This order, issued by the Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health & Family Welfare on July 3, 2014, outlines considerations for evaluating ethnicity in the approval of new drugs. It stems from recommendations made by an Expert Committee, chaired by Prof. Ranjit Roy Chaudhury, regarding new drug approvals, clinical trials, and drug banning.
The order specifies characteristics of compounds that may be sensitive to ethnic factors. These include: non-linear pharmacokinetic/pharmacodynamic curves, high metabolism (especially via single pathways), metabolism by enzymes with genetic polymorphism, prodrug administration, high intersubject bioavailability variation, low bioavailability, likely use with multiple comedications, and high likelihood of inappropriate use.
Factors to consider when determining if available data are ethnically sensitive or insensitive include: disease definition and patient diagnosis, method of case controls group of safety, similarity of medical practice to the country of origin, regional medical practice, concomitant medication use, severity distribution of eligible subjects, similarity of dose and dosage regimen and acceptability of the clinical endpoint to the region in assessing efficacy. NDAC experts are requested to consider the above factors that may result in ethnic variations in the evaluation of new drug applications.
Key Entities Referenced
Central Drugs Standard Control Organization: An organization under the Directorate General of Health Services, Ministry of Health & Family Welfare, involved in drug regulation.
Ministry of Health Family Welfare: The government ministry responsible for health and family welfare policies.
Prof. Ranjit Roy Chaudhury: Chairperson of the Expert Committee constituted by the Ministry of Health Family Welfare.
Expert Committee: A committee constituted by the Ministry of Health Family Welfare to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs.
New Delhi, Delhi: Location of FDA Bhawan, Kotla Road, the address of Central Drugs Standard Control Organization.
NDAC: Acronym for an expert group, NDAC experts are requested that applications for approval of new drugs should be evaluated keeping in view the factors that may result in ethnic variations
IDMA: Mentioned as a recipient of the communication, possibly an industry association.
US D, Ministry of Health and Family Welfare: Recipient of the communication, possibly refers to Under Secretary of Ministry of Health and Family Welfare
File No, 12-01/14-DC Pt.47
Central Drugs Standard Control Organization
Directorate General of Health Services
Ministry of Health & Family Welfare
FDA Bhawan, Kotla Road, New Delhi-110002
Date: 03.07.2014
ORDER
SUBJECT: Consideration of ethnicity for approval
+FH
of new drugs- regarding
The Ministry of Health & Family Welfare had constituted an Expert Committee under the
Chairmanship of Prof. Ranjit Roy Chaudhury to formulate policy and guidelines for approval of new
drugs, clinical trials and banning of drugs. The Expert Committee submitted its report to the:Ministry __-
of Health.& Family-Welfare. The actions proposed to be taken on the recommendations of the -
Expert Committee were finalized by the Ministry of Health & Family Welfare.
In pursuance to. above, in regard to the consideration of ethnicity for approval of new drugs,
it has been-decided-that the following properties of a compound which make it more likely to be
sensitive to ethnic factors shall be taken into consideration during evaluation of new drug
applications:
21)) ANo-n-lsinteare pehp aprhmaarmcaockoidnyneatmiiccs curve (a small change in dose results in a large change in
effect) for both efficacy and safety in the range of the recommended dosage and dose
regimen
43)) .HAingahlryr omwe ttahbeorlaipzeeudt,i ce sdpoescei arlalyn gtehrough a single pathway, thereby increasing the potential
for drug-drug interaction
5) Metabolism by enzymes known to show genetic polymorphism
6) Administration as a prodrug, with the potential for ethnically variable enzymatic conversion
7) High inter-subject variation in bioavailability
8) Low bioavailability, thus more susceptible to dietary absorption effects
9) High likelihood of use in a setting of multiple-co-medications -
10) High likelihood of inappropriate use, e.g. analgesics and tranquiltizers.
it has also been decided that the following factors may be taken into consideration in
deciding whether the available data could be ethnically sensitive or insensitive:
1) Definition of-the disease and diagnosis of the patient
23)) CMheotihcoed poff. caosntsreosls gmreonutp of safety- Similarity- of- medical practice to the country of forigin | — =
4 5) ) RDu er ga it oi no an l o mf etr di ia cl a. l practice of concomitant medication use a . Foe cles oom
6) Sevetity distribution of eligible subjects Ob as. TE
7) Similarity of dose and dosage regimen
8) Clinical end- ‘Point has to be acceptable to the region in assessing efficacy.
NDAC experts are therefore requested that applications for approval of new. drugs should
be evaluated keeping in view the above factors that may result in ethnic-variations:~ ~7 —o
To |
1. IDMA/IPA/ OPPI/ISCR/ ACRO
Oe
2. NDAC Members
CC to:
US (D), Ministry of Health and Family Welfare