Union Government, Extraordinary, 2011-01-19, Part II-Section 3-Sub-Section(i), Ref. G.S.R. 40(E)

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WINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Heath)
NOTIFICATION
‘New Doty, the 98th Jenuary.2011
GSR. 40(E)— "The folowing ora rules further to amend the Drugs and

Coematics Rides, 1848, which the Centra, Government proposes to make [n exercise of the
powers conferred by secon 12 and section 39 of the Drugs avd Cosmetics Act, 1940 (23 of
840), ator consultation with the Diygs Technical Advisory Board, is hereby putlished for the
Information of ail parsons likey #o be affected thareby, and the notice is hereby given that the
said daft rules shall be taken inte consideration on er atte” the expty of a petiod of fortysve
days Thom the date on whieh the copias of the Gazette of India contarning these draft rules are

rade availabie to the publ,
‘Any yerson interested in raking any objections of suggestions on the proposed draft

rules may do 0 In writing for consideration of the Central Soveramunt within the period 50
of

specified through post to the Secretary, Ministry of Héahh and Family Wettare. Govern

India, Sean Biswan, New Dathi- #40011
DRAFT RULES
1. (1) These rules may he called the Drugs and Cosmet

{Fit Amendenent Fules. 2011

19S GT
TE GAZEYTE OF INDIA : EXTRAOWAINARY se Sk. 3

2. tnthe Drugs and Cosmetics Rules, 1948 (hereinafter referred to as the said
ules) after rule 122 DAA, the folowing rule shall be inserted, namel
"Rule 122 DAB. - Registestion of clinica! research organisation tor
conducting clinical tials: - (1) The clinical research organisations shal be
Fequired to be registered by the Licensing Authority defined in clause {b)

of nile 21 for the purpose of conducting clinical trials in the country

{2)An application for registration of clinical research organisation for the
purpose of condyeting clinical trials shall be made to the Licensing
Authority defined in Clause (b) of Rule 21 accompanied by the
inforration as required under Schedule Y-1

(3) If the Licensing authority after such further enquiry. if any, a8 he may
consider neoessary, is satisfied thal the requirements of the rules have
bbeer complied with and the conditions of registration will be observed,
he may grant registration subject to the conditions stated therein.

(4) A regististion, unless it is sooner suspended oF canceled, shall be
valid for a pesiod of five years ftom the date of issue.

GBIF tha licensing authorty is not so satisfied, ne shalt reject the
application and shall inform the applicant of the reasons for such
rejection and the conditions which must be satisfied before the
{egistration oan be granted.

(G)iT the clinical research organisatfon falls ta comply with any of the
conditions of registration, the licensing autnority may after ging an
‘opportunity 9 show cause why such an order should not be passed,
ey an rcer in wring stating the seasons therefor, suspend or cancel
{fe registration for sch period as deemed fit

(7) The clinica! research organisation, whose registration has been
‘suspended ar canceled by the licensing authorily. may within sinaty
day$ of the receipt of the copy of the order by him prefer an appeal to
the Central Government end the Central Government may after giving
an opportunity of being heard, confir, reverse of modify such order

Explanation — For te purpose of this rule a clinical research organization
isan individu or an arganisation (commercial, acaderic or other) to
‘which the sponsor may transfer or delegate some of all of the tasks, duties
and / or obligations regardiag @ Clinical trial, provided tit all such
‘contractual transfers or obligations are defined in wing”
1 tar 36] Sa ae = TEM

(2) They shell come inty force on the date of their fal publication in the Official

Gavene,

3. nthe said rules after Schedule Y, the following Schedule shall be ineerted,
nemoly:-

"Schedule Y4
{Soe Rules 422 DA, 122 DAA, 122 DAB)

Requirements and Guidelines for registration of clinical rosnarch
organisations

1. Scope

These guidelines cover all organisations, individuals, institutions and

companies thal take the resporisibity af conducting clinical trials ineluaking these
who seek permission for clniva Iral from Ligensing Authority defined in clause
{b) of rule 21. tt does not include clinical trial sites.

‘Thase guidelines are not stand alone guidelines and are not in derogation

of any other rules or guidalines applicabie to the cinicab trials e.9, Schedule Y of
‘the rules, Indian Good Clinical Praviive (GCP) guidelines and Ethical Guidelines
ter Bio-Medical Research on human participants by the Indian Council of
Medical Research,

2, Criteria for Registration

i

@

‘iy

wy

The Clinical Research Organisation shail be undes the charge of a porson
who is responsible for the overall activities of the organisation. The
organisation should have competent persons who are thoroughly familiar
\with the investigational preduct{s}, the protocol, writen informed consent
forms or other information provided to the subjects, the standard operative
procedures by the spansars, GCP guidelines and other rules applicable to
the conduct of clinical als

‘The organisaton shall have adequate resources. qualified and tained
staff for oversight of cinica! tials. The staff mambers are Foquirad fo 80
tained regularty to update thei skis

‘The trial rclated duties and functions transfered to and assumed by the
Clinical Research Organisation shall be specified in wring and properly
quantified

The organisation shall ensure that the trials are adequately monitored and
the trial related sesponsibiles trensfened to it, partially or fully, by the
sponsor ave discharged effectively and efficiently.

SGHftt—>
{WIR GATEUIE OF INDLA : EXERAORDINARY

{The organisation shall implement quality assurance and quality control as
per standard operative procedures designed for the pumose. Such
Btandard Opelalive Procedures shall be well documented.

(vi) The organisation shall maintain complete data, documentations and other
related records accurately. The organization shall also check and ensure
that the invastigatoris) have riainlained properly the essential documents
Tequied for the conduct of the trial

(vil) The organisation shall ensure that the investigators) received all
<ocuments and tral related suppies needed to conduct the tial propery

ivi} The organisation shall nave education programmes 19 help its
investigators to cary gut the research studies aa per guidelines and
eguletin’s applicable fo such trials. Training will include protacol
adherence. GCP guidelines. infernad consent process, and imvestigato:’s
responsibilties for GCP compliance.

, Record Keeping

All recaids (writen documents, eléctonic, magnetic of optical records, scans,
ef.) suc as protocols, approvals fort the Central Drugs Standard. Control
Organization (COSCO) and ethice committee, investigator's) particulars, biank
consent forms, monizar reports, audit certificates, ‘elevant correspondence,
reference ranges, completed and the fina! reports, shal be maintamed. All
documentation and communication are to be dated, fied and preserved safely fo>
a period of 5 years after the compiciion of siudy or submission af the data io
CDSCO. Strict confidentiality is ۩ be maintained during access and retrieval
procedures,

Information required for registration

ft) Name and address of the organisation to he registered atong witn is
telephone nurnber, fae number. mail address.

(i) Name and address of the proprietorsipartnersidirectors,

Gi) Status of the exganisation as legal entity,

(iv) A biel profie of the specitic actwities/services undertaken by the
‘organisation including facilities, resources and infrastructure.
(¥)— Anorganogram of the organisation including brief Cvs of key personal.

(i) List of Standard Operative Procedures with salient highlights about
specific areas to be scrutinised.
(vi) An undertaking to declare that.-
[oe C9 me 5 THE ’

(@) we shall comply with the conditions imposed on the registration
certficate along with the adherence to othet guidelines like GCP
guidelines and provisions of the Drugs and Cosinetics rules, 1946.

(b) we shall comply with such further requirements, if any, a8 may be
specified by the Government of India, under the Act and the rues,
made thereunder.

{0} we shall allow the licensing authority and/or any person authorised by
‘im in that behalf fo enter and inspect the premises and to examine the
processiprocedure and documents in respect of any clinical tral
conducted by us.”

FF No X-ttoazamo.orog;
ARUN PANDA J, Sey

Foot note ha prinepal rules ere pbshed Inthe Ofc Gezata vce rotcai hes F.28-1045-4 (1: satee
ibe, 185 an [nat amended vite acHnetion number GSR 3ERF), dalea the