Conditions of a license for the manufacture of Drugs for the purpose of Test, Examination and Analysis:

  1. The license must specify the place of manufacture and Test of the drugs. 
  2. The Application must be signed by the Head of the Institution where the Test, Examination is supposed to be happened. 
  3. License is valid for 1 year period if not cancelled before. 
  4. For the purpose of Examination of a drug, the drug must be placed in container with proper labelling. 
  5. Shall allow Drug inspectors for inspect and check the records.
  6. Shall maintain a Inspection Book with all records done by the inspector. 

Condition for Loan License:

It is issued by a licensing Authority to a person who do not have any manufacturing license. 
  1. A separate license may be issued for the sale of drug more than 1 place. 
  2. Before the grant of license the license authority must satisfy the conditions for the grant of license like the manufacturing unit must have enough staff and components for manufacture. 
  3. For the manufacture of drugs more than 10 items per each category of drug is only applicable if the licensing authority is paying additional 300 rupees per items as per schedule M and M3.
  4. License must allow the inspector to inspect the premises.
  5. License shall maintain inspection book. 
  6. License shall Test the raw materials and finished products and maintain the records. 
  7. Shall maintain the reference sample for 3 years. 
  8. For schedule C and C1 drugs the license shall keep a record of stability and date of expiry. 


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