Category: Startups

Industry Information update : Sector-wise Compendiums of Indian Standards

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Sector-wise Compendiums of Indian Standards published – BIS

BIS Unveils 130 Sector-wise Compendiums of Indian Standards to Enhance Industry and Consumer Awareness

The Bureau of Indian Standards (BIS) has released a comprehensive collection of 130 sector-specific compendiums of Indian Standards, now accessible on the BIS portal.

Organized by industry sectors and product/service categories, these compendiums serve as consolidated reference guides for a wide range of stakeholders, including regulatory authorities, industry professionals, academic institutions, and consumer organizations.

Stakeholders can access the compendiums at
https://services.bis.gov.in/php/BIS_2.0/bisconnect/compendium_of_indian_standards_dept_wise

Please scan the QR code given below to download :

Source: https://services.bis.gov.in/php/BIS_2.0/bisconnect/compendium_of_indian_standards_dept_wise

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

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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 Update – New Draft Guidelines on Similar Biologics 2025 Released

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New Draft Guidelines on Similar Biologics 2025 – CDSCO

The CDSCO and DBT have jointly released the much-anticipated Draft Guidelines on Similar Biologics 2025. This marks a significant update over the 2016 version, incorporating global regulatory trends and streamlining the approval pathway for biosimilars in India.

Key updates include:

🔹 Enhanced focus on Quality by Design (QbD)
🔹 Revised preclinical and clinical study requirements
🔹 Stronger post-marketing surveillance framework
🔹 Greater alignment with WHO, EMA, and USFDA standards

This is a step forward in strengthening India’s position as a global hub for affordable, high-quality biologics.

The Draft Guidelines is now being placed in the public domain for inviting comments/suggestions from concerned stakeholders. All interested stakeholders are requested to provide comments/suggestions within the window of 30 days at biological@cdsco.nic.in in word document as per the format given below.

The suggestions/comments received on the above email address within the 30 days shall be taken into consideration for finalisation of the draft Guidance document.  

Stakeholder’s Comments format

Name and Designation: 
Firm Name: 

S.No.Page NoLine NoSection/Sub- section/ HeadingCurrent textProposed TextExplanation/Reference
       
       
       
Click here for Draft Guidelines

Source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Draft%20Guidelines%20on%20Similar%20Biologics%202025.pdf

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

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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 1st 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 – Boot-camp by FABA

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A month-long intensive boot-camp (8 May-4 June 2025) is organised by Federation of Asian Biotech Associations (FABA) on Foundations in MICROBIOLOGY, MOLECULAR BIOLOGY, CELL CULTURE & SOFT SKILLS

The Federation of Asian Biotech Associations (FABA) and Indian Immunologicals Limited (IIL), jointly organising a One-month program – Foundations in MICROBIOLOGY, MOLECULAR BIOLOGY, CELL CULTURE & SOFT SKILLS.

This one-month course will provide students with a strong foundation in microbiology, molecular biology, and cell culture techniques, enabling them to pursue further studies or research in these exciting fields.

About the Organisers :

The Federation of Asian Biotech Associations (FABA) is a non-profit organization established in 2004 for providing a platform for academy, industry, and government bodies. FABA has launched the FABA academy to bridge the gap between academy and industry in human resources development by providing professional development programs to science graduates (https://biofaba.org.in/).

Indian Immunologicals Limited (IIL): Indian Immunologicals Ltd (IIL) is the market leader in veterinary and human biologicals in India. It manufactures over 150+ products. IIL operates one of the largest plants in the world for veterinary vaccines. IIL has adequate infrastructure and cold chain distribution capability to reach out to various parts of India and world market.

Why choose this program?

  • Comprehensive curriculum covering microbiology, molecular biology, and cell culture
  • Hands-on laboratory experience with cutting-edge techniques and equipment
  • Career development through professional soft skills training
  • Expert instruction from experienced faculty members
  • Industry-relevant skills that enhance employability
  • Networking opportunities with professionals in the field

What you’ll learn:

Technical Skills:

  • Microbial culture techniques and analysis
  • DNA isolation, PCR, and gel electrophoresis
  • Cell culture maintenance and advanced applications
  • Laboratory safety and aseptic techniques
  • Experimental design and data analysis

Professional Skills:

  • Scientific literature searching and evaluation
  • Laboratory notebook maintenance
  • Career development strategies
  • Personal branding and CV building
  • Using AI tools for scientific research

Faculties to Program

Project Head: Dr. M V Jagannadham is a distinguished scientist with a Ph.D. in Life Sciences from Jawaharlal Nehru University, New Delhi. He served as Chief Scientist at CCMB, Hyderabad, visiting professor, University of Hyderabad and currently scientific committee member of FSSAI, New Delhi, specializing in mass spectrometry, protein chemistry and proteomics.

Industry experts will share practical insights and cutting-edge applications in biotechnology, providing participants with valuable industry perspectives and networking opportunities.

Experienced faculty members with expertise in microbiology, molecular biology, and cell culture.

Program Fee:

Students (Undergraduates/Graduates/Postgraduates) – Rs. 10,000

Faculties/Ph.Ds and Postdocs -Rs. 15,000

Industry Professionals- Rs. 20,000

Application Deadline: 1st May 2025

Course Period : 8th May to 4th June 2025

Since the experiments are hands-on, seats are limited to only 20. Apply early to secure your spot in this careerenhancing program.

How to Apply

Register here: https://lnkd.in/gx3MT2pM

Registration Fee Payment

Bank Details:


Name of the account: Federation of Asian Biotech Associations
Bank Name & Branch: Indian Overseas Bank / Rajbhavan Road
Account number: 118001000010387
Account type: Savings Bank
IFSC Code: IOBA0001180
Bank Address: R.V.S. Kamala Castle, Raj Bhavan Road, Somajiguda, Hyderabad 500082

Please upload a screenshot of your payment:

Selection Process

• Selection Criteria:
Participants will be selected based on:
  – Academic/professional background relevance
  – Statement of purpose submitted in this application
  – Order of registration (for equally qualified candidates)
  – Institutional diversity (to ensure representation across organizations)

• Notification Timeline:
All applicants will be notified about their selection status by May 1, 2025.

• Refund Policy:
If you are not selected for the program, your full registration fee will be automatically refunded to your original payment method within 5 business days of notification.

Early registration is appreciated as applications are reviewed on a rolling basis. 

For any questions regarding the selection process, please contact
Dr. T.N.G. Sharma at info@biofaba.org.in or +91 7989957263.

Contact Information

Federation Of Asian Biotech Associations (FABA)
Agri Biotech Foundation Campus,
Rajendra Nagar, Hyderabad
Dr. T N G Sharma, Senior Manager
Email: info@biofaba.org.in
Ph: +91 7989957263

Dr. Jagadeesh Gandla Chief Operating Officer
Email: coo@biofaba.org.in
Ph: +918074648547

Click here for Brochure

Source: https://biofaba.org.in/

Industry update – Release of India Bioeconomy Report 2025

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India Bioeconomy Report 2025

Union Minister of Government of India has released the “India Bioeconomy Report 2025” (IBER 2025)  at the BIRAC Foundation Day ceremony at the National Media Centre

During the meeting the following informations were shared on India’s Bio Economy Growth :

India’s bioeconomy has grown from $10 billion in 2014 to $165.7 billion in 2024, marking a 16-fold increase. This growth is attributed to the government’s commitment to fostering biotechnology as a key economic pillar.

The bioeconomy now contributes 4.25% to India’s GDP, comparable to major economies like the US and China

The number of biotech startups has surged from 50 to over 10,075, showcasing a thriving ecosystem.

Government has recently approved BIO-E3 Policy i.e Biotechnology for Economy, Employment, and Environment—which aims to accelerate research, innovation, and entrepreneurship in the sector. Assam is the first state to adopt this framework. Under this policy, initiatives such as Bio-AI Hubs, Bio foundries, and bio-enabler hubs will be set up to integrate advanced technologies with biomanufacturing.

Government has initiated BioSaarthi, a pioneering global mentorship initiative aimed at nurturing biotech startups. Designed as a six-month cohort, BioSaarthi will facilitate structured mentor-mentee engagements, offering personalized guidance to emerging entrepreneurs in the biotech sector. This initiative will strengthen India’s biotech ecosystem by fostering innovation, enhancing industry-academia collaboration, and positioning Indian startups for global success. The initiative would engage overseas experts, particularly from Indian diaspora as international mentors who would volunteer to give back to the society

The Key highlights of the India BioEconomy Report (IBER) 2025 :

Sector Growth

  • India’s bioeconomy grew by 9.8% in 2024, reaching $165.7 billion, contributing 4.25% to the national GDP, aligning with global leaders like the US (5%) and China (4%)
  • The sector is on track to achieve $300 billion by 2030 and $1 trillion by 2047, with required compound annual growth rates (CAGR) of 10.6% (2024–2030) and 7.5% (2030–2047)

Segment Contributions

  • BioIndustrial led with a 47.2% share, followed by BioPharma at 35.2%
  • Maharashtra emerged as the top contributing state, followed by Karnataka and Telangana

Startup Ecosystem

  • India now has over 10,075 biotech startups, supported by initiatives like Bio-Nests, which provide incubation facilities
  • Plans include expanding incubation spaces to 2 million square feet and establishing a $3 billion Biotech Venture Fund by 2028

Policy Recommendations

The report outlines strategies across five key sectors: BioPharma, BioAgri, BioIndustrial, TechMed, and startups:

  • Launching a National Bio-fortification Mission.
  • Establishing biomanufacturing consortia and incentivizing academic-industry collaborations.
  • Strengthening the Ayushman Bharat Digital Mission to enhance healthcare delivery

Strategic Roadmap

The “5-5-5 Model” emphasizes:

  1. Five key sectors for focus.
  2. Five implementation phases (e.g., acceleration phase in 2025–2026).
  3. Five core enablers: policy reforms, skilled workforce, shared infrastructure, partnerships, and global promotion

Frontier Technologies

Five transformative technologies identified for disproportionate growth include:

  • Cell & Gene Therapy.
  • Synthetic Biology.
  • AI + Biology integration.
  • Precision Agriculture.
  • Biomanufacturing

Regional Clusters

Specialized regional clusters are being developed:

  • Bengaluru-Mysore-Mangalore for BioPharma and Digital Health.
  • Hyderabad for vaccines and biosimilars.
  • Pune-Mumbai for industrial biotechnology

The IBER 2025 underscores India’s potential to become a global leader in biotechnology through coordinated efforts in policy-making, infrastructure development, and innovation promotion.

Click here to read the full report of IBER 2025

Source: https://pib.gov.in/PressReleasePage.aspx?PRID=2113745

CROs Registration

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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 – Karnataka Biotechnology Policy 2024-2029 – Operational Guidelines

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Karnataka Biotechnology Policy 2024-2029
– Operational Guidelines

Karnataka has been at the forefront of biotechnology in India and is rightly known as the biotech capital of India. Over the years, the development of a strong ecosystem and modern infrastructure through a proactive policy framework enabled Karnataka to achieve sustainable development and become the flag bearer of India’s biotechnology growth. Bengaluru, Karnataka’s science capital and Asia’s fastest growing technopolis, has developed into an ideal base for the biotechnology industry.

Department Of Electronics, Information Technology and Biotechnology, Karnataka has released comprehensive operational guidelines for implementing its new Biotechnology Policy 2024-2029.

The guidelines details the executional framework for fiscal incentives and concessions designed to catalyze the state’s biotechnology sector.

The document provides essential information on:

1. Detailed eligibility criteria
2. Application processes
3. Approval mechanisms
4. Incentive structures
5. Compliance requirements

Subsidy and reimbursement amount shall be released/disbursed on seniority basis depending upon the budget allocated under the Policy by the State Government, during the respective financial year.

The Department will put in place required mechanisms that will provide for a conducive environment for application, review, approval and disbursement of these incentives.

This release marks a significant step in Karnataka’s strategic initiative to establish itself as a global biotechnology hub, with a targeted bioeconomy valuation of $100B by 2030. Organizations interested in accessing these benefits can now submit applications through the official portal.

The guidelines ensure transparency and streamlined processing for all stakeholders.

Note: Registration under Karnataka Biotechnology Policy is compulsory to avail the fiscal incentive under policy period

To Register under Karnataka BT Policy, click the link – https://lnkd.in/gVNaYcuS

To access the OPG Document, please click the link – https://lnkd.in/gNyXaurF

To apply for incentives, please click the link – https://lnkd.in/gXSqap9x

Click here to read the Operational Guidelines

Source: https://eitbt.karnataka.gov.in/bt/public/en#

Industry Update – MNRE notifies Revised Quality Control Order for Solar Photovoltaic Products

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MNRE notifies Revised Quality Control Order for Solar Photovoltaic Products

The Union Ministry of New and Renewable Energy (MNRE) has officially notified the Solar Systems, Devices, and Components Goods Order, 2025, which supersedes the previous Solar Photovoltaics, Systems, Devices, and Components Goods (Requirements for Compulsory Registration) Order, 2017.

This revised order was published in the Gazette of India on January 27, 2025, and will take effect 180 days from this date.

It encompasses regulations for Solar PV modules, inverters used in Solar PV applications, and storage batteries.

Key Highlights of the Order:

  1. Mandatory Standards:
    • All solar PV modules, inverters, and storage batteries must comply with the latest Indian Standards as specified by the Bureau of Indian Standards (BIS) and must carry the Standard Mark under a BIS license.
    • Minimum efficiency standards have been established:
      • 18% for Mono Crystalline Silicon and Thin-Film PV Modules.
      • 17% for Poly Crystalline Silicon PV Modules.
  2. Applicability:
    • The order applies to manufacturers, importers, distributors, retailers, sellers, and lessors of solar PV systems and components.
    • Products intended solely for export are exempt from these regulations.
  3. Certification and Enforcement:
    • The BIS will be responsible for granting licenses and enforcing compliance with the order. Market surveillance will be conducted by BIS or an agency designated by BIS in collaboration with MNRE.
  4. Concurrent Operation:
    • Existing licenses under the 2017 order will remain valid; however, renewals and new registrations will be governed by the 2025 order.
  5. Penalties for Non-Compliance:
    • Violations of this order will result in penalties as outlined in the Bureau of Indian Standards Act, 2016.
  6. Promoting Public Interest:
    • The updated standards aim to ensure that safe and high-performance solar products are available in India’s expanding renewable energy market.

The revised Quality Control Order reflects MNRE’s commitment to advancing high-quality solar photovoltaic products that align with India’s renewable energy goals.

This initiative is expected to enhance product reliability and safety while supporting innovation within the sector.

For further details, please visit MNRE website – http://www.mnre.gov.in/

Click here for Notification

Source: https://mnre.gov.in/en/notice/notification-for-solar-systems-devices-and-components-goods-order-2025/

Industry Update – Legal Metrology (Packaged Commodities) Rules, 2011 with amendments

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Legal Metrology (Packaged Commodities) Rules, 2011 with Amendments

The Ministry of Consumer Affairs, Food, and Public Distribution, Department of Consumer Affairs has issued The Legal Metrology (Packaged Commodities) Rules, 2011 with all amendments up to December 24, 2024.

It outlines the regulations for pre-packaged commodities in India, ensuring that consumers receive accurate information about the products they purchase. 

The rules apply to packages intended for retail sale but exclude certain categories such as:
(a) packages of commodities containing quantity of more than 25 kilogram or 25 litre
(b) cement, fertilizer and agricultural farm produce sold in bags above 50 kilogram
(c) packaged commodities meant for industrial consumers or institutional consumers

The document includes several key amendments to the Legal Metrology (Packaged Commodities) Rules, 2011, compared to earlier versions. ​ Here are some notable amendments:

  1. Consumer Definition Update:
    • The definition of “consumer” has been updated to align with the Consumer Protection Act, 2019. ​
  2. E-commerce Provisions:
    • Definitions for “E-commerce,” “E-commerce entity,” and “marketplace-based model of e-commerce” have been added. ​
    • E-commerce entities must ensure that mandatory declarations are displayed on their digital platforms. ​
  3. Retail Sale Price (MRP):
    • The format for declaring the maximum retail price has been standardized to ensure clarity and consistency. ​
  4. Unit Sale Price:
    • The requirement to declare the unit sale price in rupees, rounded off to the nearest two decimal places, has been introduced. ​
  5. QR Code Usage:
    • For electronic products, the use of QR codes to provide additional information such as the manufacturer’s address, common or generic name, and size/dimensions has been allowed. ​
  6. Packaging Size and Weight:
    • Specific packaging sizes for various commodities have been updated or added, such as for baby food, biscuits, edible oils, and more.
  7. Exemptions:
    • New exemptions have been introduced for certain packages, such as those containing loose commodities ordered through e-commerce channels and garments sold in loose or open form at the point of sale. ​
  8. Inspection and Testing:
    • Detailed procedures for inspecting and testing packages at the premises of manufacturers, packers, and dealers have been specified, including the use of statistical methods to determine compliance. ​
  9. Penalties and Compounding of Offenses:
    • The penalties for non-compliance have been updated, including specific fines for different types of offenses. ​
    • The sum for compounding offenses has been specified, with different amounts for retailers, wholesale dealers, manufacturers, and importers. ​
  10. Registration Requirements:
    • The process for registering manufacturers, packers, and importers has been clarified, including the requirement to provide a complete address and the option to register a shorter address. ​
  11. Declaration of Quantity:
    • The rules for declaring the net quantity of commodities have been refined, including the requirement to exclude the weight of wrappers and materials other than the commodity. ​
  12. Best Before/Use by Date:
    • The requirement to declare the “best before” or “use by” date for commodities that may become unfit for human consumption after a period of time has been emphasized. ​

These amendments aim to enhance consumer protection, ensure transparency, and adapt to the evolving marketplace, including the rise of e-commerce.

The e book of  Legal Metrology (Packaged Commodities) Rules, 2011 can be downloaded from https://doca.gov.in/lm-ebook/

Click here to read the ebook

source: https://doca.gov.in/lm-ebook/

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