New Delhi: Granting drug maker Allergan India request to change the category of "Refresh Tears" from prescription drug to over the counter drug, the Drug Technical Advisory Board (DTAB) has agreed to remove the requirement of a prescription from a Registered Medical Practitioner (RMP) in respect of drug product "Refresh Tears" (Carboxymethylcellulose Sodium eye drops IP 0.5% w/v) for its...
New Delhi: Granting drug maker Allergan India request to change the category of "Refresh Tears" from prescription drug to over the counter drug, the Drug Technical Advisory Board (DTAB) has agreed to remove the requirement of a prescription from a Registered Medical Practitioner (RMP) in respect of drug product "Refresh Tears" (Carboxymethylcellulose Sodium eye drops IP 0.5% w/v) for its retail sale.
The recommendation was made after considering the proposal made by Allergan India to remove the requirement for a prescription in respect of drug product "Refresh Tears" (Carboxymethylcellulose Sodium eye drops IP 0.5% w/v) sterile opthalmic solution for retail sale.
The drug maker, Allergen, has submitted that its product "Refresh Tears" contains Carboxymethylcellulose Sodium eye drops 0.5% w/v, sterile ophthalmic solution, indicated for the temporary relief of burning, irritation, and discomfort due to dryness of the eyes or exposure to wind or sun, and may be used as a protectant against further irritation, and stated that the product has been marketed since 1998.
The firm has also requested to change the category of this product from prescription drug to the category of non-prescription drug, i.e. "Rx to Over-The-Counter (non-prescription)".
Consequently, the firm has sought an exemption from putting the "Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only" on the labels and package inserts of "Refresh Tears" as applicable for a prescription drug.
The proposal was previously discussed at the SEC (Ophthalmology) meeting on January 28,2022, where the committee recommended that the said drug product be sold without a prescription from a Registered Medical Practitioner."Further, action may be taken as per the rules," it added.
In light of the foregoing, the Board, after detailed deliberation, agreed to the recommendation made by the Subject Expert Committee and recommended removing the requirement of a prescription from a Registered Medical Practitioner (RMP) in respect of drug products, "Refresh Tears" (Carboxymethylcellulose Sodium eye drops IP 0.5% w/v) for its retail sale. Accordingly, relevant provisions of the rules may be amended.
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