**Executive Summary**
The Ministry of Health and Family Welfare has proposed a draft amendment to the Drugs Rules, 1945, to replace the prior licensing requirement for importing small quantities of drugs for testing with an acknowledgement-based system. This initiative aims to simplify the "Form 11" process, reduce compliance burdens, and accelerate pharmaceutical R&D and innovation. Stakeholders are invited to submit feedback, objections, or suggestions regarding the draft notification to the Ministry.
**Key Points / Main Content**
**New Import Procedure**
* **Acknowledgement System:** Introduces a system where applicants submit a prior intimation form for importing small quantities of drugs for analytical and non-clinical testing.
* **Instant Permission:** Importation can proceed based on the acknowledgement generated immediately upon submission of the online intimation.
* **Form 11 Simplification:** The amendment specifically targets the procedure commonly known as Form 11 to foster ease of doing business.
**Scope and Exclusions**
* **Applicability:** The simplified process applies to drugs intended for analytical and non-clinical testing purposes.
* **Restricted Categories:** Prior licensing remains mandatory for specific categories, including sex hormones, cytotoxic drugs, beta lactam drugs, biologics containing live microorganisms, and narcotic and psychotropic substances.
**Regulatory Context and Objectives**
* **Alignment with Domestic Rules:** This amendment expands on the January 2026 notification system established for domestic test licenses under the New Drugs and Clinical Trials Rules, 2019.
* **Deregulating R&D:** The goal is to eliminate licensing delays, enabling start-ups and established industries to initiate testing and analysis more quickly.
* **Online Integration:** The system will utilize an online gateway to provide a seamless and instant process for stakeholders.
**Impact Analysis**
**Pharmaceutical Start-ups and Industry**
**Impact**
These entities will experience a significant reduction in the compliance burden and a faster transition from drug procurement to testing, facilitating quicker innovation cycles.
**Action Required**
Utilize the new online intimation system for future imports of small drug quantities and ensure imported substances do not fall under the restricted categories requiring prior licenses.
**Stakeholders (General)**
**Impact**
Stakeholders have the opportunity to shape the final regulation by providing professional feedback on the proposed changes.
**Action Required**
Submit objections or suggestions to the Under Secretary (Drugs), Ministry of Health and Family Welfare, New Delhi, or via email at drugsdiv-mohfw[at]gov[dot]in.
Key Entities Referenced
Drugs Rules, 1945: The primary regulatory framework being amended to introduce a simplified acknowledgement-based system for importing drugs for analytical and non-clinical testing.
Ministry of Health and Family Welfare: The Union Ministry responsible for proposing the draft amendment to promote research, innovation, and ease of doing business in the pharmaceutical sector.
Form 11: The specific regulatory permission for importing drugs for examination, test, or analysis, which is the focus of the procedural simplification.
New Drugs and Clinical Trials Rules, 2019: A referenced regulatory document that previously introduced a similar notification system for domestic test licenses, now being expanded to imports.
Ministry of Health and Family Welfare
Government Simplifies Procedure for Import of
Drugs for Examination, Test or Analysis under
Drugs Rules, 1945
Draft amendment to Drugs Rules, 1945 to introduce
acknowledgement-based system for import of drugs for
analytical and non-clinical testing
प्रव तथ: 26 JUN 2026 3:31PM by PIB Delhi
In a significant step towards promoting research and innovation and enhancing ease of doing business in
the pharmaceutical sector, the Union Ministry of Health and Family Welfare has proposed amendments to
the Drugs Rules, 1945 to simplify the procedure for obtaining permission for import of drugs for
examination, test or analysis. This is commonly known as Form 11.
The amendment introduces an acknowledgement-based system for import of all drugs in small quantities
for analytical and non-clinical testing purposes. Under the revised provisions, applicants intending to
import such drugs will be required to submit a prior intimation form and may import the drug based on the
acknowledgement generated upon submission of such intimation.
The simplified procedure shall be applicable for import of drugs for analytical and non-clinical testing,
except for certain drugs belonging to the categories of sex hormones, cytotoxic drugs, beta lactam drugs,
biologics containing live microorganisms, and narcotic and psychotropic substances, which shall continue
to require prior licensing.
It may be recalled that the Ministry of Health and Family Welfare had already carried out amendments to
the New Drugs and Clinical Trials Rules, 2019 in January 2026 introducing a similar notification system
for domestic test licences. The present proposed amendment expands it to imports also.
The amendment is expected to significantly reduce the compliance burden on applicants by eliminating
licensing requirements for importing small quantities of drugs for testing or R&D purposes. This will play
a substantial role in deregulating the R&D sector in pharmaceuticals and enable start-ups and industries to
quickly initiate testing or analysis. The online intimation system will offer a seamless and instant gateway
for the stakeholders.
The initiative is expected to provide a major boost to research and innovation in the country while
facilitating more efficient and streamlined regulatory process. It also aligns with the Government's
continued efforts to improve the regulatory ecosystem, promote ease of doing business and foster
innovation in the pharmaceutical sector.The draft notification has been placed in the public domain for stakeholder consultation. Objections and
suggestions, if any, may be submitted to the Under Secretary (Drugs), Ministry of Health and Family
Welfare, Government of India, U-6, Work Hall-C Wing, First Floor, Kartavya Bhawan-1, New Delhi –
110001, or may be emailed to drugsdiv-mohfw[at]gov[dot]in.
The draft Gazette Notification is available at: https://egazette.gov.in/WriteReadData/2026/273857.pdf
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SR
HFW/ Draft amendment to Drugs Rules, 1945 /26 June 2026/4
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