India: New Drug Approval: Regulatory Scenario In India

Last Updated: 29 March 2016
Article by Pankaj Musyuni

Considering the Indian pharmaceutical industry is the third largest industry in terms of output, it is necessary to understand the regulatory scenario for the pharma sector as the regulations imposed upon them are crucial not only due to essential and stringent regulatory requirements for manufacturing of products such as Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) but also due to an obligation on regulatory bodies to ensure a healthy supply of safe and quality drugs at an affordable prices to the public.. The branded generics which constitutes about 80 to 85 percent leads the market with a compounded annual growth rate (CAGR) of over 13 % in preceding 5 years and it is expected to grow at a higher rate in near future. The new drug approval in India is now in demand and primary drive of the rules governing approvals of these products is to safeguard public health. Accordingly, it is the role of statutory regulatory authorities to ensure that pharmaceutical companies comply with regulations. Drug approval process can be understood as an optimized procedure by which a new drug molecule is formally approved by drug authority for a person or organization interested to launch a drug product for commercialization. Though an overlook of Indian pharmaceutical Industry shows a complicated regulatory construction wherein pharmaceuticals companies come under the purview of the Ministry of Chemicals & Fertilizers. The Central Drugs Standard Control Organization (CDSCO) which is headed by the DCGI comes under the Ministry of Health and Family Welfare and there is a separate agency for monitoring food products which is the Food Safety and Standards Authority of India. 

Regulatory authority in every country is responsible to implement various rules and regulations for regulating the marketing of drugs. Various stages in process of drug approval include formal administrative requirements for marketing authorization, conducting of clinical trials and surveillance of post-marketing studies. It is worthy to mention here that regulatory capture of matter includes various technical uncertainties in toxicity, safety profile and clinical trials. If any company wants to manufacture, sale, registration and import/export any drug in India, CDSCO is responsible authority for such regulations, which is generally denoted by the title of the head officer, the Drugs Controller General of India (DCGI). The CDSCO ensures safety, efficacy and quality of drugs, cosmetics, diagnostics and medical devices in India. It also regulates marketing, authorization of new drugs, monitoring of clinical trials and also manages drug import and approval license for manufacturing and sale of drug product in territory of India. The new drugs are approved as per the rules and requirements specified in Rule 122A, 122B, 122D, 122E and Schedule Y of Drugs and Cosmetics Rules, 1945. When a company wants to manufacture/import a new drug it has to apply to seek consent from the licensing authority (DCGI) by filing in Form 44 and also submitting the data as given in Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945. In order to prove the efficacy and safety of proposed drug molecule in Indian population it has to conduct clinical trials in accordance with the guidelines specified in Schedule Y and submit the report in stated format thereto to the authority.

The prerequisite and comprehensive data to be submitted for application/permission to market a new drug approval application includes chemistry and manufacturing data but not limited to chemical and pharmaceutical information of drug, animal pharmacology/toxicology, human clinical pharmacology, clinical trials which include both exploratory and confirmatory, bioavailability/dissolution and stability data, regulatory status in other countries, marketing information such as proposed product monograph, drafts of packaging information such as labels and cartons, application for test license. However, a provision of exemption is specified in Rule - 122A that the licensing authority may waive certain trials considering the interest of public health and based on the data of the trials done in other countries. For such exemption generally two categories has been adopted. Category A, which includes drugs that have already gained approval by the regulatory bodies in countries as US, Germany, UK, Switzerland, Australia, Japan, South Africa, Europe Canada and for these drugs only phase-III clinical studies are required. Further, under Category B, applications for trials that are not already approved by any recognized regulatory authority are covered and such applications can be submitted at any stage of clinical trials.

With respect to requirement of clinical trial, Section 2.4 (a) of Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945 states that for those drug substances which are discovered in India, all phases of clinical trials are mandatory. Section 2.4 (b) states that for those drug substances which are registered in countries other than India; the applicant must submit the data available from other countries and the licensing authority further may require the applicant to repeat all the studies or permit him to proceed from Phase III clinical trials depending on the discretion. Section 2.8 requires that the licensing authority may require pharmacokinetic studies in terms of bioequivalence so as to show that the data generated in India is equivalent to data generated in foreign countries and then require the applicant to proceed with Phase III trials. Accordingly, the exact requirements of clinical trial depend on a case-to-case basis as to how the safety and efficacy data is sufficient to comply with the regulation.

India is emerging as a significant player in clinical research and pharmaceutical field. The continuous growth and development in regulatory framework is a case in point as to how the pharmaceutical industry is modernising under the rationale of scientific knowledge and public health.

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.

Pankaj Musyuni
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.