India Regulatory News

On 26 July 2024, the Department of Chemicals and Petrochemicals (DCPC) of India notified the World Trade Organization (WTO) of the Quality Control Order (QCO) for H Acid. The H Acid (Quality Control...

On 26 July 2024, the Department of Chemicals and Petrochemicals (DCPC) of India notified the World Trade Organization (WTO) of the Quality Control Order (QCO) for H Acid. The H Acid (Quality Control) Order, 2024 will be published in the Gazette of India and will come into force 180 days after its publication. 

Background on H Acid 

H Acid, scientifically known as 1-amino-8-naphthol-3,6-disulfonic acid, is an intermediary substance that is used in the synthesis of various dyes. It is mainly used in the production of azo dyes, which are used in the paper, leather, textile and other industries. 

Key Provision of the QCO 

Under the QCO, all H Acid, whether produced domestically or imported, must comply with the Indian Standard (IS 8637:2020). In addition, the product must display the Standard Mark, obtained through a licence from the Bureau of Indian Standards (BIS) in accordance with Scheme-I of Schedule-II of the BIS (Conformity Assessment) Regulations, 2018. 

BIS Certification Marking  

The product(s) conforming to the requirements of this standard may be certified under the conformity assessment schemes established under the provisions of the Bureau of Indian Standards Act, 2016 and the rules and regulations enacted thereunder and the products may be marked with the Standard Mark. 

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.   

On 26 July 2024, the Department of Chemicals and Petrochemicals (DCPC), the statutory body of the Government of India notified the Quality Control Order (QCO) for Vinyl Sulphone to the World Trade Org...

On 26 July 2024, the Department of Chemicals and Petrochemicals (DCPC), the statutory body of the Government of India notified the Quality Control Order (QCO) for Vinyl Sulphone to the World Trade Organization (WTO). 

Background on Vinyl Sulphone 

Vinyl Sulphone is an organic chemical used in the production of reactive dyes. These dyes are used in the textile industry to colour fabrics. Vinyl Sulphone-based reactive dyes are also used in paints, plastics, rubber, and pigments. Earlier in August 2023, the Bureau of Indian Standards (BIS) released the specifications for Vinyl Sulphone in the applicable Indian Standard IS 18340:2023. 

Requirements for Vinyl Sulphone 

As per the Indian Standard IS 18340: 2023, Vinyl Sulphone must meet the requirements given in Table 1. 

These requirements must be met when tested according to the methods prescribed in the standard. 

Compliance Strategy 

Chemicals intended for export are exempt from this order. In accordance with the Bureau of Indian Standards (Conformity Assessment) Regulations 2018, specifically Scheme I of Schedule II, all chemicals must adhere to the relevant Indian Standard, IS 18340: 2023, and bear the BIS Standard Mark upon the acquisition of a BIS product certification licence. 

Comments and Enforcement 

The draft is currently open for comments, which will close on 24 September 2024. As it is only a draft, the Vinyl Sulphone (Quality Control) Order, 2024 will come into force six months after it is published in the Official Gazette. 

On 18 July 2024, the Department of Chemicals and Petrochemicals (DCPC) of India published the Polyester Continuous Filament Fully Drawn Yarn (Quality Control) Amendment Order, 2024 in the Gazette ...

On 18 July 2024, the Department of Chemicals and Petrochemicals (DCPC) of India published the Polyester Continuous Filament Fully Drawn Yarn (Quality Control) Amendment Order, 2024 in the Gazette of India. This Quality Control Order (QCO) came into force immediately on its publication in the Gazette. 

Background: 2023 Quality Control Order   

Previously, on 17 July 2023, the DCPC had published the Polyester Continuous Filament Fully Drawn Yarn (Quality Control) Order 2023, which was effective from 5 October 2023. The Amendment Order 2024 clarifies that the provisions of the 2024 Order will not be applicable to Low Melt Polyester Yarn. 

Exemptions and Compliance 

Chemicals intended for export are exempt from this order. According to Scheme I of Schedule II of the Bureau of Indian Standards (Conformity Assessment) Regulations 2018, each chemical must comply with the relevant Indian Standard, i.e. IS 17261:2022 and bear the BIS Standard Mark following the acquisition of a BIS product certification licence. 

The Bureau of Indian Standards has recently closed its consultation on a revised standard for sodium chloride used as an analytical reagent. The consultation, which closed on 25 June 2024, outlined th...

The Bureau of Indian Standards has recently closed its consultation on a revised standard for sodium chloride used as an analytical reagent. The consultation, which closed on 25 June 2024, outlined the specifications, sampling techniques, and testing procedures for sodium chloride. 

 Key changes in the revised standard include 

• Alternative instrumentation test methods: New methods have been introduced for the determination of nitrates, sulphates, iron, lead, calcium, magnesium and arsenic. 

• Material form: The standard now specifies that the material should be in the form of cubes, white crystals or crystalline powder. 

• Packaging revisions: mandating that containers are required to be labelled with the material’s name, manufacturer’s name and trademark, the net mass and the batch number. 

• Certification Requirements: Products meeting the requirements of this standard must be certified under the conformity assessment scheme according to the provisions of the Bureau of Indian Standards Act, 2016 and its associated Rules and Regulation, and should bear the standard mark. 

Requirements for sodium chloride used as an analytical reagent are given below: 

Further details of the requirements, sampling and testing methods can be found here. 

In June 2024, the Bureau of Indian Standards (BIS) released the first draft standard on ultramarine blue for use as a colourant in plastics for toys and food contact material. The draft is currently o...

In June 2024, the Bureau of Indian Standards (BIS) released the first draft standard on ultramarine blue for use as a colourant in plastics for toys and food contact material. The draft is currently open for public comment until 23 August 2024.  

This draft also cites standard IS 9833:2018 which was already released in 2018, which lists colourants that can be safely used in FCMs. But due to the high toxicity risk, there is a strong demand to limit the lead and sulphur content in the ultramarine blue for application in both FCM and children’s toys. For this reason, a new standard specifically for ultramarine blue has been drafted. 

Substance Limits in Draft Standard  

The maximum threshold limits for heavy metals and other restricted substances in ultramarine blue are listed as follows in the draft Standard: 

Good Manufacturing Practices, Testing and Labelling 

The draft Standard emphasizes the importance of Good Manufacturing Practices (GMP). It specifies that whenever testing is conducted as per standard IS 9845 the colourant should not bleed or migrate from a product into food, nor should it show indications of instability or degradation in each process.  

Each container of ultramarine blue shall be labelled with: 

• Name of material 

• Manufacturer’s name 

• Trademark (if available) 

• Net weight  

• Lot/Batch number 

BIS Certification Marking 

Products that meet the requirements of the standard can be certified according to the conformity assessment schemes under the Bureau of Indian Standards Act, 2016, along with its associated Rules and Regulations. These certified products may then be marked with the Standard Mark. 

In India, the Central Pollution Control Board (CPCB) has launched the Extended Producer Responsibility (EPR) portal for used oil management, effective from 1 April 2024.  The online portal, mandated ...

In India, the Central Pollution Control Board (CPCB) has launched the Extended Producer Responsibility (EPR) portal for used oil management, effective from 1 April 2024.  The online portal, mandated by the Second Amendment to the Hazardous and Other Wastes (Management and Transboundary Movement) 2023, is expected to be fully operational within six months of the date of commencement. Thus, according to the latest update on the EPR portal, producers can now apply for registration. 

Extended Producer Responsibility (EPR) 

The concept of Extended Producer Responsibility (EPR) mandates that producers of base oil, lubrication oil, or importers of used oil under Chapter VII (Extended Producer Responsibility) of the Hazardous and Other Wastes (Management and Transboundary Movement) Second Amendment Rules, 2023 adhere to recycling targets exclusively through authorized recyclers. This measure aims to ensure environmentally sound handling of used oil. The Central Pollution Control Board (CPCB) has introduced an online system for the effective management and enforcement of compliance with the Hazardous and Other Wastes (Management and Transboundary Movement) Second Amendment Rules, 2023. This system acts as a centralized repository for all data related to the implementation of extended producer responsibility for used oil. 

Comprehensive EPR Framework 

The Government has introduced a comprehensive EPR framework aimed at increasing accountability and sustainability in the waste management sector. The framework includes several key functions designed to regulate entities involved in waste management. These functions include: 

1. Registration of entities 

2. Filing returns and submission of information 

3. Issuance of EPR Certificates 

4. Generation and transfer of EPR Certificates 

5. Audit of EPR compliance 

6. Environmental compensation 

These measures are part of efforts to enhance accountability and environmental sustainability in the waste management sector. 

CPCB Adopts Virtual Meetings 

The CPCB is using video conferencing for meetings aimed at resolving concerns regarding the signup and registration of entities. Entities have the option to participate in these meetings via VC on specific days (Monday, Wednesday and Friday) from 4 pm to 5 pm (Click here to join the meeting). 

On 16 May 2024, the Ministry of Health & Family Welfare (MoHFW) issued a notification dated 11 February 2020, which specifies that all medical devices are now categorized under sub-clause (iv) of clau...

On 16 May 2024, the Ministry of Health & Family Welfare (MoHFW) issued a notification dated 11 February 2020, which specifies that all medical devices are now categorized under sub-clause (iv) of clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940, which is effective from 1 April 2020. 

Notification S.O. 648 (E) 

This notification declares that all medical devices will be categorized as "drugs" under the Drugs and Cosmetics Act, 1940. 

This categorization falls under sub-clause (iv) of clause (b) of Section 3 of the Act. This sub-clause generally refers to devices intended for use in the diagnosis, treatment, mitigation, or prevention of disease or disorder in human beings. 

Notification under G.S.R. 102(E) 

On 11 February 2020, the MoHFW released notification no. G.S.R. 102 (E) to regulate medical devices in a phased manner. According to this notification, Class C and Class D medical devices are subject to a licensing regime from 1 October 2023. 

G.S.R. 102(E) aims to establish a comprehensive regulatory framework for all medical devices, ensuring that they meet essential standards of quality, safety and efficacy. 

Class C & D Devices 

The notification specifies that Class C and Class D medical devices, which are typically more complex and higher risk, will be required to comply with the licensing regime from 1 October 2023. These are typically more complex and increased regulatory oversight is critical for these high-risk devices. 

Licensing Regime for Class C & D Devices (Effective from 1 October 2023) 

In response to concerns raised by various associations and stakeholders about potential disruptions to business operations due to the licensing requirements for Class C and Class D medical devices starting on 1 October 2023, the following decision has been made: 

If an existing importer or manufacturer is already importing or manufacturing any Class C or Class D medical devices and has submitted an application for an import or manufacturing license to the Central Licensing Authority by 30 September 2023, their application will be considered valid. These applicants may continue to import or manufacture the specified devices for up to three months from the issuance of this order, or until the Central Licensing Authority makes a decision on the application, whichever is earlier. 

For more details, please visit cdsco.gov.in.