and 31, 31A (Cosmetics) to D&C Rules 1945. {Formats available online}.
  2. NOC From J&K State pollution control board for establishing a unit
  3. Registration of Unit with DIC, J&K State giving detail of the line of activity.
  4. Lease deed/ land allotment/ ownership of the land where the unit is to be established (preferably in the industrial area).
  5. Project Report of the Unit/Firm
  6. Memorandum of Article of Association/ Constitution of the unit in case of Pvt Limited.
  7. Partnership deed/Proprietorship (Documentary evidence with respect to Ownership deed.
  8. Building Plan of the unit AHU drawing.
  9. List of Machinery in the manufacturing Area
  10. List of Machinery in the QC/QA Area
  11. Fee applicable (Rs- 7500/- on form 24, 24 A, 27, 27 A, 24-B and 27-B (700),   27 C (for Blood Bank- Rs. 7500 + 300 for additional Blood Components)       24-C (Rs. 750/-), Rs 3500/- on form 31, 31 A and Form 24 D/24-E (Rs-1000 for Ayurvedic Licence for 5 years).
  12. Technical Staff- Manufacturing and Analytical Chemist as Per rule 71 and 76 of D&C Rules, 1945 along with Testimonials and Experience Certificates.

Step 4: 
a) Preliminary Inspection by Concerned Drugs Inspector Manufacturing and report for Ayurvedic Licence (AYUSH) only with definite recommendation.
b) Joint Inspection from SLA and CDSCO representatives for Grant of Drugs Licence/ Cosmetic licence/Blood Bank Licence/Loan licence or repacking licence.

Step 5:  Final Inspection by the SLA or Controlling Authority of Concerned State.
Step 6:  Licence to be issued by SLA for all categories except Blood Bank which is to be countersigned by CLAA (Central Licensing Approving Authority i.e., DCGI)