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 on page 1088 of the Indian Pharmacopoeia 2018.

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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