Amendment of rule 127 of the Drugs Rules 1945 for adding allura red in coal tar colour

## Report on Amendment to the Drugs Rules, 1945 **1. Executive Summary:** This report analyzes a proposed amendment to the Drugs Rules, 1945, as published in the Gazette of India on November 29, 2021. The amendment focuses on updating the list of permitted Coal Tar Colours by adding "Allura Red" with its corresponding Colour Index Number and Chemical Name. This change aims to ensure regulatory clarity and potentially allow for the use of Allura Red in drugs manufactured and sold in India, contingent upon the final publication of the amendment. The report details the specifics of this amendment and its likely implications for the pharmaceutical and related industries. **2. Introduction:** This report aims to provide an informative overview of a proposed amendment to the Drugs Rules, 1945, based solely on the provided official notification published in the Gazette of India. It details the amendment's content, potential implications, and relevant stakeholders. **3. Policy Overview:** * This document pertains to an *amendment* of the Drugs Rules, 1945. * The core objective of the amendment, as inferred from the provided text, is to update the list of permitted Coal Tar Colours used in drugs. **4. Background and Rationale:** This document is an amendment, and the rationale behind it is likely to update the Drugs Rules, 1945 to incorporate new colors that are deemed safe and appropriate for use. The specific addition of Allura Red suggests a need to provide regulatory clarity and potentially allow for its usage where previously it may have been ambiguous. This could be due to international harmonization efforts, new scientific data supporting its safety, or industry demand for this particular colorant. **5. Key Provisions / Changes:** This amendment focuses specifically on altering Rule 127 of the Drugs Rules, 1945. * **Specific Part Being Changed:** Subrule 1 of Rule 127, under the heading "Coal Tar Colours." * **New Rule/Provision:** The amendment adds the following entry *after* Carmoisine and *before* BLUE Indigo Carmine: | Common Name of the Colour | Colour Index Number | Chemical Name | | :------------------------ | :------------------ | :-------------------------------------------------------------------------------------------------------------------------------------------- | | Allura Red | 16035 | Disodium 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-Naphthalenesulfonic acid | * **Difference/Effect of This Change:** The addition of Allura Red with its Chemical Name and Colour Index Number to the list of permitted Coal Tar Colours means that, upon final publication of the amendment, this color can now be considered for use in drugs within the parameters defined by the Drugs Rules, 1945. Previously, there may have been ambiguity or prohibition surrounding its use. **6. Target Audience and Stakeholders:** The primary target audience and stakeholders affected by this amendment are: * Pharmaceutical manufacturers: Those involved in the production of drugs that may utilize Coal Tar Colours. * Colorant suppliers: Companies that manufacture and supply Allura Red. * Regulatory bodies: Agencies responsible for enforcing the Drugs Rules, 1945. * Consumers: Indirectly affected, as the amendment could influence the color and appearance of certain medications. **7. Implementation Aspects (Inferred):** * **Responsible Agency/Bodies:** The Ministry of Health and Family Welfare (Department of Health and Family Welfare) is responsible for implementing and enforcing the amended rules. The Drugs Technical Advisory Board was consulted during the drafting process. * **Timelines/Procedures:** A period of thirty days from the date the Gazette of India is made available to the public is provided for stakeholders to submit objections and suggestions. The rules will come into force on the date of their final publication in the Official Gazette, unless specified otherwise. * **Amendment-Specific Aspects:** Implementation would involve updating internal documentation, quality control procedures, and potentially reformulation of products to incorporate Allura Red where desired and permissible under other relevant regulations. **8. Expected Outcomes / Impact of Changes:** The likely intended outcome of this amendment is to: * Provide clarity and regulatory certainty regarding the use of Allura Red in drugs. * Potentially allow pharmaceutical manufacturers to utilize Allura Red in their products where appropriate and permissible. * Maintain the safety and quality of drugs by ensuring that only permitted and properly identified colorants are used. * Increase the range of colourants available, potentially improving product aesthetics. **9. Conclusion:** The proposed amendment to the Drugs Rules, 1945, regarding the inclusion of Allura Red, represents a minor but potentially significant update to the regulatory framework for drugs manufactured and sold in India. Upon final publication, this amendment provides pharmaceutical manufacturers with greater clarity and potentially expands their options for coloring their products. It is crucial for stakeholders to stay informed about the final publication and any further guidelines issued by the Ministry of Health and Family Welfare.

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