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. 

The Bureau of Indian Standards (BIS) has issued a draft second revision of IS 4668:20XX, the Indian Standard for ammonium nitrate used in explosives. The draft, titled “Ammonium Nitrate for Explosiv...

The Bureau of Indian Standards (BIS) has issued a draft second revision of IS 4668:20XX, the Indian Standard for ammonium nitrate used in explosives. The draft, titled “Ammonium Nitrate for Explosives – Specification (Second Revision)”, was open for public consultation until June 8, 2025. 
 
Ammonium nitrate is widely used in both military and commercial explosive formulations, and the revised standard emphasizes enhanced quality specifications, safety, and testing precision through updated methods and limits. 

Key Highlights of the Revised Standard:

Expanded Instrumental Testing: Advanced test methods such as ICP-OES, ICP-MS, and ion chromatography have been added. 

  • Grade 1 – For ANFO (Ammonium Nitrate Fuel Oil) 
  • Grade 2 – For slurry type explosives 
  • Grade 3 – For nitroglycerine-based explosives 
  • Grade 4 – For defense purposes 

and sizes: 

  • Grade 1: 0.8 mm to 2.8 mm 
  • Grade 2: 2.9 mm to 100 mm 
  • Grades 3 & 4: As per mutual agreement 

The characteristics and requirements for ammonium nitrate for explosives have been specified as follows: 

Compliance and Certification 

Ammonium nitrate products that conform to this revised standard will be eligible for Standard Mark certification under the Bureau of Indian Standards’ (BIS) conformity assessment schemes as per the Bureau of Indian Standards Act, 2016. 

This standard brings India’s explosives sector into line with the latest safety, quality, and environmental best practices, ensuring improved manufacturing and handling protocols. 

The Indian Department of Chemicals and Petrochemicals (DCPC) has extended the implementation deadlines for the quality control orders (QCOs) for polyvinyl chloride (PVC) homopolymers and polypropylene...

The Indian Department of Chemicals and Petrochemicals (DCPC) has extended the implementation deadlines for the quality control orders (QCOs) for polyvinyl chloride (PVC) homopolymers and polypropylene (PP) materials for moulding and extrusion.

• PVC Homopolymers: According to the notification published on 20 June 2025, the effective date of the Poly Vinyl Chloride (PVC) Homopolymers (Quality Control) Order, 2025 has been extended to 26 December 2025.

• Polypropylene Materials: A separate notification, published on 23 June 2025, extends the compliance date for the Polypropylene (PP) Materials for Moulding and Extrusion (Quality Control) Order, 2025, to 26 December 2025.

Both orders fall under the Bureau of Indian Standards (BIS) framework and require mandatory BIS certification before these materials can be placed on the Indian market.

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.