Health Ministry Drafts Rule Change to Halve Drug Trial Approval Time from 90 to 45 Days

New Delhi: With an aim to ease the processes for preclinical and analytical drug testing, the Ministry of Health and Family Welfare has released draft rules to amend the New Drugs and Clinical Trials Rules, 2019, proposing the approval timelines for the Central Licensing Authority to grant permissions under Rules 53 and 60 will be reduced from ninety working days to forty-five working days.

Under the proposed amended Rule 52(1) of the New Drugs and Clinical Trials Rules, 2019, no person will be allowed to manufacture a new drug or an investigational new drug for the purpose of conducting a clinical trial, a bioavailability or bioequivalence study, or for examination, testing, and analysis, without first obtaining permission from the Central Licensing Authority, or through a notification as provided under the proviso to sub-rule (2) of Rule 52, as applicable.

A new provision has been added after sub-rule (2) of Rule 52 of the New Drugs and Clinical Trials Rules, 2019, which allows the manufacture of a new drug or investigational new drug for analytical and preclinical testing on the basis of an online notification, rather than waiting for prior approval. However, this relaxation will not apply to certain sensitive categories, namely sex hormones, cytotoxic drugs, beta-lactam antibiotics, biologics containing live microorganisms, and narcotic or psychotropic substances.

This came as a draft of certain rules further to amend the New Drugs and Clinical Trials Rules, 2019, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board is hereby published for information of all persons likely to be affected thereby, and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft rules are made available to the public.

The draft amendment to Rule 53 of the New Drugs and Clinical Trials Rules, 2019, proposes to expedite approvals by reducing the time limit for the Central Licensing Authority to process applications. The existing period of ninety working days under sub-rule (1) and clause (ii) of sub-rule (3) will be cut down to forty-five working days, effectively halving the approval timeline for new drug and clinical trial applications.

The draft amendment to Rule 59 of the New Drugs and Clinical Trials Rules, 2019 introduces a proviso allowing manufacturers to produce a new drug or investigational new drug for analytical and preclinical testing on the basis of an online notification instead of prior approval. However, this relaxation will not apply to specific high-risk categories such as sex hormones, cytotoxic medicines, beta-lactam antibiotics, biologics containing live microorganisms, and narcotic or psychotropic substances.

The draft amendment to Rule 60 of the New Drugs and Clinical Trials Rules, 2019 proposes to cut down the approval timelines for permissions granted by the Central Licensing Authority.

Rule 60 of the New Drugs and Clinical Trials Rules, 2019 deals with the grant of permission to manufacture unapproved active pharmaceutical ingredients for the development of pharmaceutical formulations for tests or analysis or clinical trials or bioavailability and bioequivalence studies.

At present, the authority has up to ninety working days to approve or reject applications for manufacturing or importing new drugs and investigational new drugs. The draft amendment reduces this timeframe to forty-five working days, thereby halving the approval period and allowing faster initiation of clinical trials, bioavailability and bioequivalence studies, and related drug development activities in the country.

As per the proposed amendment,

"1. (i) These rules may be called the New Drugs and Clinical Trials (... Amendment) Rules, 2025.

(ii) These rules shall come into force from the date as specified by the Government at the time of final publication of the rules in the Official Gazette.

2. In the New Drugs and Clinical Trials Rules, 2019, the sub-rule (1) of rule 52 shall be substituted, namely:―

"(1) No person shall manufacture a new drug or an investigational new drug to conduct a clinical trial or bioavailability or bioequivalence study or for examination, test and analysis without obtaining permission or the notification as referred to in the provision to sub-rule (2) of rule 52 to the Central Licensing Authority, as the case may be, to manufacture such new drug or investigational new drug."

3. In the New Drugs and Clinical Trials Rules, 2019, after the sub-rule (2) of rule 52, the following proviso shall be inserted, namely: ―

"Provided that in case of manufacture of new drug or Investigational new drug for Analytical and preclinical testing (excluding the new drug and Investigational new drug of category of sex hormones, cytotoxic, beta lactum, Biologics with live microorganism and narcotics & psychotropic drugs) an online application shall be submitted as notification and applicant can manufacture such drugs based on the notification."

4. In the New Drugs and Clinical Trials Rules, 2019, in rule 53: ―

(a) under the sub-rule (1), the words “ninety working days” shall be substituted with the words “forty-five working days” wherever occurs.

(b) under the clause (ii) of sub-rule (3), the words “ninety working days” shall be substituted with the words “forty-five working days”.

5. In the New Drugs and Clinical Trials Rules, 2019, after the sub-rule (1) of rule 59, the following proviso shall be inserted, namely: ―

"Provided that in case of manufacture of new drug or Investigational new drug for Analytical and preclinical testing (excluding the new drug and Investigational new drug of category of sex hormones, cytotoxic, beta lactum, Biologics with live microorganism and narcotics & psychotropic drugs) an online application shall be submitted as notification and applicant can manufacture such drugs based on the notification."

6. In the New Drugs and Clinical Trials Rules, 2019, in rule 60: ―

(a) under the clause (i) of sub-rule (1), the words “ninety working days” shall be substituted with the words “forty-five working days”.

(b) under the clause (ii) of sub-rule (1), the words “ninety working days” shall be substituted with the words“forty-five working days”.

(c) under the clause (ii) of sub-rule (2), the words “ninety working days” shall be substituted with the words“forty-five working days”."

Further, the gazette notification stated that objections and suggestions that may be received from any person within the period specified above will be considered by the Central Government.

"Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 545, A Wing, Nirman Bhavan, New Delhi - 110011 or emailed at drugsdiv-mohfw@gov.in."the notification added.

To view the official notice, click the link below:

https://medicaldialogues.in/pdf_upload/20250827gsr-588e-299522.pdf