Last Updated on December 23, 2024 by The Health Master
Sensitive drugs
The Federation of Pharmaceutical Entrepreneurs (FOPE) has called for a crucial amendment to the Drugs and Cosmetics Rules to address the alarming rise in Not of Standard Quality (NSQ) drugs with respect to sensitive drugs.
In a communication to the Drugs Controller General of India (DCGI), FOPE has emphasized the need to include sensitive drugs (sensitive to temperature, humidity, and light) under Schedule P.
This move aims to enhance drug quality and safeguard public health, particularly considering India’s role as the ‘Pharmacy of the World.’
The NSQ Crisis
Jagdish Kumar, Executive Director of FOPE, highlighted the serious impact of NSQ drugs on public health and India’s global pharmaceutical image.
While factors like spurious drugs, inadequate infrastructure, and lack of expertise contribute to the issue, a critical oversight lies in the stability of drug formulations.
Focus on Temperature, Humidity, and Light Sensitive drugs
A review of recent drug alerts reveals a significant correlation between NSQ cases and the environmental sensitivity of certain medications.
- Examples: Formulations containing Clavulanic Acid, Rabeprazole, and dry syrups are particularly vulnerable due to their instability when exposed to unsuitable conditions.
- Specific Concerns:
- Rabeprazole: Degrades rapidly above 25°C, especially during transportation and storage.
- Amoxicillin-Clavulanate: Susceptible to moisture, with Clavulanate degrading rapidly in humid conditions.
- Dry Syrups: Vulnerable to moisture and temperature fluctuations, impacting their stability and reconstitution.
Variable Shelf Life and Lack of Robust Stability Data
A major contributing factor to NSQ cases is the inconsistency in shelf life assignments.
- Observation: Identical drug formulations often exhibit varying shelf lives (18-36 months) in the market.
- Concerns:
- Market-Driven Shelf Lives: Shelf lives are frequently granted based on marketer demands rather than scientific evidence.
- Lack of Expertise: Smaller manufacturers, lacking necessary expertise and infrastructure, may assign longer shelf lives without adequate stability studies.
- Patient Safety Risk: This practice compromises drug quality and poses a potential risk to patient safety.
FOPE’s Proposed Solutions
To mitigate the NSQ crisis, FOPE proposes the following:
- Expand Schedule P: Include sensitive drugs (sensitive to temperature, humidity, and light) under Schedule P, ensuring stricter regulations and enhanced quality control.
- Re-evaluate Shelf Life Limits:
- Current Scenario: Rule 96 (vii) of the Drug Rules, 1945, allows a 60-month shelf life for non-Schedule P drugs, extendable by the Central Licensing Authority.
- Proposed Framework:
- Active Ingredients/Excipients: 60 months
- Formulations: 36 months
- Temperature / Humidity / Photo sensitive drugs: 24 months
- Stringent Approvals: Any extension beyond these limits should require thorough review and approval by the Central Licensing Authority based on robust stability data.
Benefits of Implementing These Measures
- Reduced NSQ Cases: Significantly lower incidence of sub-standard drugs.
- Enhanced Patient Safety: Ensures the quality and efficacy of medications.
- Bolstered Global Trust: Reinforces the credibility of Indian pharmaceutical products in the international market.
Call to Action
FOPE has demanded the Drugs Controller General of India (DCGI) to consider these proposals and initiate discussions to address the critical issue of NSQ drugs.
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What are NSQ drugs?
NSQ stands for “Not of Standard Quality.” These are drugs that do not meet the established quality standards, including potency, purity, and safety.
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Why are temperature sensitive drugs a concern?
Many medications degrade when exposed to high temperatures or humidity, affecting their efficacy and safety.
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How does Schedule P help?
Schedule P outlines stringent quality control measures for specific drug categories. Including temperature sensitive drugs under this schedule will ensure stricter manufacturing and storage guidelines.
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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