Last Updated on May 12, 2025 by The Health Master
OTC
India’s drug regulator is considering implementing a stricter framework for commonly available over-the-counter (OTC) drugs, with reports from both internal and external development suggesting only 27 drugs will be allowed to be sold as OTC with specific dosages and pack sizes allowed.
The Drugs Likely To Become OTC
The drugs include:
- Antipyretics and analgesics
- Antacids/laxatives
- Cough syrups/nasal decongestants
- Oral contraceptives
- Antiseptics
- Domperidone (anti-emetic)
- Iron/folic acid tablets
SOS
Interestingly enough, many drugs that are currently available as OTC have not been included as per recommendation, meaning that the sub-committee created its report based on the idea that they need a doctor’s permission to be dispensed.
The Drugs Technical Advisory Board (DTAB), which has a lot of regulatory power in such matters, will meet this week to discuss and recommend.
Why Is This Happening?
The Central Drugs Standard Control Organisation (CDSCO) formed an eight-member sub-committee in India to decide on reasoning last year.
This was supposed to be a step towards institutionalizing the issuance of an OTC framework.
The CDSCO wanted to comprise a panel of doctors practicing in the field to make recommendations so that it would honor any protocol that would allow drugs to be classified in this matter.
The chairman of the OTC sub-committee, Dr. Anupam Prakash, confirmed that the report was sent.
He stated that “the aim was to enhance accessibility of commonly used drugs as well as ensure the safety of the patients.”
He stated further, “We dropped many drugs that are available at chemists and should only be dispensed with prescriptions.”
Ultimately, the pack size will be smaller.
One issue that came to light regarding addiction/overdose was related to pack size.
Thus, one of the strongest recommendations is to reduce the pack size which also correlates with the recommended duration of treatment.
According to a source with knowledge of the recommendations, “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 upon the toxicity of the drug.”
Thus, for the drugs on the shortlist, they can be dispensed OTC without a prescription from a registered medical practitioner for no longer than five days of use.
Q. What is the main goal of this proposed regulation?
The primary objective is to enhance patient safety and prevent the misuse of commonly used over-the-counter drugs.
Q. How many drugs are proposed to be sold without a prescription?
The current proposal suggests a list of only 27 specific drugs that can be sold over the counter without a doctor’s prescription.
Q. What types of drugs are included in the proposed OTC list?
The list includes common drugs such as antipyretics, painkillers, antacids, cough syrups, oral contraceptives, antiseptics, laxatives, nasal sprays, domperidone, iron and folic acid tablets, and SOS drugs.
Q. What is the recommendation regarding the pack sizes of OTC drugs?
The sub-committee has recommended smaller pack sizes, typically not exceeding the maximum dose recommended for a five-day treatment period, to promote safe use.
Q. Why are some currently available OTC drugs being excluded from the new list?
The sub-committee believes that these excluded drugs should only be dispensed with a doctor’s prescription to ensure appropriate usage and patient safety.
Q. What is the next step in implementing these regulations?
The Drugs Technical Advisory Board (DTAB) is expected to meet this week to review and potentially approve these recommendations.
Q. Does India currently have a clear legal definition for ‘over the counter’ drugs?
No, unlike some other countries, India’s Drugs and Cosmetics Act, 1945, does not currently have a specific definition for ‘over the counter’ drugs.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Disclaimer: The information we have provided is for general knowledge and for informational purpose only and it cannot be treated as medical advice. Always consult your doctor for any health issues and / or for the treatment of the same. The Health Master does not claim responsibility for this information.
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