India’s Drugs Technical Advisory Board (DTAB) has recommended amendments to the New Drugs and Clinical Trials Rules, 2019, to clarify Good Manufacturing Practice (GMP) requirements for new drugs and active pharmaceutical ingredients manufactured for clinical trials, BA/BE studies, and non-clinical testing.
The proposal could bring a clearer separation between manufacturing intended for clinical development and material produced only for analytical or non-clinical purposes, while placing stronger GMP expectations on batches that will enter clinical or bioequivalence studies.
For pharmaceutical manufacturers, API suppliers and companies developing new drugs in India, the change could affect how trial batches are planned, manufactured, documented and traced.
What Has Changed?
At its 94th meeting held on August 27, 2026, the DTAB reviewed the regulatory requirements governing the manufacture of new drugs and APIs for testing, analysis, non-clinical studies and clinical studies.
The Board noted that the existing framework does not clearly differentiate GMP requirements according to the purpose of the trial batch.
DTAB therefore recommended amendments to Rule 55 and Rule 63 of the New Drugs and Clinical Trials (NDCT) Rules, 2019. The recommendations would introduce clearer requirements for clinical trial and BA/BE manufacturing while allowing new drugs and APIs intended for analytical and non-clinical testing to be manufactured under GMP principles with proper traceability.
It is important to note that this is currently a DTAB recommendation, rather than a final amendment to the NDCT Rules. The proposed wording would still need to go through the applicable government rule-making and notification process before becoming legally effective.
Clinical Trial and BA/BE Batches Would Face Clearer GMP Requirements
Under the proposed amendment to Rule 55, new drugs manufactured in small quantities for clinical trials or bioavailability and bioequivalence (BA/BE) studies would need to be produced in facilities complying with the GMP requirements provided under the Drugs Rules, 1945.
The proposed wording would replace the more general reference to manufacturing “in accordance with the principles of Good Manufacturing Practices” with a specific requirement for manufacturing in a GMP-compliant facility for clinical trial and BA/BE purposes.
This distinction matters because clinical-trial material is ultimately administered to human subjects. Moving from a general GMP-principles requirement toward a facility-based GMP requirement could make the manufacturing environment, quality systems and documentation more clearly defined during regulatory review.
For manufacturers, this may mean that the selection of a facility for clinical trial batches becomes an earlier and more important part of drug-development planning.
Analytical and Non-Clinical Testing Would Follow a Different Path
The proposed amendment also introduces an important distinction for material manufactured for analytical and non-clinical testing.
DTAB recommended allowing new drugs manufactured for these purposes to be produced in accordance with the principles of GMP, with proper traceability, rather than applying the same facility requirement proposed for clinical and BA/BE batches.
The same approach would apply to certain API and formulation manufacturing under Rule 63.
This creates a clearer regulatory structure:
| Purpose of Manufacturing | Proposed Regulatory Approach |
|---|---|
| Clinical trials | GMP-compliant manufacturing facility |
| BA/BE studies | GMP-compliant manufacturing facility |
| Analytical testing | GMP principles + proper traceability |
| Non-clinical testing | GMP principles + proper traceability |
The distinction could be particularly relevant during early-stage drug development, when companies may need small quantities of an API or drug substance for laboratory testing before moving into human studies.
Proposed Changes to API Manufacturing Under Rule 63
Rule 63 covers permission for the manufacture of certain unapproved APIs and their pharmaceutical formulations for specified development and testing purposes.
DTAB has recommended that where an API or formulation is intended for clinical trials or BA/BE studies, manufacturing should take place in a facility complying with the GMP requirements under the Drugs Rules, 1945.
For analytical and non-clinical testing, the proposed wording would allow manufacture in accordance with GMP principles, provided that proper traceability is maintained.
For API manufacturers, this distinction is important because the regulatory expectations could differ depending on where the material sits in the development pathway.
An API produced for laboratory evaluation would not necessarily be treated in exactly the same way as an API destined for a clinical trial batch.
Why the Change Matters for Pharmaceutical Manufacturers
The proposed amendments come at a time when India is tightening the quality framework for pharmaceutical manufacturing while also introducing measures intended to streamline certain drug-development procedures.
India amended the NDCT Rules in January 2026 to introduce a “prior intimation” system for the manufacture of certain new drugs or investigational new drugs for analytical and non-clinical testing, excluding specified higher-risk categories. The same amendment reduced several timelines under Rule 53 from 90 working days to 45 working days.
The latest DTAB recommendation can therefore be viewed in the context of a broader regulatory effort: reduce unnecessary procedural requirements for lower-risk development activities while making quality requirements more explicit for material used in human studies.
For drug developers, this distinction could help reduce uncertainty when deciding how a particular development batch should be manufactured.
Potential Impact on API Suppliers
The proposed change could also affect API manufacturers supplying materials for Indian drug development programs.
An API supplier may need to determine at an early stage whether a batch will ultimately be used for:
- Laboratory analysis
- Non-clinical studies
- Clinical trials
- Bioavailability studies
- Bioequivalence studies
The intended use could determine the manufacturing facility and quality-system expectations applicable to the batch.
For suppliers supporting clinical development programs, this may increase the importance of demonstrating that the manufacturing site meets the applicable GMP requirements under the Drugs Rules, 1945.
It could also make batch documentation, manufacturing records, traceability and quality-system controls more important when supplying APIs for development programs.
Connection With India's Revised GMP Framework
The proposed NDCT changes should also be viewed alongside India's broader GMP reforms.
India revised Schedule M of the Drugs Rules, 1945 in December 2023, bringing its pharmaceutical GMP framework closer to international standards. The revised requirements became effective for manufacturers with turnover above ₹250 crore from June 29, 2024. The compliance timeline for manufacturers with turnover up to ₹250 crore was subsequently extended to December 31, 2025.
The revised Schedule M covers requirements relating to pharmaceutical manufacturing premises, plant, equipment and GMP systems.
Against this background, the proposed NDCT amendments would provide a more explicit connection between clinical-development batch manufacturing and the GMP requirements established under the Drugs Rules.
For companies operating across both API production and finished pharmaceutical manufacturing, this could make regulatory alignment between development batches and commercial manufacturing systems increasingly important.
What Should Companies Prepare for?
Although the DTAB recommendation is not yet a final rule, pharmaceutical companies and API suppliers involved in Indian drug development may want to review their current trial-batch manufacturing arrangements.
1. Identify the intended use of each development batch
Companies should clearly distinguish between batches intended for analytical or non-clinical testing and those intended for clinical or BA/BE studies.
2. Review manufacturing-site qualification
For clinical and BA/BE material, companies should assess whether the proposed manufacturing facility can meet the applicable GMP requirements under the Drugs Rules, 1945.
3. Strengthen traceability
For analytical and non-clinical batches, the proposed framework specifically emphasizes proper traceability. Batch records, material movement, testing records and disposal or retention procedures may therefore become increasingly important.
4. Align API suppliers with development plans
Drug developers working with external API manufacturers may need to communicate the intended regulatory use of the API at an earlier stage.
A supplier capable of producing material for laboratory research may not necessarily be the appropriate manufacturing site for material intended for a clinical trial.
A More Clearly Defined Regulatory Path for Trial Batches
The significance of the DTAB proposal is not simply that India may introduce “stricter GMP.”
The more important change is the clearer differentiation of manufacturing requirements according to the intended use of the drug or API.
Clinical trial and BA/BE batches would move toward a more explicit facility-based GMP requirement, while analytical and non-clinical testing would retain a comparatively flexible route based on GMP principles and traceability.
For pharmaceutical companies, this could make early development activities easier to classify while setting clearer quality expectations before a product reaches human studies.
The proposal is still subject to the formal rule-making process, so companies should not treat the DTAB recommendation itself as a new legally effective requirement yet. However, it provides a useful indication of where India's regulatory framework for new drug and API development is heading.
What Comes Next?
The next key step will be the government's consideration and formal notification of any amendment to Rules 55 and 63 of the NDCT Rules, 2019.
Until such notification is issued, the existing provisions remain the applicable legal framework.
For international API suppliers, contract manufacturers and pharmaceutical companies developing products for the Indian market, monitoring the final wording will be important—particularly for projects moving from laboratory and non-clinical development into clinical trials or BA/BE studies.
