India Regulatory News

India’s Central Drugs Standard Control Organization (CDSCO) announced a major improvement to the registration and import procedure for cosmetics on August 9, 2024. Companies submitting applications ...

India’s Central Drugs Standard Control Organization (CDSCO) announced a major improvement to the registration and import procedure for cosmetics on August 9, 2024. Companies submitting applications through the online portal SUGAM will be restricted to 50 products per application under the new policy, but numerous applications can be submitted. This policy was developed in order to handle and dispose of applications within the timeframe specified by the Cosmetic Regulations of 2020.

The proposed restriction took effect on August 16, 2024. All stakeholders are asked to take note of this change when submitting applications via the SUGAM online site.

For further details, please refer to the official CDSCO announcement.

On 26 July 2024, the Department of Chemicals and Petrochemicals (DCPC) of India has notified the World Trade Organization (WTO) of a draft Quality Control Order (QCO) for K Acid used in wastewater tre...

On 26 July 2024, the Department of Chemicals and Petrochemicals (DCPC) of India has notified the World Trade Organization (WTO) of a draft Quality Control Order (QCO) for K Acid used in wastewater treatment. The draft was issued in accordance with the Bureau of Indian Standards (BIS) and is now open for public comment. The final date for comments is 60 days from the date of notification. 

K Acid: Properties and Uses 

K Acid, with the systematic name 2-Naphthylamine-3:6:8-trisulfonic acid, is a stable, water-soluble compound resulting from ammonolysis and has a sulfonic acid functional group. It is a highly effective diazonium salt precursor that can be used in the manufacture of dyes. It is also used as a catalyst for the removal of chlorides and sulphates from wastewater.  

Regulatory and Certification Requirements 

As per the requirement of the order, K Acid must conform to the Indian Standard (IS 11557:1986) and must bear the standard mark under a license from the Bureau of Indian Standards as per Scheme-I of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018. The Bureau of Indian Standards Act, 2016 governs the use of Standard Marks, with the Bureau of Indian Standards as the certifying and enforcing authority.  

The Quality Control Order mandates that covered substances to carry the certification mark of the Bureau of Indian Standards, ensuring that the existing rules remain in force until the new QCOs are implemented. 

India’s Department of Chemicals & Petrochemicals (DCPC) has extended the enforcement dates of Quality Control Orders (QCOs) for morpholine and 3 other chemicals. The notifications were published in ...

India’s Department of Chemicals & Petrochemicals (DCPC) has extended the enforcement dates of Quality Control Orders (QCOs) for morpholine and 3 other chemicals. The notifications were published in the Official Gazette of India on 1 August 2024 and 5 August 2024 respectively. The QCO for morpholine was originally published on 16 June 2020, while the QCO for acetic acid, methanol and aniline was published on 5 August 2019. 

The old and extended enforcement dates for morpholine and the other 3 chemicals are as follows: 

The chemicals listed in the above table shall comply with the applicable Indian Standard stated in accordance with Scheme-I of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018, and bear the Standard Mark under licence from the Bureau of Indian Standards. 

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.