Last Updated on December 23, 2023 by Hitesh Goyal
Pharma Industry
The Drugs Controller General of India (DCGI) has recently issued a crucial advisory, emphasizing the necessity for pharma industry to strictly adhere to the conditions outlined in their manufacturing licenses and prescribed Good Manufacturing Practices (GMP).
This directive is aimed at ensuring that pharmaceutical products meet the highest standards of quality, safety, and efficacy.
Quality Tests Raise Concerns
In response to alarming reports, the DCGI’s move comes on the heels of revelations that industrial excipients, crucial components in drug manufacturing, have led to the failure of quality tests for over 50 companies producing cough syrups.
Importance of Manufacturing Compliance
The advisory underscores the paramount importance of adhering to prescribed standards not only for the active pharmaceutical ingredient (API) but also for various excipients used in the formulation.
The DCGI stresses that the quality, safety, and efficacy of both APIs and excipients are critical elements that cannot be compromised.
Focus on Cough Syrups
In the case of cough syrups, where critical excipients like propylene glycol, glycerine, sorbitol, etc., are extensively used, the DCGI emphasizes that companies must ensure these excipients meet regulatory norms for quality.
This precaution is vital to prevent contamination in the formulations derived from such excipients.
Advisory for Pharma Industry
The advisory directs pharma industry to exclusively procure and use pharmaceutical-grade excipients from approved sources and vendors.
These sources must adhere to quality standards in line with regulatory requirements under the prevailing laws and rules.
This measure is deemed essential to guarantee the quality, safety, and efficacy of drug formulations.
Significance Amidst Winter Season
The DCGI’s advisory assumes even greater significance as the winter season, synonymous with an uptick in respiratory issues, witnesses an increased use of cough syrups across the country.
By issuing this directive, the regulatory body aims to mitigate potential risks associated with the heightened demand for pharmaceuticals during this period.
Quality Concerns for Propylene Glycol
In a separate note, DCGI Rajeev Singh Raghuvanshi highlighted specific quality concerns pertaining to propylene glycol (PG) supplied to cough syrup manufacturers.
This underscores the need for meticulous scrutiny of each component to guarantee the overall quality of the final product.
Conclusion
In conclusion, the DCGI’s advisory serves as a pivotal guide for pharma industry to uphold the highest standards in their operations.
By emphasizing compliance with manufacturing licenses and GMP, the regulatory body aims to safeguard the health and well-being of the public.
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.
FAQs
- What is the significance of the DCGI’s advisory for pharma industry?
The advisory is crucial as it mandates strict adherence to manufacturing standards to ensure the quality, safety, and efficacy of pharmaceutical products. - Why is the focus on cough syrups in the advisory?
Cough syrups often use critical excipients, and the advisory aims to prevent contamination by ensuring these components meet regulatory quality norms. - How does the advisory impact pharma industry during the winter season?
The advisory gains significance during the winter season due to increased usage of cough syrups, necessitating stringent quality control measures. - Why is the quality of propylene glycol highlighted separately in the advisory?
Quality concerns regarding propylene glycol underline the need for meticulous scrutiny of individual components to maintain the overall quality of pharmaceutical formulations. - Where can one access more information on pharmaceutical-grade excipients and approved sources?
- For further details on pharmaceutical-grade excipients and approved sources, manufacturers can refer to the regulatory requirements outlined in the advisory.
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