Category: Industry Update

Procedure for submission of cough syrups for Testing

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Mandatory Testing of Cough Syrup before Export – Procedure for submission of cough syrups for Testing

Cough syrup exporters will have to undertake testing of their products at specified Government Laboratories and obtain Production of Certificate of Analysis with effect from June 1 before getting permission for the outbound shipments

Ministry of Commerce & Industry has issued a Notification No.06/2023 dated 22nd May 2023 permiting export of cough syrups, subject to the export sample being tested and production of Certificate of Analysis (COA) issued by any of the Central Government Laboratories and any NABL Accredited State Drug Testing Laboratory.

The specified Central Government labs include Indian Pharmacopoeia Commission, Regional Drug Testing Lab (RDTL – Chandigarh), Central Drugs Lab (CDL – Kolkata), Central Drug Testing Lab (CDTL – Chennai Hyderabad, Mumbai), RDTL (Guwahati)] and the NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited drug testing labs of State Governments

In order to facilitate the process of testing of cough syrups at the said laboratories, the following are the pre-requisite requirements for submission of samples :

  1. Covering letter from the Manufacturer / Exporter on Letterhead addressed to concerned Laboratory
  2. Manufacturing License of the product for Export purpose
  3. Export Order
  4. Representative sample from the export consignment
  5. Thrice the quantity required for performing complete analysis of the sample
  6. Qualitative composition of product including excipients
  7. Certificate of analysis by the manufacturer of the particular batch and method of analysis (STP)
  8. Reference / Working standard (with traceability certificate) and placebo as applicable
Click here to read the Notification

Source: https://www.dgft.gov.in/CP/?opt=notification

I-T invites comments

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I-T invites comments on draft rules for valuing startup investment by non-residents

THE INCOME TAX department on 26th May 2023 invited comments from stakeholders on rules for valuing non-resident investment in unlisted startups

The Central Board of Direct Taxes (CBDT) has, in a draft notification, invited comments on the draft rule 11UA of Income-tax Rules, 1962 on the computation of Fair Market Value (FMV) of unquoted equity shares through five methods under Section 56(2)(VIIb) of Income-tax Act, 1961.

Rule 11UA, which is now in practice, prescribes two valuation methods – Discounted Cash Flow (DCF) and Net Asset Value (NAV) – for resident investors.

The Government intends to include five additional valuation methods specifically for non-resident investors, in addition to the existing DCF and NAV methods.

Draft notification released by CBDT is given below. Stakeholders and the general public can send suggestions and comments on the draft rules by June 5 to ustpl2@nic.in

Click here to read the Draft Notification

EGA 2023 – Application Now Open

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Envirocare Green Awards 2023

Envirocare Green Awards is an initiative by Envirocare Labs started in 2018 with a vision to motivate and empower professionals & organization’s in the field of environment. 

EGA is a non-commercial activity of self-motivated and like-minded people dedicated to making a positive difference to Sustainable Care. 

The objective is to inspire stakeholders to think green & contribute towards a world that is not only progressive but also responsible towards its provider.

The applicants for these awards will be evaluated by an independent international Jury – renowned & respected in their professional fields. The award ceremony would be preceded by keynote speaker sessions.  

The application for this award is online and is open for across the globe under the following categories:

1. Individual / s

2. Private Ltd / LLP / MSME

3. Public Sector / Large Corporates

4. Non Government Organisation NGO / Cooperatives

5. Government Organisation / Municipal

6. Academia

7. Others

To apply please click here for online Google Form:https://forms.gle/ZfWBjSR8PA6W5Bqe7

The short listed applicants will be required to make online presentation for Jury evaluation. The data submitted would be confidential and used only for the purpose of EGA

Application deadline 15th June 2023, Please feel free to reach out to EGA Secretariat Ms Deenal Shah: +91 9167232025 | ega@envirocare.co.in

For regular updates on EGA 2023 , visit  https://lnkd.in/eDiKu3R

Best Practices in Social Sector

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NITI Aayog released the “Best Practices in Social Sector: A Compendium, 2023”

NITI Aayog released the “Best Practices in Social Sector: A Compendium, 2023” in collaboration with the United Nations Development Programme.

To commemorate 75 years of India’s independence and highlight and laud the efforts of Union Ministries and State Governments, this compendium includes 75 case studies cutting across 14 key social sectors. The case studies have been sourced from all States/ Union Territories and 30 Ministries and Departments of the Government of India.

The seventy-five best practices highlight models which are innovative, sustainable, replicable and impactful. The aim of this exercise has been to synthesise lessons for the future to expand, enhance and improve life at the grassroots level. Due care was taken to ensure that the cases identified are spread over diverse themes, including education, health and nutrition, e-governance and digitization, agriculture, women’s empowerment, sports, and financial inclusion, among others.

Click here to read the document

Source: https://niti.gov.in/node/3568

Certification Schemes from AMTZ 

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Program on Healthcare Textiles Processing Facility Certification Scheme and Program on Biomedical Equipment Maintenance Certification (BEMC) Scheme 

Program on Healthcare Textiles Processing Facility Certification Scheme  

The scheme aims to ensure the quality of healthcare textiles, including personal protective equipment (PPE), by certifying the facilities that process them. Scheme covers Multiple-use healthcare Textiles to be processed only as Single-use healthcare Textiles are not meant to be used again.   

Program on Biomedical Equipment Maintenance Certification (BEMC) Scheme    This voluntary scheme applies to maintenance process certification including Testing and verification of MEDICAL EQUIPMENT and SYSTEM (combination of medical equipment), or parts of such equipment or systems, which need maintenance on a periodic basis.

This voluntary scheme can be implemented by the hospital through biomedical maintenance department, biomedical maintenance by the manufacturer and third-party maintenance provider.  

These voluntary schemes are an initiative of AMTZ, in collaboration with the Association of Indian Medical Device Industry (AiMeD) and Association of Healthcare Providers India (AHPI).


Date: 27th May 2023

Time: 3:00 pm to 6:00pm IST

Mode – Virtual Mode / Webinar
Program Agenda
Click here to Register

Announcement – AMR Quest 2023

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AMR Quest 2023-The Call for Applications is now open! Apply by 15th June 2023

The Centre for Cellular and Molecular Platforms(C-CAMP) is excited to announce C-CAMP AMR Quest 2023 and invites applications from innovators and start-ups working in the domain of Antimicrobial Resistance.
 
C-CAMP AMR Quest is one of its kind events to attract, identify, reward, and foster the innovators who are working towards the development of solutions to tackle AMR and present opportunities for funding and commercialization. The ideas can be from any domain of AMR like Non-traditional therapeutics, Preventatives, Diagnostics, and Direct Acting Small Molecules.  
 
The exciting rewards associated are (*conditions apply):

  1. Acceptance into the 3-month C-CAMP AMR Accelerator Program 2023. In this, an opportunity will be provided to develop the solution further with mentorship in the domains of science, business, regulatory, patent law, fundraising, etc
  2. Acceptance into one week C-CAMP AMR Innovators School 2023.
  3. Participation in any one of the following International Conferences/Programs, with all costs covered: 
    • The 8th AMR Conference Novel Antimicrobials & AMR Diagnostics cocci and Staphylococcal Infections. Congress Center Basel, Switzerland on 6-7 March 2024.
    • The 34th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2024, Barcelona, Catalonia, ES on 27 – 30 April 2024
  4. Mentorship for seeking funding opportunity through CARB-X funding round.
  5. Spotlight in C-CAMP’s social media platforms.
  6. Opportunity to attend appropriate C-CAMP workshops & events.

C-CAMP AMR Quest 2023 is open to Individuals (Including researchers, scientists, post-doctoral fellows, academicians, students, and individual innovators), startups, SMEs, and Large Companies.

Link to apply: https://forms.gle/z46DZi7bbxzpgSZJ9

Last date to apply: 15th June 2023

For further queries write to us at amr@ccamp.res.in

Source: https://www.ccamp.res.in/amr-quest?utm_source=sendinblue&utm_campaign=AMA-AMR%20Quest%202023_copy&utm_medium=email

Young Entrepreneurs Program

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TiE Chennai – Young Entrepreneurs Program (TYE) 2023

TiE Young Entrepreneurs Program (TYE) – 2023

TiE conducts TYE (TiE Young Entrepreneur), a global program for school students of classes 9 – 12. Through this program, TiE is fostering Entrepreneurship and Leadership among the youth at an early age. The classes are conducted by professionals and successful entrepreneurs, followed by students brainstorming a business idea and preparing a business plan. Each team is assigned a senior industry leader as a mentor.
 
TYE is running in various cities across the world including Atlanta, Austin, Boston, North Carolina, Colorado, Detroit, Seattle, San Diego, Ohio, Dallas, Oregon,  Vancouver, Washington DC, Delhi, Hyderabad, Jaipur, Kanpur, Ahmedabad, Kolkata, Chennai, Melbourne, Australia, Singapore, London and Manchester. 

This TYE Session is organised by TiE Chennai

Who Can Attend?

High School Students of Classes 9th to 12th

📅 Jun 17 – Jul 16, 2023     ⏲  04:30 PM (IST)

📍Chennai, Tamil Nadu – India

Mode – Physical Classroom Sessions (Weekend Sessions – Sat & Sun)

Program Fee – Rs 5000

More Information
Register Here

Workshop by IBSC – AMTZ

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Workshop on Indian Medical Device Regulations

IBSC – AMTZ is organising a Workshop on Indian Medical Device Regulations

Indian Medical Device Regulations workshop ensures the safety and effectiveness of medical devices and gives overview of the efficient and safe manufacture of medical devices

LEARNING OBJECTIVE

  • Candidate will get the knowledge on new legal requirements of the Indian Medical Device Regulations (IMDR).
  • Overview of the safe and efficient manufacture of medical devices in accordance with the Indian Medical Device Regulations (MDR).
  • To understand the responsibilities and obligations as a manufacturer, importers, and distributers of medical devices.

COURSE AGENDA

  • Contents and Fundamentals of the Indian Medical Device Regulation (IMDR)
  • Classification of Medical Devices
  • Basic Requirements
  • Content Requirements for Technical Documentation
  • Validity of Conformity Assessment and Certification, Transition Periods
  • Requirements for Manufacturers, Importers, Distributors and Service Partners

TARGET AUDIENCE

  • Medical device manufacturers
  • Consultants 
  • Regulatory Affairs Specialists
  • Expert advisors in medical devices regulatory affairs
  • Working biomedical engineers / medical device professionals
  • Pursuing Students are also eligible

Fee: INR 3,540 including 18% GST

CANDIDATES WILL BE PROVIDED WITH IBSC CERTIFICATE


LAST DATE FOR REGISTRATION: 30th May 2023 


TRAINING DURATION: 2 DAYS (9th & 10th June 2023)


LOCATION: Faculty of Pharmacy, MS Ramaiah University of Applied Sciences, Bangalore 

For more information, please contact

Mr. Nitturi Naresh Kumar
Mobile: +91-8897330990 | +91-7075737284
WhatsApp Link: https://wa.me/918897330990
WhatsApp Link: https://wa.me/917075737284
trainings@amtz.in

Source: https://ibsc-amtz.in/coursedetails/25

Announcement by MoHFW on CROs

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Draft New Drugs and Clinical Trials (……Amendment) Rules, 2022

Ministry of Health and Family Welfare issued a Notification regarding Draft New Drugs and Clinical Trials (……Amendment) Rules, 2022 on 11th May 2023 to amend the New Drugs and Clinical Trials Rules, 2019. They shall come into force on the date of their final publication in the Official Gazette unless otherwise specified.

in rule 2, in sub-rule
(1), after clause (i), the following clause shall be inserted, namely:—
“(ia) ‘Clinical Research Organization’ means 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 some or all of the tasks, duties and/or obligations regarding clinical trial, such transfer or delegation of contractual transfers or obligations must be in writing.”

After Chapter V, the following Chapter shall be inserted, namely:— CHAPTER VA CLINICAL RESEARCH ORGANISATION

38A. Registration of Clinical Research Organisation

38B. Application for Registration of Clinical Research Organisation

38C. Grant of registration to Clinical research organisation

38D. Validity period and renewal of registration of Clinical Research Organisation

38E. Conditions of registration

38F. Inspection of Clinical Research Organisation registered with Central Licencing Authority

38G. Suspension or cancellation of registration of Clinical Research Organisation

In the Eighth Schedule, after Form CT-07A, following Forms shall be inserted, namely

Form CT-07B Application for Registration / Renewal of Clinical Research Organisation

Form CT- 07C Grant of Renewal of Registration of Clinical Research Organisation

After the Eighth Schedule, following Schedule shall be inserted, namely NINTH SCHEDULE – REQUIREMENTS AND GUIDELINES FOR REGISTRATION OF CLINICAL RESEARCH ORGANISATION

Objections and suggestions which may be received from any person within 15 days from the date on which the copies of the Gazette of India containing these draft rules are made available to public;


Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare,Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi – 110011 or emailed at drugsdiv-mohfw@gov.in.

Click here to read the Notification

Announcement – NMC

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Common National Medical Register for all practitioners across country – Announcement by NMC

All registered medical practitioners across the country will now be covered under a common National Medical Register with each of them allotted a unique identification number, as per a gazette notification recently released by the National Medical Commission (NMC) titled “Registration of Medical Practitioners and Licence to Practice Medicine Regulations, 2023”.

The notification also makes the passing of National Exit Test (NEXT) compulsory for both Indian and foreign medical graduates for the purpose of registration with the National Medical Register.

Under the latest notification, the national register will contain all the entries of the registered medical practitioners of all State registers maintained by the various State Medical Councils.

Further, this register will be made public on the official NMC website and will contain relevant information about a medical practitioner including registration number, name, father’s name, date of registration, place of working (name of hospital/institute), medical qualification including additional medical qualification, speciality, year of passing, university, name of the institute/university where qualification was obtained.

The notification explains that until such time that these regulations and appropriate sections are in force, licence to practise and prevailing system of registration shall continue.

Besides, the notification also notes down the process of renewal clearly noting that a licence to practise is valid only for five years, after which all doctors will have to apply for renewal to the State Medical Council.

The NMC has also laid down the process of registration of additional qualifications, renewal of licence to practise medicine, transfer of licence to practise, removal and restoration of registration, transitory provisions, denial of licence to practise, among others.

On denial of licence to practise, the notification says that if the application of a candidate for grant of licence to practise /for renewal is rejected by the State Medical Council on any ground, the applicant concerned may file an appeal to the Ethics and Medical Registration Board (EMRB) against the decision of the State medical Council, within 30 days of receipt of such decision.

The EMRB shall examine the appeal and in case the first appeal is rejected by the Board, the applicant may file a second appeal to the NMC, within a period of 60 days from receipt of communication from the EMRB. “The decision of the NMC shall be final,” said the notification.

Click here to read the Notification

Source:https://www.thehindu.com

Source:https://www.nmc.org.in/

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