India: Food & Pharma Flash - October 2014

Last Updated: 24 October 2014
Article by PSA

1.        DoP for setting up VC fund for R&D in pharmaceuticals

The government would initially allocate Rs.500 crore between all the pharma funds to be set up under this project. Each fund would then be expected to invest (i) at least Rs.150 crore or more and (ii) 4 times of investment sought from the government. The project sets out the manner in which fund will be established and managed, the roles of key stakeholders and estimated event schedules and timelines.

The government would act as an investor whose contribution would be managed by the fund manager in terms of the contribution agreement between them and the trustee. The funds will be provided as a financing solution for high-risk, potentially high-reward projects that, due to the lack of substantial tangible assets, expected years of negative earnings, and uncertain prospects, are unable to raise funding from more traditional sources like banks or capital markets. Like pharma R&D, where the fund would promote entrepreneurship and support the development of a self-sustaining environment.

PSA view –This is a strategic move to involve direct participation of patients in the PvPI as patient awareness is the key to the success of the PvPI program and their reporting will provide hands on information about adverse events. The IPC and Central Drug Standard Control Organization ("CDSCO") plans to provide training and technical support to the stakeholders and the guidance document will be an important tool for conducting pharmacovigilance activities.

2.      Animal friendly move of health ministry

The Union health ministry has banned the import of cosmetics tested on animals. The ban comes in the form of Rule 135-B that states, "Prohibition of import of cosmetics tested on animals. - No cosmetic that has been tested on animals after the commencement of Drugs and Cosmetics (Fifth Amendment) Rules, 2014 shall be imported in to the country." The ban will be effective from November 13, 2014. Appreciable enough that, by banning the import of cosmetics tested on animals, India has become the first cruelty-free cosmetics zone in South Asia. In fact, recently, Indian government had banned animal testing of cosmetic products within the country.

PSA view –The move is quite praise worthy but the cosmetic manufacturers are going to have a tough time with this. The historic ban on the import of newly animal-tested cosmetics highlights government's anti-cruelty policy. Cosmetic formulae are many a times non-vegetarian and can be very reactive. It would not be easy to have subjects to conduct clinical trials for this. Manufacturers may resort to falsely labeling their products indicating that they are not animal tested. It would be interesting to see the implementation of the ban.

3.       Pharmaceutical companies must register on online database now

The NPPA in collaboration with the National Informatics Centre has developed IPDBMS to set-up a comprehensive in-house market database in respect of price fixation system for both scheduled and non-scheduled formulations. 

In this regard, all drug manufacturers i.e., any person who manufacturers, imports and markets drugs for distribution or sale in country have a legal obligation to register themselves and disseminate details "which include inputting of company details, details of production/procurement sources and product list", etc., on or before October 30, 2014, after which the data inputting facility shall be made available to all registered users for online submission. Thus, the pharmaceutical companies are mandated to carry out the online filing of returns in Form II, Form III and Form V under the Drugs (Prices Control) Order, 2013 (the DPCO). Non- compliance will attract penalties and punishment under the Essential Commodities Act, 2005.

PSA view –This is a commendable step by NPPA considering the significance of a robust mechanism which acts as self-contained guide on market-based data on drugs. IPDBMS is launched to fulfill the objectives of DPCO, 2013 necessitating the government to come out with an appropriate mechanism for obtaining market based data in due course of time. This mechanism will assist the authorities to monitor and regulate the price fixation and price revision system in respect to scheduled drugs and non-scheduled formulations and control the availability and production of scheduled formulations.

4.       Stricter Regulatory Scrutiny on Medical Device Industry

The recent amendments to the Drugs and Cosmetics Rules, 1945 is a wake-up call for the players in medical device industry as the new law prescribes a stern regulatory framework in respect of  labelling requirements and standard control requirements to be fulfilled by the manufacturers and exporters of medical devices. As per Gazette notification GSR 690 (E) dated September 25, 2014, the Union health ministry has notified the following changes in the Drugs and Cosmetics Rules, 1945 pertaining to the medical device industry:

(a)     Rule 109 A is amended to make labelling of medical devices mandatory in India. It is now necessary that the label should carry the proper name of the medical device, the intended number of use, substances used in the device and such other details necessary for the user to identify the device, its use and name of the manufacturer;

(b)      Rule 109 B specifies certain exemptions to labelling requirements for medical devices exported from India i.e., firstly, if the consignee does not require the device to be labeled with the name and address of the manufacturer, then it should bear a code number and the code should contain the name of the State or Union Territory, in abbreviation, followed by the word "Device and "manufacturing license number", as approved  by the licensing authority and secondly, if the consignee does not require the device to be labeled with the code number, then  the label should bear the special code number requested by the consignee and approved by the licensing authority.

(c)       Rule 109 C prescribes that the shelf life of the medical devices shall not exceed sixty months from the date of manufacture. However, the period may be extended, if satisfactory evidence is produced by the manufacturer to justify such an extension.

(d)      Schedule R-1 is amended and Union ministry has listed the standard requirements for all medical devices i.e., if there is no standard laid down by Bureau of Indian Standards for the medical device, then it should conform to the International Standards, like International Organization for Standardization, or other International Pharmacopeia Standards and such other standards as may be specified for this purpose. In case national or international standards are not available, the device shall conform to the manufacturer's validated standards.

PSA view The present amendment to the Drugs and Cosmetics Rules, 1945 is a step in the right direction as the regulatory framework for the medical device industry is more stringent than before. Further, the attempt to formulate a definite industry standard is a welcome step.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Similar Articles
Relevancy Powered by MondaqAI
SKP Business Consulting LLP
Nishith Desai Associates
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
SKP Business Consulting LLP
Nishith Desai Associates
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

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.

By clicking Register you state you have read and agree to our Terms and Conditions