Category: Pharmaceuticals

Proposal for a Directive on Green Claims

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Proposal for a Directive on substantiation and communication of explicit environmental claims (Green Claims Directive)

On 22nd of March 2023 a proposal of the Directive of the European Parliament and of the Council on substantiation and communication of explicit environmental claims (Green Claims Directive) has been published by the European Commission.

This proposal is based on Article 114 of the Treaty of the Functioning of the European Union (TFEU), which applies to measures that aim to establish or ensure the functioning of the internal market, while taking as a base a high level of environmental protection

The proposal aims to ensure the functioning of the internal market for economic actors operating in the internal market and consumers relying on environmental claims. The measures proposed in this Directive will increase the level of environmental protection, while leading to further harmonisation regarding the regulation of environmental claims, and would avoid market fragmentation due to diverging national approaches that were introduced or would be introduced in the absence of rules at EU level.

The Proposal of the Directive states that penalties can be imposed: Member States shall ensure that when penalties are to be imposed in accordance with Article 21 of Regulation (EU) 2017/239449, the maximum amount of such fines being at least at 4 % of the trader’s annual turnover in the Member State or Member States concerned.

The Directive shall not apply to sustainability information involving messages or representations that may be either mandatory or voluntary pursuant to the Union or national rules for financial services, such as rules relating to banking, credit, insurance and re-insurance, occupational or personal pensions, securities, investment funds, investment firms, payment, portfolio management and investment advice

Click here to read the proposal

Source:https://environment.ec.europa.eu/publications/proposal-directive-green-claims_en

Implementation of Section 42 (a) of Pharmacy Act & Rule 65 of D&C Act

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Implementation of Section 42(a) of Pharmacy Act 1947 and Rules 65 of Drugs and Cosmetics Act 1945

Drugs Controller General of India has issued a letter to all States / UTs Drug Controllers and Pharmacy Council of India on strict Implementation of Section 42(a) of Pharmacy Act 1947 and Rules 65 of D&C Act 1945 on the following:

  • To ensure that Pharmacists are physically present in the retail pharmacies / medical stores and that medicines are sold / dispensed under their direct supervision
  • To ensure that no prescription medicine is sold / dispensed from the retail medicine shop without a proper and valid prescription
Click here to read more

CAHO Webinars

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Webinar on Understanding Technical Regulations and Standards

Healthcare services rely on a number of products – from drugs to medical devices to food to electronic items. Many of these items not only need to be of high quality but also safe to use.

Since many products have health and safety implications, they are or should be regulated while others may not need to be regulated but quality needs to be assured.It is therefore necessary for healthcare industry to understand the world of what are called technical regulations and standards, how it should go about procurement of products it needs and what kind of certificates it should rely on

CAHO is hosting a webinar on the topic Understanding Technical Regulations and Standards by Mr.Anil Jauhri , (Former CEO,National Accreditation Board for Certification Bodies (NABCB)) on 23rd March 2023 between 4.00 to 5.30 pm.

Click here for Registration

Indian Business Delegation for Buyer Seller Meet (BSM) in ASEAN Region

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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

Click here to read more
Click here for Itinerary Details
click here for Registration

Health Ministry to rope in State Governments to establish Medical Devices Testing Laboratories

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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.

Click here to read more
Click here to read Notification

Source: http://www.pharmabiz.com/NewsDetails.aspx?aid=156725&sid=1

Andhra Chamber – Business Delegation Tour

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Andhra Chamber – Business Delegation to Vietnam Expo April 2023

Andhra Chamber of Commerce has been organising Business Delegations to various countries for the members to explore export / business opportunities. Due to Covid 19 Pandemic, we could not organise the delegation in the last three years.

Vietnam is one of the fast-growing countries in Asia, even worldwide and now since the travel industry has also opened up, the Chamber is planning for a Business Delegation to Vietnam.

The Vietnam Expo happens every year and this year it is happening in the first week of April 2023. The Expo targets many sectors like Agricultural products, Food & Beverage, Machinery & Supporting industries, Digital technology & E-commerce; Electric & Electronics; Home Living, Trade promotion; Logistics & services etc.,

The details of the delegation along with the Registration form are enclosed and we invite you to be part of this Delegation to expand your business.

Last date of Registration is extended to 04th March 2023. Please fill up and send the registration form to enable us to enroll you for the Business Delegation to Vietnam.

For any further clarifications, please feel free to contact:

Ms.R.Vijayalakshmi
Secretary General,
Andhra Chamber of Commerce,
“Velagapudi Ramakrishna Bldg.”
No. 23, Third Cross Street,
West CIT Nagar, Nandanam,
Chennai-600035.
Phone: 24315278/79
Email: andhrachamber1@gmail.com
Web: http://www.andhrachamber.com

For Registration, Click here
To view Brochure, click here

Notification – FSSAI – Instant Renewal of License/ Registration

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FSSAI – Ease of Doing Business : Instant Renewal of License/ Registration

The Food Safety and Standard Authority of India, (FSSAI) has issued a notification on 11th January 2023 regarding Ease of Doing Business: Instant Renewal of License/ Registration.

To streamline the process of licensing / registration and its renewal, Food Authority has decided the following:

With effect from 12th January 2023, Renewals of License and Registrations have been made instant [without requiring the approval of authorities] subject to the following:

(i)         No change in the existing details of the license/registration shall be allowed 

(ii)        Validity of the Renewal:

a) For License: This renewal of the license shall be for 1 year

b) For Registration: Renewal shall continue as per existing provision i.e. for 1-5 years, based on the selection and payment made by the FBO in the application.

(iii)       FBOs whose licenses/ registrations have been suspended/canceled, shall not be allowed to renew their license/registration.

(iv)       Further, i.e. November 10, 2022, the FoSCoS system ensures that FBO (Manufacturers and Importers) shah file annual returns with penalties (if any), before renewal, for FY 2021-22 onwards.

(v)        A declaration to be submitted by Food Business Operator (tick in the checkbox) has been added in FoSCoS as follows namely: –

a) I/We have complied with all the permissions/rules, which are applicable to my food business and the premises of the food business such as CGWA NOC etc.

b) I/We do not possess more than one active license/ registration for any other food businesses at the same premises.

Validity of the New License and Registration

New License – The Validity of the new License is now restricted to only 1  year instead of the existing provision

For Registration – Validity shall be continued as per the existing provision.

There shall be no late fee of Rs. 100 per day  

The renewal of license and registration shall be available as early as 180 days prior to the expiry date

Now FBOs are required to self – declare the compliance regarding the points in the inspection checklist at the time of renewal.

The Order shall be applicable on applications submitted on or after January 12, 2023

Click here to read Notification

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

Notification

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Guidelines on Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements, 2022

The Central Consumer Protection authority (CCPA) under the Department of Consumer Affairs has notified ‘Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements, 2022’ with an objective to curb misleading advertisements and protect the consumers, who may be exploited or affected by such advertisements.

The guidelines seek to ensure that consumers are not being fooled with unsubstantiated claims, exaggerated promises, misinformation and false claims. Such advertisements violates various rights of consumers such as right to be informed, right to choose and right to be safeguarded against potentially unsafe products and services

Keeping in view the sensitiveness and vulnerability of children and severe impact advertisements make on the younger minds, several preemptive provisions have been laid down on advertisements targeting children. Guidelines says that advertisement targeting children shall not feature any personalities from the field of sports, music or cinema for products which under any law requires a health warning for such advertisement or cannot be purchased by children

Guidelines also stipulates that disclaimer shall not attempt to hide material information with respect to any claim made in such advertisement, the omission or absence of which is likely to make the advertisement deceptive or conceal its commercial intent and shall not attempt to correct a misleading claim made in an advertisement.

Similarly, clear Guidelines are laid for duties of manufacturer, service provider, advertiser and advertising agency, due diligence to be carried out before endorsing and others. Guidelines aims to protect consumer’s interest through bringing in more transparency and clarity in the way advertisements are being published, so that, consumers are able to make informed decisions based on facts rather than false narratives and exaggerations. 

Penalty for violating the Guidelines are also clearly outlined. CCPA can impose penalty of upto 10 lakh rupees on manufacturers, advertisers and endorsers for any misleading advertisements. For subsequent contraventions, CCPA may impose a penalty of upto 50 lakh rupees. The Authority can prohibit the endorser of a misleading advertisement from making any endorsement for upto 1 year and for subsequent contravention, prohibition can extend upto 3 years.

Click here to read Guidelines

Source: https://consumeraffairs.nic.in/en/latestnews/guidelines-prevention-misleading-advertisements-and-endorsements-misleading

Buyer Seller Meet

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Indian Business Delegation for Buyer Seller Meet (BSM) in ASEAN Region covering Vietnam, Cambodia, Philippines & Indonesia from 20th Feb– 04th Mar 2023

SEPC with the support of Department of Commerce, Ministry of Commerce & Industry, Government of India and recommendation by EP Services Division, India is organizing India’s services sector trade delegation Buyer Seller Meet (BSM) to ASEAN region covering Vietnam, Cambodia, Philippines & Indonesia from 20th Feb. – 04th Mar. 2023 covering following sectors which have demand in ASEAN region:

➢Hotel & Tourism Services
➢Educational Services
➢Healthcare Services
➢Architectural, Construction & Related Engineering Services
➢Entertainment Services (Including AVCG)

Benefits to participants on participating at BSM to ASEAN region.

• Focused prescheduled 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

The tentative programme for this BSM is given in Annexure A for your kind reference.

An estimate of expenditure heads which has to be managed by the participants are –

  • Flight tickets: For 4 countries, approximate cost would be INR ,1,59,000
  • Hotel stay: Approximately USD 130 -165 USD per night.
  • Total Cost approximately for all 4 Countries – INR3,35,000.

SEPC shall share the details of travel partners for this delegation with participants separately.

MAI Support to Participants:

SEPC registered Members whose export turnover during the previous financial year is less than/up to Rs.50 crores 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.

Click here for Notification
Click here for Annexure A – Program schedule

Registration Link: https://tinyurl.com/7v5byhr6

Notification – UGC asks higher education institutions to get registered on BioRRAP

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Biological Research Regulatory Approval Portal (BioRRAP)

The integrated portal – Biological Research Regulatory Approval Portal (BioRRAP)-has been initiated by the Government of India (GOI) to provide regulatory information to researchers and to facilitate approvals.

The University Grants Commission (UGC) has asked higher educational institutions and their affiliated colleges/institutions to get registered on Biological Research Regulatory Approval Portal (BioRRAP).

According to UGC, it is one-of-a-kind digital gateway intended to make science and scientific research more accessible as well as make it easier to create businesses. The information on international research projects as approved by all line Ministries/Departments of GOI is expected to be integrated with BioRRAP (with unique BioRRAP ID for each proposal).

With regard to Research Projects by entities falling under the category of Central/State Government, the relevant approvals will be dealt with by the concerned Ministry of the Government of India. State Governments have been requested to forward all such proposals to the concerned line Ministry of Government of India

In respect of Non-Government Organizations, the Health Ministry’s Screening Committee, operated by DHR/ICMR, that has been reconstituted by the Ministry of Health and Family Welfare will review the research projects involving international collaboration/funding in health research including studies in humans, animals, plants & environment.

UGC advised the higher educational institutions to follow the above provisions strictly and get registered on the portal

Click here to read Notification

Source:https://odishatv.in/news/education/ugc-asks-higher-education-institutions-to-get-registered-on-biorrap-193363

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