On 27th September 2023, the Indian Government made an official declaration about the Medical Textiles (Quality Control) Order, 2023, commonly known as the “Order.” The Ministry of Textiles, in collaboration with the Bureau of Indian Standards (BIS), has released a directive mandating that certain medical textile products must adhere to designated Indian Standards (IS) and display the Standard Mark. This Order is applicable to all manufacturers, distributors, and importers involved in the production and sale of medical textile products within India.
Standards Update
The revised criteria specified in the Medical Textiles (Quality Control) Order, 2023 have been put into effect by the Ministry of Textiles. To comply with this order, manufacturers and producers of these items are required to obtain a license from the BIS. This license will allow them to use the Standard Mark on their products or packaging, signalling that the products meet the designated IS criteria.
The Order covers the following products: Sanitary Napkins, Sanitary napkins, Shoe Covers, Baby diapers, Reusable Sanitary pads, Period Panties, Dental Bib/Napkins, and Bedsheet And Pillow Covers.
The provisions stated in the Order are not applicable to goods or items meant for export or those manufactured by Self Help Groups. The new standards will take effect on 01 April 2024, known as the “Effective Date,” except for Small and Micro Enterprises (SMEs). SMEs have a designated date of 01 October 2024 to comply with the revised standards. Consequently, the industry will transition from the previous set of standards to the updated ones starting from the Effective Date. During this transitional period, which spans approximately five months, the industry will have the opportunity to prepare for the changes in compliance requirements.
Effect on the Industry
- Manufacturers should comprehend that adherence to the Medical Textiles (Quality Control) Order, 2023, mandates obtaining a license and following a meticulous certification process. The program implements the procedures specified in the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018 (known as the “Conformity Assessment Regulations”). As a result, obtaining this certification is required to use the BIS mark on medical textile items. Every manufacturer of these products must swiftly begin the licensing process, acknowledging that it is not a choice but a necessary step for compliance.
- The Bureau of Indian Standards carries out a comprehensive evaluation of the production process during the licensing process. This includes conducting factory inspections at the production site, conducting meticulous assessments, and following specific labelling and marking requirements with great adherence. Manufacturers are required to allocate resources and personnel to ensure continuous compliance checks as an integral part of the licensing procedure. Moreover, it is crucial to develop standards for adherence and record-keeping for possible audits and renewals.
- Foreign manufacturers must likewise adhere to the standards for the items specified in the Order to obtain certification. The BIS manages the Foreign Manufacturer Certification Scheme (FMCS) for international manufacturers. This scheme falls under Scheme I of the Conformity Assessment Regulations. The FMCS enables foreign companies to seek a BIS license under the BIS Act, 2016 and Conformity Assessment Regulations, expanding their scope to operate in India. The BIS license, obtained through the FMCS scheme, guarantees that the products manufactured by foreign companies and sold in India comply with the relevant Indian Standards. Given the limited timeframe of about five (5) months before the new standards take effect, overseas producers may need to work urgently and efficiently to meet the deadline and ensure their goods are updated promptly. The length of time required for the licensing process may also vary due to delays in responding to raised concerns, scheduling inspections, transporting samples, and making payments. That’s why it is of utmost importance for foreign producers to promptly begin the licensing procedure in order to introduce products that meet the required standards in the Indian market by the specified Effective Date.
- Time Constraint for Transition: The implementation of the revised regulations is set to commence in April 2024, granting the industry an approximate timeframe of five months to prepare and fulfil the requirements. Similar to foreign producers, organizations lacking the required permits face an urgent situation during this period. It is crucial to understand that the certification and licensing process for domestic producers, encompasses tasks such as document preparation, verification, on-site inspections, and reviews. Hence, initiating the process early becomes imperative to meet the compliance deadline. Effective April 1, 2024, the sale of products in India without the BIS license to adhere to the new standards will be prohibited, underscoring the significance of proactive compliance.
- Importers of medical textile products encounter a compliance challenge in complying with the Medical Textiles (Quality Control) Order, 2023. Importers, who are not foreign manufacturers, hold the responsibility of ensuring that the products they import into India conform to the specific Indian Standards and bear the required Standard Mark. From the Effective Date onwards, imported products must meet the same quality and safety standards as domestically manufactured goods in India. To achieve this goal, importers must establish a strong partnership with their foreign manufacturers, guaranteeing that the products align with the standards outlined in the Order and acquire FMCS licensing upon reaching Indian customs checkpoints.
- Additional requirements: Adherence to a particular BIS Standard may also necessitate compliance with other BIS Standards. Manufacturers need to recognize that conforming to the new requirements involves ensuring that the final product, raw materials, manufacturing process, and testing capabilities are in line with the specified standards. Take the example of the BIS standard for sanitary napkins (IS 5405:2019). If cotton gauze is used as a raw material, it must meet the specifications outlined in IS 758. Furthermore, testing the products using the manufacturer’s facilities requires compliance with multiple IS Standards. For instance, determining the pH value of the products requires following IS 1390, which mandates the use of precise and accurate testing equipment and facilities specified by IS 1390. As a result of these new compliance challenges, manufacturers may encounter increased time and expenses.
- Impact on Hospitals: The introduction of the Medical Textiles (Quality Control) Order, 2023, has significant implications for the healthcare sector, presenting a considerable obstacle for hospitals. Adherence to specific criteria for medical textiles, including bed sheets, pillow covers, shoe coverings, and dental bibs, is now mandatory under the Order. Consequently, during the transition, hospitals must locate and procure materials that satisfy these requirements. This challenge is exacerbated by the limited time available. Given that the licensing process typically takes four to six months, and the effective date of the Order is just five months away, there is a risk of encountering a shortage of items meeting the necessary standards. This scarcity of certain products may result in their unavailability, which could have implications for public health. Thus, hospitals may require assistance in maintaining sufficient inventory that aligns with the newly established standards amid this industry-wide shift.
Reference: https://www.lexology.com/
