India Regulatory News

The Central Drugs Standard Control Organization (CDSCO) has launched the ‘National Single Window System (NSWS)’ site, which is a significant step in streamlining the process of obtaining medical d...

The Central Drugs Standard Control Organization (CDSCO) has launched the ‘National Single Window System (NSWS)’ site, which is a significant step in streamlining the process of obtaining medical device approvals in India. The federal government created this platform to serve as a one-stop shop for all investor-related clearances, making it easier to do business in the medical device sector.

Key Features of the NSWS Portal-

The NSWS portal works independently of the current SUGAM portal, providing a specialized platform for medical device approvals. The following three activities have been established in response to the 2017 medical device rule and are now LIVE on ‘NSWS portal’ effective from 01.01.2024.

• Form MD-01: Application for a grant of certificate of registration of a notified body
• Form MD-12: Application for a license to manufacture a medical device for clinical research, testing, evaluation, examination, demonstration, or training.
• Form MD-16: Application for license to import medical devices for clinical investigations, testing, evaluation, demonstration, or training.

More functionalities are expected to be added in the future.

Benefits for Stakeholders-

The launch of the ‘NSWS portal’ is expected to benefit various stakeholders in the medical device industry. In light of the foregoing, it is asked that all involved stakeholders submit applications for the mentioned three activities (i.e. MD-01, MD-12, MD- 16) through the ‘NSWS portal’ only, as the previous 'cdscomdonline' portal for the stated activities would be disabled from 15.01.2024.

Overall, the CDSCO's ‘NSWS portal’ is a positive step towards creating a more efficient and transparent regulatory environment for medical devices in India. This initiative is expected to boost the medical device industry and contribute to improving healthcare outcomes for the country.

For more information, please reach out to https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA4MTE=

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On 6 December 2023, the Central Government of India, after consultation with the Bureau of Indian Standards (BIS), published a Gazette Notification regarding the Quality Control Order (QCO) for the fi...

On 6 December 2023, the Central Government of India, after consultation with the Bureau of Indian Standards (BIS), published a Gazette Notification regarding the Quality Control Order (QCO) for the five polymer products listed in the table below. 

Timeline: 

It shall come into force on the expiry of one hundred and eighty days from the date of its publication in the Official Gazette. 

  The Department of Chemicals and Petrochemicals (DCPC) has announced its plan to implement Quality Control Orders (QCOs) for a list of 10 chemicals. This initiative falls under the provisions of ...

The Department of Chemicals and Petrochemicals (DCPC) has announced its plan to implement Quality Control Orders (QCOs) for a list of 10 chemicals. This initiative falls under the provisions of the Bureau of Indian Standards Act, 2016. The enforcement of these QCOs will begin on specified dates for each chemical, as outlined below:

In light of this development, the DCPC is inviting comments and feedback from stakeholders on the proposed QCOs. The deadline for submitting any remarks or suggestions is set for 5th January 2024. This proactive engagement aims to ensure comprehensive input and consideration from all relevant parties before the enforcement of these quality standards.

On 19 December 2023, the Central Government of India, after consultation with the Bureau of Indian Standards (BIS), published a Gazette Notification regarding the Quality Control Order (QCO) for Tolue...

On 19 December 2023, the Central Government of India, after consultation with the Bureau of Indian Standards (BIS), published a Gazette Notification regarding the Quality Control Order (QCO) for Toluene. According to the notification the QCO will be called the Toluene (Quality Control) Second Amendment Order, 2023 and it will come into force on 22 December 2024,  

The Principal Order for Toluene was published in the Gazette of India on 24 December 2021 and was subsequently amended four times.

The Bureau of Indian Standards (BIS) is seeking comments on a revised standard for plastic emulsion paints until January 10, 2024. The revised standard will tighten restrictions on lead content and in...

The Bureau of Indian Standards (BIS) is seeking comments on a revised standard for plastic emulsion paints until January 10, 2024. The revised standard will tighten restrictions on lead content and introduce limits for Volatile Organic Compounds (VOCs). 

First Standard for Plastic Emulsion Paints 

Two parts of this standard were previously issued i.e. IS 5411 ‘Plastic emulsion paint: Part 1, For interior use’ and IS 5411 ‘Plastic emulsion paint: Part 2 For exterior use’. These two parts are now included in this revised standard. 

The previous standard also included various types of finishes to bring it into line with the practices that existed at the time. Therefore, the drying time requirements for both the finish and the hard dry were adjusted according to the type of finish. Additional optional requirements such as spreading capacity and hiding power as well as spreading time were removed. Gloss value at 60° was also included for various classes. 

First Revision 

The first revision of this standard was initiated with the aim of incorporating the lead limit into the standard. It was recognised that the product, which is widely used for interior and exterior surface decoration of building, may not be feasible to manufacture with a low lead restriction. The committee therefore set a lead limit of 300 ppm for a product used in building finishes. This limit aims to prevent dangerous exposure to lead and its long-term health effects. 

Second Revision 

The second revision aims to limit volatile organic compounds (VOCs) in paint products, focusing on their negative impact on human health and the environment. The limits will be set taking into account the capabilities of small, medium, and large manufacturers to produce compliant products. The ultimate goal is to eliminate VOCs by promoting advanced technologies and processes. 

Furthermore, the limit for lead has been reduced from 300 ppm in the first revision to 90 ppm. The lead content is calculated as metallic lead including the content of lead, lead compounds, or mixtures of both.    

Following surface preparation and priming, the second revision of the standard specifies the conditions and procedures for sampling and testing plastic emulsion paint, which is used for both interior and external building surface protection and decoration.  

Further conditions and requirements can be found here. 

On 17 November 2023, the Indian Department for Promotion of Industry and Internal Trade (DPIIT) notified the World Trade Organization (WTO) of the Gypsum Based Building Materials Quality Control Order...

On 17 November 2023, the Indian Department for Promotion of Industry and Internal Trade (DPIIT) notified the World Trade Organization (WTO) of the Gypsum Based Building Materials Quality Control Order, 2023. The final day for comments is 60 days from the date of notification.  

Gypsum-Based Building Materials 

The most commonly used type of gypsum-based building material is plasterboard. The unique benefit of gypsum board is its lower weight compared to other similar boards like asbestos cement and fibre hard boards. Additionally, plasterboards have superior thermal, acoustic, and fire resistance. 

There are three types of plasterboard that can be produced: plain, laminated, and reinforced. Typical examples of reinforcing materials are glass, paper, vegetable fibres, etc. 

Glass Fibre Reinforced Gypsum (GFRG) is a building panel consisting of calcined gypsum reinforced with glass fibres. The GFRG panel is produced in a semi-automated plant using a slurry of calcined gypsum mixed with certain chemicals such as waterproofing emulsion and fibre glass. Wall panels can be cut according to the dimensions and requirements of the planned building. 

Laminated gypsum board is used for the installation of the concrete ceiling. It is attached to concrete and is readymade interior plastering.  

Glass Reinforced Gypsum (GRG) is a pseudo-ductile material. GRG can be sawn, drilled, screwed or nailed like wood. It is termite and moth resistant and non-combustible. 

Compulsory use of Standard Mark 

The goods or articles in the table below shall conform to the corresponding Indian Standards specified in the table and shall bear the Standard Mark under a license from the Bureau of Indian Standards (BIS) as per Scheme-I of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018. 

Objective 

The purpose of this regulation is to prevent deceptive practices and to protect consumers, human health or safety, the environment and to ensure quality requirements.   

Timeline  

The QCO will enter into force 6 months after the date of publication in the Official Gazette. 

On 11 October 2023, India's Ministry of Environment, Forest and Climate Change (MoEFCC) notified the draft Ecomark Certification Rules, 2023. The final day for comments is 60 days from the date of not...

On 11 October 2023, India's Ministry of Environment, Forest and Climate Change (MoEFCC) notified the draft Ecomark Certification Rules, 2023. The final day for comments is 60 days from the date of notification. These rules apply to all products produced or supplied for distribution, or use in the market, unless otherwise excluded under the Ecomark Certification Rules. 

Introduction: 

The Ecomark Certification Rules, 2023 ('the Ecomark Rules') provide for the labelling of products designed to minimize their environmental impact. The primary objective is to encourage consumer acceptance of such products and to motivate manufacturers to move towards producing Ecomark certified products, thereby promoting sustainability. 

The Ecomark Rules aim to promote environmentally friendly products and ensure the level of environmental performance of such products in terms of consumption of resources and environmental effects. This includes effects on climate change, effects on nature and biodiversity, energy consumption, waste production, discharges into all environments, pollution caused by physical effects and the use and release of hazardous substances. 

The Ecomark Rules will provide labels for products that meet approved environmental criteria. 

Purpose: 

The purpose of the Ecomark Rules is to increase demand for environmentally friendly products that have less negative environmental impacts, in line with the principles of LiFE (Lifestyle for Environment). The rules promote resource efficiency and the circular economy and aim to prevent misleading information on the environmental aspects of products. 

The following are the key objectives of the Ecomark Rules: 

1. To raise consumer awareness regarding environmental issues and the consequences of their choices, thereby encouraging a shift towards more environmentally friendly behaviors and consumption patterns. 

2. To encourage manufacturers to switch to the production of Ecomark certified products. 

3. Take measures to avoid deceptive or misleading information about the fraudulent use of the EcoMark label.