India Regulatory News

On 13 April 2024, the Department of Chemicals and Petrochemicals (DCPC) of India published the Ortho Phosphoric Acid (Quality Control) Amendment Order, 2024. Background to the Amendment The Orth...

On 13 April 2024, the Department of Chemicals and Petrochemicals (DCPC) of India published the Ortho Phosphoric Acid (Quality Control) Amendment Order, 2024.

Background to the Amendment

The Ortho Phosphoric Acid (Quality Control) Order, 2021 was published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (ii), vide number S.O. 2335(E), dated 15 June 2021 and subsequently amended vide notification numbers S.O. 4914(E), dated 29 November 2021 and S.O. 2225(E), dated 13 May 2022.

Key Provision of the Amendment

The following provision shall be inserted after the table in the Ortho Phosphoric Acid (Quality Control) Order, 2021: "Provided that, nothing in this Order shall apply to the Ortho Phosphoric Acid when used as a raw material in the production of fertilizers for a period of ninety days from the date of publication of this notification."

Application and Enforcement

The QCO applies to export chemicals and requires them to conform to IS 798: 2020 Orthophosphoric Acid — Specification and bear the Compulsory Registration Scheme (CRS) Mark under the licence of the Bureau of Indian Standards (BIS). Violations will result in penalties under the BIS Act, 2016.

The published draft came into force on 13 April 2024.

On March 15, 2024, the Ministry of Environment, Forest and Climate Change (MOEFCC) notified the rules further amending the Plastic Waste Management Rules, 2016 namely the Plastic Waste Management (A...

On March 15, 2024, the Ministry of Environment, Forest and Climate Change (MOEFCC) notified the rules further amending the Plastic Waste Management Rules, 2016 namely the Plastic Waste Management (Amendment) Rules, 2024 in the Gazette of India.  

The amendment came into force from the date of publication in the Gazette. With this amendment India is taking a significant step towards tackling plastic pollution. 

The draft rules to amend the Plastic Waste Management Rules, 2016, were first published in the Gazette of India on October 16, 2023, inviting objections and suggestions from the public within a period of sixty days. 

Amendments Introduced 

In the amended rules, a few sections have been replaced with new clauses, including for biodegradable plastics under Extended producer Responsibility (EPR). 

 EPR is a waste and pollution management concept that encourages companies to design more sustainable and recyclable products and manufacturing processes. It also places the responsibility on manufacturers to minimize the environmental impact of their products throughout their lifecycle.  

In Rule 3, a few clauses are replaced and added relating to biodegradable plastics, importers, manufacturers, producers and sellers. Similarly, amendments are introduced in the several rules of the Plastic Waste Management (Amendment) Rules, 2016. 

The following amendments are also included: 

• Requirements for labelling and certification of compostable or biodegradable plastics. 

• Requirements for reporting on quantities of goods placed in the market and pre-consumer waste generated. 

• Responsibility of manufacturers, producers, importers and brand owners for the collection of plastic packaging introduced. 

• Guidelines for working with local authorities on a voluntary basis. 

• Annual reporting mechanisms for various entities involved in plastic waste management. 

Extended Producer Responsibility Targets 

In Schedule II of the Rules, the Extended Producer Responsibility target, category-wise, is given in the table below, as follows:

Minimum level of recycling (excluding end-of-life disposal) of plastic packaging waste 

                                                    (% of Extended Producer Responsibility target) 

The categories are defined as follows: 

Category I: Rigid plastic packaging 

Category II: Flexible plastic packaging of single layer or multilayer, plastic sheets or like and covers made of plastic sheet, carry bags, plastics sachet or pouches. 

Category III: Multilayered plastic packaging (at least one layer of plastic and at least one layer of material other than plastic). 

Further details of the amendments introduced can be found here: 

https://moef.gov.in/wp-content/uploads/2024/03/GSR201(E)-[14032024]-Plastic-Waste-Mangement-Rules-2024.pdf 

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.

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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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