Introduction
The Government of India notified the Medical Textiles (Quality Control) Order, 2023 (the “Order”) on 27 September 2023. This Order, drafted by the Ministry of Textiles in consultation with the Bureau of Indian Standards (BIS) mandates that certain medical textile products adhere to specified Indian Standards (IS) and bear the Standard Mark. Medical textiles are mainly used for protection from infections in hospital environment, personnel hygiene, wound treatments, wound closure, replacement surgery or as a mechanical organ. In this article, we have covered the implications with focus on personal hygiene category which is largely unregulated. The Order applies to all manufacturers, wholesalers, retailers, and importers of finished products for sale and marketing in India.
Update in Standards
The Ministry of Textiles has introduced the updated standards with the Medical Textiles (Quality Control) Order, 2023. To comply with the Order, the manufacturer/producers of these products will have to get license from the BIS to use the Standard Mark on these products/their packaging to signify that the products meet with specified IS standards.
The Order covers the following products:
| Sr. No. | Product Name | IS Number | Title of Indian Standard |
|---|---|---|---|
| 1. | Sanitary Napkins | IS 5405:2019 | Sanitary Napkins – Specification (second revision) |
| 2. | Baby Diaper | IS 17509:2021 | Disposable Baby Diaper – Specification |
| 3. | Reusable Sanitary, Pad Sanitary, Napkin Period Panties | IS 17514:2021 | Reusable Sanitary Pad/Sanitary Napkin/ Period Panties – Specification |
| 4. | Shoe Covers | IS 17349:2020 | Medical textiles – Shoe Covers – Specification |
| 5. | Dental Bib/Napkins | IS 17354:2020 | Medical Textiles – Dental Bib or Napkins – Specification |
| 6. | Bedsheet and Pillow Cover | IS 17630:2021 | Medical Textiles – Bed Sheet and Pillow Cover – Specification |
The standards in the Order do not apply to the goods or article meant for export or those that are manufactured by Self Help Groups. For others, these standards are slated to become effective from 01 April 2024 (the “Effective Date”), except for Small and Micro Enterprises (SMEs). The effective date for SMEs is 01 October 2024. Consequently, the industry will transition from the previous framework of standards to the updated framework commencing from the Effective Date. This transitional period provides the industry with approximately five months to make requisite preparations for the shift in compliance standards.
Impact on the Industry
Mandatory Licensing and Certification: Manufacturers need to be aware that compliance with the Medical Textiles (Quality Control) Order, 2023 requires obtaining a license and adhering to an elaborate certification process. The process is guided by Scheme I of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018 (the “Conformity Assessment Regulations”). This makes it a mandatory certification for using BIS mark on medical textiles products. All manufacturers of these products will require to initiate the licensing process promptly, recognizing that it is not optional but an essential compliance step.
The licensing process entails scrutiny of the production process by the Bureau of Indian Standards. This involves factory visits, review, and adherence to precise labelling and marking requirements. Manufacturers will have to allocate resources and manpower for the continuous compliance checks that accompany the licensing process. Furthermore, it is vital to establish protocols for maintaining compliance and documentation for potential audits and renewals.
Certification for Foreign Manufacturers: Foreign manufacturers are also required to comply with the standards for the products covered under the Order. For such foreign manufacturers, the BIS operates the Foreign Manufacturer Certification Scheme (FMCS), which is covered under the Scheme I of the Conformity Assessment Regulations. The FMCS is a scheme under which the manufacturers who have their factory location outside India can apply to get BIS licence in accordance with the BIS Act, 2016 and Conformity Assessment Regulations. The BIS license under the FMCS scheme ensures that the product of the foreign manufacturer sold in India conform to the applicable Indian Standards. Considering that there is approximately only five (5) months’ time before the updated standards become effective, foreign manufacturers may have to work on war footing to meet the timeline and be prepared with the updated products in time. However, as per the Frequently Asked Questions (FAQs) hosted on the BIS website, the average time taken for grant of licence is generally six (6) months from the date of receipt of complete application and its recording. It may further vary for reasons like delay in response to queries raised, organizing inspection(s), transportation of samples and remittance of dues, etc. Thus, it is of high importance for foreign manufacturers to initiate the licensing process from their end at the earliest to introduce compliant products in Indian market by the Effective Date.
Limited Time for Transition: With the updated standards slated to come into effect from April 2024, the industry has a finite window of approximately five months to prepare for compliance. Similar to foreign manufacturers, for entities lacking the requisite licenses, this timeframe becomes a pressing concern. It is crucial to understand that the certification and licensing process for domestic manufacturers, encompassing document preparation, verification, on- site inspections, and reviews, typically spans between four to six months (as per the FAQs on the BIS website). Consequently, early initiation of the process is important to meet the compliance deadline. After 01 April 2024, products that do not possess the BIS license for conforming to the updated standards will not be permitted to be sold in India, highlighting the urgency of proactive compliance.
Import of the Products: Importers of medical textile products also face a compliance challenge under the Medical Textiles (Quality Control) Order, 2023. These importers (not being the foreign manufacturer) must ensure that the products they bring into India meet the specific Indian Standards and carry the requisite Standard Mark. This means that from the Effective Date the imported products must adhere to the same quality and safety benchmarks as those produced within India. To meet this end, importers will need to establish close collaboration with their international suppliers (foreign manufacturers) to ensure that these products are in
line with the standards outlined in the Order and are licensed under the FMCS when they reach the Indian custom barrier.
Additional Compliances: The conformity to one BIS Standard may also require conformity to other BIS Standards. Manufacturers should recognize that compliance with the new standards goes beyond the finished product; it extends to the raw materials, manufacturing process, testing capabilities as well. For instance, the BIS standard for sanitary napkins (IS 5405:2019) mandates that if cotton gauze is used as a raw material, it must conform to IS 758. Further, the testing of the products (by the testing facilities of the manufacturer) also requires adherence to various IS Standards; for instance, the test to ascertain the pH value of the products must adhere to IS 1390, which will require equipment and facilities that can correctly and accurately test products as per IS 1390. These additional compliance implications may translate to increased time and costs for the manufacturers.
Balancing Inventory: Managing existing inventory compliant with older standards also presents a challenge. Manufacturers must strike a balance between maintaining a consistent supply in the market until they secure the necessary licenses and utilizing the existing inventory. It is advisable to develop a phased inventory management plan, ensuring that obsolete stock does not remain on the market after the Effective Date. This may involve strategically phasing out non-compliant items till the Effective Date or till the license is obtained.
Implications for Hospitals: The implications of the Medical Textiles (Quality Control) Order, 2023 reach into the healthcare sector, presenting a significant challenge for hospitals. With the Order mandating specified standards for medical textiles, including bed sheets, pillow covers, shoe covers, and dental bibs, hospitals will face the task of sourcing compliant products during the transition phase. This challenge is compounded by the short timeline. As the licensing process itself spans four to six months, and the effective date is just five months away, a shortage of compliant products may emerge. This scarcity could lead to unavailability of these products, affecting public health as hospitals grapple with maintaining essential inventory that adheres to the updated standards while the industry transitions.
Quality Standards in Public Interest
The issuance of the Medical Textiles (Quality Control) Order, 2023, also carries a broader societal impact. It serves the purpose of upholding stringent quality standards, particularly in contexts where these products play a pivotal role. A notable instance can be found in the welfare initiatives implemented by various state governments in India, where sanitary pads are distributed to schoolgirls as part of their welfare schemes. Historically, the procurement of these products sometimes involved the selection of agencies that imported substandard, low- quality items from foreign countries, often at significantly reduced rates. Such practices occasionally led to the circulation of products that circumvented established quality norms.
However, the enforcement of the BIS-mandated Standard Mark now provides an unequivocal assurance that even products disbursed through welfare programs strictly adhere to meticulously defined quality criteria. This safeguard upholds the health and well-being of the beneficiaries and aligns with the overarching objective of elevating the overall quality of life.
Conclusion
The Medical Textiles (Quality Control) Order, 2023, combined with the BIS Act and Conformity Assessment Regulations, marks a significant stride towards ensuring the safety and quality of medical textiles in India. By making the BIS license mandatory, the Order raises the bar for manufacturers and importers of the medical textile products and reassures the consumers.