Industry update – FSSAI Notification

FSSAI classifies packaged drinking water as ‘High Risk Food Category’. Food products that come under the ‘High Risk’ category are subjected to mandatory risk-based inspections

The Food Safety and Standards Authority of India (FSSAI) has decided to treat the packaged drinking and mineral water segment as a “High Risk Food Category” and subject to mandatory inspection and third-party audit norms.

From the recent FSSAI order, here are the specific points related to non-alcoholic soft beverages, packaged drinking water, and associated inspections:

1. Omission of BIS Certification:

Clauses related to mandatory BIS Certification for certain food products (including packaged drinking water) have been omitted. This indicates a regulatory shift, potentially delegating certification responsibility or modifying compliance requirements.

2. Inspection of Manufacturers:

The order outlines changes regarding the inspection process for manufacturers:
Specific details about the nature and scope of inspections may no longer reference previously mandatory BIS protocols.

Manufacturers might need to adhere to updated FSSAI guidelines for inspections and compliance.

3. Inspection Frequency:

Frequency of inspections for manufacturers of packaged drinking water and non-alcoholic beverages may have been updated:

It suggests a move towards a risk-based inspection framework, where high-risk categories could face more frequent inspections.

Lower-risk categories or compliant manufacturers might experience reduced inspection frequency to streamline oversight.

4. Other Relevant Amendments:

The general regulatory focus appears to be on reducing redundancy (e.g., removing duplicate certification processes like BIS) while strengthening direct oversight under FSSAI.

Packaged drinking water manufacturers must adhere strictly to the FSSAI’s revised standards for production and packaging.


In summary, the amendments simplify compliance by removing some previous certifications (like BIS), focusing on direct FSSAI oversight, and potentially altering inspection frequency to be risk-oriented.

This aligns with FSSAI’s goal of improving efficiency in regulating high-risk categories like packaged drinking water and non-alcoholic beverages.

FSSAI has recently removed the necessity for FBOs to obtain AGMARK, BIS/ISI Certifications for their Food Products and FSSAI Licensing norms will redefine the Certification, Inspection norms that are needed for FBOs.

Source : FSSAI Advisory dated Nov 29th 2024

Advisory on Medical device Standards

Public Notice on Medical Devices Standards from Department of Pharmaceuticals

Public notice on Medical Devices from Department of Pharmaceuticals on what Standards industry and stakeholders have to follow, refer while dealing with Medical Devices.

Medical Device Sector is brought under 100% Regulation which means that it’s well defined framework , structure and has well established regulatory protocols .

Healthcare Services should understand more about the Supply Chain Quality – understand the Regulations, Standards , Certifications , Testing , Inspection norms that are prescribed for the market players.

Unless the supply chain quality is understood correctly, Service providers delivery can’t have the necessary assurance to users .

Procurement teams, QA teams in healthcare services should know about National, International Conformity Assessment practices, norms for Healthcare Products.

Since Users, Patients, stakeholders etc are always seeing Global Quality Campaigns while introducing, prescribing Products, it’s important to respond to queries on the same when asked.

Source: Public Notice No.31026/83-2021-MD dt. 01.02.2022 issued by Department of Pharmaceutical

BIS LICENSES FOR MASKS AND PPES 

BIS LICENSES FOR MASKS AND PPES & REVISED GUIDELINES

BIS LICENSES FOR MASKS AND PPES & REVISED GUIDELINES – UPDATES FROM BIS

Industry and stakeholders are invited to refer the same . With the continuous spread of many variants of Sars Cov 2 , the global focus is again shifted to using Masks, protecting healthcare workers with coveralls etc. Global Call of Action is again shifted back to providing high quality masks which offer more protection to all users. BIS has released Standards for Coveralls and revised licensing guidelines too for the Indian Industry to follow.

BIS LICENSES FOR MASKS AND PPES

S.NoIndian StandardProductBIS Licenses
1IS 9473:2002Filter Half MasksClick here
2IS 16289:2014Surgical Face MasksClick here
3IS 5983:1980Eye ProtectorsClick here
4IS 17423:2020Cover AllClick here 

REVISED GUIDELINES FOR ISSUE OF LICENSES

S.NoIndian StandardProductProduct Specific
Relaxation guidelines
Product Manual
1IS 9473:2002Filter Half MasksClick hereClick here
2IS 16289:2014Surgical Face MasksClick hereClick here
3IS 5983:1980Eye ProtectorsClick hereClick here
4IS 17423:2020Cover AllClick hereClick here

Source : https://www.bis.gov.in/index.php/bis-licenses-for-marks-ppes/

BIS has released IS 17423 : 2021 – Medical Textiles — Bio-Protective Coveralls — Specification (First Revision) recently. This is the latest Product Standard for Coveralls to be followed by Industry.

BIS has compiled list of all published Technical Standards for Medical Textiles , totally 70 Standards (TXD 36) for industry reference as mentioned below :

TXD 36 – Technical Textiles for Medtech Applications

Refer the List – https://www.services.bis.gov.in:8071/php/BIS/PublishStandards/published/standards?commttid=MTM0