Guidelines – AMD-CF Scheme

Govt releases Guidelines for scheme for Assistance to Medical Devices Clusters

The Department of Pharmaceuticals (DoP) has come out with the guidelines for the scheme for Assistance to Medical Device Clusters for Common Facilities (AMD-CF) with proposed financial outlay of Rs. 300 crore to offer financial assistance to strengthen the existing and new medical device clusters through creation of common infrastructure facilities

The Scheme, with two sub-schemes, is expected to help in boosting the domestic manufacturing capacity and improving the quality of clusters for sustainable growth of the medical devices sector.

The scheme further intends to support central or state governments, institutions, or organisations to establish or strengthen the testing laboratories for medical devices to meet the needs arising due to the roll out of the licensing regime of the Medical Devices Rules (MDR), 2017.

The Scheme has two components or sub schemes – Assistance for Common Facilities (CF) and Assistance for Testing Facilities (TF) – and would be running for three years from 2023-24 to 2025-26. The tenure of the scheme is from the financial year 2023-24 to the financial year 2026-27.

Both the sub-schemes are designed to set up 12 common facilities and 12 testing laboratories, under which the common facilities will be supported with a financial assistance of Rs. 240 crore (Rs. 48 crore in the first year, Rs. 128 crore in the second and Rs 64 crore in the third year) for the common facilities and Rs. 60 crore (Rs. 18 crore for the first, Rs. 30 crore for the second and Rs. 12 crore for the third year) for the testing facilities.

Assistance for Common Facilities is planned to strengthen the medical devices clusters’ capacity for their sustained growth by creating common infrastructure facilities.

Medical devices manufacturing units in a cluster who have come together to form a Special Purpose Vehicle (SPV) to execute the project of developing common facilities and the clusters promoted by the State governments, are expected to benefit from the sub-scheme.

There shall be a minimum of five medical device manufacturing units as members of SPV. Clusters promoted by state governments may not need to form an SPV.

The SPV should have representatives from cluster members, financial institutions, state and central government and R&D organisations and the individual manufacturing unit cannot hold more than 40 per cent in the SPV. The Medical Devices enterprises shall hold at least 51 per cent equity of the SPV.

For Common Infrastructure Facilities for medical device clusters, the limit of support will be 70 per cent of the approved project cost or Rs. 20 crore, whichever is less, as per the approval of the Scheme Steering Committee (SSC).

The sub scheme is expected to have benefits including improvement in quality of medical devices, regulatory compliance specified for medical devices, increased availability of trained personnel for the clusters, increased competitiveness of units in the cluster and reduction in the manufacturing cost of the devices.

The sub scheme on assistance for Testing Facilities is aimed at strengthening availability of more Medical Device Testing Laboratories in order to boost manufacturing of quality medical devices, and national or state level government of private institutions interested to establish or strengthen testing facilities for medical devices to test Class A, B, C and D medical devices including in vitro diagnostic medical devices under MDR, 2017 can apply for the assistance.

The guideline proposes a Technical Committee constituted by the DoP to assist the SSC, which will have one representative each from the Central Drugs Standard Control Organisation (CDSCO), industry and academia, and ICMR, and two representative experts having knowledge and experience in the process development, R&D, product design, testing of medical devices or medical devices manufacturing from relevant institutes such as NIPER, IISc, IITs, Sree Chitra Thirunal Institute of Medical Sciences and Technology, and CSIR, among others.

The DoP will provide overall policy, coordination and management support for the implementation of the Scheme, while the proposals under the scheme will be considered for approval by the SSC, which will be headed by the Secretary of DoP as the Chairperson, and will have members including the Drugs Controller General of India, Financial Advisor of DoP, Joint Secretary (Schemes and Medical Devices), DoP, representatives of the Ministry of Micro, Small and Medium Enterprises (MSME), the Ministry of Electronics and Information Technology (MeitY), the Department for Promotion of Industry and Internal Trade (DPIIT), and the director or the deputy secretary (Schemes) of the DoP.

Source: https://thehealthmaster.com/2023/05/11/govt-releases-guidelines-for-scheme-for-assistance-to-medical-devices-clusters/

Guidelines on Extended Producer Responsibility for Plastic Packaging

Guidelines on Extended Producer Responsibility for Plastic Packaging

CPCB has developed the Centralized portal for registration of Producers, Importers and Brand-owners (PIBOs) & Plastic Waste Processors (PWPs) which was launched on April 05, 2022 and is available at https.//cpcbeprp1astic.in/

WHEREAS, vide letters dated 17-8-2022, 18-09-2022 & 13.1 2.22, CPCB issued directions to all Plastic raw material manufacturers not to supply plastic raw material directly to producers engaged in manufacturing of plastic packaging who have not obtained valid Registration from CPCB/SPCB/PCC on the Centralised EPR Portal

CPCB has conducted a series of Meetings, Workshops with the stakeholders and incorporated modifications on the EPR Portal based on the suggestions given by the stakeholders.

In exercise of powers vested under Sectlon 5 of Environment (Protection) Act, 1986 to the Chairman CPCB, following directions are hereby issued

    • Application for grant of EPR Registration of Producer shall be processed on proof of submission of application (Application No. generated through EPR Portal) for grant of Consent before the concerned SPCBs/PCCs. Provisional EPR Registration shall be valid for an initial period of six months which may further be extended for  a period of six months provided the justification for the same has been submitted by the concerned producers. Final EPR registration shall be issued only after submission of valid CTO.
    • Closure notices already issued in the past by SPCBs/PCCs to Producers without EPR registration shall be revoked immediately upon submission of proof of application for EPR Registration by such producers.
    • No new Closure notices to be issued to producers who have provided proof of submission of application for EPR for Registration.
    • SPCBs/PCCs shall expedite the process of grant of CTE/ CTO to the Producers of Plastic Packaging as well as the Plastic Waste Processors without linking the grant of such CTE/CTO to recovery of dues, if any, to ensure speedy implementation of the EPR framework.

    The above Directions are applicable to all Producers and will be valid till October 31, 2023. It is to be further noted that timeline for supplying raw material to unregistered Producers in MSME /informal sector by plastic raw material manufacturers has been extended to April 30, 2023

    MSME Notification

    Notification issued for MSME enterprises

    Notification issued for MSME enterprises to continue to avail of all non-tax benefits of the category it was in before the re-classification, for a period of three years from the date of such upward change

    The Ministry of MSME vide S.O. 4926 (E) dated 18.10.2022 has notified that in case of an upward change in terms of investment in plant and machinery or equipment or turnover or both, and consequent re-classification, an enterprise shall continue to avail of all non-tax benefits of the category it was in before the re-classification, for a period of three years from the date of such upward change.

    This decision has been taken after due deliberations with MSME stakeholders and is in line with the Aatma Nirbhar Bharat Abhiyan. The Ministry of MSME, Government of India, has allowed those registered MSMEs to continue to avail of non-tax benefits for three years, instead of one year, in case of an upward graduation in their category and consequent reclassification.

    Non-tax benefits include benefits of various schemes of the Government, including Public Procurement Policy, Delayed Payments, etc.

    Download the notification from here:

    Classification of MSME Enterprises

    Criteria for classifying the enterprises as Micro, Small and Medium Enterprises with effect from the 1st day of July, 2020:

    (i) a micro enterprise, where the investment in plant and machinery or equipment does not exceed one crore rupees and turnover does not exceed five crore rupees;

    (ii) a small enterprise, where the investment in plant and machinery or equipment does not exceed ten crore rupees and turnover does not exceed fifty crore rupees; and

    (iii) a medium enterprise, where the investment in plant and machinery or equipment does not exceed fifty crore rupees and turnover does not exceed two hundred and fifty crore rupees.

    Composite criteria of investment and turnover for classification.–

    (1) A composite criterion of investment and turnover shall apply for classification of an enterprise as micro, small or medium.

    (2) If an enterprise crosses the ceiling limits specified for its present category in either of the two criteria of investment or turnover, it will cease to exist in that category and be placed in the next higher category but no enterprise shall be placed in the lower category unless it goes below the ceiling limits specified for its present category in both the criteria of investment as well as turnover.

    (3) All units with Goods and Services Tax Identification Number (GSTIN) listed against the same Permanent Account Number (PAN) shall be collectively treated as one enterprise and the turnover and investment figures for all of such entities shall be seen together and only the aggregate values will be considered for deciding the category as micro, small or medium enterprise.

    Composite criteria of investment and turnover for classification

    1. A composite criterion of investment and turnover shall apply for classification of an enterprise as micro, small or medium.
    2. If an enterprise crosses the ceiling limits specified for its present category in either of the two criteria of investment or turnover, it will cease to exist in that category and be placed in the next higher category but no enterprise shall be placed in the lower category unless it goes below the ceiling limits specified for its present category in both the criteria of investment as well as turnover.
    3. All units with Goods and Services Tax Identification Number (GSTIN) listed against the same Permanent Account Number (PAN) shall be collectively treated as one enterprise and the turnover and investment figures for all of such entities shall be seen together and only the aggregate values will be considered for deciding the category as micro, small or medium enterprise.

    Calculation of investment in plant and machinery or equipment

    1. The calculation of investment in plant and machinery or equipment will be linked to the Income Tax Return (ITR) of the previous years filed under the Income Tax Act, 1961.
    2. In case of a new enterprise, where no prior ITR is available, the investment will be based on self-declaration of the promoter of the enterprise and such relaxation shall end after the 31st March of the financial year in which it files its first ITR.
    3. The expression ‘’plant and machinery or equipment’’ of the enterprise, shall have the same meaning as assigned to the plant and machinery in the Income Tax Rules, 1962 framed under the Income Tax Act, 1961 and shall include all tangible assets (other than land and building, furniture and fittings).
    4. The purchase (invoice) value of a plant and machinery or equipment, whether purchased first hand or second hand, shall be taken into account excluding Goods and Services Tax (GST), on self-disclosure basis, if the enterprise is a new one without any ITR.
    5. The cost of certain items specified in the Explanation I to sub-section (1) of section 7 of the Act shall be excluded from the calculation of the amount of investment in plant and machinery.

    Calculation of Turnover

    • Exports of goods or services or both, shall be excluded while calculating the turnover of any enterprise whether micro, small or medium, for the purposes of classification.
    • Information as regards turnover and exports turnover for an enterprise shall be linked to the Income Tax Act or the Central Goods and Services Act (CGST Act) and the GSTIN.
    • The turnover related figures of such enterprise which do not have PAN will be considered on self-declaration basis for a period up to 31st March, 2021 and thereafter, PAN and GSTIN shall be mandatory.

      In case of an upward change in terms of investment in plant and machinery or equipment or turnover or both, and consequent re-classification, an enterprise will maintain its prevailing status till expiry of one year from the close of the year of registration.

      In case of reverse-graduation of an enterprise, whether as a result of re-classification or due to actual changes in investment in plant and machinery or equipment or turnover or both, and whether the enterprise is registered under the Act or not, the enterprise will continue in its present category till the closure of the financial year and it will be given the benefit of the changed status only with effect from 1st April of the financial year following the year in which such change took place. Other aspects relating to registration of enterprises, grievance redressal, etc. are mentioned in the Gazette Notification S.O. 2119 (E) dated June 26, 2020.

    Source : IBC Laws – Classification of MSME Enterprises under the Micro, Small and Medium Enterprises Development (MSMED) Act, 2006 – N. No. S.O. 2119(E) dated 26.06.2020- amended up to date

    https://pib.gov.in/PressReleasePage.aspxPRID=1869091#:~:text=2022%20has%20notified%20that%20in,of%20three%20years%20from%20the

    https://www.rbi.org.in/Scripts/NotificationUser.aspx?Id=11934&Mode=0

    After 14 years since the MSME Development Act came into existence in 2006, a revision in MSME definition was announced in the Atmanirbhar Bharat package in May 2020

    WAD 2022 Celebrations from CCC

    2 Days Conference on Sustainability – World Accreditation Day 2022 Celebrations at Chennai on June 9-10 2022 (Hybrid Session)

    About #WAD2022

    June 9th 2022 marks World Accreditation Day (#WAD2022), a global initiative established by ILAC and IAF to promote the value of accreditation.

    Download the following announcements :

    This year’s theme :

    Accreditation: Sustainability in Economic Growth and the Environment, focuses on how accreditation supports the United Nations Sustainable Development Goals – (SDGs) 6, 7, 8, 9, 11, 12, 13, 14, 15.

    #WAD Celebrations – an annual initiative from Consultants Consortium of Chennai (CCC)

    CCC has been organising series of Knowledge Sessions for the benefit of the industry during WAD Month since its inception. WAD 2020 and WAD 2021 were well received by the industry. We had conducted virtual learning sessions during this period.

    #WAD2022 Celebrations

    WAD 2022, however would be a Hybrid Session. We are planning to organise a physical session in University Auditorium in Chennai with a target audience of around 100 -150 members (offline) and plus online viewers.

    The Conference is jointly organized by International Accreditation Service (IAS), USA and Bureau of Indian Standards

    International Accreditation Service

    IAS is a nonprofit, public-benefit corporation that help organizations demonstrate compliance and competence to their customers, regulators and the public. IAS has been providing accreditation services since 1975. IAS accredits a wide range of companies and organizations including governmental entities, commercial businesses, and professional associations. IAS accreditation programs are based on recognized national and international standards that ensure domestic and/or global acceptance of its accreditations.

    IAS also maintains signatory status in a number of global multilateral recognition arrangements under Asia Pacific Accreditation Cooperation (APAC), International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC). IAS is a member of the ICC Family of Solutions.

    As one of the leading accreditation bodies in the United States, IAS is a signatory to the three primary international organizations that form a unified system for evaluating and recognizing competent accreditation bodies worldwide.

    Bureau of Indian Standards

    BIS is the National Standard Body of India established under the BIS Act 2016 for the harmonious development of the activities of standardization, marking and quality certification of goods and for matters connected therewith or incidental thereto. BIS has been providing traceability and tangibility benefits to the national economy in a number of ways – providing safe reliable quality goods; minimizing health hazards to consumers; promoting exports and imports substitute; control over proliferation of varieties etc. through standardization, certification and testing

    Keeping in view, the interest of consumers as well as the industry, BIS is involved in various activities as given below:

    Standards Formulation
    Product Certification Scheme
    Compulsory Registration Scheme
    Foreign Manufacturers Certification Scheme
    Hall Marking Scheme
    Laboratory Services
    Laboratory Recognition Scheme
    Sale of Indian Standards
    Consumer Affairs Activities
    Promotional Activities
    Training Services, – National & International level
    Information Services

    Conference Theme :

    Sustainability in Economic Growth and the Environment
    -How accreditation supports the United Nations Sustainable Development Goals (SDGs) 6, 7, 8, 9, 11, 12, 13, 14, 15.

    Conference Sessions are built for multiple sectors touching upon the Sustainability Initiatives in various sectors and applicability of various Standards, Certifications, Accreditations , Regulations to ensure that Sustainable Products and Services are offered to Consumers.

    Sustainability is a Trade Issue and World Markets are linking World Trade to Sustainability initiatives adopted by various countries.

    ESG is based on standards set by lawmakers, investors, and ESG reporting organizations (e.g., GRI, TCFD, MSCI), whereas Sustainability Standards — while also set by standards groups like GHG Protocol — are more science-based and standardized.

    Dates :
    June 9th and 10th 2022 – Thu & Fri
    Time – 10 00 am – 5 45 pm IST
    Session Mode – Hybrid (Online and Physical)
    Venue – Auditorium inside Anna University Campus

    Who should attend ?

    Sessions would be open to Accreditation Bodies, Certification Agencies, Conformity Assessment Bodies, Inspection bodies, Govt organisations, Members of Trade & Industry Associations, Chambers of Commerce, Entrepreneurial Hubs, MS Consultants, Technical Experts, Startups, Innovators

    Sessions at a glance :

    Program Agenda
    Day 1 – Inaugural Session

    Registration Details

    Open to all stakeholders in Conformity Assessment.

    Industry, ABs, CBs, CABs, Inspection bodies, Consultants, Technical Experts, Industry Associations, Innovators, Start-ups, Entrepreneurial Platforms, Government organisations.

    There is NO REGISTRATION FEE

    However prior registration is a must for participation.


    Contact Co-ordinators

    Ms Rama Venugopal, President
    Whatsapp +91 9840870532
    Email – contact@ccc-consultants.org

    Mr D Srikanthan, Secretary
    Whatsapp +91 9003056539
    Email – secretariat@ccc-consultants.org

    Secretariat Office
    Phone+044 24462337 / 24462338
    Email – communication@cccassociation.org

    MSME Definition Widened

    MSME Definition to include Retail and Wholesale Trade Businesses

    Ministry of #MSME has announced revised guidelines for #MSMEs with inclusion of Retail and Wholesale trade businesses as MSMEs. This is done to strengthen these MSME businesses and make them engines for economic growth.

    Shri Gadkari said the revised guidelines will benefit 2.5 Crore Retail and Wholesale Traders. He said Retail and wholesale trade were left out of the ambit of MSME, now under the revised guidelines, retail and wholesale trade will also get benefit of priority sector lending under RBI guidelines.

    With the revised guidelines the Retail and wholesale trades will be now be allowed to register on Udyam Registration Portal.

    Source – https://pib.gov.in/PressReleasePage.aspx?PRID=1732193

    MSME Registration Link – Udyam Registration Portal Link