By PTI
NEW DELHI: An apex board under the central drug regulatory authority has recommended doing away with the requirement of a prescription for buying Refresh Tears, a medicine for dry eyes.
Allergan India Pvt Ltd had approached the Drugs Technical Advisory Board (DTAB) with a representation in the matter so that the medicine can be bought over the counter.
It submitted that ‘Refresh Tears’, which contains Carboxymethylcellulose Sodium eye drops 0.5 per cent w/v sterile ophthalmic solution, is for temporary relief from 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.
“The board after detailed deliberation agreed to remove the requirement of a prescription from a registered medical practitioner in respect of drug product ‘Refresh Tears’ for its retail sale. Accordingly, relevant provisions of the rules may be amended,” according to minutes of a meeting held recently.
The recommendations of DTAB are in line with the suggestions of the subject expert committee (opthalmology) under the Central Drugs Standard Control Organisation (CDSCO) that the eye-drop may be sold in retail without a prescription.
Allergan India Pvt Ltd had requested a change in the category of this product from prescription drug to the category of non-prescription drug.
Consequently, it 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.
Refresh Tears eye drop is an eye lubricant used to relieve dry eyes which can happen if not enough tears are made naturally to keep the eye lubricated.
NEW DELHI: An apex board under the central drug regulatory authority has recommended doing away with the requirement of a prescription for buying Refresh Tears, a medicine for dry eyes.
Allergan India Pvt Ltd had approached the Drugs Technical Advisory Board (DTAB) with a representation in the matter so that the medicine can be bought over the counter.
It submitted that ‘Refresh Tears’, which contains Carboxymethylcellulose Sodium eye drops 0.5 per cent w/v sterile ophthalmic solution, is for temporary relief from 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.
“The board after detailed deliberation agreed to remove the requirement of a prescription from a registered medical practitioner in respect of drug product ‘Refresh Tears’ for its retail sale. Accordingly, relevant provisions of the rules may be amended,” according to minutes of a meeting held recently.
The recommendations of DTAB are in line with the suggestions of the subject expert committee (opthalmology) under the Central Drugs Standard Control Organisation (CDSCO) that the eye-drop may be sold in retail without a prescription.
Allergan India Pvt Ltd had requested a change in the category of this product from prescription drug to the category of non-prescription drug.
Consequently, it 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.
Refresh Tears eye drop is an eye lubricant used to relieve dry eyes which can happen if not enough tears are made naturally to keep the eye lubricated.
