There has been a rapid growth in India’s pharmaceutical and biotech industry in the last few years. The government is now bringing many rules and processes online. This speeds up the work and increases transparency in the entire process.
Recently, the CDSCO has made an important announcement. Applications for rDNA drug licenses will have to be submitted online only. This application will have to be made through the ONDLS portal.
This rule has come into effect from March 10, 2026. After this, submission of applications on paper or offline has been stopped.
This change is important for drug manufacturing companies, biotech companies, and drug regulators. In this article, we will know about r-DNA drugs, the new rules, and how the ONDLS portal works.
What are Recombinant DNA (r-DNA) Drugs?
Recombinant DNA drugs are made using genetic technology. It uses DNA from different sources to make a useful protein. The protein is later used as a drug.
In this method, a specific gene is inserted into bacteria, yeast, or any other cell. A cell produces the necessary protein with the help of that gene.
Some common examples of r-DNA drugs are-
- Recombinant insulin for diabetes
- Monoclonal antibodies for cancer treatment
- Growth hormone therapy
- Some modern vaccines
Making such drugs is not easy. The entire process has to be done under a lot of control. So, the CDSCO follows strict rules in the production and licensing of such drugs.
Key Examples of r-DNA Drugs
Given below are the key examples of r-DNA drugs-
- Human Insulin (Humulin)
- Human Growth Hormone (HGH)
- Factor VIII
- Interferons (alfa-2a, 2b)
- Hepatitis B Vaccine
- Monoclonal Antibodies
CDSCO’s New Mandate for Online r-DNA Drug License Applications
CDSCO has recently introduced a new rule for r-DNA drug license applications. Applications for such licenses will have to be submitted online only according to this rule.
The ONDLS portal will be used. This portal has been designed to simplify the drug license application process. Here, all the application processes, from submitting applications to uploading documents and checking the status can all be done online.
The paper application submission method has been discontinued from March 10, 2026. So, all applications will be done through this online system.
This change simplifies the entire licensing process and reduces unnecessary paperwork. This helps companies to apply easily, and the work of regulators will also be faster.
Key Highlights:
- Application for r-DNA drug license will now have to be done online
- Applications will have to be submitted through the ONDLS portal
- The offline application will be closed from 10th March 2026
- This rule applies to companies manufacturing r-DNA products
- This may speed up the license process a bit
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Curious to know the Key Highlights of the New CDSCO Requirement?
There are some important points in the new rule. These are given below-
- All r-DNA drug license applications will have to be submitted through the ONDLS portal.
- The method of applying on paper or by hand has been stopped.
- This rule applies to Form 28-D and Form 28-DA licenses.
- All documents will have to be uploaded as per the checklist given on the portal.
- After submitting the application, its status will be visible online.
- This may take some time in the application process.
- It will be easier to maintain a uniform system in the licensing process across states.
- The new digital system will help make the entire licensing process clearer and more transparent.
- This change will make it much easier to apply and understand the process.
Forms Covered Under the New Online System
Two important forms of application for r-DNA drug license will now have to be made online, according to the new rules. These applications will have to be submitted through the ONDLS portal. Earlier, these forms could be submitted on paper, but now the system has been discontinued.
Form 28-D
Form 28-D is used to obtain a manufacturing license for certain biological products.
Products for which application is made through this form include-
- r-DNA derived drugs
- vaccines
- sera
- large volume parenterals
These types of products fall under Schedule C and Schedule C(I) of the Drugs Rules. Hence, separate licenses and strict controls are required for their production.
- Form 28-DA
- Form 28-DA is mainly used for loan licenses.
A company can manufacture products using the production facilities of another licensed manufacturer even if it does not have its own factory.
So, both the Form 28-D and Form 28-DA applications will have to be submitted digitally through the ONDLS portal.
Read more – A Guide to File Drug License Application in India
What is the ONDLS Portal?
The ONDLS is a single-window online platform for the drug licensing process in India. Applications for various types of drug licenses and approvals can be submitted online through this portal.
This system has been developed by the C-DAC, and it has been developed in collaboration with the CDSCO.
Using the ONDLS portal, applicants can easily-
- Submit a license application online
- Upload the required documents
- View the status of the application
Some of the important features of this portal are-
- Centrally managed drug licensing system
- Similar documentation process in all states
- Complete digital application system
- Facility to track applications online
- Coordination between central and state drug regulators
Many other types of applications can be made through this portal, such as:
- Manufacturing license
- Sales license
- GMP and WHO-GMP certificates
- Market standing certificate
- Post-approval changes
Thus, the ONDLS portal has brought the entire drug licensing process to one place.
Why did CDSCO Shift r-DNA Licensing to ONDLS?
CDSCO has shifted the r-DNA drug license application to the ONDLS portal to simplify and modernize the process. Here are several important reasons behind this-
1. Faster Regulatory Processing
Submitting applications online reduces the paperwork. As a result, the file verification and approval process can be done faster.
2. Improved Transparency
Applicants can now check the status of their applications online. This makes the entire process clearer.
3. Uniform Licensing System
Using the ONDLS portal, state licensing authorities of different states can follow similar rules. This maintains a certain standard in the licensing process.
4. Digital Governance
This initiative is helping to increase e-governance in the Indian drug regulatory system.
5. Global Alignment
Such a digital system helps in aligning with international regulatory standards and the guidelines of organizations like the WHO.
An attempt is being made to make the pharmaceutical regulatory system in India stronger and more effective through all these changes.
Future Outlook for Digital Drug Licensing in India
The entire system is undergoing major changes as the drug licensing process in India is gradually going digital. This change simplifies the application process but also strengthens the regulatory system. Since everything is online, the work is getting faster and the chances of errors are also decreasing. In the future, such digital systems will be further developed and will make it easier for businesses to work.
The key impacts of this change are:
- The drug regulatory process will be faster and standardized
- Quality verification and monitoring of drugs will be strengthened
- Coordination between central and state regulators will increase
- Delays in license approval will be reduced
- The growth of the biotech and biologics industry will be faster
Such digital initiatives will strengthen India’s pharma sector and help the country retain its position as a major global pharmaceutical manufacturing hub.
Read more – How to obtain a Drug License for Wholesale Business in India?
How Can Corpbiz Help with r-DNA Drug Licensing and Compliance?
The process of obtaining an r-DNA drug license can sometimes seem complicated, especially for new companies. Corpbiz can play a vital role. We assist pharmaceutical and biotech businesses with the entire licensing process.
Types of support that Corpbiz provides:
- Assistance in applying for a CDSCO drug license
- Guidelines for submitting Form 28-D and Form 28-DA
- Assistance in preparing and verifying required documents
- Registration and submission of the application on the ONDLS portal
- Assistance in obtaining GMP and WHO-GMP certification
- Complete regulatory advice from start to finish
Taking the help of experts reduces the chances of making mistakes. This saves time and makes the process of obtaining a license much easier.
Conclusion
CDSCO has brought a major change in the application process for rDNA drug licenses. It becomes mandatory to apply online using the ONDLS portal.
This rule has come into effect as of March 10, 2026. So, the paper application process is no longer required. This change will make the licensing process faster, clearer, and more systematic.
Pharmaceutical and biotech companies will now have to adapt to this new digital system. It can be a good decision to take the help of a professional company like Corpbiz to apply correctly and avoid any hassles. This can make the entire process easy.
Read more – What are the Basic Requirements for Wholesale Drug License?
Top Questions Regarding r-DNA Drug License Applications
What is CDSCO and its role in India?
CDSCO is the key drug regulatory body in India. This organization ensures the quality, safety, and efficacy of drugs. This approves new drugs before they are released on the market. This organization also plays an important role in drug licensing, clinical trials, and import-export.
What are Recombinant DNA (r-DNA) drugs?
r-DNA drugs are drugs that are made using genetic engineering. Here, a specific protein is made using DNA from different sources. This protein is used in medicine. Such drugs are usually complex, so they require special controls and licenses.
What is the ONDLS portal?
ONDLS is an online platform where one can apply for a drug license. One can submit the application, upload documents, and check the status through this portal. This makes the entire process easy and fast. It also enhances coordination between the central and state drug authorities.
When did CDSCO make ONDLS mandatory?
The CDSCO has announced that the use of the ONDLS portal for r-DNA drug licenses will be mandatory from March 10, 2026. Paper applications have been stopped from this date. So, all applications will have to be submitted online so that the entire process is fast and transparent.
What is Form 28-D used for?
Form 28-D is used to obtain a manufacturing license for certain biological products. This includes r-DNA drugs, vaccines, sera, etc. The company gets approval for its manufacturing units through this form. Since these products are complex, detailed verification is done before getting the license.
What is Form 28-DA, and who uses it?
Form 28-DA is mainly used for a loan license. A company can manufacture the product using the factory of another licensed manufacturer through this license. Companies that do not have their own manufacturing units can carry out production work by obtaining permission through this form.
Why has CDSCO stopped the offline application?
CDSCO stopped the offline application mainly to make the process easier and faster. Earlier, it was full of errors in the application and took time. Applying online keeps all the information in one place and can be easily verified. This speeds up the work and increases transparency in the entire process.
What are the advantages of the ONDLS portal?
Using the ONDLS portal makes the application process much easier. Here, everything can be done online, so it takes less time. Also, the status of the application can be seen. This allows companies to understand the status of their application easily.
Can the application be tracked on ONDLS?
It can be easily tracked after submitting the application on the ONDLS portal. Applicants can log in to their accounts and see the status. This allows them to know the stage of the application. This reduces unnecessary delays or confusion and keeps the entire process clear.
How can Corpbiz help?
Corpbiz helps pharmaceutical and biotech companies obtain drug licenses. They simplify the process of preparing applications, documenting, and submitting applications to the ONDLS portal. They also help in obtaining GMP and other certifications. This helps companies obtain licenses in less time and hassle-free.
Read more – A Complete Overview on Drug License Rules in India
