You are planning a BA/BE study in India. Your regulatory timeline budgets 90 working days for CDSCO to review your test licence application. In January 2026, India’s Ministry of Health and Family Welfare changed that. They notified the New Drugs and Clinical Trials (Amendment) Rules, 2026 via Gazette Notification G.S.R. 46(E). The new rules cut that 90-day window in half for certain drug categories. For many others, they remove the prior approval requirement entirely.

If you have not yet updated your India regulatory planning to reflect the NDCT amendment rules 2026, your timelines rest on the old framework. This article explains what changed, what did not change, and what you need to do differently from mid-March 2026 onward.

Key takeaways

• The NDCT amendment rules 2026 were notified on 20 January 2026 via G.S.R. 46(E) and became effective approximately 45 days later, in mid-March 2026. They amend the New Drugs and Clinical Trials Rules, 2019.
• The most significant change is the replacement of the test licence mechanism with a prior intimation route for most low-risk categories of non-commercial manufacture. Sponsors no longer need prior approval for manufacturing small quantities of new drugs or investigational new drugs (INDs) for purposes including research, testing, analysis, clinical trials, and BA/BE studies, where the category is not on the excluded list.
• The process under the prior intimation route is: submit an online intimation through the SUGAM portal (using forms CT-10, CT-12, or CT-13 as applicable), receive an acknowledgment, and proceed. No waiting for regulatory approval is required for covered categories.
• Five drug categories are excluded from the prior intimation route and continue to require prior permission: cytotoxic drugs, narcotic drugs and psychotropic substances, sex hormones, beta-lactam antibiotics, and biologics containing live microorganisms.
• For activities that continue to require regulatory permission, the NDCT amendment rules 2026 reduce the statutory review period from 90 working days to 45 working days. This applies to manufacturing activities in the excluded categories above.
• The Ministry estimates the reforms will reduce drug development timelines by up to 90 days in many programs. The practical impact depends on the drug category and activity type. Sponsors should map their specific India activities against the new rules before updating project timelines.

Background: What the NDCT Rules 2019 govern

The New Drugs and Clinical Trials Rules, 2019 form India’s primary regulatory framework for clinical trial conduct, new drug approval, and related manufacturing activities. They replaced Schedule Y under the Drugs and Cosmetics Act, 1940. They also introduced a structured, process-driven framework for clinical research in India.

Under the NDCT Rules 2019, sponsors needed a test licence from CDSCO before manufacturing small, non-commercial quantities of a new drug or investigational new drug (IND). This applied to clinical trials, BA/BE studies, and analytical testing. The licence sat separately from the clinical trial authorisation (CTA). It added a review step for manufacturing activities that were, in many cases, low-risk and preparatory in nature.

The test licence framework served a legitimate oversight purpose for high-risk drug categories. However, it created unnecessary regulatory burden for routine activities in low-risk categories, where the primary purpose was testing or analytical work. The NDCT amendment rules 2026 address this directly.

How the Drugs Technical Advisory Board shaped the changes

The amendments followed consultation and backing from the Drugs Technical Advisory Board (DTAB), the statutory expert body that advises India’s Central Government on technical matters under the Drugs and Cosmetics Act. CDSCO published the draft amendments for public feedback on 27 August 2025. After DTAB deliberations and industry consultation, India’s Ministry finalised and notified the rules on 20 January 2026.

DTAB’s involvement matters for sponsors evaluating the stability of the new framework. Because DTAB-backed changes carry statutory authority, CDSCO reviewers apply them consistently. They do not treat them as informal guidance subject to individual discretion.

What the NDCT amendment rules 2026 change: the prior intimation route

The NDCT amendment rules 2026 introduce a prior intimation mechanism for non-commercial manufacture of new drugs and INDs. The route covers manufacturing activities for research, testing, analysis, clinical trials, and BA/BE studies, where the drug category does not appear on the excluded list.

Under this route, the sponsor submits an online notification through the SUGAM portal. They use the applicable form: CT-10, CT-12, or CT-13, depending on the activity type. Once CDSCO issues the acknowledgment, the sponsor may proceed with the manufacturing activity. CDSCO does not review the application substantively before commencement.

Regulatory oversight does not disappear, however. The NDCT amendment rules 2026 require sponsors to maintain timely records and to submit post-activity reports where applicable. CDSCO retains authority to suspend or cancel permissions for non-compliance.

What prior intimation means for study timelines

For BA/BE sponsors, the prior intimation route removes a distinct approval step from the pre-study timeline. Under the old framework, a sponsor needed a test licence before manufacturing study batches. CDSCO took up to 90 working days to review and grant that licence. Under the NDCT amendment rules 2026, the sponsor submits the intimation and receives an acknowledgment. The acknowledgment process is substantially faster than the previous 90-day review.

For clinical trial sponsors using new drugs or INDs in low-risk categories, the same logic applies to preparatory manufacturing activities. The prior intimation route removes the approval bottleneck for the manufacturing step. However, the CTA process for the study itself continues under the separate CTA framework.

Do not conflate the prior intimation change with a change to the CTA process for Phase II or Phase III clinical trials. The CTA review for those phases remains a separate, approval-required process under CDSCO. The NDCT amendment rules 2026 streamline preparatory manufacturing steps, not clinical trial authorisation itself.

[VISUAL: flow chart — two-path diagram showing the pre-2026 test licence pathway versus the post-NDCT amendment rules 2026 prior intimation pathway for BA/BE sponsors, with form types and timing at each step]

Drug categories excluded from the prior intimation route

The NDCT amendment rules 2026 establish a clear exclusion list. Five drug categories continue to require prior CDSCO permission regardless of the activity type. They do not qualify for the prior intimation route.

Cytotoxic drugs, including oncology agents with cell-killing mechanisms, remain subject to prior permission requirements. Narcotic drugs and psychotropic substances continue to require permission under existing controlled substances frameworks. Sex hormones, including natural and synthetic oestrogens, progestogens, and androgens, remain excluded. Beta-lactam antibiotics, covering penicillins, cephalosporins, carbapenems, and monobactams, require prior permission because of contamination risk in shared manufacturing environments. Biologics containing live microorganisms, such as live attenuated vaccines and certain cell therapy products, remain in the permission-required category because of specific safety and containment considerations they present.

Sponsors working in any of these five categories should not assume the prior intimation route applies. For these categories, the NDCT amendment rules 2026 reduce the review timeline from 90 to 45 working days, but CDSCO still requires prior approval before manufacturing proceeds.

[VISUAL: comparison table — two columns: “Eligible for prior intimation route (non-excluded categories)” and “Requires prior CDSCO permission: 45 working days” with the five excluded categories listed on the right]

Biologics without live microorganisms

The exclusion specifically covers biologics that contain live microorganisms. Recombinant proteins, monoclonal antibodies, and other biologics that manufacturers produce without live microorganisms do not automatically fall into the excluded category. Sponsors working with these products should confirm with CDSCO or their India regulatory affairs team whether their specific biologic qualifies for the prior intimation route. The boundary between excluded and non-excluded biologics may require a product-specific assessment.

Human review note: Confirm the classification of specific biologic product types under the excluded/non-excluded categories against the official gazette text and current CDSCO guidance before publication.

Reduced approval timelines for excluded categories

The second major reform in the NDCT amendment rules 2026 covers activities that continue to require prior permission. For excluded categories, the rules cut the statutory review period from 90 working days to 45 working days. This halves the calendar time sponsors must budget for these reviews.

At five working days per week, 90 working days equals approximately 18 calendar weeks. Forty-five working days equals approximately nine calendar weeks. Sponsors in excluded drug categories should update their study start-up timelines accordingly. Because the saving is significant, using the old 90-day buffer will over-inflate your India timeline.

The 45-working-day clock starts from CDSCO’s acceptance of a complete application. Incomplete applications that need additional data do not start the clock. Sponsors should ensure their submission packages are complete before filing. Deficiency queries reset the timeline even under the new 45-day rule.

What a complete submission requires

The NDCT amendment rules 2026 do not formally change CDSCO’s completeness standard. A manufacturing application requires the relevant Form CT submission and quality data on the drug substance or product. The package should also include manufacturing site details, Good Manufacturing Practice (GMP) compliance documentation, and safety data relevant to the category. For excluded categories such as cytotoxics or beta-lactams, CDSCO may require additional documentation on contamination prevention and facility segregation.

Sponsors submitting applications for excluded categories should prepare complete packages before filing. Deficiency responses add significant time to the process even under the new 45-day timeline.

How the NDCT amendment rules 2026 affect BA/BE sponsors specifically

India is one of the most active markets globally for BA/BE studies. Low site costs, large patient populations across multiple therapeutic areas, and experienced BA/BE infrastructure make India a consistent first choice for generic and 505(b)(2) sponsors. The NDCT amendment rules 2026 make India more attractive by removing a significant pre-study approval step for most BA/BE study categories.

Before the amendment, BA/BE sponsors needed a test licence before manufacturing the reference and test product batches. CDSCO reviewed that application for up to 90 working days. That step sat between protocol development and study start-up and added weeks to the pre-study calendar. Under the prior intimation route, the sponsor submits the intimation, receives the acknowledgment, and proceeds. For most BA/BE drug categories, this removes weeks of regulatory lead time.

BA/BE sponsors should confirm that their drug category does not appear on the excluded list before updating timelines. A BA/BE study for a beta-lactam antibiotic, for example, still requires prior CDSCO permission, now with a 45-working-day review rather than 90. For non-excluded categories, the prior intimation route delivers a meaningful acceleration of the start-up path. For operational context on how India BA/BE programs fit into broader APAC planning, see why India leads global BA/BE studies.

What the SUGAM portal process looks like

SUGAM is India’s online regulatory submission system for CDSCO applications. Under the NDCT amendment rules 2026, sponsors use specific form types for the prior intimation submission. CT-10 covers non-commercial manufacture of new drugs or INDs for analytical and non-clinical purposes. CT-12 and CT-13 cover related categories of manufacturing activities for BA/BE studies and clinical applications. The applicable form depends on the drug category and the manufacturing purpose.

The sponsor submits the intimation online through the SUGAM portal. CDSCO issues an acknowledgment that confirms receipt. That acknowledgment lets the sponsor proceed. It is not substantive approval of the manufacturing activity. It is confirmation that CDSCO has registered the intimation.

Human review note: Verify the precise mapping of CT-10, CT-12, and CT-13 to specific activity types against the official gazette and CDSCO SUGAM guidance before publication. Form applicability may be refined in CDSCO implementation guidance.

What the NDCT amendment rules 2026 do not change

Sponsors should be clear about what these amendments do not affect. The clinical trial authorisation (CTA) process for Phase I, II, and III studies in India remains a prior-approval process under CDSCO. The NDCT Rules 2019 framework for CTA applications, including the scientific committee review for Phase II and Phase III studies, stands unchanged. Sponsors planning full clinical trials in India should continue to plan for the CTA review timeline. That timeline is separate from the manufacturing activity changes addressed here.

Ethics committee (EC) approval requirements also remain unchanged. Registered ECs review and approve clinical trial protocols independently of the CDSCO timeline. The 30-working-day simultaneous global trial pathway, where India allows a study already holding approval from a comparable regulatory authority to proceed faster, also remains in place under the existing NDCT framework.

The NDCT amendment rules 2026 target non-commercial manufacturing activities specifically, including the test licence process for producing small study quantities. They do not reform the CTA framework for clinical trial conduct.

The Second Amendment Rules 2026

A separate notification, the New Drugs and Clinical Trials (Second Amendment) Rules, 2026, appeared in early 2026. This covers additional regulatory changes that sit apart from the test licence and prior intimation reforms in the primary January 2026 amendment. Sponsors with questions about the Second Amendment should consult CDSCO’s gazette notifications page and verify which provisions apply to their specific study type.

Human review note: Confirm the specific content of the Second Amendment Rules 2026. If material, address it in this article or in a companion piece before publication.

How to update India study planning under the NDCT amendment rules 2026

Updating your India regulatory plan involves four steps. First, identify every India-based manufacturing activity in your current study timeline. Second, check each activity against the excluded drug categories list. Third, for non-excluded categories, remove the test licence approval step. Replace it with a SUGAM prior intimation submission and acknowledgment. Fourth, for excluded categories, update the approval buffer from 90 working days to 45 working days. Keep the prior permission step; CDSCO still requires approval before manufacturing proceeds.

Sponsors who currently hold test licences under the old framework should confirm with their India regulatory team or CRO. They need to check whether those licences still apply to planned activities, or whether the prior intimation route governs on a going-forward basis. The gazette notification’s transitional provisions govern this point.

CDSCO publishes the official text of G.S.R. 46(E) and all related notifications on the CDSCO gazette notifications page. Sponsors and regulatory teams should review that text directly for activities where the category boundary or form applicability is unclear. For a broader view of India’s strengths as a clinical trial market, see top reasons to choose India for clinical trials.

Conclusion

The NDCT amendment rules 2026 deliver a meaningful acceleration of the India regulatory pathway for most non-commercial manufacturing activities in clinical research. The prior intimation route removes a distinct approval step for low-risk BA/BE and IND manufacturing categories. The 45-working-day timeline cuts the remaining approval period in half for excluded categories. Sponsors who update their India timelines now will have more accurate, and in most cases faster, regulatory projections. Sponsors who continue to use the old framework will build unnecessary buffer into programs that no longer need it.

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Planning a Clinical Trial or BA/BE Study in India?

If you are preparing a study in India and want to understand how the NDCT amendment rules 2026 affect your specific timeline and drug category, Credevo can walk you through the regulatory pathway. Please fill out the form below to connect with our team.

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Frequently asked questions

What are the NDCT amendment rules 2026?

The New Drugs and Clinical Trials (Amendment) Rules, 2026 are amendments to India’s NDCT Rules 2019, notified via Gazette Notification G.S.R. 46(E) on 20 January 2026 by the Ministry of Health and Family Welfare. They became effective approximately 45 days after publication, in mid-March 2026. The primary changes are the introduction of a prior intimation route for non-commercial manufacturing of new drugs and INDs for research, testing, analysis, clinical trial, and BA/BE purposes (for most drug categories), and a reduction in the statutory review period from 90 to 45 working days for categories still requiring prior permission.

What is the prior intimation route under the NDCT amendment rules 2026?

The prior intimation route replaces the test licence approval requirement for most non-commercial manufacturing activities. Under this route, the applicant submits an online intimation via India’s SUGAM portal using the relevant form (CT-10, CT-12, or CT-13 depending on the activity). On receiving CDSCO’s acknowledgment, the applicant may proceed with the manufacturing activity without waiting for substantive regulatory approval. The route applies to manufacture of new drugs or INDs for research, testing, analysis, clinical trials, and BA/BE studies in categories not on the excluded list. Record maintenance and post-activity reporting obligations still apply.

Which drug categories are excluded from the prior intimation route?

Five categories continue to require prior permission from CDSCO and are not eligible for the prior intimation route: cytotoxic drugs, narcotic drugs and psychotropic substances, sex hormones, beta-lactam antibiotics, and biologics containing live microorganisms. For these categories, the NDCT amendment rules 2026 reduce the review period from 90 to 45 working days, but prior approval is still required before manufacturing proceeds. Sponsors working with these drug types should confirm which regime applies to their specific product with their India regulatory affairs team or CRO.

Do the NDCT amendment rules 2026 change the clinical trial authorisation process for Phase II or Phase III studies?

No. The NDCT amendment rules 2026 specifically address non-commercial manufacturing activities, including the test licence process for producing small study quantities for testing, analysis, and BA/BE purposes. The clinical trial authorisation (CTA) process for Phase I, II, and III studies in India remains a prior-approval process under CDSCO. The scientific committee review for Phase II and III applications, and the ethics committee approval process, are unchanged. Sponsors planning Phase II or Phase III studies in India should continue to plan for the CTA review timeline separately from the manufacturing activity timelines addressed by the amendment.

How much time do the NDCT amendment rules 2026 save on a typical BA/BE study start-up?

For a BA/BE study in a non-excluded drug category, the prior intimation route removes the test licence approval step entirely. Under the old framework, this step required up to 90 working days (approximately 18 calendar weeks). The replacement process, submitting intimation via SUGAM and receiving acknowledgment, is substantially faster. For excluded drug categories such as beta-lactam BA/BE studies, the review period is reduced from 90 to 45 working days, approximately nine calendar weeks. The Ministry estimates the overall reforms can reduce drug development timelines by up to 90 days in many programs, though the actual saving depends on the drug category and the specific study configuration.

Where can I find the official text of the NDCT amendment rules 2026?

The official gazette notification G.S.R. 46(E) dated 20 January 2026 is published on the CDSCO gazette notifications page at cdsco.gov.in. The SUGAM portal at sugam.gov.in provides access to the online submission system for prior intimation filings. Sponsors requiring guidance on which form type applies to their specific activity should review the official gazette text or consult their India regulatory affairs team. For multi-country programs that include India, the India regulatory pathway should be mapped against the updated NDCT amendment rules 2026 framework before timelines are finalised.