Ministry of Health and Family Welfare issues draft New Drugs and Clinical trials Rules, 2018.

Feb 07, 2018 | by Avantis RegTech Legal Research Team

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Ministry of Health and Family Welfare vide notification dated February 05, 2018 has issued draft New Drugs and Clinical trials Rules, 2018. These rules shall apply to all new drugs, investigational new drugs for human use, clinical trial, bioequivalence study, bioavailability study and Ethics Committee.

Highlights of the Rules are as under:-

          According to new draft rules for clinical trials and new drugs, if the sponsor fails to provide medical management to their trials, not only will the trial be cancelled, but the company will also be restricted from holding any more trials. However, in a boost to firms wanting to conduct trials on drugs proposed to be manufactured and marketed in India, the permission for trials will be granted within 45 days.

          As per the draft new drugs and clinical trials rules companies will have to pay compensation if the drug fails to provide the intended therapeutic effect or where the required standard care or rescue medication, although available, was not provided to the subject.

          If the clinical trial is being conducted for an indication for which no alternative therapy is available and the investigational new drug has been found to be beneficial to the trial subject, the post-trial access will be provided by the company free of cost.

          According to the new draft rules, if the patient dies or suffers a permanent disability during a trial, the companies conducting the trial will have to pay an interim compensation of 60% of the final amount within a period of 15 days,

          The local trial may not be required if no major unexpected serious adverse events have been reported and there is probability or evidence on the basis of existing knowledge, of difference in India population of the enzymes/gene involved in the metabolism of the new drug.

          As per the new draft rules, if the company proposes to conduct the clinical trial of a new drug or an investigational new drug and also the new drug is proposed to be manufactured and marketed in India, not only the permission will be granted in a time bound manner of 45 days, if the central licensing authority fails to communicate, the “permission to conduct the clinical trial shall be deemed to have been granted”.

          Time line for processing application:

       Clinical trial (in general): 90 days

       CT (innovated in India) within 45 days

       CT (if drug is already approved by other country): within 60 days

       New drug: within 90 days

Any Objection or suggestion on the said draft rules may be sent to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414 A, ‘D’ Wing, Nirman Bhawan, New Delhi – 110011 or sent on email [email protected], within forty five (45) days from the date on which the copies of this notification as published in the Official Gazette, are made available to the public.

[File No.X.11014/10/2017- DRS -Part (1)]




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