Need Help for Your Dry Eyes? You May Soon be Able to Buy These Popular Drops Without a Prescription

You may not need a prescription anymore to buy the next bottle of Refresh Tears eye drops.

The apex panel under the drug regulatory body of India is considering a proposal to remove the requirement of prescription for buying Refresh Tears, a medicine for treatment of dry eyes, News18.com has learnt.

The Drugs Technical Advisory Board (DTAB), which will meet on Monday in its 88th meeting, has received an application from Allergan, an American biopharmaceutical firm listed at New York Stock Exchange and maker of Refresh Tears, to remove the condition of prescription for buying the eye drops.

“The panel has received an application from M/s Allergan India Pvt Ltd, seeking approval to remove the requirement of a prescription from Registered Medical Practitioner (RMP) in respect of drug product ‘Refresh Tears’ for its retail sale,” said a government official who is part of the meeting.

The firm, according to the official, has submitted that its product — containing carboxymethylcellulose sodium eye drops — is a sterile ophthalmic solution for the temporary relief of burning, irritation, and discomfort due to dryness of the eyes.

It is a lubricant or artificial tears used to relieve dry eyes. It soothes irritation or burning which can happen because of the inability to form enough tears to keep eyes lubricated.

It is also indicated to prevent discomfort due to dry eyes triggered by exposure to wind or sun, and may be used as a protectant against further irritation.

The company has stated in its application that the product has been marketed since 1998.

“The firm has requested to change the category of this product from prescription drug to the category of non-prescription drug which is over the counter medicine,” the source said.

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 insert of Refresh Tears as applicable for a prescription drug.

The proposal was previously deliberated upon by the subject expert committee in January wherein the committee recommended that the said drug product may be sold by retail without the prescription of the doctors.

Now, the final proposal has been sent to DTAB for consideration.

Dr Digvijay Singh, HOD, Opthalmologist department, Narayana Superspeciality Hospital, Gurugram, said, “Dry eyes, computer vision syndrome has become rampant in the current tech era. Therefore, it is important to make lubricant eye drops freely available. I think it’s a good step that eye drops like Refresh Tears should be made over the counter products because it’s the need of the hour.”

What else is on the agenda?

Apart from the proposal on Refresh Tears, the panel will deliberate on banning fixed dose combination drugs, including codeine-based cough syrups.

According to the agenda document of the DTAB meeting seen by News18.com, the panel will deliberate on the report by expert committee constituted for evaluation of certain pre-1988 Fixed Dose Combinations (FDCs) de novo, licensed for manufacturing for sale in the country without due approval from Central Licensing Authority.

It will also deliberate on the report of evaluation of FDCs related to vitamins, minerals formulations, etc. considered as irrational by the Prof Kokate Committee and where show-cause notices were issued to the applicants for submitting their replies.​

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