New Delhi: India's top advisory board on drugs is considering a plan to rein in the sale of commonly used over-the-counter (OTC) medications to prevent misuse and ensure patient safety, said people with knowledge of the matter. Under the proposal, only 27 drugs can be sold without a doctor's prescription, that too with curbs on dosage and amounts.
On the list are antipyretics, painkillers, antacids, cough syrups, oral contraceptives, antiseptics, laxatives, nasal sprays, domperidone (anti-emetic), iron and folic acid tablets, besides SOS medication.
Several drugs that are currently being dispensed without the need for a prescription have been excluded, as the sub-committee is of the view that these should only be sold on doctor's approval. The Drugs Technical Advisory Board is expected to meet this week to decide on the recommendation.
The Central Drugs Standard Control Organisation, the country's regulatory authority, last year formed an eight-member sub-committee to draw up a framework for OTC drugs. It was asked to create a mechanism for determining which medications would qualify as OTC drugs, incorporating suggestions from clinicians.
Dr Anupam Prakash, the OTC sub-committee chairman, confirmed that the report had been submitted. "The aim was to increase the accessibility of commonly used medicines and at the same time ensure safety of the patient," he said.
"All SOS medicines have been included on the list. We have dropped many medicines which are available at pharmacists and should only be dispensed with prescriptions," said Prakash.
For those on the OTC list, the sub-committee has recommended "smaller" pack sizes appropriate for the duration of the treatment to promote safe use, especially for medications with the potential risk of misuse or overdosing.
"One of the recommendations is that the pack size of the drug should not exceed the maximum dose recommended for five days. The pack size (2-3-5) has been recommended, depending on the toxicity of the drug," said one of the persons cited.
In other words, the shortlisted drugs can be sold over the counter without the prescription of a registered medical practitioner only if the maximum duration of treatment or use does not exceed five days.
The term 'over the counter' is not defined in India's Drugs and Cosmetics Act, 1945, unlike in the US, the UK and elsewhere, which have well-defined guidelines on drugs that can be sold without a prescription.
On the list are antipyretics, painkillers, antacids, cough syrups, oral contraceptives, antiseptics, laxatives, nasal sprays, domperidone (anti-emetic), iron and folic acid tablets, besides SOS medication.
Several drugs that are currently being dispensed without the need for a prescription have been excluded, as the sub-committee is of the view that these should only be sold on doctor's approval. The Drugs Technical Advisory Board is expected to meet this week to decide on the recommendation.
The Central Drugs Standard Control Organisation, the country's regulatory authority, last year formed an eight-member sub-committee to draw up a framework for OTC drugs. It was asked to create a mechanism for determining which medications would qualify as OTC drugs, incorporating suggestions from clinicians.
Dr Anupam Prakash, the OTC sub-committee chairman, confirmed that the report had been submitted. "The aim was to increase the accessibility of commonly used medicines and at the same time ensure safety of the patient," he said.
"All SOS medicines have been included on the list. We have dropped many medicines which are available at pharmacists and should only be dispensed with prescriptions," said Prakash.
For those on the OTC list, the sub-committee has recommended "smaller" pack sizes appropriate for the duration of the treatment to promote safe use, especially for medications with the potential risk of misuse or overdosing.
"One of the recommendations is that the pack size of the drug should not exceed the maximum dose recommended for five days. The pack size (2-3-5) has been recommended, depending on the toxicity of the drug," said one of the persons cited.
In other words, the shortlisted drugs can be sold over the counter without the prescription of a registered medical practitioner only if the maximum duration of treatment or use does not exceed five days.
The term 'over the counter' is not defined in India's Drugs and Cosmetics Act, 1945, unlike in the US, the UK and elsewhere, which have well-defined guidelines on drugs that can be sold without a prescription.
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