India Regulatory News

On May 15, 2024, the Directorate General of Health Services under the Ministry of Health and Family Welfare in India issued a new circular for medical devices through the Central Drugs Standard Contro...

On May 15, 2024, the Directorate General of Health Services under the Ministry of Health and Family Welfare in India issued a new circular for medical devices through the Central Drugs Standard Control Organization. 

The circular states that all medical devices, including in vitro diagnostic medical devices, will now be regulated under the Drugs and Cosmetics Act of 1940 and the Medical Devices Rules of 2017. A license/approval is required for the import/manufacture and marketing of devices in India. 

Ensuring Quality and Safety 

Licenses are issued under the aforementioned rules, subject to certain restrictions, to ensure the quality, safety and performance of medical devices on the market, as well as compliance with the Quality Management System. It is also essential that all medical device license holders have strong systems and processes in place for the timely identification, documentation, and reporting of adverse events related to medical devices.  

Importance of Post-Market Surveillance 

Post-market surveillance (PMS) of medical devices is a critical part of ensuring their safety and performance. PMS helps to identify and resolve any potential risks or adverse events associated with the medical device.  

Timely reporting of adverse events enables the identification of unrecognized dangers, analysis of the frequency of previously identified risks, and the implementation of necessary actions by manufacturers and regulatory agencies to mitigate these risks and protect public health. 

Materiovigilance Programme of India 

The Materiovigilance Programme of India (MvPI), initiated by the Ministry of Health and Family Welfare, aims to improve patient safety in India by monitoring, recording and analyzing the root causes of adverse events or risks associated with the use of medical devices. This includes in vitro diagnosis by healthcare professionals or patients/users and providing appropriate resources to regulatory authorities with the sole purpose of improving patient safety.  

The Indian Pharmacopoeia Commission (IPC) has been appointed as the National Coordinating Center (MvPI) for the Material Monitoring Programme of India. In addition to healthcare professionals/public/users/patients, one of the most important stakeholders in MvPI is the medical device industry, and their participation needs to be encouraged to have a significant impact on the outcome. 

As MVPI is an important program for adverse event reporting and coordinated analysis of medical devices, including in vitro diagnostic devices, it is proposed that all licensees use the MVPI platform to also report potential adverse events/serious events. Device-related adverse events to improve processes for identifying risks associated with medical devices. 

Reporting of Adverse Events 

In view of the above, stakeholders are urged to promptly report any adverse events related to medical devices to the MvPI. Guidance documents to facilitate the effective use of MvPI resources are available on the website of the Indian Pharmacopoeia Commission (IPC) (https://www.ipc.gov.in), to help streamline reporting processes and ensure the continued safety and efficacy of medical devices in India. 

On May 20, 2024, Government of India has published a notification revising the Public Procurement (Preference to Make in India) Order 2017. This revision is aimed at encouraging the “Make in India�...

On May 20, 2024, Government of India has published a notification revising the Public Procurement (Preference to Make in India) Order 2017. This revision is aimed at encouraging the “Make in India” initiative by promoting the manufacture and production of goods, services and works in India, thereby increasing income and employment. 

Publication and Revisions of the Procurement Order 

The Procurement Order was published by the Department for Promotion of Industry and Internal Trade (DPIIT) vide Order No. P-45021/2/2017-B.E.-II dated 15.06.2017 with subsequent revisions vide Order No. 45021/2/2017-PP (BE-II) dated 28.05.2018, 29.05.2019, 04.06.2020 and 16.09.2020. 

Following the DPIIT Orders previously issued, the Department of Chemicals and Petrochemicals (DCPC) issued Orders No. C.I.-43012/52/2017-Chem-I(B) on 25.5.2018, 23.10.2018, 13.03.2020, and 01.06.2020. The DPIIT's amended order dated September 16, 2020, is now being used as a future reference, and the earlier orders have been revoked. 

Eligibility and Included Products 

Based on the information available, the Department has determined that there is adequate local capacity and local competition. Therefore, only Class-I local suppliers will be qualified to submit bids for the 28 products listed in the table below, regardless of the purchase price:    

Verification and Compliance 

For the purpose of independently verifying self-declarations and certificates of auditors and accountants on a random basis, as well as handling complaints that are received or referred, each procurement body must form a committee composed of internal and external specialists. 

The order takes immediate effect and will be revised as needed. It will remain in force until an updated notification is issued. 

India has published a revised schedule for the implementation of new standards for a few substances. The schedules were published in the Gazette of India by the Bureau of Indian Standards (BIS) on 30 ...

India has published a revised schedule for the implementation of new standards for a few substances. The schedules were published in the Gazette of India by the Bureau of Indian Standards (BIS) on 30 April and 6 May 2024 respectively in consultation with the Department of Consumer Affairs (DCA). 

The substances covered under the schedule along with the establishment and withdrawal dates are as follows:   

The notification published on 30 April 2024 includes 3 products: 

The notification published on 6 May 2024 includes 5 products: 

It should be noted that the existing version of the standards would normally be withdrawn on the same day as the effective date of the new standards. However, in this instance, the Department of Consumer Affairs (DCA) has postponed the effective dates for their withdrawal. 

The Bureau of Indian Standards is seeking comments until 26 June on the second revision of the standard for Ammonium Bromide, Pure and Analytical Reagents (IS 2723). This compound is widely used in th...

The Bureau of Indian Standards is seeking comments until 26 June on the second revision of the standard for Ammonium Bromide, Pure and Analytical Reagents (IS 2723). This compound is widely used in the production of silver bromide in the chemical industry, in medicine and as an analytical reagent. 

Historical Background  

This standard was first issued in 1964 and later amended in 1985. In the first revision, a more sensitive reference method for the determination of iron was added, reducing the amount of reagents required. The method for the determination of heavy metals was also updated, and a new requirement for analytical reagent grade arsenic was established. 

Scope  of Application 

This standard specifies the requirements and techniques for the collection and testing of ammonium bromide, pure and analytical reagent. 

Key Provisions of the Amendment 

Instrumental methods for the determination of iron, lead, arsenic, sulphates, and chlorides have been added as alternative test procedures in this revision. Furthermore, editorial corrections have been made where necessary. The Reference clause has also been added. Additionally, the clause on packaging and marking has been revised. 

Grades and Properties 

Ammonium bromide is divided into two grades: pure and analytical reagent. The maximum permissible limits for the two grades are as follows:  

The material shall be in the form of small colourless crystals or white crystalline powder, free from foreign bodies and visible impurities. It is slightly hygroscopic and slowly turns yellow in air and should be stored in tightly closed containers. 

Packaging and Labelling 

The product must be packaged in clear galvanized iron drums lined with polyethylene or in glass bottles. 

Each container must be marked with the following information: 

a) Name and grade of the material; 

b) Net mass of the material; 

c) Date of manufacture; 

d) Manufacturer's name and/or his recognized trade-mark, if any; and 

e) Batch number. 

Containers of analytical reagent grade material should also be labelled with analytical data according to the revised standard. 

BIS Certification Marking 

The product(s) meeting the requirements of this standard may be certified under the conformity assessment schemes established under the provisions of the Bureau of Indian Standards Act, 2016 and the rules and regulations enacted thereunder and the products may be marked with the standard mark. 

The Bureau of Indian Standards is seeking comments until 24 June on the second revision of the standard for magnesium sulphate, commonly known as Epsom salts (Second Revision of IS 2730).     ...

The Bureau of Indian Standards is seeking comments until 24 June on the second revision of the standard for magnesium sulphate, commonly known as Epsom salts (Second Revision of IS 2730).  

First standard for Epsom salts 

This standard was first published in 1964 and subsequently revised in 1977. Initially, two Indian Standard specifications were published for magnesium sulphate, IS 257 focusing on technical grade and IS 377 on pharmaceutical grade. These specifications were subsequently merged into IS 2730. 

 In the first revision, changes were made to the magnesium sulphate content limit and the chloride and iron were limits for the technical grade of the material for use in the leather industry. Furthermore, the criteria for pharmaceutical grade were deleted. 

Changes in the second revision of the standard 

• The revised standard proposes that there are two grades of material: pure and technical. 

• The pure grade of the material is used in cosmetics, mineral water, explosives and silk weighting. The technical grade of the material is used in the textile and leather industries where it is used as a tan precipitant for the purpose of fixing tan. It is also used as a micronutrient in fertilizers to meet magnesium deficiency in plants. 

• The material shall be in the form of colourless crystals, soluble in water and sparingly soluble in ethyl alcohol (90 percent v/v). 

• The crystals are liable to become powdery on efflorescence and, unless otherwise agreed to between the purchaser and the supplier, this condition shall not render the material unacceptable. 

• The material shall be packed in airtight containers as agreed between the purchaser and the supplier. The containers used for packing the pure grade shall be lined with polyethylene. 

Additional requirements for Epsom salts are given in the table below. 

Further details of the requirements, methods, marking and sampling and BIS certification marking can be found here: WCCHD17025380_24042024_2.pdf (bis.gov.in) 

The Government of India has taken a step towards ensuring the quality and safety of biostimulants used in agriculture. A new amendment, the Fertiliser (Inorganic, Organic or Mixed) (Control) (Third) A...

The Government of India has taken a step towards ensuring the quality and safety of biostimulants used in agriculture. A new amendment, the Fertiliser (Inorganic, Organic or Mixed) (Control) (Third) Amendment Order, 2024, establishes a stricter regulatory framework for these emerging agricultural products.

Key Changes in the Amendment:

• In Clause 20 C, relating to Specifications in respect of Biostimulants, the term ‘tracer elements’ is added along with active ingredient.

• The new category, ‘Live micro-organisms excluding biofertilizers and biopesticides’ has been added to Schedule VI. The addition of this new category by the Ministry is a positive step for companies in this field. It paves the way for clearer regulations, increased market potential, and ultimately the development of beneficial products for Indian agriculture.

• Toxicity Testing: To support their claims, manufacturers can submit not only the name of the testing institute but also details of the relevant report or publication. Acute and ecotoxicity tests are required, with exemptions for specific categories such as protein hydrolysates and seaweed extracts. Only the manufacturer/importer should submit an affidavit to the effect that their product is non-toxic and shall be safely used as biostimulants.

• Stricter Testing: Manufacturers will need to submit detailed data on the product's composition, effectiveness on crops (bio-efficacy), and potential risks to the environment and human health (toxicity). As more data becomes available on a biostimulant's chemistry effectiveness on crops (bio-efficacy), it may be grouped with similar products and potentially exempted from some testing requirements for specific crops.

• Focus on Safety: The amendment raises the permissible limit for pesticide residues in biostimulants from 0.01 ppm to 1 ppm. It also exempts certain low-risk categories from submitting full toxicity data.

• Manufacturing/Import Restriction: Only approved biostimulants listed in Schedule VI can be manufactured or imported.

Impact:

This amendment is expected to:

• Increase farmer confidence in the quality and safety of biostimulants.

• Encourage the responsible development and marketing of effective biostimulant products.

• Streamline the regulatory environment for manufacturers and importers of biostimulants.

The increased focus on safety and efficacy testing may initially slow the introduction of new biostimulants. However, it is expected to benefit farmers in the long run by ensuring access to reliable and effective products that can improve their agricultural productivity These changes aim to ensure the safety, quality and efficacy of biostimulants used in Indian agriculture.

Source

The Government of India has amended the Fertiliser (Inorganic, Organic, or Mixed) (Control) Order, 1985 to include several additional fertiliser alternatives. This amendment is aimed at providing farm...

The Government of India has amended the Fertiliser (Inorganic, Organic, or Mixed) (Control) Order, 1985 to include several additional fertiliser alternatives. This amendment is aimed at providing farmers with more options to meet their individual crop demands.

Key & new additions to the Schedule include:

• Dispersible Granular Sulfur: This new fertilizer provides a readily available source of sulfur, a crucial nutrient for plant growth.

• NPK, Si, Ca, Mg and NPK, Si, Ca, B Fertilizers: These multi-nutrient blends combine nitrogen (N), phosphorus (P) and potassium (K) with additional elements like silicon (Si), calcium (Ca), magnesium (Mg) and boron (B). These combinations can address specific soil deficiencies and promote overall plant health.

• Sulfur with Zinc Granules: This option combines sulfur with zinc, another essential micronutrient for many crops.

• Liquid Urea Ammonium Sulphate: This liquid fertilizer provides a readily soluble source of nitrogen and sulfur for efficient nutrient uptake.

• Potassium Nitrate with Iodine: This specialized fertilizer provides potassium, nitroge and iodine, which can be beneficial for certain crops and potentially improve their nutritional value.

Furthermore, the amendment changes the ''specifications'' for nano nitrogen fertilisers, allowing for a wider range of particle sizes.

These modifications should help farmers by giving them additional alternatives to tailor fertiliser applications to specific crops and soil conditions. This could potentially contribute to higher agricultural yields and quality. As part of the nano fertilizers category, nano zinc and nano copper are also included with their specifications.

This update to the fertiliser list gives farmers more tools to meet the specific needs of their crops. These amendments can maximise plant health, increase yields and even improve the nutritional content of crops by adding high-sulphur varieties, micronutrients and combinations designed to address certain deficiencies.

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