Date: 2014-07-03Category: Not ApplicableState: Union GovernmentCountry: India
Office Order dated 03.07.2014 - Requirement of local trial for a generics or similar biologics (bio similar) in other country like USA for its approval in the country
**Policy Summary: Requirements for Local Trials of Generic and Biosimilar Drugs Approved in the USA**
This order, issued by the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health & Family Welfare, dated July 3, 2014, addresses the requirements for local clinical trials in India for generic drugs and biosimilars already approved and marketed in other countries, specifically the USA.
The policy stems from the recommendations of an Expert Committee chaired by Prof. Ranjit Roy Chaudhury, which was formed to formulate policies and guidelines for new drug approvals, clinical trials, and drug bans.
The key decision outlined in the order is that generic drugs and biosimilars already marketed in countries like the USA for more than four years, and possessing a satisfactory safety record, will be eligible for marketing approval in India following abbreviated clinical trials.
The order directs all NDAC (presumably New Drugs Advisory Committee) experts to evaluate applications for such drugs, keeping the aforementioned requirements in consideration. The Drugs Controller General is instructed to disseminate this information. The order also lists IDMA, IPA, OPPI, LiSCR, ACRO, US, and D, Ministry of Health and Family Welfare.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body in India responsible for the approval of drugs, clinical trials, and setting standards for pharmaceuticals.
Ministry of Health Family Welfare: The Indian government ministry responsible for public health in India.
New Delhi, Delhi: The location of FDA Bhawan, where Central Drugs Standard Control Organization is located.
USA: Refers to the United States of America, a country whose regulatory approvals are being considered for generics and biosimilars.
NDAC: An expert committee whose members are requested to evaluate applications of new drugs.
Prof: Ranjit Roy Chaudhury: The Chairman of an Expert 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.
Drugs Controller General: An authority related to drug control.
IDMA IPA OPPI LiSCR ACRO: A group of pharmaceutical organizations
_ 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
, oe _.._... . Date:03.07.2014
LL aneeennannne ORDER - oo
. _ SUBJECT: Requirements of local trial for a generics or similar biologics (Bio- _
“similars) in ‘other country like USA for its approval in
, 14. . NDAC Members | ae — - ae
| the country-
regarding
The M
a as
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 tobe
taken on' the recommendations.of the. Expert Committee were finalized by tr the @ Ministry of
Health & Family Welfare.
In pursuance to above, in regard to consideration of requirements of local trial for .
a generics or similar biologics (Bio- -similars) in other country like USA for its approval in the:
country, it has been ‘decided that the drugs considered generics and similar biologics
(biosimilars). in other countries like USA that have been marketed in such countries for oe
‘more than four years and: have a satisfactory report ‘would be ‘approved for marketing in
India after abbreviated trials. i So eee |
In view of above, all the NDAC experts are requested to evaluate applications of
-such new drugs whieh are considered generics “and similar’ biologics ‘(biosimilars) in other |
countries like USAa are evaluated keeping. in. view the | above requirements. _
| Drugs.¢ Controlter ‘Gen ral (naa) ot
2. IDMA / IPA / OPPI LiSCR/ ACRO-
-US (D), Ministry of Health and Family Welfare - oe oo