India: Food & Pharma Flash - October 2014

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

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

In association with
Up-coming Events Search
Font Size:
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
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.