A compilation of conversation on use of anaesthetic drugs in a different route other than prescribed ways of administration:
[2/23, 9:24 PM]: Can MgSO4, Dexmedetomidine, Clonidine. Tramadol be used by intrathecal, epidural or in other regional blocks in India??
Today institutional ethics committee refused all thesis projects stating that DCGI does not permit the use of these drugs other than IV or IM.
According to DCGI , drugs can only be used only by route for which it was invented. If it has to be used by other route (off label use) than DCGI permission is required.
This means what ever researches done and published in India on these drugs were UNETHICAL??
What is the opinion of the forum??
Please state the position in your institutions.
[2/23, 9:59 PM]: Yes..by DCGI guidelines you can not use it. We have not used dexmed or mgso4, or clonidine in spinal region. Duraclon is FDA approved epidural clonidine. We used it after procuring from USA.
[2/23, 10:08 PM]: Company has to get it approved for neuraxial use.
[2/23, 10:39 PM]: There are many studies published in india and abroad. Don’t know whether they got DCGI permission or not.
But nowadays the human ethics committee asks for DCGI permission if the drug is used other than the prescribed route in its brochure.
[2/23, 10:45 PM]: Regulatory authorities e.g USFDA, DCGI approve drugs for a particular indication and route for which clinical trial data has been presented to the regulatory authority. Any other route, indication, combination is considered as an off label use. Off label use is not illegal as long as it is supported by some good data in literature. Many drugs are used off label e.g. intrathecal or epidural fentanyl.
[2/23, 10:47 PM: True, majority is not aware about it.
[2/23, 10:48 PM]: True when it comes to doing studies, comes the problem of permission from regulatory authorities.
[2/23, 10:49 PM]: If research is done on an off label use e.g intrathecal or epidural Dex or mgso4, the ethics committee needs to approve the study and inform the DCGI. If the DCGI does. Not respond within 30 days approval is assumed. This applies only to academic studies, where the results will not be used to promote the use of a drug for profit by a company. If a pharma company wants to do such studies, the study must be cleared by the DCGI and the ethics committee.
[2/23, 10:50 PM]: One has to apply to DCGI for approval/permission if drug us to be used by any other route or for any other indication.
[2/23, 10:52 PM]: Sir you would have been right about a year ago. Now for an academic study DCGI approval is not required. This is a recent modification of the previous rules.
[2/23, 10:52 PM]: Can DCGI grant the permission or approval on account of existing literature published in National and international journals.??
I suppose they should .
[2/23, 10:55 PM]: Usually the DCGI would want a study approved by it to grant approval for a new drug/ route / indication. For a new chemical entity DCGI Permission is mandatory even for academic studies. e.g. A brand new drug never used in india before or a brand new drug never used anywhere before.
[2/23, 11:20 PM]: Advisory Board, hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945, namely:- 1. (1) These rules may be called the Drugs and Cosmetics (Second Amendment) Rules, 2016. (2) They shall come into force on the date of their publication in the Official Gazette. 2. In the Drugs and Cosmetics Rules, 1945, (hereinafter referred to as the said rules), in rule 122 DA, after sub-rule (3), before the Explanation, the following shall be inserted, namely:- “(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,- (a) the trial is approved by the Ethics Committee; and (b) subject to the provisions of sub-rule 5, the data generated is not intended for submission to 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 trial 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.”. 3. In Schedule Y to the said rules, in Appendix I, in item 4, after sub-item 4.8, the following note shall be inserted, namely:- “Note.- Where the data on animal toxicity as per the specifications of Appendix III has been submitted and the same has been considered by the regulatory authority of the country which had earlier approved the drug, the animal toxicity studies shall not be required to be conducted in India except in cases where there are specific concerns recorded in writing.”. [F. No. X.11035/289 /2015-DFQC] K. L. SHARMA,Jt.secy