Manufacture of New Drugs: 

As per the Rule:

  • A new drug can be a new substance of chemical or biological origin; in bulk or prepared dosage from; used for prevention, or treatment of disease in human or animal which is not used in the country except the clinical Trial 
  • If the ratio of ingredients is in an already marketed combination must be changed with certain factors like-
  1. Indications 
  2. Dosage from 
  3. Route of Administration 
  • All vaccines are new drugs unless certified by the licensing authority. 
  • A drug is said to be a new drug for about 4 years from the date of tits approval. 

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. 

Repacking License:

  1.  it is granted only for drug other than schedule C, C1 drugs.
  2. Repacking must be done under hygienic condition by expert persons.
  3. There must be efficient arrangements for carrying out the tests of repacked drugs. 
  4. The license must allow the inspectors to inspect the premises. 
  5. Must maintain Inspection book.
  6. Shall test the raw material and final products and must keep the records for 5 years. 
  7. Must keep the reference sample for specified time. 
  8. License is valid for 5 years of the date of granted and must be renewed otherwise cancelled. 

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