Homeopathy, an alternative medicine system that has been around for more than two centuries, relies heavily on the effectiveness of natural remedies often formulated as dilutions, solutions, and pills. The manufacturing, storage and distribution of these treatments are complex processes that require strict standards for packaging materials. The Indian Standard IS 19085: 2024 provides comprehensive specifications for glassware used in homeopathic pharmaceutical preparations. These containers, which include glass fills, drop-dispensing bottles, and screw-neck bottles, must meet several requirements to ensure that they preserve the quality and integrity of the drug contained within.

--------------Blog Contact Form-------------

What is IS 19085: 2024?

Indian Standard IS 19085: 2024 specifies specifications for glass containers used in homeopathic pharmaceutical preparations. These containers, primarily designed for primary packaging and dispensing, ensure safe storage, transportation and delivery of homeopathic medicines. This Indian Standard was adopted by the Bureau of Indian Standards (BIS) after the draft was finalized by the Homoeopathy Sectional Committee had been approved by the Ayush Division Council. 

These containers, which are mainly designed for primary packaging and distribution, ensure the safe storage, transportation, and distribution of homeopathic medicines. For glass containers used in homeopathic pharmaceutical preparations BIS registration is required. As homeopathy grows and gains recognition globally, the quality of packaging materials, especially glass containers, is becoming increasingly important. IS 19085: 2024 addresses this concern by conforming to international standards and best practices to ensure the safety, integrity and efficacy of homeopathic products.

Significance of IS 19085: 2024

IS 19085: 2024 is an important standard for the homeopathic pharmaceutical industry that focuses the importance of packaging materials in maintaining the quality of medicines. It concentrates on ensuring that the glass containers used for homeopathic medicines are not only protective but also preserve the delicate ingredients inside. This standard introduces a new level of precision and consistency in how these products are stored and transported, preventing any potential contamination or degradation. By establishing clear guidelines, it also helps manufacturers streamline their processes, ensuring they meet the necessary quality and safety requirements. 

The objective of the standard is to build trust between both consumers and manufacturers, assuring them that medicines are safe, of high quality and free from harmful substances. It also conforms to global standards, helping Indian homeopathic products gain international recognition and acceptance. This is an important step towards improving the overall reputation and trust of homeopathic products, fostering an environment where both quality and safety is preferred, resulting in better outcomes for patients and a more secure market for manufacturers.

Also Read: IS 19084: 2024 Plastic Containers and Closures for Homoeopathic Pharmaceutical Preparations - Specification

Key Components of IS 19085: 2024 Glass Containers for Homoeopathic Pharmaceutical Preparations

• Material requirements: Containers must be made of clear or amber-coloured non-glass (type III or better). The type of glass is important because it affects the properties of the container, especially its interaction with the contents. Type III glass, with its moderate hydrolytic resistance, is suitable for most homeopathic preparations.
• Dimensions, capacity, and neck finish: Containers must adhere to the specified dimensions and neck finish, mentioned in the standard. This ensures that containers are uniform in size and can accommodate standard closures, such as screw caps, dropper plugs, or other suitable closure systems.
• Annealing process: Glass containers must undergo proper annealing to relieve internal stress and ensure that they do not crack or deform under stress. Annealing is particularly important to avoid the development of cracks or fractures during handling.
• Closure systems: Containers should have pilfer-proof caps made of materials such as aluminium or plastic. These closures must provide a liquid-tight seal to prevent contamination or leakage. Closure systems should be designed to ensure ease of use while maintaining product integrity.
• General requirements: The standard states that containers must have smooth surfaces without cracks, pinholes, or sharp edges. The glass should be free of defects such as blisters, stones or loading marks. Containers should be washed with clean water and air dried to prevent contamination during storage or use.
• Testing and quality control: The standard outlines a number of tests to assess the quality of glass, including hydrolytic resistance tests, etching tests, spectral transmittance tests (for coloured glass containers), vertical load resistance, thermal shock resistance, leaching tests for toxic elements such as lead and cadmium, and weathering tests for durability under environmental stresses.
• Sampling: A detailed methodology is provided for sampling from large consignments to ensure that the sample selected accurately represents the lot. Process testing ensures randomness and fairness in the process.

Scope of IS 19085: 2024

IS 19085:2024 suggests closure systems with these containers to ensure safe and convenient delivery. The standard covers the testing and quality control procedures required to verify compliance with the standard. The glass containers used in the preparation of standard homeopathic medicines apply to the following types:

• Glass phials: Small cylindrical containers, typically used for dispensing homeopathic preparations in solid and liquid forms. 
• Drop-dispensing glass bottles: Amber-coloured bottles, usually with a dropper plug, used for homeopathic dilutions.
• Screw-neck glass bottles for liquids: Amber coloured bottles with a stopper or dropper plug, used for storing and dispensing liquid homeopathic preparations such as syrups or mother tinctures.
• Screw-neck glass bottles for solids: Wide-mouthed containers for storing dried homeopathic pills and other solids.

Also Read: IS 18994: 2024 Vastra Dhauti - Specification

Benefits of IS 19085: 2024

• Improved safety: By specifying materials, dimensions and testing methods for glass containers, IS 19085 ensures that homeopathic medicines are stored in containers where harmful substances do not escape, preventing contamination and degradation.
• Global market compatibility: As homeopathic products continue to gain worldwide recognition, this standard aligns Indian products with global pharmaceutical practices, facilitating international trade and acceptance.
• Improved product integrity: Through rigorous testing (hydrolytic resistance, vertical load resistance, leaching test, etc.), the standard guarantees that the packaging material will maintain the quality of the drug during storage and transportation.
• Standardization: Clear specifications on container dimensions, closure systems, and testing methods promote uniformity in manufacturing, which increases production efficiency and reduces the chance of defective products entering the market.
• Consumer trust: As consumers become more conscious of product safety and quality, adherence to recognized standards gives them confidence in the homeopathic medicines they buy. Having a BIS certification helps to gain more trust of the consumers

Implications for Stakeholders

• Manufacturers: Pharmaceutical manufacturers, especially those in the homeopathic sector, ensure that their glass containers meet the new standards. This may include upgrading manufacturing processes, testing equipment and training staff. But, investing in meeting these standards will ultimately lead to higher quality products and greater market acceptance.
• Suppliers of glass containers: Suppliers of glass containers must ensure that their products comply with IS 19085: 2024, which may require them to improve quality control and testing processes. To meet the specific needs of homeopathic pharmaceutical companies, they may need to offer additional services such as customization. Require dimensioning or closure solutions.
• Regulatory bodies: Regulatory bodies must adopt this standard for certification purposes. This will ensure that only glass containers that meet safety, quality and performance standards will enter the market, improving the overall safety of homeopathic products.
• Consumers: Consumers will benefit from safer, more reliable products with greater assurance of the quality and integrity of the medicines they use. The standard also ensures transparency in labelling, so consumers are well informed about the product's origin and specifications.
• Global market: International stakeholders including importers, distributors and regulatory bodies will benefit from this standard, by ensuring that Indian homeopathic products meet internationally recognized packaging and safety standards.

Conclusion

The adoption of IS 19085: 2024 marks a significant milestone for the homeopathic pharmaceutical industry in India. By setting clear guidelines for glass containers used in homeopathic medicines, this standard enhances product safety, quality and consumer confidence. It provides manufacturers, suppliers and other stakeholders with the necessary framework to produce and distribute homeopathic medicines that meet stringent international standards.

The global recognition of homeopathic products is expanding, and IS 19085:2024 plays an important role in ensuring that these products meet the needs of the domestic and international market. By following this standard, manufacturers and suppliers can ensure that their products are safe, effective, and of the highest quality, giving consumers confidence that their homeopathic medicines are stored and distributed in the safest and most reliable way.