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Draft
amendment to Drugs Rules, 1945 to introduce acknowledgement-based system for import
of drugs for analytical and non-clinical testing
·
The Union Ministry of Health and Family
Welfare has proposed amendments to the Drugs Rules, 1945 to
simplify the process of obtaining permission for importing drugs for examination, testing, or analysis
(commonly known as Form 11).
·
The
proposed amendment introduces an acknowledgement-based
system for importing small quantities of drugs meant for:
o Analytical testing
o Non-clinical testing
o Research and development (R&D)
activities
·
Under
the new system:
o Applicants will submit a prior online intimation form.
o Import of drugs will be allowed based on
the acknowledgement
generated after submission.
o Separate licensing approval will no longer
be required for eligible categories.
·
The
simplified process will apply to most drugs, except certain categories that
will continue to require prior licensing, including:
o Sex hormones
o Cytotoxic drugs
o Beta lactam drugs
o Biologics containing live microorganisms
o Narcotic and psychotropic substances
·
The
Ministry had earlier introduced a similar notification-based system for domestic test licences
through amendments to the New
Drugs and Clinical Trials Rules, 2019 in January 2026.
·
The
proposed change extends the simplified approach to drug imports for testing and research
purposes.
·
The
reform is expected to:
o Reduce compliance burden on pharmaceutical
companies
o Remove unnecessary licensing requirements
o Enable faster initiation of testing and
analysis activities
o Support start-ups and innovation-driven
industries
·
The
online intimation system will provide stakeholders with a faster and seamless regulatory pathway
for importing drugs for R&D purposes.
·
The
initiative aligns with the government’s efforts to:
o Improve the regulatory ecosystem
o Promote ease of doing business
o Encourage pharmaceutical innovation and
research
·
The
draft notification has been placed for public
consultation, inviting objections and suggestions from
stakeholders before final implementation.
·
The
reform is expected to strengthen India’s pharmaceutical research ecosystem and
support growth in the country’s drug
development and innovation sector.
<Gazette Notification G.S.R.
509(E) dated 23 June, 2026>
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.