India Regulatory News

As the focus of global trade shifts from tariffs to technical regulations, India’s chemical and petrochemical industries are under increasing pressure to strengthen their regulatory frameworks. The ...

As the focus of global trade shifts from tariffs to technical regulations, India’s chemical and petrochemical industries are under increasing pressure to strengthen their regulatory frameworks. The introduction of Quality Control Orders (QCOs) is seen as a crucial step towards aligning with international standards and protecting domestic markets. 

Global Trends Drive Regulatory Action 

Countries such as China, the US, and EU Member States have reinforced non-tariff measures (NTMs), such as product standards and conformity assessments, to protect their markets. India is following suit, by increasingly using QCOs to regulate sectors such as chemicals, electronics, and food-contact materials. 

QCOs Expand, but Challenges Remain 

India has now notified over 105 QCOs, covering more than 1,000 chemical substances. While this signals progress, experts note that further investment in testing infrastructure and enforcement capacity is still needed. 

According to Anupam Razi, a former director at Underwriters Laboratories and a member of the BIS Technical Committee, QCOs help close regulatory gaps and protect against low-quality imports. Recent improvements include faster testing times for PVC resin and expanded licensing for companies adapting to the updated QCOs. 

Strengthening Market Surveillance 

Despite these steps, delays in implementation have contributed to market risks, particularly in sectors such as polymers and agrochemicals. Experts stress that robust enforcement and stronger market surveillance will be essential for India to support domestic manufacturing and meet global trade expectations. 

India’s Department of Chemicals and Petrochemicals (DCPC) has issued the Polyethylene Material for Moulding and Extrusion (Quality Control) Amendment Order, 2025, further amending the original 2022 ...

India’s Department of Chemicals and Petrochemicals (DCPC) has issued the Polyethylene Material for Moulding and Extrusion (Quality Control) Amendment Order, 2025, further amending the original 2022 Quality Control Order. The latest amendment was published in the Official Gazette on 11 June 2025 and came into force on that date.

Key Changes Introduced by the 2025 Amendment

The 2025 amendment introduces two modifications to the exemption list introduced by the 2024 amendment:

• Deletion of Item (c): The previous exemption for Linear Low Density Polyethylene (LLDPE) Butene Grades has now been removed, meaning this material will become subject to the mandatory BIS certification requirements under the Quality Control Order.

• Addition of a New Exemption: A new exemption has been introduced for high-density polyethylene (HDPE) for pharmaceutical moulding (EP/USP grade, CAS No. 25087-34-7), specifically for the manufacture of disposable hypodermic syringe plungers and IV catheter/cannula components.

These changes continue the government’s phased tightening of quality control requirements for polyethylene materials, while maintaining targeted exemptions for critical medical and industrial applications.

The full text of the amendment is available here.

The Department of Chemicals and Petrochemicals has extended the enforcement dates for Quality Control Orders (QCOs) for three chemicals: H Acid (CAS No: 90-20-0), K Acid (Cas No: 118-03-6), and Vinyl ...

The Department of Chemicals and Petrochemicals has extended the enforcement dates for Quality Control Orders (QCOs) for three chemicals: H Acid (CAS No: 90-20-0), K Acid (Cas No: 118-03-6), and Vinyl Sulphone (CAS No: 16071-86-6). The updated dates were announced in a notification published in the Gazette of India on 14 May 2025, in consultation with the Bureau of Indian Standards (BIS). The QCOs were originally published on 14 November 2024.  

Chemicals and Revised Enforcement Dates:    

The Quality Control Order mandates that the substances in questioncarry 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 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.