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LETTER TO EDITOR
Year : 2016  |  Volume : 14  |  Issue : 4  |  Page : 471

Amendment of the drugs and cosmetics rules, 1945


Department of Public Health Dentistry, Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidyapeeth, Pune, Maharashtra, India

Date of Web Publication15-Dec-2016

Correspondence Address:
Sahana Hegde Shetiya
Department of Public Health Dentistry, Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidyapeeth, Pune, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2319-5932.195835

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How to cite this article:
Shetiya SH. Amendment of the drugs and cosmetics rules, 1945. J Indian Assoc Public Health Dent 2016;14:471

How to cite this URL:
Shetiya SH. Amendment of the drugs and cosmetics rules, 1945. J Indian Assoc Public Health Dent [serial online] 2016 [cited 2019 Oct 14];14:471. Available from: http://www.jiaphd.org/text.asp?2016/14/4/471/195835

I was going through the “Instructions to author” on Pg. 360 of JIAPHD, Vol 14, Issue 3, July-September 2016.

I read that JIAPHD favors registration of clinical trials which have begun enrollment of participants in or after June 2008 and those which enrolled participants before June 2008 have to register retrospectively in a trial registry that allows free online access to public.

However, the Ministry of Health and Family Welfare in its notification dated January 6, 2016, has given Draft rules which is called, Drugs and Cosmetics (9th amendment) Rules, 2016.[1]

Drugs and Cosmetics Rules, 1945, in rule 122DA, has inserted the following sub-rule in sub-rule (3).

“(4) No permission for conduct of clinical trial intended for academic purposes in respect of approved drug formulation shall be required for any new indication or new route of administration or new dose or new dosage form where,

  1. The trial is approved by the Ethics Committee; and
  2. Subject to the provisions of sub-rule (5), the data generated is not intended for submission to the licensing authority.


(5) The Ethics Committee shall however inform the licensing authority about the cases approved by it and also about cases where there could be an overlap between the clinical trials for academic and regulatory purposes and where the said authority does not convey its comments to the Ethics Committee within a period of thirty days from the date of receipt of communication from the Ethics Committee, it shall be presumed that no permission from the licensing authority is required.”

However, from the above statement, it looks like, most of the academic trials carried out by the PG students (3 years tenure) which likely form the crux of the publications are unlikely to be registered in the trial registry as they would not have carried out research on new drug (4 years), new substance having therapeutic indication, modified or new claims, new route of administration for already approved drug, and fixed-dose combination.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

1.
Available from: http://www.cdsco.nic.in/writereaddata/GSR%2011(E)%20dated%2006_01_2016.pdf. [Last accessed on 2016 Mar 03].  Back to cited text no. 1
    




 

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