India Regulatory News

On 25 April 2025, the Indian Ministry of Health and Family Welfare published the official gazette of Drugs and Cosmetics (Compounding of Offences) Rules, 2024, introducing a structured framework for r...

On 25 April 2025, the Indian Ministry of Health and Family Welfare published the official gazette of Drugs and Cosmetics (Compounding of Offences) Rules, 2024, introducing a structured framework for resolving specific offences under the Drugs and Cosmetics Act, 1940, through compounding.

Objective and Scope

These new regulations enable offenders to reach settlements without going through drawn-out legal proceedings. To supervise the compounding process, the Central Government will designate officers at the level of the Central Licensing Authority, Central License Approving Authority, or Central License Approving Authority. State Governments will designate officials at lower levels for the same purpose.

Application and Process

According to the regulations that specify the application procedure, companies or individuals engaged in the production, importation, sale, or distribution of pharmaceuticals and cosmetics may apply for compounding before or following the institution of prosecution. After receiving an application, the compounding authority may request a report from the reporting authority; this report must be submitted within a month, though the compounding authority may extend this deadline.

Payment and Immunity

The applicant must provide proof of payment and pay the compounding amount within 30 days of the offense being compounded. However, if the court denies immunity from prosecution the money paid will not be reimbursed. The regulations also make it clear that the authority has discretion over whether to grant immunity, so compounding does not guarantee immunity.

These clauses seek to ensure compliance with the regulations while expediting their enforcement.

Further details can be found in the official notification here.

On 11May 2025, the Bureau of Indian Standards (BIS) issued several draft Indian Standards and amendments for public consultation. This presents an important opportunity for stakeholders to provide fee...

On 11May 2025, the Bureau of Indian Standards (BIS) issued several draft Indian Standards and amendments for public consultation. This presents an important opportunity for stakeholders to provide feedback and ensure that the standards are aligned with current industry needs and practices. Participation is essential to ensuring these standards effectively meet the industry’s evolving needs. 

Draft Standards and Amendments Open for Comment 

The following documents are open for public comment: 

How to Submit Comments 

Interested parties are encouraged to review the draft standards and submit their comments by the respective deadlines, especially if any provisions may affect their business or professional activities once adopted.  

Feedback can be submitted directly via the BIS portal here, using the prescribed template.  

India’s Ministry of Mines has issued a set of new Quality Control Orders (QCOs) that will make Bureau of Indian Standards (BIS) certification a compulsory prerequisite for the import and sale of cer...

India’s Ministry of Mines has issued a set of new Quality Control Orders (QCOs) that will make Bureau of Indian Standards (BIS) certification a compulsory prerequisite for the import and sale of certain non-ferrous metals. Effective from October 17, 2025, the regulation aims to improve product quality, safety, and standardization in the Indian metals market. 

Metals Affected and ISI Mark Requirements 

The metals impacted include refined nickel, tin ingots, primary lead, and refined zinc. These metals must carry the ISI mark as proof of BIS certification. Without this certification, imports will be barred from the Indian market. 

Certification Process 

The BIS certification process includes factory inspections, product testing, and document verification. Since this process may take several months, exporters should start early to avoid delays or disruptions. 

Metals Covered Under the New BIS Certification Requirement 

The affected non-ferrous metals and their applicable Indian Standards are listed below:  

• Refined Nickel – IS 2782:2023 

• Tin Ingot – IS 26:2024 

• Primary Lead – IS 27:2023 

• Refined Zinc – IS 209:2024 

Final Thoughts 

The introduction of mandatory BIS certification for these metals underscores the importance of compliance in global trade and supply chain management. Exporters to India must carefully review their product lines and certification status to ensure uninterrupted market access. 

The Department of Chemicals and Petrochemicals has extended the enforcement dates for Quality Control Orders (QCOs) for six chemicals. The updated dates were announced in a notification published in t...

The Department of Chemicals and Petrochemicals has extended the enforcement dates for Quality Control Orders (QCOs) for six chemicals. The updated dates were announced in a notification published in the Gazette of India on 25 April 2025, in consultation with Bureau of Indian Standards (BIS). The QCOs were originally published on 27 April 2022. 

Chemicals and revised enforcement dates   

The Quality Control Order mandates that the concerned substances 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.  

On March 21, 2025, the Ministry of Micro, Small, and Medium Enterprises (MSME) of the Government of India, issued a notification announcing amendments to an earlier notification published on June 26, ...

On March 21, 2025, the Ministry of Micro, Small, and Medium Enterprises (MSME) of the Government of India, issued a notification announcing amendments to an earlier notification published on June 26, 2020, under the Micro, Small, and Medium Enterprises Development Act, 2006.  

The updated guidelines, which came into force on April 1, 2025, introduce significant changes to the investment and turnover criteria for classifying Micro, Small and Medium Enterprises (MSMEs).  

Key Changes:  

1. Increased Threshold for Classification:  

• The maximum investment limits for different categories have been substantially increased:  

• Micro Enterprises: The investment limit has been raised from ₹1 crore to ₹2.5 crore.  

• Small Enterprises: The investment limit has been raised from ₹10 crore to ₹25 crore.  

• Medium Enterprises: The investment limit has been revised from ₹50 crore to ₹125 crore.  

2. Turnover Limits Revised:  

• The turnover limits for these enterprises have also been adjusted:  

• Micro Enterprises: From ₹5 crore to ₹10 crore.  

• Small Enterprises: From ₹50 crore to ₹100 crore.  

• Medium Enterprises: From ₹250 crore to ₹500 crore.  

3. Overall Growth Potential  

• The updated notification is expected to provide MSMEs with greater opportunities to expand, access more benefits and receive more government support. This will boost the overall growth of the sector.  

Impact of MSME Sector Growth  

The new thresholds align with the evolving economic landscape and the government's commitment to strengthening the MSME sector. This change is anticipated to allow more businesses to qualify as MSMEs, thereby increasing their access to various schemes and financial support.  

Implementation and Further Information  

The notification follows the recommendations of the Advisory Committee and took effect on April 1, 2025. For further details, the full notification is available here.  

The Food Safety and Standards Authority of India (FSSAI) has introduced significant amendments to the Food Safety and Standards (Packaging) Regulations, 2025 to allow the use of specific categories of...

The Food Safety and Standards Authority of India (FSSAI) has introduced significant amendments to the Food Safety and Standards (Packaging) Regulations, 2025 to allow the use of specific categories of recycled plastics in food packaging. The amendments were published in the Official Gazette on 28 March 2025 and came into effect from the date of publication. They support the move towards sustainable packaging while ensuring consumer safety. 

Key Highlights of the Amendment 

• Use of Recycled Plastics: Certain categories of recycled plastics are now permitted in food packaging, subject to strict quality and safety standards. 

• Safety Compliance: All recycled plastics must meet specific migration limits to prevent contamination and ensure food safety. 

• Approved Recycling Methods: Only plastics processed through FSSAI-approved recycling technologies can be used. 

• Traceability and Labeling: Packaging must be clearly labeled to indicate the use of recycled materials and ensure traceability. 

Stakeholder Impacts 

For Manufacturers: 

• Compliance with new testing and certification requirements is mandatory. 

• Recycled plastics must be sourced from authorized suppliers using approved recycling processes. 

For Food Businesses and Brands: 

• Packaging materials must be sourced from FSSAI-compliant suppliers. 

• Internal quality checks must be updated to align with the new material standards. 

For Consumers: 

• The amendment ensures safer food packaging with greater transparency. 

• Consumers will have access to more sustainable packaging options. 

Compliance Requirements and Next Steps 

• Testing and Certification: Businesses must get their packaging materials certified under FSSAI guidelines. 

• Implementation Timeline: The regulation is already in force as of 28 March 2025. 

• Regulatory Audits: Regular inspections will be conducted to ensure compliance with the revised standards. 

Call to Action 

To avoid penalties and ensure regulatory compliance, businesses need to review their packaging materials and align with the new FSSAI standards. Detailed guidelines can be found in the official FSSAI document here. 

The Indian Department of Chemicals and Petrochemicals has extended the enforcement dates of the Quality Control Orders (QCOs) for vinyl acetate monomer and methyl/ethyl acrylate. The notification was ...

The Indian Department of Chemicals and Petrochemicals has extended the enforcement dates of the Quality Control Orders (QCOs) for vinyl acetate monomer and methyl/ethyl acrylate. The notification was published in the Gazette of India on 1 April 2025, in consultation with the Bureau of Indian Standards (BIS). The QCOs were originally published on 22 December 2021.  

Chemicals and revised enforcement dates   

The Quality Control Order mandates that the concerned substances 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.