CDSCO ONDLS Update: r-DNA Drug Licence Applications, Rules & Compliance Guide

Could it be that one of the most important stages in securing an r-DNA drug licence in India could no longer be carried out by means of a conventional paper application?

The pharmaceutical and biotechnology sector in India is rapidly progressing towards the use of digital regulatory systems, and the most recent update to the CDSCO ONDLS in 2026 is a significant step forward for companies producing recombinant DNA products. Applications for licences in Form 28-D and Form 28-DA for r-DNA products have to be submitted via the Online National Drugs Licensing System (ONDLS) from 10 March 2026.

This implies that for pharmaceutical manufacturers, biotechnology companies, and any other businesses intending to produce drugs derived from recombinant DNA, regulatory preparation must now be both technically accurate and conform to digital requirements.

This blog from UMSPCS covers the r-DNA Drug Licence, the process for applying for an ONDLS, the documents required, the legal framework, the benefits, the validity period, the timelines involved, the common problems encountered, and the compliance considerations.

What Are r-DNA Drugs?

Drugs known as recombinant DNA (r-DNA) drugs are pharmaceuticals which have been developed by means of recombinant DNA technology. This technology consists of inserting a chosen gene or DNA sequence into an appropriate host system in order that the host will be able to produce the wanted biological substance or protein.

Depending on the product, recombinant technology may be used in the development or manufacture of products such as:

• Recombinant human insulin
• Recombinant human growth hormone
• Recombinant Factor VIII
• Interferons
• Certain vaccines
• Monoclonal antibodies
• Other recombinant biological products

Since these products involve complicated biological manufacturing processes and demand strict quality controls, their production is governed by particular regulatory requirements within India’s drug regulatory framework.

What is the latest CDSCO ONDLS Update in 2026?

The update to the CDSCO ONDLS in 2026 was sent via a circular from the CDSCO dated 10 March 2026 relating to online applications for the grant of licences in Form 28-D/28-DA for r-DNA products.

The important change is straightforward:

Now applications for licences for r-DNA products under Form 28-D and Form 28-DA must be made via the ONDLS portal.

The CDSCO has also made it clear that the facility for processing applications submitted in hard copy form will not be available from 10 March 2026.

Key Highlights of the 2026 Update:

• Applications for r-DNA drugs must be made online
• The applications have to be submitted via the ONDLS portal
• The regulations include applications for r-DNA products based on Form 28-D and Form 28-DA
• Applicants must follow the checklist and requirements found in the relevant ONDLS module
• The option to submit hard copies offline will no longer be available for processing from 10 March 2026
• The information relating to the application and the regulatory documentation is managed via the digital system
• It is therefore very important to get the documents properly prepared before starting the online submission

Which Licence Applies: Form 28-D or Form 28-DA?

One of the first steps in obtaining licences for r-DNA drugs in India is to understand the relevant form.

Form 28-D

Form 28-D is the licence that allows products listed in Schedule C and C(I) to be manufactured for sale or distribution, such as large volume parenterals, sera, vaccines and drugs derived from recombinant DNA, but with the exception of those products specified in Schedule X.

The listing for the ONDLS service names the relevant application as Form 27-D and the licence as Form 28-D.

Form 28-DA

Form 28-DA is concerned with a loan licence enabling the manufacturing for sale or distribution of specified large volume parenterals, sera, vaccines and recombinant DNA-derived drugs.

This route applies in cases where manufacturing is carried out by another licensed manufacturer, provided that the relevant regulatory conditions are met.

It is essential therefore to choose the right application route before submitting an r-DNA Drug Licence Application.

What is the ONDLS Portal?

The Online National Drugs Licensing System (ONDLS) is a digital system which is used for granting licences for drugs and for other regulatory services.

The official portal offers the facilities of online applications, tracking of applications and the verification of licences. The services it provides cover manufacturing and sale licensing, certificates, post-approval activities and other regulatory functions.

The portal now offers the online means of submitting the relevant Form 28-D and Form 28-DA applications for r-DNA products.

The shift to ONDLS supports:

• Digital application submission
• Online document handling
• Application tracking
• Greater standardisation
• Easier regulatory communication
• Centralised access to licensing services

Documents Required for ONDLS r-DNA Licence Application

In the ONDLS module concerned, the exact checklist should be adhered to. For different applications, the documentation may include:

• Applicant/company details
• Constitution documents
• Manufacturing-site information
• Details of technical staff
• Product and formulation information
• Manufacturing process details
• Specifications and testing information
• Quality-control documentation
• Site and facility information
• GMP-related documents
• Supporting declarations and undertakings
• Existing regulatory approvals, where applicable
• Documents required under the ONDLS checklist

A gap in the documentation prior to submission may result in regulatory questions or delays; it therefore seems advisable to carry out a CDSCO r-DNA compliance document review before filing.

Step-by-Step r-DNA Drug Licence Application Process

Step 1: Identify the Regulatory Route

Find out if the suggested activity calls for Form 28-D or Form 28-DA and decide whether any further product approvals are needed.

Step 2: Assess Product and Manufacturing Compliance

Look at the product, the method of manufacturing, the premises, the technical staff, the arrangements for testing, and the relevant regulatory requirements.

Step 3: Prepare the Documentation

Gather the documents required by the applicable CDSCO and ONDLS checklist.

Step 4: Register with ONDLS

Set up the applicant’s account on the ONDLS platform or access it and fill in the required profile details.

Step 5: Select the Relevant Application

Select the r-DNA licensing service that applies and the corresponding application form as well.

Step 6: Upload Documents and Submit

Upload the documents and information that are required, fill in the application form, and then submit it via ONDLS.

Step 7: Regulatory Review

The competent regulatory authority examines the application and may raise questions or point out any deficiencies if further clarification or additional documentation is needed.

Step 8: Address Queries

Address the regulatory observations in the relevant process and supply the information that has been requested or the amended documents.

Step 9: Licence Grant

When the regulatory requirements in question have been satisfactorily fulfilled, the licence will be granted by means of the prescribed regulatory process.

What Caused the CDSCO to Transfer the r-DNA Licensing to ONDLS?

As part of its wider effort to simplify and modernise India’s drug licensing system, CDSCO has transferred the r-DNA Drug Licence Applications to the ONDLS portal.

The aim of the digital system is to decrease the need for physical paperwork and at the same time make the regulatory workflow more structured and transparent.

1. Faster Regulatory Processing

Filing applications online cuts down on the amount of paperwork and the need for manual handling. As a result, it is possible to improve the processing of documents, communication, and regulatory procedures.

2. Improved Transparency

Applicants have the option of using the digital system to keep an eye on the status of their applications. The ability to track things online gives one better visibility into the progress of a regulatory submission.

3. Uniform Licensing System

The ONDLS platform offers a common digital framework enabling licensing authorities to handle applications, thus helping to achieve greater consistency in the CDSCO Drug Licensing Process in different jurisdictions.

4. Digital Governance

This step aligns with the Government’s wider e-governance efforts in the pharmaceutical regulatory area and means that regulatory interactions can become more systematic and accessible.

5. Global Alignment

Digital regulatory systems are becoming more important in modern pharmaceutical regulation, and the shift to structured electronic submissions can help India to strengthen its regulatory systems and bring its processes in line with changing international practices.

The CDSCO ONDLS Update 2026 is once again a move in the direction of a more digital, standardised, and transparent pharmaceutical licensing system in India.

Common Challenges in r-DNA Drug Licence Applications

Despite digitalisation, applicants may still face challenges such as:

• Choosing the wrong application route
• Incomplete technical documentation
• Incorrect product classification
• Missing supporting documents
• Gaps in GMP or quality documentation
• Difficulty interpreting regulatory requirements
• ONDLS upload or submission issues
• Regulatory queries after filing
• Delays caused by incomplete responses

The complexity of the regulations is not removed by digital filing; it only alters the way in which the application is submitted.

How UMSPCS Can Help With r-DNA Drug Licensing

UMSPCS helps businesses to cope with the complicated regulatory requirements and can help applicants by using a systematic method when applying for a CDSCO r-DNA Drug Licence Registration.

Our support can include:

• Regulatory pathway assessment
• r-DNA Drug Licence application guidance
• Form 28-D and Form 28-DA applicability assessment
• ONDLS application support
• Document checklist preparation
• Technical document review
• Application preparation and filing assistance
• Regulatory query support
• Compliance-gap identification
• Post-submission coordination
• Guidance on applicable CDSCO requirements

For biotechnology and pharmaceutical companies, carrying out the application in the right way before it is submitted can help to avoid problems relating to documentation and make the regulatory process easier to manage. Also, get to know more information about CDSCO for ISO 13485.

Conclusion

From 10 March 2026, applications for the grant of licences for r-DNA products in Form 28-D and Form 28-DA are to be made via the ONDLS portal, offline hard-copy applications no longer being available for processing from that date.

Pharmaceutical and biotechnology companies should therefore give priority to accurate product assessment, the right form selection, full documentation, and the correct online submission.

Since India’s drug regulatory system is still progressing towards digital governance, businesses can avoid unnecessary compliance gaps by keeping up with the CDSCO ONDLS Updates 2026.

Looking to apply for an r-DNA Drug Licence or requiring assistance with Form 28-D/Form 28-DA and ONDLS compliance?

Connect with UMSPCS now and obtain professional advice regarding your CDSCO licensing requirements, the documentation needed, and the application process.

Read more about: Get Foreign Manufacturer Certification India 2026 Requirements

FAQs

1. Will ONDLS be required for applications for an r-DNA Drug Licence in 2026?

Starting on 10 March 2026, CDSCO will require that applications for Form 28-D/28-DA licences for r-DNA products be submitted via ONDLS.

2. What constitutes an r-DNA Drug Licence?

It is a licence for manufacturing which applies to certain drugs derived from recombinant DNA and which are included within the provisions of the Drugs Rules, 1945.

3. What is Form 28-D used for?

Form 28-D is the licence which is required for the manufacture of products listed in the specified Schedule C and C(I), including recombinant DNA-derived drugs, vaccines, sera and large volume parenterals, but excluding those listed in Schedule X.

4. What is Form 28-DA?

Form 28-DA is used for obtaining a loan licence to manufacture specified products, including drugs derived from recombinant DNA, provided that the relevant regulatory requirements are met.

5. Is it possible for me to submit an r-DNA licence application offline?

The circular issued by the CDSCO on 10 March 2026 states that, from that date, offline hard-copy applications for Form 28-D/28-DA relating to r-DNA products will no longer be accepted for processing.