The Union Ministry of Health and Family Welfare has proposed an amendment to the Drugs Rules, 1945, to simplify the process of obtaining permission to import drugs for examination, test or analysis, a permission commonly known as Form 11. The amendment introduces an acknowledgement-based system for the import of small quantities of all drugs for the purpose of analytical and non-clinical testing. Under the revised provisions, applicants wishing to import such drugs will have to submit a prior intimation form and will be able to import the drug on the basis of the acknowledgement received upon submitting such intimation. This eased process will apply to the import of drugs for analytical and non-clinical testing except for certain specified drugs. These specified drugs include sex hormones, cytotoxic drugs, beta-lactam drugs, biologicals containing live microorganisms, and narcotic and psychotropic substances, for which the requirement of obtaining a licence beforehand will continue. In January 2026, the Ministry had introduced a similar intimation system for domestic test licences by amending the New Drugs and Clinical Trials Rules, 2019, and the present proposal extends this to the case of imports. The amendment is expected to substantially reduce the compliance burden on applicants by removing licensing requirements for the import of small quantities of drugs for testing or research and development. An online intimation system will provide stakeholders an easy and instant gateway. The draft notification has been made public for consultation with stakeholders, and objections or suggestions may be sent to the Under Secretary (Drugs), Ministry of Health and Family Welfare, or emailed to the drugs division.
Acknowledgement-based Form 11 System Proposed for Import of Drugs for Analytical and Non-Clinical Testing
The MoHFW has proposed amending the Drugs Rules, 1945, to replace licensing with an acknowledgement-based Form 11 system for importing small quantities of drugs for analytical and non-clinical testing, while certain drugs remain under licensing.
Key facts
- The Union Ministry of Health and Family Welfare has proposed an amendment to the Drugs Rules, 1945, to simplify the import permission for drugs meant for examination, test or analysis (Form 11).
- The amendment introduces an acknowledgement-based system for importing small quantities of all drugs for analytical and non-clinical testing.
- Applicants must submit a prior intimation form and can import the drug on the basis of the acknowledgement received.
- Specified drugs are excluded and continue to require a licence: sex hormones, cytotoxic drugs, beta-lactam drugs, biologicals containing live microorganisms, and narcotic and psychotropic substances.
- In January 2026, the Ministry had introduced a similar intimation system for domestic test licences by amending the New Drugs and Clinical Trials Rules, 2019; the present proposal extends this to imports.
- An online intimation system will be provided, and the draft notification has been released for stakeholder consultation.
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Practice MCQ from this story
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With reference to the proposed amendment to the Drugs Rules, 1945 for import of drugs, consider the following statements: 1. The acknowledgement-based system applies to the import of small quantities of drugs for analytical and non-clinical testing. 2. Beta-lactam drugs are excluded from the eased process and will continue to require a licence beforehand. Which of the statements given above is/are correct?
Both statements are correct. The amendment introduces an acknowledgement-based system for importing small quantities of drugs for analytical and non-clinical testing, so statement 1 is correct. Beta-lactam drugs are among the specified drugs (along with sex hormones, cytotoxic drugs, biologicals containing live microorganisms, and narcotic and psychotropic substances) that are excluded and continue to require a licence beforehand, so statement 2 is correct.
Source: Press Information Bureau
Frequently asked questions
What is Form 11 in this context?
Form 11 is the permission commonly used to import drugs for the purpose of examination, test or analysis under the Drugs Rules, 1945.
What does the proposed acknowledgement-based system require?
Applicants wishing to import such drugs must submit a prior intimation form and can then import the drug on the basis of the acknowledgement received upon submitting the intimation, instead of obtaining a licence beforehand.
Which drugs are excluded from the eased process?
Sex hormones, cytotoxic drugs, beta-lactam drugs, biologicals containing live microorganisms, and narcotic and psychotropic substances are excluded and will continue to require a licence beforehand.
How does this relate to the January 2026 change?
In January 2026, the Ministry introduced a similar intimation system for domestic test licences by amending the New Drugs and Clinical Trials Rules, 2019; the present proposal extends the same approach to imports.
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