India: Pharmaceutical Update

Last Updated: 22 August 2016
Article by Trilegal .

POLITICAL AND ECONOMIC UPDATE

Government Taking Steps to Set Up Funds to Promote Pharma Sector

The Department of Pharmaceuticals (DoP) is formulating a Pharmaceutical Technology Upgradation Assistance Scheme to support the pharma industry (medium enterprises only) "to upgrade their regulatory technology compliance from Schedule M of the Drugs and Cosmetics Act, 1940 to World Health Organization (WHO) - Good Manufacturing Practices (GMP) norms by facilitating low interest loans". The Government of India is also considering providing INR 2,000,000,000 (Indian Rupees Two Billion) each to 3 new bulk drug manufacturing parks in order to create common minimum facilities. 
http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/government-taking-steps-to-set-up-funds-to-promote-pharma-sector/articleshow/52145576.cms

ISRO Carries Out Successful Testing of RLV-TD

Indian Space Research Organisation (ISRO) successfully concluded its first step towards testing India's first ever indigenous space shuttle Reusable Launch Vehicle Technology Demonstrator (RLV-TD).  While this test was the hypersonic flight experiment, the next test will be focused on landing the RLV-TD back on earth. 
http://www.isro.gov.in/update/23-may-2016/india%E2%80%99s-reusable-launch-vehicle-technology-demonstrator-rlv-td-successfully 
http://www.thehindu.com/sci-tech/science/india-successfully-launches-reusable-launch-vehicle/article8635448.ece

Patent Systems Should Be Country-Specific Favouring National Interest: India at WIPO

Despite pressure on the country to amend its patent laws to enable more patent protection, the Indian delegation, in the opening statement at the 24th session of World Intellectual Property Organisation (WIPO)'s Standing Committee on the Law of Patents (SCP) in Geneva, has suggested a country-specific patent system that favours the interest of the national economy.  On the issue of patents' quality, including patent opposition systems, the Indian delegation stated that the quality of examination needs to improve substantially in conformity with the policy objective of a country.
http://www.businesstoday.in/current/corporate/patent-systems-should-be-country-specific-favouring-national-interest/story/234342.html

BREXIT to Majorly Impact Drug and Medical Device Regulation: Global Data Report

The Brexit is expected to have consequences for the pharmaceutical and medical device industries in 5 key areas, namely: regulatory impacts, research and development, access to talent, intellectual property rights and market access. There are other ramifications of Brexit for the healthcare sector. For instance, European Medicines Agency (EMA), which is headquartered in the UK, is likely to be swiftly relocated to the European Union.
http://www.business-standard.com/content/b2b-pharma/impact-of-brexit-to-be-majorly-on-drug-and-medical-device-regulation-report-116062700271_1.html
 

World Bank to India: Activate Stalled Growth Engine

 
According to the World Bank, India needs to activate "stalled engines" - agricultural growth and rural demand; trade; and private investment, while ensuring that demand from urban households and public investments do not run out of fuel, to sustain 7.6% growth rate in the coming years.
http://economictimes.indiatimes.com/news/economy/indicators/private-spending-and-rural-demand-need-a-push-for-7-6-per-cent-growth-world-bank-to-india/articleshow/52833992.cms

Note: Since this update only covers issues and events till 31 July 2016 we have not included an update on the Goods and Services Tax (GST) Bill here. This will be covered in our next update.

ECODATA

Basic Economic Data:

GDP Growth (2015-16) (Jan-March): 7.9%
(CPI) Inflation (June, 2016):  5.40 % (Rural & Urban combined)
Foreign Exchange:  INR   66.7407 for 1 USD.
Unemployment Rate (2013-14): 4.9%
 
Sources:
http://mospi.nic.in/Mospi_New/upload/nad_press_release_31may16.pdf
http://mospi.nic.in/Mospi_New/upload/cpi_pr_12july16t.pdf
https://www.rbi.org.in/  
http://labourbureau.nic.in/Press_note_4th_EUS.pdf

LEGISLATION AND REGULATION

Union Cabinet Approves IPR Policy

The Union Cabinet of India recently approved the National Intellectual Property Rights (IPR) Policy (IPR Policy).
http://pib.nic.in/newsite/PrintRelease.aspx?relid=145338

IN-DEPTH: The key objectives of the IPR Policy are:

(a)  to create public awareness about the economic, social and cultural benefits of IPRs among all sections of society;
 
(b)  to stimulate the generation of IPRs;
 
(c)  to have strong and effective IPR laws which balance the interests of rights owners with larger public interest;
 
(d)  to modernize and strengthen service-oriented IPR administration;

(e) to get value for IPRs through commercialization;
 
(f) to strengthen the enforcement and adjudicatory mechanisms for combating IPR infringements; and
 
(g) to strengthen and expand human resources, institutions and capacities for teaching, training, research and skill building in IPRs.

FSSAI Establishes Central Advisory Committee

Food Safety and Standards Authority of India (FSSAI) has established the Central Advisory Committee under the Food Safety and Standards Act, 2006.
http://www.fssai.gov.in/Portals/0/Pdf/Gazette_Notification_Constitution_CAC_Member_27_05_2016.pdf
 
IN-DEPTH: The committee consists of the Mr. Pawan Agarwal (CEO, FSSAI) as the chairman, members of the food industry, consumers, Commissioners of Food Safety of States and Chairperson of the Scientific Committee.

NPPA Fixes/Revises Ceiling Price of Scheduled Drugs and Retail Price of Specified Formulations

The National Pharmaceutical Pricing Authority (NPPA), by its orders has fixed/revised the ceiling price and retail price in relation to specified formulations. 

http://www.nppaindia.nic.in/wh-new-2016/wh-new-33-2016.html
http://www.nppaindia.nic.in/wh-new-2016/wh-new-40-2016.html
http://www.nppaindia.nic.in/ceiling/press9may16/so1686e-9-5-16.html
http://www.nppaindia.nic.in/ceiling/press9may16/so1687e-9-5-16.html
http://www.nppaindia.nic.in/ceiling/press9may16/so1688e-9-5-16.html
http://www.nppaindia.nic.in/ceiling/press18may16/so1816e-18-5-16.html
http://www.nppaindia.nic.in/ceiling/press18may16/so1817e-18-5-16.html
http://www.nppaindia.nic.in/ceiling/press18may16/so1818e-18-5-16.html
http://www.nppaindia.nic.in/ceiling/press18may16/so1819e-18-5-16.html
http://www.nppaindia.nic.in/ceiling/press2june16/so1993e-3-6-16.html
http://www.nppaindia.nic.in/ceiling/press2june16/so1951e-2-6-16.html
http://www.nppaindia.nic.in/ceiling/press2june16/so1952e-2-6-16.html
http://www.nppaindia.nic.in/ceiling/press23june16/so2193e-23-6-16.html
http://www.nppaindia.nic.in/ceiling/press23june16/so2194e-23-6-16.html
http://www.nppaindia.nic.in/ceiling/press23june16/so2195e-23-6-16.html
http://www.nppaindia.nic.in/ceiling/press23june16/so2209e-24-6-16.html
http://www.nppaindia.nic.in/ceiling/press23june16/so2210e-24-6-16.html
http://www.nppaindia.nic.in/ceiling/press29july16/so2568e-29-7-16.html
http://www.nppaindia.nic.in/ceiling/press29july16/so2569e-29-7-16.html
http://www.nppaindia.nic.in/ceiling/press29july16/so2570e-29-7-16.html
 
IN-DEPTH:  By these orders, the ceiling price in relation to 225 scheduled formulations have been notified, retail price of 74 formulations have been fixed and ceiling price of 15 formulations have been revised by the NPPA.

NPPA Issues Office Memorandums in Relation to Implementation of Drug Prices Fixed Under DPCO, 2013

The NPPA has issued office memorandums regarding: (a) Implementation of prices fixed under the provisions of Drug Price Control Orders (DPCO), 2013, (b) Representations against ceiling prices fixed by NPPA under DPCO, 2013, (c) Price fixation of I.V. Fluids under DPCO, 2013, (d) National List of Essential Medicines, 2015 formulation under provisions of DPCO, 2013, and (e) representation of companies aggrieved by the NPPA's price fixation.
http://www.nppaindia.nic.in/order/om25-5-14-10-5-16.pdf
http://www.nppaindia.nic.in/order/om19-174-16-11-5-16.pdf
http://www.nppaindia.nic.in/order/om10-sec-26-2-0-3-14-13-5-16.pdf
http://www.nppaindia.nic.in/order/om16-697-16-13-5-16.pdf
http://www.nppaindia.nic.in/order/om19-174-16-20-5-16.pdf
 
IN-DEPTH: The office memorandums contain directions and obligation for marketing/manufacturing companies wherever relevant.

SUGAM Portal Rolled-Out for Additional Compliances

The online portal 'SUGAM' launched by the Central Drugs Standard Control Organization (CDSCO) has been rolled-out for additional compliances to be made by manufacturing companies.  Following the introduction of the online system, the south zonal office of the CDSCO in Chennai has kicked off the online issuance of licences and approvals.

http://www.cdsco.nic.in/writereaddata/NOTICE-TL-27_05_2016.pdf
http://www.cdsco.nic.in/writereaddata/NOTICE-%20COSECR.pdf
http://www.cdsco.nic.in/writereaddata/notice9_5_2016.pdf

IN-DEPTH: The SUGAM portal can now be accessed for: (a) filing application for grant of licence to import drugs for examination, tests or analysis, and (b) filing applications for grant of registrations of cosmetics and ethics committee.

FSSAI Issues Notices For Stakeholder Comments

The FSSAI has issued notices calling for suggestions, views, comments etc. from stakeholders in relation to certain specific regulations.

http://www.fssai.gov.in/Portals/0/Pdf/Draft_Notice_Comment_Atta_Rice_20_07_2016.pdf
http://www.fssai.gov.in/Portals/0/Pdf/Draft_Notice_Comment_Fruits_Veg_12_07_2016.pdf
http://www.fssai.gov.in/Portals/0/Pdf/Draft_Notice_Comment_Microbio_Fruits_Veg_12_07_2016.pdf
http://www.fssai.gov.in/Portals/0/Pdf/Draft_Notice_Comment_Oil_Fat_Emulsion_12_07_2016.pdf
 
IN-DEPTH: The notifications relate to: (a) Standards for Fortified Atta, Fortified Maida, Durum Wheat Maida, Quinoa, Fortified Rice, Instant Noodles, Tapioca Sago or Palm Sago & Pearl Millet Flour, (b) "Fruit & Vegetable products" in Regulation 2.3 in Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011, (c) Table 4 in Appendix B in Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, and (d) Fats, Oils and Fat Emulsions in Regulation 2.2 of Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011.  The comments are to be shared within the timelines specified in each of these notifications.

FSSAI Releases Draft Amendment Regulations under Food Safety and Standards Act, 2006

The FSSAI, has released drafts of certain specified amendment regulations.
http://www.fssai.gov.in/Portals/0/Pdf/Draft_Notification_SP_SC_31_05_2016.pdf
http://www.fssai.gov.in/Portals/0/Pdf/Draft_Notification_Inclusion_Ethylene_Gas_Fruits_11_05_2016.pdf
http://www.fssai.gov.in/Portals/0/Pdf/Draft_Notification_Iron_Filling_25_05_2016.pdf
http://www.fssai.gov.in/Portals/0/Pdf/Draft_Notification_Inclusion_Rabbit_Family_02_06_2016.pdf
http://www.fssai.gov.in/Portals/0/Pdf/Draft_Notification_Fish_Histamine_Level_23_06_2016.pdf
http://www.fssai.gov.in/Portals/0/Pdf/Draft_Notification_Restriction_Sale_23_06_2016.pdf
http://www.fssai.gov.in/Portals/0/Pdf/Draft_Notification_Fats_Oils_Oats_Pasta_12_07_2016.pdf
 
IN-DEPTH: The amendment regulations include: (a) Food Safety and Standards Authority of India (Transaction of Business and Procedures for the Scientific Committee and Scientific Panels) Regulations, 2016, (b) Food Safety and Standards (Prohibition and Restriction on Sales) Amendment Regulations, 2016,  (c) Food Safety and Standards (Food Product Standards and Food Additives) Amendment Regulations, 2016, (d) Food Safety and Standards (Contaminants, Toxins and Residues) Amendment Regulation 2016, and (e)  Food Safety and Standards (Packaging and Labelling) Second Amendment Regulation, 2016.  These amendment regulations will be taken into consideration after the expiry of the time specified in each of the notifications for receiving objections and comments, if any, from the relevant stakeholders.

FSSAI Notifies Amendment Regulations under Food Safety and Standards Act, 2006

The FSSAI has notified certain specified amendment regulations.

http://www.fssai.gov.in/Portals/0/Pdf/Gazette_Notification_FBO_Extension_Time_26_07_2016.pdf
http://www.fssai.gov.in/Portals/0/Pdf/Gazette_Notification_Plant_Sterol_HFD_25_07_2016.pdf
http://www.fssai.gov.in/Portals/0/Pdf/Gazette_Notification_Silver_Leaf_19_07_2016.pdf
http://www.fssai.gov.in/Portals/0/Pdf/Gazette_Notification_Cotton_Seed_Rice_Bran_Oil_04_07_2016.pdf
http://www.fssai.gov.in/Portals/0/Pdf/Gazette_Notification_Edible_Trans_Oils_Fats_02_06_2016.pdf
http://www.fssai.gov.in/Portals/0/Pdf/Gazette_Notification_Heavy_Metals_11_05_2016.pdf
http://www.fssai.gov.in/Portals/0/Pdf/Gazette_Notification_Gluten_11_05_2016.pdf
http://www.fssai.gov.in/Portals/0/Pdf/Corrigenda_Amendment_Melamine_09_05_2016.pdf
 
IN-DEPTH:  The notifications relate to: (a) Food Safety and Standards (Licensing and Registration of Food Business) First Amendment Regulation, 2016, (b) Food Safety and Standards (Packaging and Labelling) Third Amendment Regulation, 2016, (c) Food Safety and Standards (Food Products Standards and Food Additives) Fourth Amendment Regulations, 2016, (d) Food Safety and Standards (Food Product Standards and Food Additives) Fifth Amendment Regulation, 2016, (e) Food Safety and Standards (Food Product Standards and Food Additives) Third Amendment Regulation, 2016, (f) Food Safety and Standards (Packaging and Labelling) Second Amendment Regulation, 2016, (g) Food Safety and Standards (Contaminants, Toxins and Residues) Amendment Regulations, 2016, (h) Food Safety and Standards (Food Product Standards and Food Additives) Second Amendment Regulation, 2016, (i) Food Safety and Standards (Packaging and Labelling) First Amendment Regulation, 2016, (j) Corrigenda for Food Safety and Standards (Contaminants, toxin and residues) Amendment Regulation, 2016.

Revision of FSSAI Testing Charges

FSSAI has reconsidered the analysis charges for different food products and decided to introduce package rates for food testing for ease of operation and integration of single window system of imports.

http://www.fssai.gov.in/Portals/0/Pdf/Order_Testing_Charge_10_06_2016.pdf
 
IN-DEPTH: These package rates shall be uniformly applicable for both domestic and import samples.

FSSAI Operationalises List of Food Additives

FSSAI operationalised the final list of 11,000 food additives provisions that can be used by food businesses in various food categories.
http://www.fssai.gov.in/Portals/0/Pdf/Press_Note_Operationalization_Standards_Additives_21_06_2016.pdf
 
IN-DEPTH:  This culminates an important process in developing food standards for food additives that began about 3 years ago.
 
Direction on Application of Food and Safety Standards Act and Regulations Thereunder to Duty Free Shops
 
FSSAI has issued a direction clarifying that duty free shops would be outside the ambit of Food Safety and Standards Act, 2006 and Regulations made thereunder.
http://www.fssai.gov.in/Portals/0/Pdf/Directions_Duty_Free_Shop_Airport_24_06_2016.pdf
 
IN-DEPTH: Accordingly, clause 14.3 of the notice for operationalization of the Food Safety and Standards (Food Import) Regulations 2016, which stipulated that the act and the regulations would be applicable to all duty free shops in all airports of India stands deleted till such time the above regulations are notified.

ICMR Lays Down New Rules for Clinical Trials and Consent, Applies Them to Traditional Medicine

The Indian Council for Medical Research (ICMR) has recently released draft National Ethical Guidelines for Biomedical and Health Research involving Human Participants which lays down the rules on informed consent of people participating in trials.
http://www.dnaindia.com/india/report-icmr-lays-down-new-rules-for-clinical-trials-and-consent-applies-them-to-traditional-medicine-2239676
 
IN-DEPTH: The draft clarifies what informed consent will mean: one where participants are provided all relevant information, comprehend the nature of that information, and their consent is voluntary.  It also provides that payments be made as reimbursements for travel, etc., or for wages lost, but never as "undue inducement".

Amendments to India's FDI Policy on the Pharma Sector

In a major overhaul, the government has relaxed foreign direct investment (FDI) norms in various sectors, including the pharmaceutical sector.

http://dipp.nic.in/English/acts_rules/Press_Notes/pn5_2016.pdf
 
IN-DEPTH: With the objective of promoting the development of this sector, the government has permitted up to 74% FDI under automatic route in brownfield pharmaceuticals and government approval route beyond 74% will continue.

SIGNIFICANT COURT ACTIONS AND GOVERNMENT ENFORCEMENT

5 Web Portals Under FDA Scanner for Selling Drugs Online

5 web portals have come under the radar of the Food and Drug Administration (FDA) for selling prescription drugs online.While the FDA has already registered First Information Reports (FIRs) against 3 web portals, the process of initiating action against the other 2 is under way.

http://indianexpress.com/article/cities/mumbai/epharmacy-online-drugs-fda-web-portals-2825176/ 

IN-DEPTH: Web portals (a) MeraPharmacy.com, (b)  Web portals (a) MeraPharmacy.com, (b) mChemist.com, (c)  Web portals (a) MeraPharmacy.com, (b) mChemist.com, (c) Healercart.com, (d)  Web portals (a) MeraPharmacy.com, (b) mChemist.com, (c) Healercart.com, (d) Pharmeasy.in, and (e)  Web portals (a) MeraPharmacy.com, (b) mChemist.com, (c) Healercart.com, (d) Pharmeasy.in, and (e) Netmeds.com were found selling drugs, available over the counter and scheduled drugs, through an online system.  While action has been initiated against each of these portals, the FDA is also looking to take action against pharmacies that are supplying drugs to these web portals.

Reckitt Benckiser Given Due Hearing on Condom Order

Delhi High Court disposed of the plea filed by Reckitt Benckiser, challenging the State licensing authority's order directing the company's Indian joint venture firm TTK Protective Devices Limited (TTK) to surrender its licence for manufacturing and selling Benzocaine dosed condoms. (W.P.(C) 4442/2016 disposed of on 23 May, order accessible at

http://lobis.nic.in/ddir/dhc/MMH/judgement/24-05-2016/MMH23052016CW44422016.pdf)
http://www.business-standard.com/article/pti-stories/hc-puts-on-hold-orders-to-reckitt-to-surrender-licence-to-make-116052301063_1.html
 
IN-DEPTH:  The order put on hold the orders of the Centre and State licensing authority directing TTK to surrender its licence for manufacture and sale of Benzocaine dosed condoms.  The Delhi High Court has now directed TTK, to file its representation within two weeks and to maintain a "log and accounts" of the number of such condoms manufactured and sold by it.

INR 2,500 Crore Drug Bust: Pharma Companies Under Scanner

The Thane crime branch busted an international drug cartel and seized narcotics worth around INR 2,500 crore leading to increased scrutiny on pharmaceutical companies at Maharashtra Industrial Development Corporation (MIDC).

http://www.dnaindia.com/mumbai/report-rs2500-crore-drug-bust-pharma-companies-under-scanner-directors-quizzed-2207779
 
IN-DEPTH: The police caught the racket run by Avon Lifesciences Limited and arrested eight people.  This event has alerted the Food and Drugs Administration which is now conducting surprise inspections on pharmaceutical companies.

Supreme Court Directs Cipla to Pay INR 175.07 Crore

The Supreme Court of India had directed drug maker Cipla to deposit a sum of Rs 175.07 crore in a case related to alleged overcharging in certain drugs as per the provisions of Drug (Price Control) Order, 1995.  In a note to stock exchanges on 22 July, Cipla said the writ petitions filed in the Bombay High Court that were pending before the Supreme Court have been retransferred to the Bombay High Court for final hearing.  The initial order for the deposits were issued by Supreme Court in 2003, which had directed the government to recover 50% of the overcharged amount by the company.

http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/drug-overcharging-case-supreme-court-directs-cipla-to-pay-rs-175-07-crore/articleshow/53345143.cms

MEDIA ACTIVITY

Pharma Exports Growth Heading for a Sharp Decline

The Credit Rating and Information Services of India Limited (CRISIL) has issued a report stating that the Indian pharmaceutical sector is heading for a tough time as exports growth in formulations is expected to almost halve to 10-12% annually over the next 5 years.

http://articles.economictimes.indiatimes.com/2016-05-17/news/73152016_1_exports-growth-indian-companies-drugs-administration
 
IN-DEPTH: Domestic companies will have to step up investments in new molecules and draw up a roadmap to deal with lower generics growth in order for growth to sustain beyond 2020.

WHO Unveils Global Regulatory Framework for Medical Devices

The WHO has released a draft proposal for its global regulatory framework for medical devices and In Vitro Diagnostics (IVDs).

http://www.who.int/medicines/areas/quality_safety/quality_assurance/ModelregulatoryFramework-MedicalDevices_QAS16-664_10052016.pdf?ua=1
 
IN-DEPTH: The WHO framework provides guidance for a staged development.  Public comments on the draft proposal were also invited.

Government Looking to Amend Drugs and Cosmetics Act

The Central Government of India is working towards amending the Drugs and Cosmetics Act, 1940 as the existing legislation does not differentiate between offline and online pharmacies.

http://www.business-standard.com/article/pti-stories/govt-looking-to-amend-drugs-and-cosmetics-act-116072501075_1.html
 
IN-DEPTH: Additional Secretary in the Ministry of Health & Family Welfare, Mr. K B Aggarwal said, though e-pharmacy will allow easy availability of drugs at all hours, certain concerns with respect to legitimacy of e-pharmacies, patients' safety and privacy, misuse of e-pharmacy and adverse effect on retailers business should be flagged and addressed.

EVENTS

Workshop on 'Building Consumer Awareness on Improving Accessibility to Medicines"
on 18-19 August 2016 at Delhi, in association with Consumer Online Foundation
 
Seminar on "BioPharma: Biosimilar & Biogeneric; Emerging Investment Destination"
on 6 October 2016 at Hyderabad, in association with ASSOCHAM
 
http://pharmaceuticals.gov.in/events

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Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

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