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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, 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.

1. India’s Central Pollution Control Board has further extended the timelines for the filing of Quarterly Returns and Annual Returns of E-waste under E-waste Management Rules, 2022 for all registered entities on the online EPR portal till 31st December 2024.
Source: bit.ly/4eMsXZA

2. India’s Ministry of Health and Family Welfare (MoH&FW) is considering a proposal to amend the Medical Device Rules (MDR), 2017, to introduce specific timelines for various regulatory processes. These include conducting inspections, addressing non-conformities identified during inspections, and granting manufacturing licenses for medical devices across four classes (A, B, C, and D). The proposed changes aim to streamline approvals, enhance transparency, and improve regulatory efficiency in medical device manufacturing.
Source: bit.ly/4eH8aGL

3. The Indian Council of Medical Research (ICMR) has invited proposals for clinical studies on innovative medical devices and diagnostics under its Centre for Advanced Research (CAR) scheme. Offering up to ₹15 crore per project over five years, the scheme aims to validate and promote safe, effective, and regulatory-compliant healthcare technologies in India.
Source: bit.ly/4eH70vc

4. India’s Supreme Court has suggested the Central Government to formulate a policy on the construction of exclusive feeding rooms and childcare rooms in public places. Currently, there is no concrete law or policy on the feeding rooms and childcare rooms in public places.
Source: bit.ly/3ZiaQX1

5. The U.S. Food and Drug Administration (FDA) has released a guidance document titled Chemical Analysis for Biocompatibility Assessment of Medical Devices. This document outlines chemical characterization methods that can be used as alternatives to certain biological tests to demonstrate the biocompatibility of medical devices. It aims to enhance the consistency and reliability of analytical chemistry studies conducted as part of the biocompatibility assessment process for these devices.
Source: bit.ly/3OkJtFu

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, 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.

1. The Indian government has made it mandatory for students pursuing medical education in Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa Rigpa, and Homoeopathy (AYUSH) to clear the National Exit Test (NExT) after graduation. This requirement will apply to medical graduates from the 2021-2022 batch.
Source: bit.ly/4egpEdy

2. India’s central drug regulator (CDSCO) has asked a pharmaceutical company to explain its claims that its eyedrops can augment near vision in 15 minutes and that it has received marketing approval from CDSCO.
Source: bit.ly/4eyIWLp

3. The Bombay High Court restricted the CEO of a leading e-commerce luxury brand from hiring individuals from another e-commerce beauty brand on grounds that the CEO was misusing employee personal data that it had access to when he was the Chief Business Officer of the rival e-commerce beauty brand.
Source: bit.ly/4glsuzN

4. India’s central drug regulator (CDSCO) has issued an order providing guidance for industry on Pharmacovigilance Requirements for biological products.
Source: bit.ly/4dVKiQ7

5. India’s Directorate General of Foreign Trade (DGFT) has released a public notice amending the timeline for meeting the export obligation of drugs which have been imported from unregistered source.
Source: bit.ly/47qXv1a

Posted on

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.