Conditions of license for the manufacture of Schedule C, C1 and X drugs 

Following are the general conditions for the manufacture of schedule C, C1 and X drugs;

License Must -

01

Provide and maintain staff, premises and equipments as per schedule M and M3

02

Test raw materials and final products of each batch by licensing authority.

03

Maintain records of Manufacturing and Testing of each batch.

04

Allow drug inspector to enter to inspect the premises and conduct the essential tests.

05

Allow drug inspector to check the registers and records.

06

Time to time report to the licensing authority about the

(i)              Changes in staff

(ii)            Alterations in material

(iii)          Samples of Drugs

07

Not sell any batch until the licensing authority gives permission

08

Withdraw a drug from sale if the licensing authority wishes.

09

Comply with the drugs and cosmetics act 1940.

10

Maintain the inspection Book.

11

Comply with the requirements of “Good Manufacturing Practice” as per schedule M

12

(i)              Must forward a statement of sale, manufacture, wholesale, RMPs, to the licensing Authority.

(ii)            Maintain the account of all transactions in the manufacture, storage or sale of schedule X drugs.

(iii)          Store the schedule X drugs under lockage in the responsibility of a trusted and skilled person.


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