Last Updated on March 28, 2024 by The Health Master
DTAB
The Drugs Technical Advisory Board (DTAB), a key advisory body in India, recently endorsed a report by the Indian Council of Medical Research (ICMR) advocating for the restriction of nicotine replacement therapies (NRTs) to prescription-only status.
This recommendation has significant implications for public health policy and the regulation of smoking cessation aids.
Let’s delve deeper into the reasons behind DTAB’s backing of this proposal and the potential impact it may have.
Understanding the Proposal
What is the DTAB’s Recommendation?
In its 89th meeting held on May 10, 2023, the DTAB discussed a proposal to amend the Schedule K of the Drugs Rules, 1945.
The proposal aimed to include nicotine orally disintegrating strips in addition to nicotine gums and lozenges for exemption from the requirement of a sales license.
The Role of ICMR
DTAB sought insights from the Indian Council of Medical Research (ICMR) regarding this proposal.
ICMR highlighted the potential abuse of over-the-counter (OTC) NRTs among both smokers and nonsmokers.
They recommended that all NRTs should be used under medical supervision and made available exclusively on prescription.
DTAB’s Agreement with ICMR
After careful deliberation, DTAB concurred with ICMR’s report.
They recommended amendments to the rules in line with ICMR’s suggestions.
This decision reflects a consensus among experts regarding the regulation of NRTs for better public health outcomes.
The Rationale Behind Prescription-Only Status
Preventing Abuse Potential
ICMR’s report emphasized the risk of abuse associated with OTC NRTs.
By restricting access to prescription-only, the likelihood of misuse or improper usage decreases significantly.
Ensuring Medical Supervision
Placing NRTs under prescription ensures that users receive appropriate guidance from healthcare professionals.
This supervision is crucial for maximizing the effectiveness of these therapies and minimizing potential risks.
Related news: DTAB: Proposal to restrict Nicotine Replacement Therapies Sales to Prescription Only
Addressing Concerns and Challenges
Balancing Access and Regulation
While the move towards prescription-only status enhances regulation, it also raises concerns about accessibility.
Striking a balance between ensuring adequate access for smokers seeking cessation aids and regulating their use is paramount.
Impact on the Industry
The NRT market in India, experiencing steady growth, will likely undergo changes due to these regulatory shifts.
Pharmaceutical companies operating in this sector may need to adapt their strategies to comply with new requirements.
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.
Regulatory Control to Combat the Menace of Spurious / Counterfeit Drugs
Govt to Enhance Local Manufacturing of Drugs and Medical Devices
The proposal for a Unified Drug Regulatory Authority in India
Reforming Drug and Medical Device Pricing: The Mission of Govt
DCGI to SLAs: Cancel this Antibiotic Drug Combination
Need for a Unified Licensing and Drug Approval System in India
Govt Job: For Analyst at State Drugs Testing Laboratory
Operation Double-Check: Kerala’s Bold Move to Ensure Drug Quality
DTAB advocates Bar Codes and QR Codes on Vaccine Products
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
