Last Updated on October 9, 2024 by The Health Master
OTC Drugs
In a significant move to enhance the accessibility of over-the-counter drugs (OTC drugs), the Drugs Technical Advisory Board (DTAB) has proposed the formation of a sub-committee.
This committee is tasked with scrutinizing the conditions determining a drug’s OTC status, along with the development of a comprehensive mechanism for such categorization.
The Ministry of Health, aligning with this initiative, issued a draft amendment in the Schedule K of the Drugs Rules, 1945, on May 25, 2022.
The Draft Amendment
The proposed amendment lists approximately 16 drugs earmarked for exemption under Schedule K.
These drugs are deemed fit for retail sale over the counter without the prescription of a Registered Medical Practitioner (RMP).
Among the specified conditions, a crucial point is the stipulation that the maximum duration of treatment or use should not exceed five days.
If symptoms persist, patients are advised to consult an RMP.
Key Conditions for OTC Exemption
The conditions set in the draft encompass various aspects, such as the maximum recommended doses for five days and the provision that the pack size should not surpass the stated doses.
These precautions are crucial to maintaining consumer safety and well-being.
DTAB’s Deliberation
In its recent meeting in January 2024, the DTAB discussed the draft notification and considered individual applications from pharmaceutical companies.
Notable among these were requests from Intermed Laboratories Private Limited for diclofenac diethylamine transdermal patch 200 mg, Reckitt Benckiser Private Limited for acetylsalicylic acid effervescent 500 tablets, and Glenmark Private Limited for dextromethorphan HBr lozenges 50 mg, mometasone furoate nasal spray 50 mcg.
Sub-Committee Formation
DTAB, acknowledging the intricacies involved, recommended the establishment of a sub-committee.
This committee is tasked with a detailed examination of the conditions influencing a drug’s OTC status and the formulation of a mechanism for the consideration of drugs under this category.
DCC’s Earlier Endeavors
The Drugs Consultative Committee (DCC) had previously appointed a sub-committee under the chairmanship of NK Ahooja, drugs controller of Haryana.
This sub-committee submitted a report emphasizing the urgent need to define OTC drugs and lay down specific provisions for their regulation.
OTC Drugs Classification
The sub-committee proposed the inclusion of a clear definition for OTC drugs in the Drugs & Cosmetics Rules 1945.
It advocated for the incorporation of basic characteristics of OTC drugs, along with their classification into OTC-1 and OTC-2.
Factors considered for classification include evidence of safety, therapeutic index, accessibility, non-habit forming nature, supply chain mechanism, and socioeconomic conditions of the country.
Regulatory Recommendations
Apart from classification, the sub-committee recommended regulations on switching prescription drugs to OTC status, new OTC drug approval, distribution, sale, and advertisement of OTC drugs.
These comprehensive guidelines aim to streamline the OTC drugs landscape in the country.
DCC’s Validation
The recommendations of the subcommittee were considered in the 57th meeting of the DCC held on August 8, 2019.
The DCC recommended suitable amendments in the Schedule K of the Drugs and Cosmetics Rules, 1945, incorporating necessary provisions for OTC drugs, subject to specified conditions.
DTAB’s Continued Advocacy
The matter was revisited in the 87th meeting of DTAB in November 2021.
Following this, the list of 16 drugs was published as a draft notification in May 2022.
The Board emphasized the need to adopt best practices concerning the dispensing of drugs by various professionals.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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