Enclomiphene is not approved in India for manufacture and marketing according to a CDSCO regulatory communication dated 10 August 2026. The Central Drugs Standard Control Organization (CDSCO) has directed State and Union Territory Drugs Controllers to identify manufacturers, marketers, distributors and retailers dealing with Enclomiphene-containing products without the required approval from the Central Licensing Authority (CLA).
The communication concerns Enclomiphene and its combinations and refers to their status as New Drugs under the New Drugs and Clinical Trials Rules, 2019.
Quick Summary
CDSCO has stated that Enclomiphene and its combinations are not approved by the Central Licensing Authority for manufacture and marketing in India. The 10 August 2026 communication directs State/UT Drugs Controllers to identify entities dealing with such products and take appropriate regulatory action under applicable drug laws.
Enclomiphene CDSCO Notice 2026: Key Details
| Particular | Details |
|---|---|
| Drug concerned | Enclomiphene and its combinations |
| Regulatory authority | Central Drugs Standard Control Organization (CDSCO) |
| Communication date | 10 August 2026 |
| Issue | Manufacture and/or marketing without requisite CLA approval |
| Regulatory classification mentioned | New Drug |
| Applicable rules | New Drugs and Clinical Trials Rules, 2019 |
| Relevant provisions | Rule 2(1)(w), Rule 19 and Rule 80 |
| Application form | Form CT-21 |
| Action authority | State/UT Drugs Controllers |
| Action Taken Report | Requested by CDSCO |
What Has CDSCO Said About Enclomiphene?
According to the CDSCO communication, certain manufacturers were found to be manufacturing and/or marketing drug products containing Enclomiphene and its combinations without obtaining the requisite permission from the Central Licensing Authority.
CDSCO has stated that Enclomiphene and its combinations fall within the definition of a New Drug under the New Drugs and Clinical Trials Rules, 2019.
The communication further states that Enclomiphene and its combinations have not been approved by the Central Licensing Authority for manufacture and marketing in India.
Therefore, entities manufacturing or marketing such products without the required regulatory permission may face action under the applicable provisions of the Drugs and Cosmetics Act, 1940 and the rules made thereunder.
Is Enclomiphene Approved in India?
According to the CDSCO communication dated 10 August 2026, Enclomiphene and its combinations have not been approved by the Central Licensing Authority for manufacture and marketing in India.
This is the key regulatory point highlighted in the communication.
The notice specifically concerns the regulatory approval required for manufacture and marketing of Enclomiphene-containing drug products.
Why Is Central Licensing Authority Approval Required?
The CDSCO communication refers to the New Drugs and Clinical Trials Rules, 2019, including Rule 2(1)(w) read with Rule 19.
The communication also refers to Rule 80, which deals with the requirement for prior permission to manufacture a new drug, whether as an Active Pharmaceutical Ingredient (API) or as a pharmaceutical formulation for sale or distribution.
The application for such permission is made through Form CT-21, along with the applicable prescribed fee under the relevant provisions.
Key Regulatory Requirements
| Requirement | Details |
|---|---|
| Drug category mentioned | New Drug |
| Approval authority | Central Licensing Authority |
| Application form | Form CT-21 |
| Relevant rules | New Drugs and Clinical Trials Rules, 2019 |
| Manufacturing requirement | Prior permission required |
| Purpose | Manufacture for sale or distribution |
CDSCO Directs State and UT Drugs Controllers to Take Action
Following the regulatory concern, CDSCO has directed State and Union Territory Drugs Controllers to identify entities involved in the manufacture, marketing, distribution and sale of Enclomiphene-containing products without the requisite approval.
The communication calls for appropriate regulatory action under the Drugs and Cosmetics Act, 1940 and the rules made thereunder.
Regulatory Actions Mentioned by CDSCO
The communication includes directions relating to:
- Identifying manufacturers and other entities involved in the supply chain.
- Initiating appropriate regulatory action.
- Taking action against unauthorized manufacture, where applicable.
- Preventing the manufacture of unapproved Enclomiphene products.
- Preventing their sale, distribution or marketing.
- Cancelling or suspending manufacturing permissions, wherever applicable.
- Submitting an Action Taken Report to CDSCO.
Action Taken Report Requested by CDSCO
CDSCO has also requested the concerned State and UT authorities to submit an Action Taken Report.
The report is expected to provide information regarding the regulatory action taken against entities involved in the manufacture or marketing of Enclomiphene-containing products without the required approval.
Information Requested
The authorities have been asked to provide details such as:
- Manufacturers identified
- Regulatory action initiated
- Current compliance status
- Other relevant action taken by the respective authorities
This reporting mechanism will allow CDSCO to monitor the regulatory response across different jurisdictions.
What Is Enclomiphene?
Enclomiphene is the trans-isomer of clomiphene and has been investigated in relation to male reproductive and hormonal health.
However, the main issue highlighted by the CDSCO communication is its regulatory approval status in India, rather than its potential therapeutic applications.
According to the communication, Enclomiphene and its combinations have not been approved by the Central Licensing Authority for manufacture and marketing in India.
What Does the CDSCO Enclomiphene Action Mean for Manufacturers?
Manufacturers dealing with Enclomiphene-containing products need to ensure compliance with the applicable provisions of the Drugs and Cosmetics Act, 1940 and the New Drugs and Clinical Trials Rules, 2019.
The CDSCO communication emphasizes that the required permission from the Central Licensing Authority must be obtained before manufacturing a new drug for sale or distribution, where applicable.
Companies involved in the manufacture, marketing, distribution or sale of such products should therefore carefully review their regulatory status and applicable permissions.
What Does It Mean for Marketers, Distributors and Retailers?
The CDSCO direction is not limited to manufacturers.
State and UT Drugs Controllers have been asked to identify manufacturers, marketers, distributors and retailers involved in dealing with Enclomiphene-containing products without the required approval.
Therefore, entities across the pharmaceutical supply chain may need to verify whether the products they handle have the necessary regulatory authorization.
Important Points for Drug Inspector and Pharmacy Exams
The Enclomiphene CDSCO notice 2026 is important for students preparing for Drug Inspector, Pharmacist, Regulatory Affairs and other pharmacy-related examinations.
Quick Revision
| Exam Point | Answer |
|---|---|
| Drug concerned | Enclomiphene and its combinations |
| Authority | CDSCO |
| Communication date | 10 August 2026 |
| Approval status mentioned | Not approved by CLA for manufacture and marketing in India |
| Drug classification | New Drug |
| Applicable rules | New Drugs and Clinical Trials Rules, 2019 |
| Relevant provision | Rule 2(1)(w) read with Rule 19 |
| Manufacturing provision mentioned | Rule 80 |
| Application form | Form CT-21 |
| Action authority | State/UT Drugs Controllers |
| Report requested | Action Taken Report |
Why Is This Update Important for Pharmacy Students?
This regulatory update is useful for:
- D.Pharm students
- B.Pharm students
- M.Pharm students
- Pharm.D students
- Drug Inspector aspirants
- Pharmacist exam aspirants
- Regulatory Affairs professionals
- Quality Assurance professionals
- Pharmaceutical industry professionals
It provides a practical example of how the CDSCO and State/UT drug regulatory authorities deal with the manufacture and marketing of products that require regulatory approval.
For Drug Inspector aspirants, the update is particularly useful for understanding the relationship between New Drug approval, Central Licensing Authority permission, Form CT-21 and regulatory enforcement.
Important Dates
| Date | Event |
|---|---|
| 10 August 2026 | CDSCO communication issued |
| Further action | State/UT Drugs Controllers to take appropriate regulatory action |
| Action Taken Report | Requested by CDSCO |
Important Regulatory Provisions
The communication refers to provisions of the New Drugs and Clinical Trials Rules, 2019.
Rule 2(1)(w)
The communication refers to this provision in relation to the definition of a New Drug.
Rule 19
The communication refers to Rule 19 in connection with the requirement concerning permission for manufacture of new drugs.
Rule 80
The communication refers to Rule 80 regarding the requirement for prior permission to manufacture a new drug for sale or distribution.
Form CT-21
Form CT-21 is the application form mentioned in the communication for obtaining the required permission for manufacture of a new drug, as applicable under the relevant provisions.
Important Links
Official CDSCO Website: Add the official CDSCO website link here.
Official CDSCO Communication/PDF: Add the verified 10 August 2026 CDSCO communication here.
New Drugs and Clinical Trials Rules, 2019: Add the official government/authoritative regulatory source here.
Note: Use only verified official sources for regulatory documents. Do not link to an unverified copy of the CDSCO communication.
FAQs About Enclomiphene CDSCO Approval
1. Is Enclomiphene approved in India?
According to the CDSCO communication dated 10 August 2026, Enclomiphene and its combinations have not been approved by the Central Licensing Authority for manufacture and marketing in India.
2. What did CDSCO say about Enclomiphene products?
CDSCO stated that certain entities were manufacturing and/or marketing Enclomiphene-containing products without the required permission from the Central Licensing Authority.
3. Why has CDSCO taken action against Enclomiphene products?
The communication states that Enclomiphene and its combinations fall within the definition of a New Drug and have not received the required CLA approval for manufacture and marketing.
4. Which authorities have been directed to take action?
All State and Union Territory Drugs Controllers have been directed to identify relevant entities and initiate appropriate regulatory action.
5. Which form is mentioned for new drug manufacturing permission?
The CDSCO communication mentions Form CT-21 for the application for the required permission, along with the applicable prescribed fee.
6. What are the relevant rules for Enclomiphene approval?
The communication refers to the New Drugs and Clinical Trials Rules, 2019, including Rule 2(1)(w), Rule 19 and Rule 80.
7. What action can State/UT Drugs Controllers take?
The communication calls for appropriate regulatory action, which may include identifying involved entities, preventing unauthorized manufacture and marketing, and cancellation or suspension of manufacturing permissions wherever applicable.
8. What is the CDSCO Action Taken Report?
An Action Taken Report is the report requested by CDSCO from the concerned authorities regarding manufacturers identified, regulatory action initiated and the current compliance status.
What Should Manufacturers and Pharmacy Professionals Watch Next?
The key developments to monitor are:
- Regulatory action by State and UT Drugs Controllers.
- Identification of manufacturers and other supply-chain entities.
- Compliance status of affected products.
- Action Taken Reports submitted to CDSCO.
- Any further clarification or communication issued by CDSCO.
- Any additional regulatory action under the Drugs and Cosmetics Act, 1940.
Conclusion
The Enclomiphene CDSCO notice 2026 highlights an important regulatory issue concerning the manufacture and marketing of Enclomiphene and its combinations in India.
According to the 10 August 2026 CDSCO communication, these products have not been approved by the Central Licensing Authority for manufacture and marketing in India. CDSCO has consequently directed State and UT Drugs Controllers to identify entities involved in dealing with such products without the requisite approval and to take appropriate regulatory action.
The communication also highlights the importance of compliance with the New Drugs and Clinical Trials Rules, 2019, including the relevant requirements concerning new drug permission and Form CT-21.
For pharmacy students, Drug Inspector aspirants and pharmaceutical professionals, this update is an important example of new drug regulation, CDSCO enforcement and pharmaceutical regulatory compliance in India.
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