Materiovigilance Program of India (MvPI) News Letter
Indian Pharmacopoeia Commission has released its News Letter – Materiovigilance Program of India Volume 5 – Issue 1 recently.
Sharing the same for information
News Letter
Category: Services Exports
Procedure for submission of cough syrups for Testing
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 :
- Covering letter from the Manufacturer / Exporter on Letterhead addressed to concerned Laboratory
- Manufacturing License of the product for Export purpose
- Export Order
- Representative sample from the export consignment
- Thrice the quantity required for performing complete analysis of the sample
- Qualitative composition of product including excipients
- Certificate of analysis by the manufacturer of the particular batch and method of analysis (STP)
- Reference / Working standard (with traceability certificate) and placebo as applicable
SEPC News Letter
SEPC News Letter
SERVICES EXPORT PROMOTION COUNCIL has released its latest News Letter for the month of May 2023
Launch of Healthcare textiles processing facility certification Scheme
Healthcare Textiles Processing Facility Certification Scheme Launched in India
On the occasion of World Health Day on 7 April, the triple A partnership of AMTZ LTD, Association of Healthcare Providers – AHPI (India) and Association of Indian Medical Device Industry – Aimed India, launched Healthcare Textiles Processing Facility Certification Scheme (HTPFCS) to ensure the quality of healthcare textiles, including personal protective equipment (PPE), by certifying the facilities or laundries that process them for reuse
While the Covid-19 pandemic has highlighted the importance of healthcare textiles and PPE in protecting healthcare workers and patients from infection, the quality of these products depends not only on the materials used but also on the processing facilities where they are sterilized, cleaned, and packaged.
The Healthcare Textiles Processing Facility Certification Scheme will help ensure that these facilities meet international standards for quality and safety. It aligns with international standards and guidelines, including those of the World Health Organization (WHO) and the International Organization for Standardization (ISO).
Under the scheme, healthcare textiles processing facilities can apply for certification by undergoing a rigorous evaluation process that includes site visits, documentation reviews, and testing of samples.The certification will be valid for three years, after which the facility will need to undergo a recertification process.
The Certification would be carried out by independent third party certifying agencies to be accredited as per applicable international standard, ISO 17065, and approved by AMTZ to assure their competence, impartiality and consistent implementation of certification process.
The Healthcare Textiles Processing Facility Certification Scheme is open for applications from healthcare textiles processing facilities in India and abroad.
Conference on Telehealth
SMART Hospitals India Conference 2023 at Medical Fair India, Pragati Maidan, New Delhi
SMART Hospitals India Conference 2023 at Medical Fair India, New Delhi
Conference Theme 2023
Telehealth : Where SMART Technologies connect with healthcare settings for better patient outcomes
Healthcare Service Providers are increasingly adopting multiple digital health initiatives for better patient connect and seamless delivery of patient care. FUTURE SMART Healthcare Establishments focus on providing solutions to meet the rising needs of SMART PATIENTS across the globe.
Smart Hospitals Business Sessions this year are designed to create focused discussions around TELEHEALTH Technologies as listed below
Session 1 – Telehealth Technologies , Solutions for Better Patient Care in Healthcare Settings in India
Session 2 – Delivering Quality Care through Telehealth Quality System Program in Clinical Settings
Session 3 – Health Technology Assessments and Regulatory Requirements of Telehealth Solutions in India
Program Date :
Date: 29th April 2023 – Saturday
Time: 10:00 a.m. – 5:00 p.m.
Venue: Hall 5, Pragati Maidan, New Delhi
For more information on program, registration links, do visit – https://www.medicalfair-india.com/en/Special_Shows/Smart_Hospitals
Prior registration is a must to attend the conference.
For enquiries related to Conference Partnerships, Stall bookings in the Expo, enquiries, 𝗽𝗹𝘀 𝘄𝗿𝗶𝘁𝗲 𝘁𝗼 :
VermaA@md-india.com / +91-124-4544507
For enquiries related to Delegate Registration to the Conference, please write to :
Ms Rama Venugopal
Vice Chairperson – SMART Hospitals Conference
Email – info@smarthospitals.events
WhatsApp – +91 7338992778 / +91 9840870532
SEPC pavilion at Hannover Messe 2023
Request for participation in SEPC Pavilion at Hannover Messe 2023 (17th to 21st April, 2023)
SEPC is taking up a space to create and facilitate business opportunities for companies in India in Engineering. Engineering Consulting, Architecture, Construction and Design, Environmental, Agriculture & Forestry services. SEPC is taking all necessary steps towards the export promotion of this sector in its renewed focus
SEPC lndia invites participation of its members at their stand at Hannover Messe 2023 which is scheduled from 17th April to 21st April,2023. SEPC is taking 100 sqm space from two sides open in the prominent hall dedicated for services sector covering:
- Engineering Design & related Construction
- Energy Management & Solutions
- Industry 4.0
- Artificial Intelligence & Machine Learning
- Digital Ecosystems
- Automation, Motion & Drives
- Compressed Air & Vacuum
- Engineered Parts & Solutions
- CO2-neutral Production
- Hydrogen and Fuel Cells
- Global Business & Markets
- Logistics
Key Takeaways from participation apart from International Branding:
- To forge new business networking, enable newer concepts and new trend adaptation for increasing the exports.
- Exploring business prospects/overseas busters from all fegions.
- Expand the marketing network and strengthen the business contracts of Indian companies.
- Direct Contact with leading Decision makers of the industry.
- List of visitors being shared post event
Indian Business Delegation for Buyer Seller Meet (BSM) in ASEAN Region
Indian Business Delegation for Buyer Seller Meet (BSM) in ASEAN Region from 27th Mar– 07th April, 2023
SEPC with the support of Department of Commerce, Ministry of Commerce & Industry, Government of India and recommendation by EP Services Division, is organizing India’s services sector trade delegation Buyer Seller Meet (BSM) to ASEAN region covering Indonesia, Philippines, Vietnam & Thailand from 27th March to 07th April, 2023 covering following sectors which have demand in ASEAN region:
➢ Accounting and Auditing Services
➢ Educational Services
➢ Healthcare Services
➢ Architectural, Construction & Related Engineering, Environmental Services
➢ KPO/ ITO Services
➢ Logistics Services
➢ Tourism Services
➢ Entertainment Services
➢ Other Professional services
Benefits you may get while participating at BSM to ASEAN region.
• Focused pre scheduled B2B meetings in each country
• Understand the market potential from experts in ASEAN region.
• Networking Opportunities with potential buyers in ASEAN region.
• Generate business leads and sign MOUs for collaborations.
• Meetings with relevant government and related stakeholders.
SEPC registered Members whose export turnover during the previous financial year is less than/up to Rs.50 crores (should not be zero) and who have completed one year of membership with SEPC will be eligible for assistance under new MAI scheme up to a maximum of Rs. 75,000/- towards economy class air fare, subject to terms and conditions of new MAI scheme and approval by the Ministry of Commerce & Industry
Health Ministry to rope in State Governments to establish Medical Devices Testing Laboratories
Health Ministry to rope in State Governments to establish Medical Devices Testing Laboratories
The Ministry of Health and Family Welfare (MoHFW) is planning to rope in state governments also to establish or designate their existing laboratories as state medical devices testing laboratories and bring in enabling rules to support setting up of more testing laboratories for medical devices across the country as the sector is experiencing major regulatory paradigm shift including the introduction of a licensing regime.
A draft rule has been notified by the Ministry, under which it has proposed to insert a new sub-rule to the Rule 19, that the state government may, by notification, establish state medical devices testing laboratory for the purpose of testing and evaluation of medical devices or to carry out any other functions as may be specifically assigned to it.
The State Government may also designate any laboratory having facility for carrying out and evaluation of medical devices as state medical devices testing laboratory for the purpose, with a condition that the laboratory should be accredited by the National Accreditation Body for Testing and Calibration Laboratories (NABL).
It has also added a definition to the state medical devices testing laboratory, stating that it means a laboratory established or designated by the state government under the Rule 19(3), which is the freshly proposed sub-rule. While the Rule 19 was specifically for Central medical devices testing laboratory, it has been proposed for amendment by omitting the word ‘Centre’, this emphasising that the laboratories could be established either by the Central or the state government. The draft amendment is expected to be taken into consideration in seven days from the date of making the draft available to the public.
Source: http://www.pharmabiz.com/NewsDetails.aspx?aid=156725&sid=1
USDA Proposes New Requirements for the “Product of USA” Label Claim
USDA Proposes New Requirements for the “Product of USA” Label Claim
USA’s Agri Products Regulator proposes to introduce New Labelling Norms for Made in USA to bring more clarity to Consumers and also to protect Consumer Safety.
Some key takeaways from the announcement are : –
-New regulatory requirements are proposed to better align the voluntary “Product of USA” label claim with consumer understanding of what the claim means –
-The proposed rule allows the voluntary “Product of USA” or “Made in the USA” label claim to be used on meat, poultry and egg products only when they are derived from animals born, raised, slaughtered and processed in the United States.
– The increased clarity and transparency provided by this proposed change would prevent consumer confusion and help ensure that consumers understand where their food comes from.
– “American consumers expect that when they buy a meat product at the grocery store, the claims they see on the label mean what they say”
– “These proposed changes are intended to provide consumers with accurate information to make informed purchasing decisions
– USDA’s proposed rulemaking is supported by petitions, thousands of comments from stakeholders, and data.
– The nationwide consumer survey conducted by the Regulator has revealed that the current “Product of USA” labeling claim is misleading to a majority of consumers surveyed, with a significant portion believing the claim means that the product was made from animals born, raised, slaughtered and processed in the United States
– USDA’s comprehensive review shows there is a clear need to revise the current “Product of USA” label claim so that it more accurately conveys U.S. origin information.
THE MEDICAL DEVICES RULES, 2017
THE MEDICAL DEVICES RULES, 2017
The draft of the Medical Devices Rules, 2016 was published, as required under sub-section (1) of Section 12 and sub-section (1) of Section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), vide notification number G.S.R. 983(E), dated the 17th October, 2016, by the Central Government.
All objections and suggestions received in response to the said draft notification have been duly considered by the Central Government; Now, therefore, in exercise of the powers conferred by Section 12 and Section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the Medical Devices Rules, 2017
These rules shall, unless specified otherwise, come into force with effect from 1st day of January, 2018
These rules shall be applicable in respect of,—
(i) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 2 of 248 and blood component collection bag with or without anticoagulant covered under sub-clause (i);
(ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and
(iii) devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940).
Source:https://www.drugscontrol.org/pdf/Medical%20Devices%20Rules,%202017.pdf