FAQs – on Ear Drops
Q1. Under which category of Schedule-M Ear Drops or preparation are covered ?
Ans: Ear Drops or preparation are covered under Schedule-M. Part-I-D if non-sterile and Part-1-I if sterile.
Q2: Whether Ear Drops are Sterile or Non-Sterile preparations ?
Ans: Ear drops are of both types – Sterile and Non-Sterile preparations. The ear drops intended for use in surgical operation / injured ear are sterile preparations.
Q3: Where is the general Monograph of Ear Drops is given?
Ans: It is given in Indian Pharmacopoeia 2018 at page no. 1088.
Q4: In which section Non-Sterile Ear Drop preparation can be manufactured?
Ans: Non-sterile Ear Drops can be manufactured in external section as given in Part-I-D of Schedule M.
Q5: In which section Sterile Ear Drop preparation can be manufactured?
Ans: Sterile Ear Drops can be manufactured in sterile area and sterile dedicated area to avoid mixing of external preparation in other sterile preparation.
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Q6: What are the special labelling requirements for the Ear Drops?
Ans: In addition to the requirements under Rule 96, 97 and general requirements under IP-2018 all the ear drops should be labelled with “For external use only and not for injection”
Q7: Whether sterile Ear Drops should meet the sterility test?
Ans: Yes and their dropper should also compliant with sterility test.
Q8: Whether sterile Ear Drops contain any anti-microbial preservatives?
Ans: No, multi dose preparations may contain anti-microbial however standard dose shall not contain anti-microbial preservatives.
Q9: Whether Ear Drops are Schedule-H drugs?
Ans: All the Ear Drop preparations containing antibiotics or steroids are covered under Schedule-H drugs.
Q10: What are the pack-sizes of ear drops allowed under Drugs Act?
Ans: 3 ml, 5 ml and 10 ml pack sizes are allowed under Drugs Act.
Q11: Is there any exemption in pack sizes of ear drops under Drugs Act?
Ans: No such exemption is given under Schedule P-I of Drugs Act.
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