What do I need to do to conduct my study in India?
You will need to plan ahead.
If you are NIH funded, you mustobtain a special clearance herein the US in order to use your funding for the conduct ofa clinical trial in India .The Indian government also imposes special restrictions on studies receiving overseas (non-Indian) funding.
These are in addition to the actual application procedures that will be required.
US“Fogarty”Clearance:
1) NIH funded studies conducted overseas require special clearances obtained through
the Fogarty International Center for AdvancedStudy in Health Sciences (FIC). Clearances for India, China and Brazil can take a long time, with no process available to expedite or monitor the process.
If you are receiving fundsfrom the NIH you must obtain a “Fogarty Clearance” for the conduct of the study at yourselected Indian sites before any NIH funds are spent in India or before you incur any costs there thatwill be paid from the NIH funds.
The Fogarty International Center for Advanced Study in Health Sciences (FIC) coordinates international activities on behalf of the NIH. It facilitates the State department review for all awards involving significant scientific components in foreign countries for their relation to US policy interests, overall HHS policy, and international agreements.
Timing is crucial here. While the actual clearance is supposed to take
1-4 weeks, experience has shown that this can often take substantially longer.
Since the Indian statutes prohibit foreign entities from entering intocontracts in India, actual site set up will have tobe done by a local contract organization hired for this purpose. However, as NIH specifically forbids the use of grant funds in any country before Fogarty clearance is obtained for that country any costs incurred before Fogarty Clearanceis obtained cannot later be paid from the Federal funds. Thus, until Fogarty Clearance is obtained, any local contract entity will either have to remain idle inIndia ornot conduct any activity that will be billed to the project. Alternatively, ifthe local entity is allowed to move forward in India, any costs incurred byit through this pre-Fogarty activity will have to be paid from some source offunds other than theFederalfunding.
current as of 28 April 2015
INDIAREQUIREMENTS:
1) If you will be using foreign (non-Indian) funding for the study you will have to obtain clearance for the conduct of the study from the Government of India (GOI) AND you will have to select an Indian collaborator in order to obtain the GOI approval.
Government of India (GOI) clearance must be obtained beforethe transfer of foreign funding into India for collaborative research projects. Only Indian investigators may apply for GOI clearance for Indo-US collaborative projects. Proposals can be submitted at any time but it can take6-9months for clearance to be obtained.
If you are submitting an NIH grant proposal, the Indian Council for Medical Research (ICMR) recommends that yourIndian co-PIs submit the proposal for GOI review while the grant is being reviewed by the NIH funding agency. This way GOI approval will be obtained while NIH is making the funding decision and the project can be initiated promptly following the grant award.
2) You will need to establish a local presence in order to do business in India.
Foreign entities are prohibited from executing contracts in India. Under Indian lawforeignentitiesmustestablishsome type of presence in India inorder to conduct business there. While there are several avenues available for setting up this base, clinical studies originating outside India usually hire a contract
research organization with a presence in India to do the local site contracting on their behalf.
3) All of the clinical trial application filings must be done by the local agent.
Clinical trials in India are regulated by Schedule Yof the Drug and Cosmetics Rules, 1945. Schedule Y can be consideredthe Indian equivalent to the U.S. FDA regulations. These regulations require foreign sponsors to use a local agent to file all of the requisite applications relating to the conduct of a clinical trial. This prevents a foreign sponsor having no presence in India from independently requesting clinical trial approval. There must be a local presence
(similar to the EU’s authorized representative) in order to conduct a trial in India.
4) The category of your trial will determine how long theclinical trial application approval will take.
The Central Registry Agency for drugs and drug trials is Drugs Controller General (India) or “DCGI”.All clinical trial applications are submitted to the DCGI office by the sponsor or the sponsor’slocal representative for approval.
current as of 28 April 2015
Under a procedure initiated in 2006, clinical trials are either Category “A”
or “B”.
CategoryA includes clinical trials whose protocols have been approved by EMA or regulatory agencies in the US, UK, Switzerland, Australia, Canada, Germany, South Africa or Japan. Category A application review and approval is projected to take 2 to 4 weeks.
CategoryB clinical trial applications do not have prior approval ofan acceptable foreign authority and will be reviewed under the old review system: by an expert committee of the applicable Ministry. This process takes (optimistically) 8 to 12 weeks for approval, not including potential delays due to incomplete applications and time required for sponsor responses to queries. Once an application is considered underCategoryB,itcannotbeshifted to CategoryA, even if the applicant produces an approval from a CategoryAcountry.
5) The time periods for the approval processes in India are uncertain.
The foregoing time periods should be considered more optimistic than realistic. Commentary on the review and approval process indicates that notwithstanding the estimated review periodsgiven in the regulations and guidelines, timelines for study approvals are often unpredictable.
The office that grants approvals - DrugsController General (India) or “DCGI - dependsonexternalexpertsandother government agencies for advice on applications making the process subject to external delays.
There are also additional permissions required for the import of trial samples and export of blood samples to foreigncentral laboratories that may add to your time frame if either will be applicable toyour study.
6) You need local Ethics Committee review and approval before commencing the trial
There is no national Ethics Committee in India. Ethics Committees are situated regionally and/or associated with specific institutions. There are independent Ethics Committees (like “Copernicus” here) available for the review of studies using investigators that are not affiliated with institutions.
The submission to the appropriate local Ethics Committee(s) can be made in parallel with the application to the DCGI. Either yourIndian investigator or your local agent can make the initial submission to the applicable Ethics Committee(s).
current as of 28 April 2015
Meeting dates and review timelines areestablished by each Ethics Committee’s operating procedures. The Indian GuidelinesonEthicalProceduressuggest
that no decision is to remain pendingbefore an Ethics Committee for more than
3-6months.
Under new rules implemented in July 2014 by the Central Drugs Standard Coordinating Center of India, the primary regulatory authority for clinical trials in India, academic clinical trials for research can be approved by the Institutional Ethics Committee alone, unless it involves a new drug or a new use of an existing drug in which case government approval is also necessary.
7) If importing an investigational product a special license will be needed.
Products shipped from other countries require a separate import license, called the T‐License (Trial license), for investigational drug products. Once the license is issued, it is valid for multiple shipments for one year. The T‐License and Schedule Y clinical trial applications may be submitted together. The T license may be granted with the Schedule Y approval or within 2-4 weeks of it.
8) If biological samples are to be shipped out of India another license is required.
Aseparateapplicationis required for shipping biological samples collected during the trial (e.g., body fluids) out ofIndia. This application (the No-objection Certificate) can be submitted simultaneously with the Schedule Y application for the clinical trial. Once the clinicalstudy is approved by the DCGI, the import license and No‐Objection Certificate (NOC) for shippingbiologicalsamplesare granted within 2 to 4 weeks.
9) Special restrictions exist for Phase I trials
India prohibits Phase 1 trials formoleculesdiscoveredoutsideIndiawith exceptionsmadeonlywhenthe drug being tested is of “relevance” to the health problems in India or if itis a repeat phase I study.
10) Pre-submissions meetings are available
In January of 2015, the Central Drugs Standard Coordinating Center of India, the primary regulatory authority for clinical trials in India , introduced a system of formal Pre-submission Meetings (PSM) for applicants with CDSCO officers and subject experts to discuss regulatory pathway in respect of specific application for approval of clinical trials. The system is intended to facilitate to understand the regulatory pathways required to be followed by the applicants in order to bring predictability and speedy disposal of applications
current as of 28 April 2015