- FAQs – on Drug Permission in Brand or Generic Name - October 23, 2020
- FAQs – on Disinfectants (Series-2) - October 16, 2020
- Gist of Notification 25th September 2020: Medical Oxygen - October 7, 2020
Q 11. What are the requirements / conditions for the manufacturing of disinfectants ?
Ans: Disinfectants are drugs u/s 3(b)(ii) of Drugs and Cosmetics Act. Manufacturing license is issued on Form-25 and conditions are laid down in Schedule-M, Part-ID and Part-II for external preparation.
Q 12. How much area is required for the manufacturing of disinfectants?
Ans: 30 sq. meters for basic installation and 10 sq. meters. for ancillary area is required for manufacturing of Disinfectants apart from other facilities i.e. Raw material store, Packing material store and Finished goods stores etc.
Note: If a unit is already having external preparation section, then too above said area is separately required for the manufacturing of disinfectants.
Q 13. Standards of disinfectant is given in which Schedule?
Ans: Schedule-O of the Drugs and Cosmetics Act.
Q 14. Is Testing Laboratory is required in the factory premises for the testing of disinfectants ?
Ans: Yes, all the facilities which are used to test disinfectants are required in the laboratory.
Q 15. What is the qualification of Manufacturing Chemist for disinfectants?
Ans: It is given in Rule 71(1)(d) of the Drugs and Cosmetics Act.
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Q 16. What is the qualification of Analytical Chemist for disinfectant?
Ans: It is given in Rule 71(4) of the Drugs and Cosmetics Act.
Q 17. Whether AHU is required in the manufacturing area ?
Ans: 100% fresh air required for the product containing inflammable solvent and force drop ventilation is required for phenolic disinfectants.
Q 18. Is price rate of disinfectants fixed by the Govt. ?
Q 19. Are disinfectants covered under Legal Metrology (Packed Commodities Rules, 2011) ?
Ans: No, as these are drugs and exempted from above Act.
Q 20. Is any poison license required for the use of Hydrochloric Acid (HCL), hypochlorite solution etc. in the manufacturing of disinfectants ?
Ans: Hydrochloric Acid (HCL), Hypochlorite solution etc are poison as per Poison Act 1919. Percentage Limit of such poisons is notified by the State Govt. under Poison Rule of the state and percentage limit of the poison differs from state to state.
e.g. HCL 5 % and Hypochlorite solution 6%. are allowed in Haryana. Beyond this percentage Poison License is required in Haryana for stocking and sale of such poison.
Also read Q 1 to 10 : FAQs – on Disinfectants (Series-1)
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