Pharmaceuticals Archives

Industry Information Update – BIS – Sector wise Calendar for Upcoming Webinars

July 25, 2025July 25, 2025by valueaddedinLeave a comment

BIS – Sector wise Calendar for Upcoming Webinars

Bureau of Indian Standards is organising Sector specific awareness programs

In order to spread the awareness among the concerned stakeholders, manufacturers, importers and common consumers BIS is organising ‘Interactive lecture series and Sector-wise webinar’ on the below mentioned topics.

Manufacturers including MSMEs are requested to attend the above webinars based on their respective business interests for a particular sector.

Participation in these webinars does not require any preregistration and can be joined conveniently and remotely through Computer / Laptops / Mobiles.

The link for joining these webinars are hosted well in advance on BIS Website: www.bis.gov.in

Source: https://www.bis.gov.in/

Industry Information Update – HOSPEX–QAI Quality Culture Award 2025

July 25, 2025July 28, 2025by valueaddedinLeave a comment

HOSPEX–QAI Quality Culture Award 2025

4th Edition of HOSPEX Healthcare Expo cum Conferences will be held at Kochi, Kerala from Aug 22nd – 24th 2025. This is Kerala’s first B2B Medical Expo which will take place at KINFRA International Exhibition Centre, Kakanad, Kochi, Kerala

As a part of the Expo, to encourage, nurture the Culture of Practicing Quality in Small Hospitals, Hospex-QAI Quality Culture Award 2025 is designed this year.

About the Award:

The award is a joint initiative of HOSPEX India and QAI.

This award is a recognition of the Quality Focus that is built in Small Hospitals and the efforts taken by Small Hospitals to make Quality a Culture in their clinical settings.

For any Practice to become a Culture needs lot of commitment in any organisation. This award is created to motivate healthcare facilities to come forward and pitch their Quality Practices which have become a Culture in their settings.

About HOSPEX:

Hospex is the initiative of Trithvam Integris, a company that specialises in managing Health and Medical Fair Events. Hospex is solely focused on digital health, healthcare and organising conferences for the medical industry by a group of doctors.

HOSPEX 2025 is the only Medical & Healthcare Exhibition in Kerala targeting Hospitals, Other Healthcare organisations, Medical Device Manufacturers, Pharmaceutical Manufacturers, Startups, Innovators in Health Tech and Med tech space.

The core focus of HOSPEX Healthcare Expo 2025 (Fourth Edition) is Medical Knowledge dissemination thereby hosts multitude of conferences focused on the futuristic trends in the medical industry. These conferences provide attendees with the opportunity to learn about new products and technologies, network with other professionals in the field, and stay up-to-date on the recent and futuristic developments in the industry

About QAI – Quality & Accreditation Institute

Quality and Accreditation Institute (QAI) is an International Accreditation Body that provides Accreditation/ Certification to Healthcare Organisations (Hospitals, Clinics, Dental centres, Eye Clinics, Imaging centres, IVF centres, Dialysis centres, Home Care, Stroke centres, Telehealth services, Hair Transplant Centres, Bone Marrow Transplant centres, Rehabilitation centres, Ambulatory care centres etc.).

QAI provides a platform to stakeholders including professionals and organisations, associated with Quality in any way, to share their wisdom and Knowledge in order to make healthcare services delivering better outcomes.

QAI is closely working with stakeholders including Government agencies to support accredited healthcare facilities in terms of empanelment and other benefits.

Target Segment:

Any healthcare facility such as Hospitals, Clinics, Dental centres, Eye Clinics, Imaging centres, IVF centres, Dialysis centres, Home Care providers, Stroke centres, Telehealth services, Hair Transplant Clinics, Bone Marrow Transplant centres, Rehabilitation centres, Ambulatory care centres etc.).

Wellness Centres offering AYUSH Services

Applicants can be from Private or Government settings.

Eligibility Criteria:

Applicant must have implemented a Quality Management System/ Patient Safety Program/ any Certification or Accreditation Program for a minimum period of last 3 years continuously
QAI accredited healthcare facility will be given preference
Applicant can be from any part of India

Application Form Content:

To be filled in the format given
General Information about the Healthcare facility
Specific information about Quality Practices/ Certifications / Accreditation (Evidences to be submitted to support any such claims)
2 case studies/ examples to demonstrate improvement/ patient safety in last 3 years
Language for submission – English

Application Fee:

Rs. 1180/- (including 18% GST) for each application

To be payable to HOSPEX India’s account as shared below:

Tritvam Integris Pvt. Ltd.
GST No: 32AAJCT2250M1ZA
Tritvam Integris, Jyothi Trade Centre, Chettupuzha, PO, Thrissur – 680 012

Application Submission Date:
Last date for submitting applications: 10 August 2025.

Completed Application including payment proof to be mailed to:

Ms. Chandni Rohila
Accreditation Officer
Quality & Accreditation Institute (QAI)
709, Wave Silver Tower, Sector 18, Noida-201301, India
Ph. No.: +911206664981
M: +91 8287841146
Email – chandni@qai.org.in

Terms and Conditions:

Only completed applications will be taken up for evaluation.
Jury will comprise of experienced professionals with healthcare operations, management, quality, clinical background
Only one application per location is acceptable.
Applicants can save the completed application and all evidences on a google drive folder and can share the folder access link to QAI through email to chandni@qai.org.in.
Applications submitted after the last date will not be entertained.
Jury will evaluate the applications and decide on the winners of the Award.
Shortlisted applicants may be called for virtual presentation, if needed.
Winners will be announced by 12 August 2025.
Winers will have to travel to Kochi (Cochin), to collect their Awards in an event to be held on 23 August 2025.
Organisers will not make any travel, stay arrangements and winners have to make their own arrangements.
Decision of the Jury shall be final and binding on all.

Click here to download the application

Click here for Brochure

Source: https://hospex.in/

Industry update – FAQs-CDSCO

May 2, 2025May 2, 2025by valueaddedinLeave a comment

Medical Devices – Frequently Asked Questions (FAQ)

Medical Device Division of CDSCO (Central Drugs Standard Control Organization) releases FAQ document on periodical basis to clarify the frequently raised questions by industry and other stakeholders .

Latest FAQ Document was released on 3rd April 2025 . This FAQ document is released for Medical Device Sector , not for IVDs.
Doc No.:CDSCO/FAQ/MD/01/2024. Addendum No.: 01. Date: 03.04.2025

CDSCO’s Note :

The replies to the FAQs are aimed only for creating public awareness about Medical Devices Regulation by CDSCO and are not meant to be used for legal or professional purposes. The readers are advised to refer to the statutory provisions of Drugs and Cosmetics Act & Rules and respective Guidelines / Clarifications issued by CDSCO from time to time for all their professional needs.

The document is released as an Addendum to FAQ on Medical Devices Rules, 2017:

Questions covered in the FAQ are listed below :

Whether the manufacturer or importer need to conduct the Biocompatibility test on the all applied products?
Whether the manufacturer can release the sterile medical device to the market based on parametric release?
Whether for a Medical device which is supplied in non-sterile state, the expiry/shelf life is mandatory on its label?
Whether the validation and QC data of medical device generated by the manufacturer for the medical device which is marketed in the country prior to implementation of the mandatory licensing regime under MDR, 2017 can be considered for grant of manufacturing license in the country?
In case of Change of constitution of the company/firm holding the manufacturing license under the MDR-2017, whether fresh license is required?
In case of Change of constitution of the company/firm holding the import license under the MDR-2017, whether fresh license is required?
In case of Change of constitution of the company/firm holding the registration certificate under the MDR-2017, whether fresh registration is required?
Whether the applicant can submit a single application for multiple actual manufacturing site for obtaining import license?
In case of change in the location of manufacturing site of the manufacturer whether a fresh license is required?
What is a ‘non-sterile medical device’ ?
What are the packaging and labelling requirements for a ‘non-sterile medical device’ if it is intended to be sterilized before use?
What is a ‘sterile medical device’ ?
Whether wholesale licence in Form 20B/21B under Drug Rules, 1945 or Registration certificate in Form MD-42 under Medical Devices Rules,2017 is mandatory for Class A (non-sterile and non-measuring) medical devices?
What is the regulatory pathway to be followed for obtaining manufacturing/ import license for medical device under MDR-2017?
Whether the manufacturer of medical device require to obtain ISO 13485:2016 certificate for obtaining manufacturing license under MDR-2017?
In case of Import of medical devices, whether Brand name of a medical device owned by an Indian authorized agent can be mentioned on the application for import in Form MD-14?

To read the replies shared for each of the FAQs listed above, read the FAQ document released by CDSCO which can be downloaded from the button below

Click here to download FAQ document

Source of the Document released by CDSCO :
https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/Addendum-0152.pdf

Industry Update – MoHFW Notification

May 2, 2025May 2, 2025by valueaddedinLeave a comment

Compounding of Offences under Drugs and Cosmetics Act , 1940 for Pharma and Drug Manufacturers

Ministry of Health and Family Welfare has released a gazette notification notifying the new rules that may be called the Drugs and Cosmetics (Compounding of Offences) Rules, 2025. The rules are framed by the Central Government using the powers conferred by the Drugs and Cosmetics Act, 1940.

The notification introduces rules under an existing act, under section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940).

These rules provide a framework for “compounding of offences” under the Drugs and Cosmetics Act, 1940. This means that instead of going through full prosecution, certain offences might be resolved by paying a specified amount (compounding amount). The rules outline the process for applying for compounding, the authorities involved, and the conditions for granting immunity from prosecution.

Key highlights of the Drugs and Cosmetics (Compounding of Offences) Rules, 2025 notification:

Compounding of Offences: The primary focus is to establish rules for compounding certain offences under the Drugs and Cosmetics Act, 1940, offering an alternative to traditional prosecution.

Application Process: The rules detail how an applicant (a company or person involved in the pharma industry) can apply for compounding of an offence. This can be done before or after prosecution begins.

Compounding Authority: The notification defines the “compounding authority” and how they are appointed by the Central or State Government to manage the compounding process.

Procedure: It outlines the step-by-step procedure the compounding authority must follow, including gathering reports and making decisions on whether to allow compounding.

Immunity from Prosecution: The rules explain the conditions under which the compounding authority can grant immunity from prosecution to an applicant.

Withdrawal of Immunity: The notification also specifies the circumstances under which this granted immunity can be withdrawn.

Form for Application: The inclusion of a specific form for applying for compounding of offences

Why the need for “Compounding of Offences” ?

The Jan Vishwas (Amendment of Provisions) Act, 2023, aims to decriminalize various offenses in 42 Central Acts, enhancing ease of doing business and living by reducing compliance burdens. It accomplishes this by removing imprisonment and/or fines in many provisions, replacing them with penalties or enhancing existing fines.

Key features and objectives of the Jan Vishwas Act include:

Decriminalization:The Act decriminalizes 183 provisions across 42 Central Acts, which are administered by 19 Ministries/Departments.
Enhanced Ease of Doing Business:The Act aims to simplify compliance for businesses by removing or modifying existing criminal penalties.
Trust-Based Governance:By decriminalizing certain offenses, the Act seeks to foster a more trust-based environment for businesses.
Pragmatic Penalties:The Act introduces mechanisms for adjudicating officers and appellate authorities, ensuring penalties are commensurate with the severity of the offense.
Flexibility in Enforcement:The Act allows for compounding of certain offenses, providing an alternative to full-fledged prosecution.
Focus on Specific Acts:The Act addresses provisions in various Acts, including those related to intellectual property, media, and other sectors.

Drugs and Cosmetics Act, 1940 Amendment: The Drugs and Cosmetics Act, 1940 is one of the acts amended by the Jan Vishwas Act.

Implementation of Jan Vishwas Act’s Intent: The Drugs and Cosmetics (Compounding of Offences) Rules, 2025, can be seen as a mechanism to implement the changes brought about by the Jan Vishwas Act to the Drugs and Cosmetics Act, 1940. It provides the specific procedures and framework for how these offenses will be dealt with, in alignment with the intent of decriminalization and promoting ease of doing business.

Overall, the Jan Vishwas Act aims to create a more business-friendly and less punitive environment by decriminalizing certain offenses and rationalizing legal provisions across various sectors.

Hence the new Rules on Compounding of Offences under Drugs & Cosmetics Act may have originated from the recent amendments made to Jan Vishwas (Amendment of Provisions) Act 2023.

In essence, the Jan Vishwas Act provides the legislative amendment to allow for decriminalization, and the Drugs and Cosmetics (Compounding of Offences) Rules, 2025, provides the procedural rules for implementing that change through compounding of offenses.

Click to read the Notification

Industry Update – Revision of Risk based Classification of Medical Devices – CDSCO

April 7, 2025April 7, 2025by valueaddedinLeave a comment

Revision of Risk based Classification of Medical Devices – CDSCO

Central Drugs Standard Control Organisation (CDSCO) has revisited the existing risk based classification of Medical Devices in the categories of Cardiovascular and Neurological and added new entries based on their classification as per the First Schedule (Part I) of the MDR 2017

In this regard, CDSCO has issued a notification dated 1^st April 2025, inviting all Stakeholders in the Medical Devices sector, such as Healthcare professionals, Manufacturers, Policymakers, Regulatory bodies, and other entities involved in the classification and regulation of medical devices to review the draft document and provide feedback within 30 days of publication to refine the risk-based classification framework for medical devices.

All concerned associations/stakeholders are requested to forward your comments by filling the Google form at https://forms.gle/62xF3BtXWC5pgD3TA within 30 days from the date of publication of this draft.

Click here for the List

Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTI2MjM=

Industry Update – Application Process for Seeking Extension of Schedule M

March 31, 2025March 31, 2025by valueaddedinLeave a comment

Application Process for Seeking Extension of Schedule M

The Central Drugs Standard Control (CDSCO) has issued a Circular on 24th March 2025, that an online portal ONDLS has been launched for submission of application for extension of the timeline to comply with Schedule M by Small and Medium Manufacturers.

Small and Medium manufacturers with turnover of less than Rs.250 crores, can submit an application within 3 months of this notification in Form A (plan of upgradation) to the Central License Approving Authority for extension of implementation till 31st December 2025.

In this regard, CDSCO has developed an online system for submiting application through ONDLS portal.

The applicant / manufacturer seeking extension of the timeline has to register on the ONDLS portal and thereafter submit an application.

No hard copy of the application for seeking extension will be considered.

Circular of CDSCO is given below :

Source: https://statedrugs.gov.in/SFDA/ondls-login.html

Industry update – PRIP Scheme

March 9, 2025March 9, 2025by valueaddedinLeave a comment

PRIP Scheme’s
Expression of Interest (EOI)

The Department of Pharmaceuticals announces the launch of the Expression of Interest (EoI) under the Scheme for Promotion of Research & Innovation in Pharma, MedTech Sector (PRIP)

The EoI has been designed to provide you with an opportunity to co-shape India’s journey towards becoming an R&D innovation hub. All interested entities are encouraged to participate in PRIP Scheme’s Expression of Interest (EoI) process and share description of suitable projects.

Please visit the scheme’s website to access the EoI form: https://pharma-dept.gov.in/prip/

About the PRIP Scheme:

The PRIP Scheme aims to transform India into a global powerhouse for R&D in the Pharma MedTech sector. The scheme has a total outlay of ₹5,000 Cr, of which ₹4,250 Cr is focused on accelerating investments in industry-led R&D projects within six priority research areas, including: New Chemical Entities, New Biological Entities and Phyto-pharmaceuticals, Complex generics and Biosimilars, Precision Medicine, Medical Devices, Orphan Drugs and Drug Development for Antimicrobial Resistance (AMR)

For any queries about the scheme or EoI process please write to us at support-prip@pharma-dept.gov.in

Source : https://www.linkedin.com/posts/pharma-dept_innovation-healthcare-pharmaceuticals-activity-7303677221112541184-9yrW?utm_source=share&utm_medium=member_desktop&rcm=ACoAAABYr-QBBx6RLFkUHnEgb2n9GcB2vrhm0cg

Scheme Overview

The Scheme for “Promotion of Research and Innovation in Pharma MedTech sector (PRIP)” has been launched by the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India, with the goal of transforming India into a global powerhouse for R&D in the Pharma MedTech sector. The scheme has been notified vide Gazette Notification No. 199 dated 17th August 2023. The scheme has a total financial outlay of Rs. 5,000 Crores, of which Rs 4,250 Crores is focused on accelerating investments in the R&D ecosystem within the sector.

The scheme proposes funding across 6 priority areas and 3 funding categories:

Priority Areas
There are six priority research areas which will be covered by the PRIP scheme

New Chemical Entity, New Biological Entity and Phyto-pharmaceuticals
Complex generics and Biosimilars
Precision medicine (Targeted innovative therapeutics)
Medical devices
Orphan Drugs
Drug development for AMR

Key Funding Categories

R&D projects (focused on one or more of the priority areas above) need to be submitted within one of the following three funding categories:

1. B I: Funding up to 35% of total project cost or ₹125 Cr (whichever is less)

Applicants must be Pharmaceutical or MedTech companies with:
o Annual revenue ≥ Rs. 1,000 Cr (Pharma) or ≥ Rs. 250 Cr (MedTech)
o R&D expenditure of 3-5% (Pharma) or 1-3% (MedTech) of total revenue in the last five years
o Collaboration with a Government Research Institution (See Appendix II for more details)
o Projects in priority areas at any TRL 1 to 9

2. B II: Funding up to 35% of total project cost or Rs. 100 Cr (whichever is less)

Entities working on R&D projects in priority areas that are at TRL 5 or 6

3. B III: Funding up to Rs. 1 Cr per project

Startups and MSMEs working in priority areas at TRL 1 onwards to TRL 4
For more information on TRL, kindly refer to the Appendix III of the EoI document

Invitation for Expression of Interest
Department of Pharmaceuticals invites Expression of Interest (EoI) from interested entities – e.g.,
Proprietary Firm or Partnership Firm or Limited Liability Partnership (LLP), Startups or a Company /Group
of companies registered in India for project funding under the PRIP scheme.
This EoI has been designed to provide you with an opportunity to co-shape India’s journey towards
becoming an R&D innovation hub, by soliciting your inputs on:
Current R&D projects in the scheme’s priority areas for PRIP funding consideration
Challenges in execution of an R&D projects
Actions to strengthen the R&D ecosystem for Pharma and MedTech innovation in India

Download the EOI Document here

Source: https://pharma-dept.gov.in/prip/

CROs Registration

March 9, 2025March 10, 2025by valueaddedinLeave a comment

Launching of registration of Clinical Research Organisation applications through SUGAM Portal

The Ministry of Health and Family Welfare has published G.S.R. 581(E) dated 19th September 2024, wherein registration of Clinical Research Organisation (CRO) has been made mandatory with effective from 1st day of April, 2025.

In this regard, the online registration of Clinical Research Organisation (CRO) is now functional on SUGAM portal (www.cdscoonline.gov.in). Applications for registration shall be submitted through SUGAM portal only along with the prescribed checklist of documents for the registration.

Click here to download Notification

Health Ministry notified Rules to register CROs under NDCTR (New Drugs and Clinical Trials Rules), 2019 and amendment to the Rules was introduced in September 2024 notifying the Chapter on CROs with related requirements to the Registration of CROs in the country. These amended rules shall come into force on and from the 1st day of April, 2025.

The New Drugs and Clinical Trials (Amendment) Rules, 2024, notified on September 19, defines CROs as “the sponsor or a body, commercial or academic or of other category, owned by an individual or an organisation having status of legal entity by whatsoever name called, to which the sponsor may, delegate or transfer in writing, some or all of the tasks, duties or obligations regarding clinical trial or bioavailability or bioequivalence study.”

Amendment in NDCTR on CROs stipulates that no clinical research organisation shall conduct any clinical trial or bioavailability or bioequivalence study of new drug or investigational new drug in human subjects without registration granted by the Central Licencing Authority (CLA) under these rules.

Newly inducted Chapter VA addresses the following :

Registration of Clinical Research Organisation
Application for Registration of Clinical Research Organisation
Grant of registration to Clinical Research Organisation
Validity period and renewal of registration of Clinical Research Organisation
Inspection of Clinical Research Organisation registered with Central Licencing Authority.
Suspension or cancellation of registration of Clinical Research Organisation

Subsequent to this MoHFW has issued a notification of 4th Feb 2025 launching mandatory registration of CROs and applications for the same through Sugam Portal of CDSCO.

Sharing the notifications issued by MoHfW here for references :

Ministry of Health and Family Welfare has published G.S.R. 581(E) dated 19th September 2024 – New Drugs and Clinical Trials (Amendment) Rules (NDCTAR), 2024.

NDCTAR 2024 Notification

STUDY ON CRO SECTOR IN INDIA CONDUCTED BY DEPARTMENT OF PHARMACEUTICALS MINISTRY OF CHEMICALS & FERTILIZERS GOVERNMENT OF INDIA AUGUST, 2023

Department of Pharmaceuticals has released a report of Clinical Research Organisations in the country in 2023 based on a study conducted.

The Pharmaceutical global contract outsourcing market has been picking up after the covid pandemic. During the years between 2022-30, the global contract research outsourcing market is expected to grow @ CAGR of 7 % and reach USD 90.4 Billion by 2030. Out of this about USD 61.2 Billion will be contributed only by the outsourcing done in the domain of clinical development. The CRO sector in India has been growing @ CAGR of 10.75 % and will reach USD 2.5 Billion by the year Hence, it is imperative to identify the emerging opportunities for the Indian CRO sector beforehand, draft and implement strategies which will help in promoting the Indian CRO business.

Under the PMPDS Scheme, the Department of Pharmaceutical, Government of India took an initiative to conduct an independent study on the CRO sector/ market in India to identify and understand the real issues faced by CROs operating in India and work out a proposed roadmap to resolve those issues and make the necessary policy revisions.

Report has detailed information on :

RESEARCH FRAMEWORK
Business Trends in CRO industry
MARKET DYNAMICS
INDIAN CRO MARKET, BY END USER
INDIA CROs CATEGORIZATION, BY SERVICE TYPE
CROs CATEGORIZATION BY THERAPEUTIC AREA
CROs CATEGORIZATION BY LOCATION
CROs CATEGORIZATION BY SIZE
PROFILES OF SOME PROMISING CROs OPERATING IN INDIA
INSIGHTS & RECOMMENDATION

Click here to download the report

Source https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTI1Njk=

Industry Update – Bioenablers: Biomanufacturing Hubs

October 25, 2024October 25, 2024by valueaddedinLeave a comment

Invitation Proposal for Setting up of Bioenablers: Biomanufacturing Hubs – BIRAC

Department of Biotechnology, Govt of India and Biotechnology Industry Research Assistance Council (BIRAC) , jointly invite proposals for seeking support to establish Bio-Enabler: Biomanufacturing Hubs

About the Proposal

Enabling Access to Infrastructure and Resources [Bio-foundries] for Bio-manufacturing

Recognizing the potential of Biomanufacturing to power green growth, the Department of Biotechnology (DBT), Govt. of India has undertaken an initiative on Fostering High Performance Biomanufacturing.Against this backdrop, Biotechnology Industry Research Assistance Council (BIRAC), a PSU under the aegis of DBT, invites proposals from Industries/ Academic Institutes/ Incubators etc. to set up biomanufacturing hubs.

The proposals are envisaged in the Public Private Partnership (PPP) mode with financial co-sharing to co-develop integrated infrastructure (bio-foundries) including automation,workflows, processes, scale up facilities and related resources for access by start-ups andresearch communities engaged in biomanufacturing.

Key Features of the Call

Proposed facilities will support process innovation for rapid design and testing of organisms and scale-up engineering to accelerate biomanufacturing processes in the sectoral areas including but not limited to: functional foods and smart proteins, bio-based chemicals and enzymes, precision bio therapeutics, climate change and resilient agriculture, carbon capture and utilization, futuristic marine and space research.

Who can Apply?

The proposals can be submitted by Companies established under the Companies Act 2013/ The Limited Liability Partnership (LLP) incorporated under the Limited Liability Partnership Act,2008/ Academic Research Institutes, Universities, Research Foundation, Medical Colleges and Institutes – both public and private who are valid legal entities such as Trust, Society or established under central or state statute, Recognised Incubators. Applications from academia proposing facilities to be located in institutes premises should mandatorily have an industry collaborator who should operationalize and run the facility.

How to apply?

Proposals for the Scheme is required to be submitted online only. To submit a proposal online, please log on to the BIRAC website (www.birac.nic.in).

No Hard Copy to be submitted. Proposals submitted online only would be considered.

Last date for Submission of Proposals : 04th November 2024( 5:30 p.m.)

Details of the scheme including eligibility requirements, categories for proposal submission; guidelines for support as grant and loan; agreement templates etc. are available at www.birac.nic.in

𝗟𝗮𝘀𝘁 𝗱𝗮𝘁𝗲 𝗳𝗼𝗿 𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻:

The last date for submission of proposals under Bioenablers: Biomanufacturing Hubs is extended till 4th November 2024 (till 5.30 PM). Those who have already submitted the proposal need to revise as per the specific guidelines and revised proposal format

Click here to read Specific Guidelines

Click here to read Implementation Plan

Source: https://www.birac.nic.in/desc_new.php?id=1144

Industry Update – Establishment of the Global Accreditation Cooperation

October 25, 2024October 25, 2024by valueaddedinLeave a comment

Establishment of the Global Accreditation Cooperation (GLOBAC)

The establishment of the Global Accreditation Cooperation (GLOBAC) marks a significant shift in the global accreditation landscape, merging the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC) into a single entity.

This transition, aimed to be operational by January 2026, follows extensive discussions and agreements among IAF and ILAC members in 2024.

Key Developments

Formation of GLOBAC:

In 2019, IAF and ILAC members decided to create GLOBAC, which will take over their existing roles. The formal incorporation process began in New Zealand in October 2024 after the approval of GLOBAC’s Constitution and General Rules.

Mutual Recognition:

GLOBAC aims to enhance international trade by ensuring mutual recognition of accredited services across borders, thereby removing technical barriers. Until GLOBAC becomes operational, IAF and ILAC will continue their normal operations with existing recognition arrangements remaining valid

Transition Plan

Before Transition Date:

Until the Transition Date, IAF and ILAC will maintain their operations, and existing guidance for regulators will remain applicable. The IAF Multilateral Recognition Arrangement (IAF MLA) and ILAC Mutual Recognition Arrangement (ILAC MRA) will continue to function until GLOBAC takes over

After Transition Date:

Following the Transition Date, GLOBAC will assume all responsibilities of IAF and ILAC. Regulations referencing IAF MLA or ILAC MRA will gradually be updated to reflect GLOBAC’s framework. It is anticipated that the use of IAF MLA and ILAC MRA Marks will cease three years post-transition

Recommendations for Regulators:

Regulators are encouraged to collaborate with IAF and ILAC members to prepare for necessary changes in their documentation as GLOBAC becomes operational. This proactive approach will facilitate a smoother transition to the new accreditation framework

For further inquiries regarding this transition, stakeholders can contact the GLOBAC Executive Committee through its Secretary : secretary@globac.org

Click here to read more

Transition Plan

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