India Regulatory News

On 16 May 2024, the Ministry of Health & Family Welfare (MoHFW) issued a notification dated 11 February 2020, which specifies that all medical devices are now categorized under sub-clause (iv) of clau...

On 16 May 2024, the Ministry of Health & Family Welfare (MoHFW) issued a notification dated 11 February 2020, which specifies that all medical devices are now categorized under sub-clause (iv) of clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940, which is effective from 1 April 2020. 

Notification S.O. 648 (E) 

This notification declares that all medical devices will be categorized as "drugs" under the Drugs and Cosmetics Act, 1940. 

This categorization falls under sub-clause (iv) of clause (b) of Section 3 of the Act. This sub-clause generally refers to devices intended for use in the diagnosis, treatment, mitigation, or prevention of disease or disorder in human beings. 

Notification under G.S.R. 102(E) 

On 11 February 2020, the MoHFW released notification no. G.S.R. 102 (E) to regulate medical devices in a phased manner. According to this notification, Class C and Class D medical devices are subject to a licensing regime from 1 October 2023. 

G.S.R. 102(E) aims to establish a comprehensive regulatory framework for all medical devices, ensuring that they meet essential standards of quality, safety and efficacy. 

Class C & D Devices 

The notification specifies that Class C and Class D medical devices, which are typically more complex and higher risk, will be required to comply with the licensing regime from 1 October 2023. These are typically more complex and increased regulatory oversight is critical for these high-risk devices. 

Licensing Regime for Class C & D Devices (Effective from 1 October 2023) 

In response to concerns raised by various associations and stakeholders about potential disruptions to business operations due to the licensing requirements for Class C and Class D medical devices starting on 1 October 2023, the following decision has been made: 

If an existing importer or manufacturer is already importing or manufacturing any Class C or Class D medical devices and has submitted an application for an import or manufacturing license to the Central Licensing Authority by 30 September 2023, their application will be considered valid. These applicants may continue to import or manufacture the specified devices for up to three months from the issuance of this order, or until the Central Licensing Authority makes a decision on the application, whichever is earlier. 

For more details, please visit cdsco.gov.in. 

The Bureau of Indian Standards (BIS) invites public comments on the first revision of the standard for sodium bromide, pure (IS 2780) until 24 June. Sodium bromide is widely used in the chemical indus...

The Bureau of Indian Standards (BIS) invites public comments on the first revision of the standard for sodium bromide, pure (IS 2780) until 24 June. Sodium bromide is widely used in the chemical industry and laboratories for the preparation of bromides and in medicine. The revised standard specifies the requirements and testing procedures for pure sodium bromide. 

Revised Standard: Specifications and Test Methods 

This standard was originally published in 1964. In this first revision, instrumental test methods for the determination of chlorides, sulphates, iron, lead and arsenic have been added as alternative test methods. In addition, editorial corrections have been made where required. A reference clause has also been incorporated. Furthermore, the clause on packing and marking has been updated. 

According to the notice, pure sodium bromide should be free from impurities and foreign matter. It should appear as tiny, colourless, transparent or opaque crystals or as a white granular powder. The chemical must be stored in tightly sealed containers as it readily absorbs water from the environment.  

 
 
The following table contains requirements for sodium bromide when tested by the methods specified in Annex A of the revised standard 

Packaging and Labelling  

The product must be packaged in clean galvanized iron drums lined with polyethylene or in glass bottles. Each container must be labelled 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) conforming to 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 made thereunder and the products may be marked with the standard mark.  

India’s Department of Chemicals and Petrochemicals (DCPC) has extended the enforcement date of the Quality Control Orders (QCOs) for four polymer products. The notifications were published in the Ga...

India’s Department of Chemicals and Petrochemicals (DCPC) has extended the enforcement date of the Quality Control Orders (QCOs) for four polymer products. The notifications were published in the Gazette of India on 4 June 2024 in consultation with the Bureau of Indian Standards (BIS). The QCOs were originally published on 6 December 2023 and were due to come into force on 3 June 2024.  

The revised implementation dates and corresponding standards for the polymer products are as follows:   

The Quality Control Order mandates that the substances concerned must carry the Bureau of Indian Standards (BIS) certification mark to ensure compliance with the specified standards until the implementation of the new QCOs.  

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.