India Regulatory News

The Bureau of Indian Standards (BIS) is holding a consultation process until May 11 on a proposed amended standard for ready-mixed paint, air drying, and red oxide-zinc chrome priming, which would ext...

The Bureau of Indian Standards (BIS) is holding a consultation process until May 11 on a proposed amended standard for ready-mixed paint, air drying, and red oxide-zinc chrome priming, which would extend lead content limitations in place for domestic purposes to the industrial sector. Lead, lead compounds, and lead combinations would be limited to no more than 90 parts per million (ppm).

This is currently set at 1,000ppm for industrial use and 90ppm for domestic use. To eliminate consumer confusion and raise attention to the health and safety risks linked with lead, a BIS technical committee has proposed a "unified single allowable level."

The draft establishes material standards, as well as the sampling and testing techniques. It is used "as a primer in the enamel painting system for metal surfaces and also to keep steelwork in good shape for home and decorative purposes, as well as in coastal and inland outdoor environments." says the BIS. If approved, Indian Standard (IS) 2074 for ready-mixed paint, air drying, red oxide – zinc chrome, priming – specification' will be revised for the fourth time. In addition, the draught suggests quantities for substances utilised in its production, such as:

• Minimum zinc chrome content of 16 percent by mass, 6.88 percent by mass chromic anhydride content, and zinc oxide content of 5.84 percent by mass;
• minimum synthetic red oxide or natural red oxide content of 50% by mass.

The official draft document can be accessed here

The Bureau of Indian Standards (BIS) has granted licences to 661 domestic toy manufacturers after determining that they comply with a 2020 quality control order that limits the use of certain heavy me...

The Bureau of Indian Standards (BIS) has granted licences to 661 domestic toy manufacturers after determining that they comply with a 2020 quality control order that limits the use of certain heavy metals, phthalates, and flame retardants. Companies must apply to the standards bureau and allow its auditors to inspect manufacturing facilities and test product samples to obtain a licence. If they are granted a licence, they must then purchase a quality certification logo demonstrating that their products do not exceed the limits for restricted substances specified in Indian Standard (IS) 9873.

Licences are valid for one year and can be renewed subject to additional inspections. Anyone found in violation of the Quality Control Order (QCO), which went into effect on January 1, 2021, faces up to two years in prison and a minimum fine of 200,000 Indian rupees ($2,627). According to a press release issued by the Ministry of Consumer Affairs, Food, and Public Distribution on April 6, 630 – or 95 percent – of the licences granted were to small and medium-sized businesses.

The Food Safety and Standards Authority of India (FSSAI) amended the Food Safety and Standards (Packaging) Regulations 2018, allowing for the use of recycled plastics in food contact materials (FCM) w...

The Food Safety and Standards Authority of India (FSSAI) amended the Food Safety and Standards (Packaging) Regulations 2018, allowing for the use of recycled plastics in food contact materials (FCM) with certain restrictions. The update clarifies the ambiguity caused by an amendment to India's plastic waste management rules published last September. The amendment permitted the use of recycled plastic in FCMs, in contrast to the 2018 packaging regulations, which prohibited its use. The amendment serves as a stopgap measure until the draught Food Safety and Standards (Packaging) Amendment Regulations 2022 are completed. However, it is unknown how long it will take for the new legislation to take effect.

In 2016, the Food Safety and Standards Authority of India prohibited the use of recycled plastics in food contact. The recent change has "shocked experts and environmental activists," according to The Times of India. According to Vijay Habbu of the Institute of Chemical Technology, when a plastic product is recycled, "there is some degradation of the plastic with the generation of contaminants or impurities." Most of the time, the contaminants are unknown. As a result, there are no reliable test methods for detecting and determining impurities that can seriously endanger human life and the environment."

As part of its drive to use safer alternatives, India has imposed restrictions on certain hydrofluorocarbons (HFCs) and ozone-depleting substances (ODSs), requiring importers and exporters to obtain g...

As part of its drive to use safer alternatives, India has imposed restrictions on certain hydrofluorocarbons (HFCs) and ozone-depleting substances (ODSs), requiring importers and exporters to obtain government permission before trading.

The new rules, which were introduced as amendments to India's existing HFC export and import policies, went into effect on March 9 for importers and March 23 for exporters via Directorate General for Foreign Trade (DGFT) notifications. Before entering into agreements with overseas buyers or suppliers, domestic HFC and ODS manufacturers, exporters, and importers must obtain "no objection certificates" (NOCs) from the Ministry of Environment, Forests, and Climate Change (MoEFCC). In August of last year, India ratified the Kigali Amendment to the Montreal Protocol on Substances that Deplete the Ozone Layer, committing to an 85 percent reduction in HFC production and consumption by 2047. According to a MoEFCC spokesperson, the international trade restrictions are intended to "align domestic HFC user industries with the government's goal of reducing use of the substances and a gradual shift to the use of alternatives."

The Indian Government proposes a new Draft National Policy for Medical Devices, 2022, to reduce India's reliance on high-end medical device imports. The government intends to adopt public-private p...

The Indian Government proposes a new Draft National Policy for Medical Devices, 2022, to reduce India's reliance on high-end medical device imports. The government intends to adopt public-private partnerships to reduce healthcare costs, increase efficiency, and improve the quality of medical devices manufactured in the country.

Among the key proposals are:

·       The use of tax breaks and refunds to encourage the export of medical devices and related technology projects.

·       Increasing government spending on "high-risk" medical device projects

·       A single-window clearance system to be used for the licencing of medical devices.

·       Pricing environment with no price control on newly developed sector innovation

·       A dedicated fund to be established for encouraging collaborative research among existing industry players, reputable academic institutions, and start-ups.

·       Incorporate a framework for consistent pricing regulation to make high-quality, cost-effective medical devices available to all citizens at reasonable prices.

·       The National Pharmaceutical Pricing Authority (NPPA) will be strengthened with adequate manpower and appropriate expertise to provide effective price regulation while balancing the needs of patients and industries.

India started consultation on a draft international standard (IS) for sodium hypochlorite, also known as bleach. The item is described as an inorganic chemical widely used as bleach liquor. It is g...

India started consultation on a draft international standard (IS) for sodium hypochlorite, also known as bleach. The item is described as an inorganic chemical widely used as bleach liquor. It is generally sold in aqueous solutions, according to the draft published by the Bureau of Indian Standards (BIS) on February 21.

Bleach is considered a significant safety risk by the BIS due to the substance’s corrosive characteristics, widespread availability, and reaction products. 

These follow the provisions of five other standards:

1.     Glossary of terms relating to chemical and radiation hazards, as well as hazardous chemicals (IS 4155: 1966);

2.     Guide for selection of industrial safety equipment for body protection (IS 8519: 1977);

3.     Guide for selection of industrial safety equipment for eye, face, and ear protection (IS 8520: 1977);

4.     Guide for selection of industrial safety equipment for protection of arms and hands (IS 8807: 1978);

5.     Guide for selection of industrial safety equipment for protection of arms and hands (IS 88 (IS 10667: 1983).

In addition, the proposal suggests that substance containers be marked or labeled to identify:

·       The manufacturer's or importer's name and address.

·       The contents of the container; and the physical, chemical, and toxicological data as specified in the relevant Schedule of the Hazardous Chemicals Manufacture, Storage, and Import Rules 1989.

Furthermore, if sodium hypochlorite poses, or is likely to pose, health dangers in the workplace, the draught mandates the use of personal protective equipment (PPE). Employers would be responsible for selecting and providing suitable personal protective equipment (PPE) to employees, ensuring that it is used properly, and training them on all elements of the PPE.

The consultation period will end on April 22, 2022.

On March 10, 2022, the Department of Chemicals & Petrochemicals publishes its decision to extend the Quality Control Order implementation date for five chemical products. The new date is Septembe...

On March 10, 2022, the Department of Chemicals & Petrochemicals publishes its decision to extend the Quality Control Order implementation date for five chemical products. The new date is September 12, 2022. The concerned chemical products are Ethylene Dichloride, Vinyl Chloride Monomer, Acrylonitrile Butadiene Styrene, and Polycarbonate. 

You can view the official gazette here.