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Health ministry to amend D&C Rules to exempt clinical trials for academic research from DCGI nod
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Ramesh Shankar, Mumbai
November 27 , 2015
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The Union health ministry will soon amend the Drugs and Cosmetics Rules,
1945 for providing exemption in the case of clinical trials undertaken
in the medical institutions or hospitals for academic research. Once the
amendment is done, these institutions and hospitals do not have to take
the now mandatory prior permission from the Drugs Controller General of
India (DCGI).
According to sources, the Drugs Technical
Advisory Board (DTAB), the highest authority under the Union health
ministry on technical matters, in its 70th meeting held on August 18,
2015, has given its approval for a proposal by the ministry in this
regard.
There were concerns regarding difficulties in submission
of application to DCGI for such clinical trials by the investigators
and medical students from different parts of the country and
subsequently making presentation before the subject expert committees
(SECs) for their approval. It was felt that the cumbersome procedures
for obtaining permissions in each and every case of academic research is
not permitting free growth of academic clinical research in the medical
institutions.
The Prof. Ranjit Roy Choudhury Committee had also
recommended in its recent report that academic research should be
approved by the Institutional Ethics Committees. The approval of DCGI
should only be required if a new drug is being evaluated or a new use
for an existing drug is being tried out. It was therefore decided by the
ministry of health and family welfare that academic clinical research
may be approved by the Institutional Ethics Committee, however, in the
case of new drug is being evaluated or a new use of an existing drug is
being evaluated, then approval of DCG I is required as per rules.
In
the DTAB meeting, it was proposed that a provision may be provided
under the Drugs and Cosmetics Rules, 1945 that permission for clinical
trial purely for academic research may be approved by the Institutional
Ethics Committees. The approval of DCGI should be mandatory only when
the new drug is being evaluated or a new use for an existing drug is
being tried out under certain conditions.
A proviso to the rule
122 DA relating to application for permission to conduct clinical trial
for new drug/investigational new drugs was proposed to be introduced as
under to provide specific exemptions in the case of clinical trials for
academic research as under: Provided that permission for conduct of
clinical trial is not required from the licensing authority if the study
is related to already licenced or approved drug and drug formulations
permitted to be marketed, for new indication, new route of
administration, new dose, etc. for academic research purposes and
complies with the conditions that the trial has been duly approved by
the Ethics Committee and the data generated is not intended for
submission to any regulatory authority.
After deliberations, the DTAB agreed to the proposed amendment.
Clinical
trials on new drugs are regulated under the provisions of the Drugs and
Cosmetics Rules, 1945. Rule 122DA provides that no clinical trial for a
new drug, whether for clinical investigation or any clinical experiment
by any institution, shall be conducted except under, and in accordance
with, the permission, in writing, of the Licensing Authority. Further,
Rule 122E includes not only the new molecules but also the new claims
namely new indication, route of administration, dosage, etc. of already
approved drugs.
Under these provisions conduct of clinical trial
of already approved drugs for new claim by any institution/medical
researcher for academic purposes require prior permission of DCGI.
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