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The Drugs (Twelfth Amendment) Rules, 2026, have been notified by the Ministry of Health & Family Welfare. These rules modify Rule 89 of the Drugs Rules, 1945. The rule came into force on 7 August 2026.
According to the Drugs Rule 89 Amendment 2026, the manufacturing licenses for ten forms will be included in the list of acceptable manufacturing license forms for drugs produced solely for examinations or tests. Previously, Forms 25 and 28 were the only forms listed under Rule 89. These include license forms for loan purposes, Schedule X, vaccines, sera, LVP, recombinant DNA substances, blood products, and umbilical cord blood stem cells.
This does not mean that Form 29 has been removed. A business may still need Form 29 if its existing manufacturing license does not cover the drug concerned. The exact words "in respect of such drugs" remain central to the rule. Manufacturers should therefore check the license form, approved products, site, and proposed activity before starting a test batch.
Drugs and Cosmetics Act, 1940
The Drugs and Cosmetics Act, 1940, is the primary law governing drug regulation in India. The notification states that the Central Government used the rule-making powers given by sections 12 and 33 of the Act.
The final rules were made after consultation with the Drugs Technical Advisory Board. The Board gives technical advice to the Central and State Governments on matters arising from the administration of the Act.
Drugs Rules, 1945
These procedures are explained in the Drugs Rules, 1945. Rule 89 is found in Part VIII of the said rules entitled "Manufacture for Examination, Test or Analysis."
Part VIII deals with small quantities made for limited technical purposes. Rules 87 and 88 cover labels. Rule 89 decides when Form 29 is needed. Rules 90 to 93 cover its application, duration, conditions, and cancellation.
Meaning of Form 29
Form 29 is a license to produce particular drugs for examination, testing, or analysis purposes. Form 29 is not a general manufacturing permit. The manufactured drugs can be used only for this particular purpose.
Under Rule 90, an application for Form 29 is made in Form 30 to the State Licensing Authority. It must be made or countersigned by the head of the institution or a director of the firm or company. The stated fee is Rs. 250.
Rule 91 states that Form 29 normally remains in force for three years from its date of issue unless canceled sooner. It may then be renewed for one year at a time. These are existing provisions that were not amended.
Earlier Position Under Rule 89
Before this amendment, a person had to obtain Form 29 for test manufacture if the person did not hold Form 25 or Form 28 in respect of that drug. Other forms for loan licenses and special products were not expressly named, creating possible uncertainty.
Draft Notification and Public Consultation
The draft amendment was published on 21 April 2026, and it became available on 22 April 2026. Thirty days were allotted for objections and suggestions. In the last notification, the comments were acknowledged to be considered.
Final Notification
The final Drugs (Twelfth Amendment) Rules, 2026, were notified on 6 August and published on 7 August 2026. They came into force on publication.
The final text includes Form 28E. The earlier draft text available through the Central Drugs Standard Control Organization did not appear to include Form 28E in its operative list. This is a material point when comparing the draft with the final notification. Businesses must follow the final notified text.
Old and New Position
| Compliance area | Earlier position | New position from 7 August 2026 | Business meaning |
| License forms named in Rule 89 | Form 25 and Form 28 | Ten manufacturing license forms | More license categories are expressly recognized |
| Loan licenses | Not expressly named | Forms 25A, 28A, and 28DA are named | Loan-licensees receive clearer treatment |
| Schedule X categories | Limited express coverage | Forms 25F and 28B are named | Schedule X manufacturers are expressly addressed |
| Vaccines and specialized biological products | Form 28D not named | Forms 28D and 28DA are named | Specialized and loan-license units are covered |
| Blood products | Form 28E not named | Form 28E is included | Blood-product manufacturing is expressly recognized |
| Umbilical cord blood stem cells | Form 28F not named | Form 28F is included | Cord blood stem-cell establishments are expressly recognized |
The amendment substitutes the earlier words "Form 25 or Form 28" with a longer list. The new list covers Form 25, Form 25A, Form 25F, Form 28, Form 28A, Form 28B, Form 28D, Form 28DA, Form 28E, and Form 28F.
What Has Not Changed
The amendment does not remove the Form 29 assessment. It expands the forms considered during that assessment.
It also does not:
Each form covers a different permission. These broad descriptions do not replace a check of the actual license and product endorsements.
Form 25 and Form 25A
Form 25F
Form 28 and Form 28A
Form 28B
Form 28D and Form 28DA
Form 28E
Form 28F
Businesses Most Likely to Be Affected
The amendment affects businesses making small quantities for examination, testing, or analysis, including:
The Product-Specific Test
The key limit is "in respect of such drugs." Holding a listed form does not automatically remove Form 29 for every test product.
The business must check the drug, site, category, dosage form, activity, and product permission. If coverage is missing, Form 29 may still be required before manufacture.
No Express Blanket Exemption
The amendment does not use the words "blanket exemption." It changes the license form list under the existing conditions. This is why a written review of applicability is safer than relying solely on the number printed on a license.
| Event | Date | Practical meaning |
| Draft notification issued | 21 April 2026 | Proposed wording was published |
| Draft made available to the public | 22 April 2026 | Thirty-day consultation period began |
| Final notification dated | 6 August 2026 | The government signed the final rules |
| Official Gazette publication | 7 August 2026 | Amendment came into force |
| Separate transition period | Not expressly specified | Businesses should apply the revised wording from commencement |
The rule came into force on 7 August 2026. The notice does not provide any separate compliance period or phased implementation period. It does not clearly stipulate how the State Licensing Authority is to deal with a Form 29 application pending at the time of commencement.
Pending cases require a different kind of attention, as the business should not assume the application is automatically over. Instead, they should send their license, products covered, and status of the application to the licensing authority.
Official Position
The final notice concerns the legal procedure but does not provide a lengthy statement of reasons. The notice shows that the draft was published, public opinions were sought, those opinions were considered, and the Central Government acted in consultation with the DTAB.
Regulatory Analysis
The purpose of the regulation could be seen from the language used. Rule 89 was earlier confined to Forms 25 and 28, while the Drugs Rules included other manufacturing license forms as well. The amendment makes the Rule 89 list similar to the format of the entire license.
This could help reduce confusion among specialized manufacturers. This could also ensure consistency in decision-making between companies and authorities. But this is a practical evaluation, and not a direct commitment in the notification that each application will get easier or cheaper.
Pharmaceutical and Loan-License Manufacturers
The persons holding Forms 25A, 25F, 28A, 28B, or 28DA can now refer to a more clearly worded document. The forms were not explicitly mentioned in Rule 89 before 7 August 2026. The use of this new language may minimize reliance on similarity to Form 25 or 28.
Loan licensees still need to verify the exact license arrangement and the facility where the activity will occur. A loan license does not erase the conditions attached to the approved manufacturing premises.
Vaccine and Biological-Product Manufacturers
Forms 28D and 28DA are now explicitly mentioned. This is important for companies that manufacture high-volume parenterals, sera, vaccines, and products made using recombinant DNA technology. Such companies perform development and validation activities and may require a Rule 89 evaluation, which will impact their projects.
The amendment does not remove other approvals that may apply to a new drug, biological product, clinical program, or product change. Rule 89 should not be read in isolation.
Blood Products and Cord Blood Stem Cells
The inclusion of Forms 28E and 28F adds blood products and umbilical cord blood stem cell activity to the list. This area has its own technical and safety requirements. Companies need to ensure that any reliance on the revised rule is consistent with their license.
Compliance and Quality Teams
There is also a need for the regulatory, quality assurance, research, and manufacturing departments to update their internal decision trees. The current process, which relies on asking whether the firm has Form 25 or 28, is outdated.
The revised procedure should record all ten forms and require a product-specific check. It should also separate the legal question under Rule 89 from other approval, labeling, testing, and record duties.
Step 1: Check the Purpose
Step 2: Check the Existing License
Step 3: Check Drug Coverage
Step 4: Check Other Approvals
Step 5: Check Whether Form 29 Is Needed
Step 6: Follow Test-Manufacturing Rules
Step 7: Keep a Written Decision Record
Record:
This note is not required in this exact format, but it can help during an inspection.
| Document or record | Status | Purpose |
| Existing manufacturing license | Required for reliance on a listed form | Confirms form, holder, and premises |
| Product list and endorsements | Required to establish drug coverage | Supports the "in respect of such drugs" check |
| Form 30 application | Required where Form 29 is needed | Application for the test license |
| Form 29 license | Required where Rule 89 applies | Authorizes specified test manufacture |
| Labels for test material | Required under Part VIII | Shows the limited purpose and identification details |
| Quantity and recipient records | Required for Form 29 licensees | Tracks manufacture and supply |
| Inspection Book | Required for Form 29 licensees | Allows inspectors to record observations |
| Internal applicability note | Recommended | Explains why Form 29 was or was not considered necessary |
Businesses should not use this table as a universal checklist for applications. Exact filings may depend on the product, the State Licensing Authority, the premises, and other applicable laws.
Treating the Amendment as the End of Form 29
Form 29 continues to exist. The amendment changes the circumstances in which an existing manufacturing license is considered under Rule 89. A business without suitable drug coverage may still need it.
Checking Only the Form Number
A listed form is only the first check. The license should relate to the drug concerned. Ignoring product endorsements, premises, or approved categories can lead to a weak compliance position.
Starting Manufacture Too Early
Where Form 29 is required, Rule 89 requires that it be obtained before manufacture begins. Production planning should therefore include a regulatory release point before any test batch is started.
Selling Test-License Material
Rule 92 restricts material prepared using Form 29 to be used only for examination, testing, or analysis. Companies need to ensure that the material does not become part of their commercial supply or sales.
Ignoring Labels and Records
Labelling and record-keeping responsibilities are set out in Rules 87, 88, and 92. Regardless of how small the batch may be, labelling and quantity records are important issues.
The clearest benefit is better recognition of the license system already used by the pharmaceutical sector.
These are possible compliance and operational benefits. The notification does not guarantee lower costs, faster approval, or exemption in every case.
| Assessment area | Why is it the right decision | Possible burden or concern |
| Broader recognition of license forms | The old Rule 89 referred only to Form 25 and Form 28. The amendment recognizes additional manufacturing license forms used for loan licenses, Schedule X drugs, vaccines, biological products, blood products, and other specialized categories. | Businesses must identify which license form applies to their product and activity. |
| Alignment with the current licensing system | Rule 89 now better reflects the wider structure of pharmaceutical manufacturing licenses under the Drugs Rules, 1945. | Compliance teams must update old policies, checklists, and decision trees that mention only Form 25 and Form 28. |
| Reduction in regulatory uncertainty | Expressly naming more license forms can reduce doubt about whether manufacturers operating under those forms are recognized under Rule 89. | The amendment does not answer every product-specific question. Different interpretations may still arise. |
| Potential reduction in duplicate paperwork | Where a business already holds an appropriate manufacturing license covering the drug, a separate test license could create repetitive paperwork without materially changing the approved premises or technical capability. | This benefit applies only when the existing license is genuinely âin respect ofâ the drug concerned. |
| Meaning of âin respect of such drugsâ | The phrase ensures that the existing license must have a real connection with the drug being manufactured for examination, testing, or analysis. | This is the most important area of interpretation. A license form number alone may not prove product coverage. |
| Product permissions and endorsements | The amendment recognizes more license categories without removing existing product-level controls. This protects the regulatory system from overly broad exemptions. | Companies may incorrectly confuse a manufacturing license with permission to manufacture every drug at the site. |
| Site-specific approval | Keeping the assessment tied to the licensed premises helps ensure that test manufacturing occurs at an approved facility. | A business may have the correct license form but plan to conduct the activity at another unit, laboratory, or pilot facility. |
| Dosage-form coverage | Product-specific assessment helps ensure that the facility is suitable for the dosage form being manufactured. | A site licensed for tablets may not necessarily be authorized to manufacture sterile injections, vaccines, or another specialized dosage form. |
| Specialized pharmaceutical products | Adding forms related to Schedule X drugs, vaccines, biological products, blood products, and cord blood stem cells makes Rule 89 more relevant to specialized manufacturers. | These products are subject to greater safety, quality, storage, testing, and documentation controls. |
| Loan-license manufacturers | Express recognition of loan-license forms provides greater clarity to businesses using another licensed manufacturerâs facilities. | Compliance may involve both the loan-licensee and the owner of the manufacturing facility. Responsibilities can be misunderstood. |
| New drugs and additional approvals | The amendment deals with the Rule 89 and Form 29 framework. It does not weaken separate approval requirements that may apply to new drugs. | A company may wrongly treat the amended rule as permission to manufacture or test a new drug without other approvals. |
| Commercial sale restrictions | The regulatory distinction between test manufacturing and commercial manufacturing remains important. It protects patients and the market from unapproved products. | Businesses must maintain strict controls to prevent test batches from entering commercial distribution. |
| Internal compliance procedures | The amendment allows businesses to create a clearer and more complete Form 29 decision process. | Revising SOPs, forms, software, and training programs requires time and resources. |
| Regulatory inspections | Clearer documentation can help inspectors understand why a company relied on an existing manufacturing license instead of obtaining Form 29. | A weak or undocumented interpretation may be challenged during an inspection. |
| Impact on smaller businesses | The amendment may help smaller companies holding one of the newly recognized licenses by reducing uncertainty and potentially avoiding unnecessary applications. | Smaller businesses may lack an in-house legal or regulatory team to interpret the phrase âin respect of such drugs.â |
| Different State-level practices | A clearer central rule can support more consistent decisions across jurisdictions. | State Licensing Authorities may initially interpret or implement the amendment differently. |
| Implementation cost | The amendment does not create a completely new license category or a broad new filing obligation. | Businesses may still spend money on license reviews, SOP revisions, staff training, and professional advice. |
| Long-term regulatory benefit | Broader, clearer wording can improve consistency, reduce redundant applications, and support research, testing, and product development. | Benefits may be delayed if authorities and businesses do not apply the new language consistently. |
| Risk of treating the amendment as a blanket exemption | The amendment can provide relief where an appropriate existing license already covers the drug. | The greatest risk is assuming that every holder of a listed license is automatically exempt from Form 29 for every drug. |
The amendment should be considered more as an effective clarification rather than a new licensing requirement. This is because it enhances compliance with current licensing requirements rather than introducing a new approval process. Nevertheless, the amendment's effectiveness can only be achieved through prudent, case-by-case application.
These changes may require specialized compliance services. The probabilities exist because there is a need to review existing licenses and internal systems, and not due to any guarantees of a new market.
Manufacturers may also gain from clearer planning. When the legal route is known early, research, validation, and testing work can be scheduled with fewer last-minute licensing questions.
Immediate Review
Any internal checklist for Rule 89 that includes only Forms 25 and 28 must be updated to include all ten forms and a specific question about product coverage.
Product and Site Mapping
Regulatory teams need to map proposed test products against existing licenses, endorsements, approved sites, and related permissions. If anything is unclear, it needs to be resolved before scheduling the batch.
Pending Applications
If there was any pending Form 29 application on 7 August 2026, the applicant needs to see whether the amended rule has affected their position. The notification doesn't mention that pending applications are either automatically withdrawn or approved.
Ongoing Control
Businesses should make the Rule 89 review part of change control or R&D batch approval. This will help ensure that the question is checked each time a new product, site, process, or license arrangement is introduced.
Corpseed supports pharmaceutical businesses with a clear, document-based assessment of the Drugs Rule 89 amendment 2026. The process begins with a review of the companyâs actual license, products, premises, and proposed test-manufacturing activity.
1. Rule 89 Applicability Assessment
2. Manufacturing License Review
3. Product and Premises Coverage Check
4. Form 29 License Consultant Support
5. Form 30 Application Assistance
6. Pharmaceutical Regulatory Gap Assessment
7. SOP and Internal Checklist Updates
8. Document Review and Inspection Readiness
9. Ongoing CDSCO and State License Compliance
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