The Drug Controller General of India (DCGI) is in charge of regulating the pharmaceutical industry in India and works under the Ministry of Health and Family Welfare to ensure that medicines, medical devices, cosmetics, and health supplements are safe for use.
When you’re looking to bring your new product to market in India, it’s critical that you meet DCGI approval requirements to prevent any delays or issues with obtaining necessary DCGI approval licenses.
This guide will give you an overview of what DCGI approval means, how to obtain it, and why getting FDA-approval may help you with your new product launch in India.
What’s the Difference Between OTC and Rx Drugs
The difference between OTC and Rx drugs is that OTC stands for over-the-counter, which means it can be sold to anyone without a prescription. With OTC drugs, you don’t need to see a doctor before purchasing them or fill out any paperwork.
On the other hand, Rx or prescription drugs have to be filled out for by a licensed professional and require a visit with your physician. If you have insurance, both Rx and OTC medications will be covered by your plan.
Some people prefer to use OTCs because they are easy to obtain and less expensive; however, because they don’t require a prescription, there’s no guarantee of quality or effectiveness of what you purchase.
The Costs Associated with Drug Registration
In order to get a drug registered, manufacturers need to demonstrate that their products are safe and efficacious. The cost of doing so is variable, but it generally ranges from $1 million to $4 million per product.
Drugs aren’t tested for efficacy on humans because clinical trials for approval take too long and would be too expensive. So, drugs must prove their worth through animal trials and then tests on cells.
General Requirements for Drug Registration
Companies seeking to register drugs must provide data demonstrating safety, quality and efficacy of its products. The applicant should submit evidence showing that a drug is fit for its intended use.
This should include information on: Drugs are required to meet standards of purity, identity and strength. A drug cannot contain adulterants or be in any way harmful to people using it.
Information on toxicity and side effects is also required so patients know what they’re getting into when taking a drug, as well as instructions on how much they need and how often they should take it.
Clinical data (evidence) indicates that your product/drug works exactly as promised, is not harmful if taken correctly, but offers a benefit compared to other treatments available today.
How to Get Started with DCGI Registration
To begin your journey toward getting a brand-new, innovative product approved by MCI, you first need to submit an application. There are two major steps involved with MCI registration.
First, you need to obtain clearance from DCGI (Drug Controller General of India). Second, and only after you’ve cleared regulatory hurdles, will your product be allowed for sale in India.
Your application will be assigned a serial number that allows you to track its progress throughout each step of testing and regulation.
Types of Drugs That Require Prior Approval
The Drugs and Cosmetics Act defines drugs as anything that is used to prevent, treat or cure a disease, disorder or abnormal physical state or its symptoms, by modifying a physiological activity.
Drugs are classified into various categories depending on their therapeutic uses. Prior approval is required for formulations that are: anabolic steroids; hormones; antibiotics; homeopathic remedies; fertilizers; pesticides and radiology contrast media.
As per The Narcotic Drugs and Psychotropic Substances Act of 1985, cannabis-based products need prior approval before being sold over-the-counter (OTC).
India does not approve of any cancer drugs for use until they have been clinically tested on humans as per ICMR (Indian Council of Medical Research) guidelines.
Tips for Preparing your Pharmaceutical Product File
Obtaining Drug Controller General of India (DCGI) approval is an important milestone for any pharmaceutical company, but it can be an overwhelming and complicated process.
For a new company or new product, there are several factors to consider before submitting your application. Preparation is key to success. Here are some tips on what to do before you submit your application.
Research: One of the first steps should be conducting thorough research into your market, competitors and pricing of similar products on both global and local levels. Understanding how pharmaceuticals have been approved before gives you a good idea about how you’ll need to proceed with getting DCGI approval.
Submitting Your Drug Application
The Drug Controller General of India (DCGI) is a federal government agency that is responsible for ensuring that all drugs sold in India are safe and effective.
Each year, hundreds of new products are submitted to them for approval; about 80% of those are approved. If you’re planning on selling your pharmaceutical product here, you’ll need to get approval from the DCGI—but you won’t be alone!
That’s because they receive more than 600 applications each year and recently saw approval rates rise above 90%. With such competition, how do you know how best to submit your drug application? We sat down with experts from across different industries and got their input on how best to get started.
Registering a New Production Facility
DCGI approval is very important for any company that wants to manufacture products in India, so it’s wise to know how to go about getting it. If you already have a business registered with your city and district registration offices, obtaining a DCGI license will be relatively easy.
Simply register your production unit with them and obtain all of your business licenses and certificates from there. If you don’t have a manufacturing facility yet, then register one at your city office and begin accumulating all of your documents from there. If you have any hassle you can get quote here DCGI Approval India
Why Do I Need to Maintain Records for The Expiration of My Drug License?
As a pharmaceutical company, one of your main responsibilities is to make sure that you comply with all local and federal laws. One of these laws is known as The Drug Controller General of India.
Since 1996, companies like yours have been required to submit reports about new drugs entering the market and even renewing existing drug licenses. Understanding why you need to adhere to DCGI rules will help ensure your company remains compliant with current regulations.
The primary benefit of knowing how DCGI approval process works will help make sure your medicines are safe for use by consumers. While it might be challenging to understand at first, looking into how FDC inspection takes place can clarify some confusion over how international medication approvals work.
What Are the Benefits of Registering as an Export House?
Registering as an export house is one of those things that everyone needs to do at some point.
If you plan on trading with multiple countries, your business will need to be registered for regulatory compliance.
You may think it’s a lot of paperwork, but there are some serious benefits that come along with registration.