India Regulatory News

On March 7, 2024, India’s Directorate General of Foreign Trade (DGFT) published notification 69/2023. The notification explains the provisions for the import of inputs that are subjected to mandator...

On March 7, 2024, India’s Directorate General of Foreign Trade (DGFT) published notification 69/2023. The notification explains the provisions for the import of inputs that are subjected to mandatory Quality Control Orders (QCOs) by advance authorization (AA) holders and registered export-oriented units (EOUs).

The DGFT has announced exemptions for duty-free imports of goods for final exports, including those in special economic zones (SEZs) and EOUs. However, goods not used for export production will be destroyed by customs officials.

CHEMEXCIL, India's trade body council that represents basic chemicals, cosmetics, and dye exporters, has been consulting with its members regarding this initiative.

While the CHEMEXCIL secretariat has expressed support for the DGFT notification allowing the import of items without mandatory QCOs under AA and SEZ schemes, industry representatives have advocated for mandatory QCOs for all imports, requesting detailed representation.

In a consultation that closed on March 28, 2024, CHEMEXCIL members were asked to share their views on the following questions for onward submission. 

• Do we support the current notification allowing import of specific items without mandatory QCOs under AA and EOU please provide the reasons?

• Are there any concerns regarding potential quality issues due to this policy?

• If we support mandatory QCOs for all imports, then please provide your rationale.

The Bureau of Indian Standards (BIS) has issued a draft Indian Standard for Polystyrene (Crystal and High Impact) to ensure its safe use with food, pharmaceuticals, and drinking water. The standard, a...

The Bureau of Indian Standards (BIS) has issued a draft Indian Standard for Polystyrene (Crystal and High Impact) to ensure its safe use with food, pharmaceuticals, and drinking water. The standard, a revision of IS 10142, focuses on preventing toxic hazards from polymer additives and impurities. Comments are invited until 13 April 2024.

Addressing Safety Concerns in the Use of Polystyrene

The standard emphasizes the inert nature of polystyrene but recognizes the potential for additives and impurities to migrate into packaged materials, posing risks to consumers over time. It is based on the original standard of 1982 and the first revision of 1999 and is in line with international regulations such as the FDA regulations in the USA and EU directives. This second revision introduces modifications to Clause 4.1 on basic resins and updates cross-referenced standards.

In addition, the standard is designed to complement existing Indian Standards on plastics for food contact applications and to improve quality monitoring of polystyrene materials. It emphasises the importance of using these standards together to ensure consumer safety and health.

Promoting Compliance and Consumer Safety

Polystyrene materials that comply with these standards are considered safe for various applications, including packaging, manufacturing, and processing of food, pharmaceuticals, and drinking water. Compliance with the standards is essential for manufacturers and fabricators of thermoplastic packaging materials as it provides a framework for regulatory compliance and assuring consumer safety.

The draft standard outlines requirements for basic resin, residual monomer content, materials, pigments, total migration, storage, and control. It also defines sampling methods and conformity assessment criteria.

Inviting Stakeholder Input

Interested stakeholders are encouraged to provide feedback on the draft standard, which aims to promote the safe and responsible use of polystyrene materials in contact with consumables.

India’s Department of Chemicals and Petrochemicals (DCPC) has extended the Quality Control Orders (QCOs) for several chemicals. The notifications were published in the Gazette of India on 5, 6, 7 an...

India’s Department of Chemicals and Petrochemicals (DCPC) has extended the Quality Control Orders (QCOs) for several chemicals. The notifications were published in the Gazette of India on 5, 6, 7 and 18 March 2024 respectively in consultation with the Bureau of Indian Standards (BIS), extending the enforcement dates of the QCOs for 18 chemicals. 

The chemicals and revised dates along with the released notifications are as follows:  

The notification published on 5 March 2024 includes 3 chemicals: 

The notification published on 6 March 2024 includes the following 5 chemicals: 

The notification published on 7 March 2024 includes the following 6 chemicals: 

The notification published on 18 March 2024 includes the following 4 chemicals: 

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

The Regulatory Guidelines for Sampling of Drugs, Cosmetics & Medical Devices were approved and released by the Central Drugs Standard Control Organization (CDSCO) of India on February 9, 2024. The pur...

The Regulatory Guidelines for Sampling of Drugs, Cosmetics & Medical Devices were approved and released by the Central Drugs Standard Control Organization (CDSCO) of India on February 9, 2024. The purpose of these guidelines is to improve and standardize the sampling process for these items across the country.

The published guidelines consist of 10 sections and 5 Annexes. The guidelines are aimed at selecting samples and locations for drugs, cosmetics, and medical devices at various locations, including manufacturing facilities, wholesale outlets, retail outlets, and government distribution channels. It maintains a centralized monthly list of Not of Standard Quality (NSQ)/Spurious drugs and publishes it on the CDSCO website to prevent further use. It also helps in effective monitoring of the quality and efficacy of drugs.

Key Highlights of the Guidelines

List of Annexes

Annexure-1: Quantity of Drugs Sample Required for Complete Analysis

Annexure-2: Quantity of Cosmetics Sample Required for Complete Analysis

Annexure-3: Quantity of Vaccine Sample Required for Complete Analysis

Annexure-4: Quantity of Biological/ Medical Devices Samples

Annexure-5: Quantity Required for Complete Analysis of Medical Device Samples

On February 23, 2024, the Central Drugs Standard Control Organization (Cosmetics Division) of India issued a circular outlining the import regulations for cosmetics. The CDSCO has issued the Circular ...

On February 23, 2024, the Central Drugs Standard Control Organization (Cosmetics Division) of India issued a circular outlining the import regulations for cosmetics. The CDSCO has issued the Circular urging importers to comply with the requirement to provide annual import details for cosmetics as per Form COS-4A to avoid potential regulatory penalties.

Details of the Circular

The Government of India has issued an Import Registration Number (lRN) under Form Cos-4A for cosmetics already registered under Rule 13 for import and sale in the country. Importers are required submit an annual declaration to the Central Licensing Authority of cosmetics imported und the IRN conditions specified in Form 4A. However, the Central Licensing Authority has not received the details of cosmetics imported annually by these importers, under the Cosmetics Rules, 2020.

Import Registration Number

An import registration number issued under sub-rule (2) is valid for three years unless suspended or cancelled. If an importer fails to meet conditions, the Central Licensing Authority may suspend or cancel the number, with cause given.

Information required

Every applicant is required to provide the following details of the cosmetic product:

• Number of consignments/bill of entries of each consignment

• Imported quantity in each consignment

• The total cost of imported cosmetics in each consignment

• Warehouse details where those are stored for further distribution

• Sale

The CDSCO encourages importers to comply with the cosmetic import restrictions and submit their annual reports.

The Bureau of Indian Standards (BIS) is seeking comments until 20 April 2024 on the third revision of the standard for iron oxide pigments used in paints. The standard (IS 44) was first released in 19...

The Bureau of Indian Standards (BIS) is seeking comments until 20 April 2024 on the third revision of the standard for iron oxide pigments used in paints. The standard (IS 44) was first released in 1950. 

The draft standard proposed by BIS aims to address health and safety concerns and restrictions related to lead and toxic heavy metals in paint ingredients. 

Changes to the revised standard:  

The aim of this third revision is to improve the acceptability and relevance of the product by bringing it into compliance with current market requirements. Notable changes include:  

1. The material classification has been reorganized into color-based groups, categories (represented as iron (III) oxide), grades based on sieve residue, types based on water soluble matter content and total water soluble chlorides and sulfates (represented as Cl^– and SO₄^2– ions), and classes based on the origin of the material. By replacing the previous seven classes, this change brought the criteria into line with current market practice.  

2. Furthermore, requirements of each classification and associated test procedures have been revised. For example, new standards have been added to the colour measurement, staining power, and undertone test methods.  

3. Restrictions have been introduced for lead and toxic heavy metals to address health and safety concerns. 

4. Finally, several revisions and updates to references have been made to make the updated standard more accurate and relevant. 

According to the proposed standard, iron oxide pigments are classified as follows:  

• By groups depending on their colour.  

• By categories depending on their iron content, expressed as iron (III) oxide.

• By types depending on their content of water-soluble matter and their total content of water-soluble chlorides and sulfates, expressed as the ions Cl^– and SO₄^2–.

• By grades depending on their residue on sieve. 

• By classes depending on their origin. 

Furthermore, according to the draft, the substance should not contain more than 90 ppm of lead, lead compounds or mixtures of the two,. Also, the following substances, separately or in combination, are limited to a maximum of 0.1 percent by weight: 

• mercury

• mercury compounds

• cadmium

• arsenic

• chromium VI

• antimony

• and their oxides 

The draft recommends that packaging be marked or labelled with the following information: 

• The name of the substance

• Group, Category, Type, Grade and Class of the substanc

• Source of manufacture 

• The month and year of manufacture

• Expiry date/shelf life/best before  

• The substance’s net mass

• The batch and lot number 

• The maximum lead content 

• The toxic heavy metals content 

• Cautionary notes (‘Keep out of reach of children’ or ‘This product may be harmful if swallowed or inhaled’). 

Timeline  

The Bureau of Indian Standards (BIS) is consulting on the revised standard for iron oxide pigments used in paints until 20 April 2024 

On 6 March 2024, India’s Basic Chemicals, Cosmetics and Dyes Promotion Council (CHEMEXIL) issued a circular requesting concerned members and end-user industries to urgently submit data regarding the...

On 6 March 2024, India’s Basic Chemicals, Cosmetics and Dyes Promotion Council (CHEMEXIL) issued a circular requesting concerned members and end-user industries to urgently submit data regarding the implementation of 8 Quality Control Orders (QCOs) by 10 March 2024. The data is needed for a Stakeholder’s Consultation Meeting scheduled for the coming week.

Substances included in the QCOs

The QCOs for the eight substances were notified by the Department of Chemicals and Petrochemicals (DCPC to the World Trade Organization (WTO) on 13 September 2023). Details of the notifications are available here. The eight substances subject to the QCOs are as follows:

• Ethylene Oxide

• Monocrotophos

• Captafol (technical grade)

• Anhydrous Ammonia

• Alumina Calcined

• Sodium Cyanide

• Toluene Diisocyanate (TDI-80)

• Industrial Grade Urea (Technical grade Urea)

Data requested

Stakeholders are requested to submit the following data before 10 March by email to pw@chemexcil.in with a copy to dg@chemexcil.in.

• Name of Chemical

• Uses

• HS Code for the chemical

• Domestic capacity (in MT) in last 3 years (2020-2021, 2021-2022, 2022-2023)

• Domestic demand (in MT) in last 3 years (2020-2021, 2021-2022, 2022-2023)

• Domestic production (in MT) in last 3 years (2020-2021, 2021-2022, 2022-2023)

• Import (MT) in last 3 years (2020-2021, 2021-2022, 2022-2023)

• Country-wise import shar in last 3 years (top 5 countries)

• Justification for implementing/not implementing Quality Control Order

The CHEMEXCIL circular is available here.