Last Updated on October 9, 2024 by The Health Master
Pharma Industry
India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has exposed the widespread use of industrial grade excipients in pharma industry, unfit for human consumption, in the country’s drug manufacturing.
This alarming discovery followed international complaints, prompting the CDSCO to conduct extensive investigations and inspections.
Discovery of Industrial Grade Excipients
The excipients in question include industrial grade gelatin, propylene glycol, and other substances supplied by unlicensed traders.
These traders imported these substances from various countries, leading to a concerning compromise in the quality of drugs produced in India.
Violation of Drugs and Cosmetics Act
The Drugs and Cosmetics Act explicitly mandates the use of pharma grade excipients in drugs.
The Drug Consultative Committee (DCC), responsible for advising governments on the Act’s uniform implementation, highlighted this issue in a recent meeting.
The DCC observed the need for an advisory to direct manufacturers to use only pharma grade excipients in drug formulations.
Advisory for Proper Enforcement
To address this issue effectively, the DCC recommended issuing advisories to state licensing authorities.
These advisories would instruct manufacturers under their jurisdiction to adhere strictly to the use of pharma grade excipients in the manufacturing process of drugs in pharma industry.
This proactive step aims to ensure the safety and efficacy of drugs.
Importation of Unfit Excipients from China
The meeting minutes revealed a disturbing trend where low-cost industrial/technical-grade gelatin, unsuitable for human consumption, was being imported from China.
Unscrupulous traders sold this gelatin to soft capsule manufacturers, who blended it with high-quality gelatin made in India for capsule production.
Adulteration of Pharma Excipients
Reports indicated multiple instances of adulteration of pharma excipients, including glycerin, propylene glycol, and isopropyl alcohol.
These substances, imported as industrial grade, were supplied to drug units by traders not licensed under the Drugs and Cosmetics Act, raising serious concerns about the safety of drugs.
Regulatory Concerns
The drug regulator received representations highlighting the use of technical or industrial grade gelatin from China in the manufacture of capsules intended for human consumption.
The lack of regulation specifying maximum limits for chromium, heavy metals, salmonella, and the absence of sample testing further intensified regulatory challenges.
Toxic Compounds in Technical Gelatin
Technical gelatin, prohibited for human consumption due to the presence of carcinogenic compounds, posed a significant threat to public health.
The absence of specific regulations regarding maximum limits for chromium and other contaminants added complexity to ensuring the safety of industrial grade gelatin.
Safety Concerns for Human Consumption
The revelation emphasized the critical safety concerns associated with the use of industrial grade excipients in drugs.
The presence of carcinogenic compounds and the lack of safety regulations raised questions about the integrity and safety of the pharma supply chain.
Meeting Minutes and Panel Information
Insights from the DCC meeting highlighted the urgent need for addressing pharma excipient adulteration.
The panel was informed about the importation of industrial grade excipients by unlicensed traders, creating vulnerabilities in the pharma supply chain.
Reports of Adulteration
The frequency and severity of reported cases of excipient adulteration underscored the gravity of the issue.
The panel acknowledged the need for swift and decisive action to safeguard the quality of drugs produced in the country.
Recommendations for Capsule Manufacturers
The DCC provided specific guidelines for soft and hard capsule manufacturers, emphasizing the importance of using only pharma grade excipients.
These recommendations aim to restore confidence in the pharma industry by ensuring the safety and efficacy of capsules consumed by the public.
Awareness and Education Initiatives
Addressing the issue requires a multifaceted approach, including awareness among manufacturers and education initiatives for stakeholders.
Creating awareness about the risks associated with using unfit excipients is crucial for preventing further compromises in the drug manufacturing process.
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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