India: Health Ministry Panel To Frame Clinical Trial Policy

Last Updated: 27 February 2013
Article by PSA and Ashutosh Chandola

The health ministry has set up a seven-member expert committee ("Committee") to formulate policy framework for the approval of new drugs and clinical trials. The Committee would study the feasibility of conducting clinical trials in local population for drugs which have already been approved in other regulated markets such as the US, Japan and Europe and would also recommend guidelines for post marketing trials to ascertain the impact of drugs which have been already launched in the market. Another of its role will be to lay down the requirements of global clinical trials, for a new drug discovered abroad which seeks approval here. It will also cite the functions of ethics committee attached to a clinical trials and prescribe the way to monitor them.

PSA view  – Though a welcome move, the success of formulating such a Committee can only commented upon once the policy is released and successfully implemented. It has been seen in many case, be it with regard to compensation for the injured party or the family of the dead in a clinical trial or amendments to the pricing guidelines, that policies are made, even comments from the public are sought; however, the implementation of these policies takes a lot of time which in turn somewhat thwarts their effectiveness.

CDSCO to pre-screen SAE

A recent amendment to the Drugs & Cosmetics (D&C) Rules introduced rule 122DAB which empowers the DCGI to determine the quantum of compensation that is to be paid to the family of the subject in case of a SAE in clinical trial. This amendment was introduced to allow a case by case review of the facts and circumstances that lead up to the SAE and accordingly determine the extent of negligence by each of the parties involved. Further to this, the CDSCO has now introduced a system to prescreen all SAE Reports that are to be considered by the DGCI. The prescreening will be done by CDSCO officers based on a prescribed checklist for determining the acceptability of an SAE report in order to ensure that it contains all necessary administrative and technical information necessary for ascertaining the nature and cause of the SAE, thereby allowing prudent determination of the quantum of compensation.

PSA view  –  The purpose for introducing the prescreening process appears to be to streamline the process for screening of all SAE reports and to make the process more efficacious. While the intention is praiseworthy, adding another administrative layer to the process of determining the quantum of compensation may not work out to be in the best interest of the subject and the families. While it is essential to ensure that all administrative and technical information is provided in the SAE reports prepared for the DCGI, it may be more efficacious if including this information is made mandatory for the parties preparing the reports, instead of having an additional agency check them for inconsistencies.

States express reservations about Food Security Bill

A majority of the State Governments in India have expressed their reservation about passing the Food Security Bill in the budget session. The said bill is an attempt by the Central Government DFPD to ensure that people specified below a particular economic strata have access to a minimum amount of food grains and necessary food items. However, many States have opposed many provisions in the aforesaid bill as there are many contentious provisions. The states categorically opposed cash transfers in lieu of grains as they are utterly confused about how to identify the beneficiaries. The states also argued that there is a lack of availability of grains to match it with the detailed distribution schemes provided in the bill. Many states have also suggested that the Central Government should include more food items like pulses and edible oils so and to take into account the already existent public distribution schemes regarding food grains that are in operation in various states.

PSA view  –  The purpose hurrying with the present bill appears more political than practical. If the Central Government is really serious about proper implementation of the Food Security Bill, it should genuinely look to arrive at a consensus with the concerns of the various State Governments. The proper implementation of the provisions of the bill will ensure an effective public distribution system rather than being an impediment and failure like other Central Government schemes.   

FSSAI extends registration deadline for FBOs

Under the Food Act and its Food Safety and Standards (Licensing and Registration of Food Business) Regulations, 2011 it has been made necessary for the existing FBOs carrying on food business in the country to get themselves compulsorily registered with the FSSAI. The FSSAI had to yet again extend the deadline for registration for the existing FBOs by a year from February 2013 to February 2014. This is the second time the deadline has been extended. The Confederation of All India Traders ("CAIT") has been alleging that the food regulations are formulated keeping the interests of foreign investors and not the domestic existing FBOs.

PSA view  –  Though the requirement of registration is essential to maintain and affirm the safety and standard of food in India, it is becoming largely impossible unless all the FBOs are registered with FSSAI. The FSSAI cannot monitor all unregistered FBOs and with the extended deadline it has provided the respite to unregistered FBOs as the CAIT has been opposing this move.     

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
Related Topics
Related Articles
Related Video
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
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 (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

To Use 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.


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.


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