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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

Manufacturers of tobacco products required to register their packing machine(s) with tax authorities
India’s Central Board of Indirect Taxes and Customs (CBIC) has postponed the timeline for manufacturers of tobacco products such as pan-masala, chewing tobacco, smoking mixtures, etc. to report their production capacity. CBIC had in January this year announced that producers must register their filling and packing machines and report these details. The measure was set to be implemented from 1st April 2024. However, the new effective date for implementation of the timeline is now 15th May 2024.
Source: bit.ly/3xz7400

NPPA releases draft ceiling price calculation sheets of seven scheduled formulations
The National Pharmaceutical Pricing Authority (NPPA) has published a preliminary calculation of ceiling prices for seven drug and vaccine formulations, inviting feedback from stakeholders within a ten-day period. These ceiling prices have been adjusted to reflect the minimum and maximum market prices of the products, in accordance with the updated Schedule I of the Drugs (Prices Control) Order, 2013, aligning with the National List of Essential Medicines (NLEM), 2022. The move shall be affecting major pharmaceutical giants in the business of ORS, vaccines and more.
Source: bit.ly/3UhjK4J

High Courts should interfere only when the case in lower court was decided by fraud or collusion: Supreme Court of India
While deciding an appeal against the order of the High Court, the Supreme Court of India observed that the High Court should apply care and caution while entertaining the petitions under Article 226 of the Constitution. The Court further explained that, in case of an already available alternative statutory remedy, the High Court should interfere in the matter only when the case is decided by fraud or collusion, otherwise an order in the same matter by the High Court will mean reopening the issues that have achieved finality.
Source: bit.ly/4cNGwIJ

Goa FDA to get the status of “US FDA observer” amid surge in increase in retail and wholesale licenses
The Goa Food and Drug Administration (FDA) has been extended the invitation to participate as “FDA observer” for inspections conducted by the USFDA India Office. This development came as a result of increase in retail and wholesale licenses issued by Goa FDA and their familiarity with the US FDA’s inspection process.
Source: bit.ly/3UfqIHq

Rejecting apology of the Directors of a Company for misleading advertisements, the Supreme Court sets caution for FMCG companies
Observing caution for fast-moving consumer good (FMCG) companies, the Supreme Court of India has refused to accept an apology from a major Indian Ayurvedic medicine manufacturer for misleading advertisements regarding its products in contravention of an undertaking provided to the Court. The Supreme Court stated that misleading advertisements by FMCG companies result in deceiving innocent consumers and play with public health.
Source: bit.ly/3PYqoKq

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PROCESS FOR OBTAINING BIS LICENSE UNDER MEDICAL TEXTILES (QUALITY CONTROL) ORDER, 2023

Introduction:

Medical textile products such as sanitary napkins, baby diapers, reusable sanitary pad/ sanitary napkins/ period panties, dental bib/ napkins, bedsheet, pillow cover, and shoe covers have been regulated for quality in India by  the Medical Textiles (Quality Control) Order, 2023 (the “Order”). The Order requires all manufacturers and importers of medical textile products to label the products with the Indian Standard (IS) Mark. A license over the IS Mark is issued by Bureau of Indian Standards (BIS) after it has determined that the medical textiles and the manufacturing process meet with the standards prescribed by BIS. Such license is commonly referred to as the BIS license.

Which are the standards prescribed by BIS that medical textiles have to meet?

The medical textiles covered by the Order have to mandatorily meet with the standards described in the table below.

Sl. No.Goods or articleIndian Standard (IS)Title of Indian Standard
 1.Sanitary napkinsIS 5405:2019Sanitary napkins – Specification (second revision)
 2.Baby DiaperIS 17509:2021Disposable baby diaper – Specification
 3.Reusable Sanitary Pad Sanitary Napkin Period PantiesIS 17514:2021Reusable sanitary pad/ Sanitary Napkin/ Period Panties – Specification
 4.Shoe coversIS 17349:2020Medical textiles – Shoe covers – Specification
 5.Dental bib/NapkinsIS 17354:2020  Medical textiles – Dental Bib or Napkins – Specification
 6.Bedsheet and Pillow CoverIS 17630:2021  Medical Textiles – Bed sheet and pillow cover – Specification  

How to obtain license to use Indian Standard mark on medical textiles?

The process to obtain license over the Indian Standard (IS) mark is described in Scheme – I of Schedule – II to the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018 (the “Conformity Assessment Regulations”). The process entails on-site factory inspection, review of manufacturing process, sampling/testing of products at BIS recognized labs, and strict adherence to prescribed labelling and marking requirements.

Do all manufacturers and importers of medical textiles require declaration of Indian Standard (IS) mark on label?

Yes, the Order applies to all manufacturers (Indian and foreign) of medical textiles who wish to sell medical textiles in India. Therefore, such manufacturers will have to obtain license over IS mark from BIS.

However, the Order does not apply to:

  1. Goods/articles intended for export, or
  2. Sanitary napkin, baby diaper, reusable sanitary pad / sanitary napkins / period panties manufactured by Self Help Groups (SHG)

The above-mentioned goods/articles need not be mandatorily labelled with IS Mark.

What are the timelines for the Order to become effective?

All manufacturers (domestic and foreign) of sanitary napkins, baby diapers, reusable sanitary pad/ sanitary napkins/ period panties have to ensure that any of their products sold in India on or after October 1, 2024, ought to contain an IS Mark on their label.

All manufacturers (domestic and foreign) of dental bib/ napkins, bedsheet, pillow cover, and shoe covers have to ensure that any of their products sold in India on or after April 1, 2024, ought to contain an IS Mark on their label.

Conclusion:

It generally takes around 4 – 6 months, depending on the delay caused in responding to queries raised (if any), organizing inspection(s), sample deposition, and clearance of fee dues, etc., to receive license over IS Mark from BIS. Therefore, manufacturers and importers of medical textiles should ensure that they make the license application in time so that the business does not suffer.

For more insights on the Medical Textiles (Quality Control) Order, 2023, please refer to our article Medical Textiles (Quality Control) Order, 2023: Impact Analysis for Personal Hygiene Products.