Health Ministry Proposes Easier Drug Import Test Process with Prior Intimation Instead of Form 11 Licence

New Delhi: The Ministry of Health and Family Welfare (MoHFW) has issued a draft notification proposing amendments to the Drugs Rules, 1945 to simplify the process for obtaining test licences for the import of drugs under Form 11.

Published as G.S.R. 509(E) on June 23, 2026, the draft rules have been framed under Section 12(1) of the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board (DTAB).

The proposed amendments seek to introduce a prior intimation mechanism for specified imports of drugs meant for analytical and non-clinical testing, while making consequential changes across the Drugs Rules, 1945.

The Ministry has invited objections and suggestions from stakeholders and the public, which will be considered after the expiry of 30 days from the date on which copies of the Gazette containing the draft rules are made available to the public. Objections and suggestions 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 emailed to drugsdiv-mohfw@gov.in.

The notification further states that the proposed amendments will be called the Drugs (...... Amendment) Rules, 2026 and will come into force from the date specified by the Government at the time of their final publication in the Official Gazette.

A key proposal is the amendment to Rule 34, under which applicants importing drugs for analytical and non-clinical testing will be permitted to use a prior intimation mechanism instead of obtaining a Form 11 test licence in eligible cases.

Under the proposed proviso to Rule 34(1), an applicant will be required to submit an online application in Form 12 to the Central Licensing Authority as prior intimation and may import the drug on the basis of the acknowledgement of such prior intimation. However, this proposed mechanism will not apply to imports of sex hormones, cytotoxic drugs, beta lactam drugs, biologics containing live microorganisms, and narcotic and psychotropic drugs, which will continue to remain outside the scope of the prior intimation route.

To align the regulatory framework with the proposed mechanism, the draft notification introduces a series of amendments to Rule 33. In clause (a), the reference to "Form 11" will be substituted with "Form 11 or the acknowledgement of prior intimation under the proviso of sub-rule (1) of Rule 34, as the case may be." In clause (b), the word "licensee" will be replaced with "licensee or the holder of the acknowledgement of prior intimation under the proviso of sub-rule (1) of Rule 34, as the case may be," while every reference to "licence" will similarly be expanded to include the acknowledgement of prior intimation.

Corresponding substitutions have also been proposed in clauses (c), (d) and (e), including replacing references to "holders of licences" with "holders of licences or the acknowledgements of prior intimation under the proviso of sub-rule (1) of Rule 34, as the case may be."

The draft notification also proposes to amend the marginal heading of Rule 34 by replacing the word "licence" with "licence or prior intimation". Likewise, the marginal heading of Rule 35 will be revised to read "licence or acknowledgement of prior intimation." In addition, wherever the word "licence" appears in Rule 35(1), it will be substituted with "licence or the acknowledgement of prior intimation under the proviso of sub-rule (1) of Rule 34, as the case may be."

Further, the draft proposes to substitute Rule 35(2) to provide that a licensee or the holder of the acknowledgement of prior intimation whose licence or acknowledgement of prior intimation has been cancelled may file an appeal before the Central Government within three months from the date of the order.

Consequential amendments have also been proposed in Schedule A relating to Form 12. The heading of Form 12 will be changed from "LICENCE" to "LICENCE OR PRIOR INTIMATION", while the opening paragraph of the form will also be amended by replacing the word "licence" with "licence or prior intimation." These amendments are intended to align the prescribed form with the proposed prior intimation mechanism.

To view the official notice, click the link below: