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.
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
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