Background Rules were notified to address various problems such as

India has • systematic and structured regulatory rname- hazardou.s chemlcab, hazardous was te,, solid wu,tcs,
work for biosafety evaluation or geneticllly modified or• biomt"dica.l wast.es, etc.
ganisms (GMOs) and products thereoL India w.is one of In coMcction with the use of micro-organisms and •P·
the early movcr1 in dcvclopmcm of a bil!Hfrty rqula· plk;allon ol grnc ICChnology, lhc MoEFOC ootilled the
tory sy,,t,,m for GMO., way bade in 1989. The apex rules "Rules ror manufacture. use/ lmpon/Cl<pOf't & norage of
for regubtion of all activities rebred to GMO. are baz:anlous microorganisms/~ y engineered organ•
notified under Environnx,nt (Protection) Act, 1986. In isms or mis. 1989" II I as per powen conferred by
addition, there are other acts, rules and polkles which Sections "Regulation of Genome Engineering Tcch11ologk'"
are al<o applicable to lh<,se organisms. in India", 8 and 25 of Environment (Protttt.ion) Act, 1986.
These rules are very broad in scope essentially covering en•
Regulation of GMOs In India tire sp«1nlm of activiti•• involving GMO. ond products
An ovcrviAow of biosarety regulations is pttSented below: thcr<of. They also apply to any substancrs, product,, 11nd
food stuffs. ffl:., of which such cells, organisms or tissues
hcreor ronn part. New gene technologies apart from gen•
Rui.s, 1989
die engineering haYI! also been included. ~ gene tech•
In India, Mlnl•try or Environment, Forest and Climate nology and genetic engineering have b,,en deftned as
Change (MoEFCC) introduced the Environment
follows in the IEXt of the Rules. I 989.
(Prorection) Act, 1986 as an umbrella legisbtion to
provide • holistic fr11mewon: ror the protection and (i) "Gene Technology" means the application of
improvement to the environmenL Thereafter. a Sttics o(
the gene technique called genetic en p,ineering,
 (ii) "Genetic engineering" me.ans the technique by which were u,pted by the Government for
which heritable material, which does not usually conducting research and handling of GMOs in India.
occur or will not occur naturally in the org:an.ism or (li) butitDtional Biola&ty Com.mitttt {IBSC): It is
cell concerned. generated outside the organism. or necessary that each institution intending to carry out
the cell is inserted into 5'lid cell or organism. It research activities involving genetic manipulation of
shall also mean the formation of new combinations microorganisms, pbnts or animals should constitute
o( genetic materui by incorpor:ition ol a cdi into a the IBSC. The l8SCs comprise o( the btead o( the
host cell. where they occur natur.illy (self-cloning) as organization. scientists engaged in DNA work. a
well as modification man organism a: in a cell by medlcal expert and a nominee of the DBT. The IBSC
deletion and removal of parts of the heritable material. is the nodal point for inter:iction within the
institution for implementation of the guidelines.
Rules, 1989 are implemented by MoEfCC jointly with (iii) llnlew Commltttt OD Genetic Manipulation
the Department of Biotechnology (DBT). Ministry of (RCGM): The RCGM functions as a b ody under
Science & Technology and state governments. Six Com- the DBT to monitor the safety related upects in
petent Authorities and their composition hare bttn respect of 011-going research projects and activities
notlfled under these Rules that Includes: im·olving GE organlmas/haz.ardous microorganisms.
RCGM b also mandated to bring out manual, or
I. rDNA Advisory Commit!«- (RDAO guidelines sp«ifying procedure for regulatory
2. Institutional Blosafety Commlu<e (IBSC) process with respect 10 actJvitie, involving GE
3. Review Commltltt on Gcnclk: Manlp\llalion (RCGM) Ol'pnimli In mcarc:h. UK and appllcallo,u with a
4. Genetic Engineering AppralAI Commlu..- (GEAO view to ensure environmental safety. The RCGM
5, State Blot«hnology Coordination commit!«- (SBCO includes n,prescntatlves of scientiOc departments/
6. District level Commlttte (DLC) organizations In the country viz. Indian Council or
Medial R,search (ICMR), Indian Council of
While the RDAC is advisory In function, the IBSC. Agricultural R,search (ICAR). Council of Scientific
RCGM, and GEAC arc rosponslble for rcgubting func- and Industrial R,search (CSIR) and 01her experts in
tion. SBCC and DLC arc for monitoring purposes. their individual capacity.
The role of each of the commlt!CCS is summariud in (iv) Geadic Enpnerrtn1 Appralaal Committee
Table I and detailed below: (GEAC): GEAC is the apex committee functioning
in MoEFCC and has representatives from concerned
(i) Rttombhwlt DNA Advllo,y Commltttt minimies/agenclcs and experts. GEAC is chaired by a
(RDAC): Thls committte constitutM by the DBT senior officer of MoEFCC and co-chaire:I by expert
takes note of developments in biol«hnology at nornuuu,d by DBT. GEAC is resporuible for approval
national and iniernational kv,,ls. The RDAC is oi activities involving large scale use of hazardous
advisory im nature and expected to ~ microorganisms and m:ombinant products in research
recornmemdations from time to time on safety and indwttial production from the environment angle.
regubtions in research and applications mGMOs and (v) ~ Biotechnology Cool'dination Committee
products thcreo{ This Committee pn,pared the (SBCC)! SBCC is constitutM in each State where
Recombinant DNA Biosafety Guide!ines in 1990, rese,irch and applications of GMOs are underway.
 SBCC is headed by the Chief Secretary of the, State Approvals and prohibitions
and has primarily monitoring RSpOtuibilitirs: Rules. 1989 provid• for complLmce of the biosafety safe,
(vi) Diotrict Level Committft (D1.C): DLCs an, guards and any violation and non-compliance in this
constituted. ln districts, wherever required to area allr>ca punitive actions provided under the EPA,
monitor th,e safety regulations In in1tallatlon 1986. The approvals and prohlbltion1 under Rules 1989
enll"8ed in me use of GMOs/haz:lrdous are summarized below:
mlcroorgan.lsms and Its appllcatlons in the
environment Ellch DLC Is head,ed by th,e District • No person shall Import. export, transport,
Collector (officer respoMible for admlnlsuatlon of a manufacture. process, use or odl any GMOs,
district) with ollicen ronaemtd with publJc health. subswu:es or cells exc<p< with the approval of
environment pollution control etc. at the district lrvc,L th<GEAC.
The interactive mechanisms ~ committre:s • Us, of pathogenic organisms or GMOs or cells
have also been provided in Rules. I 989. All lBSCs for research purpose shall only be allowed in
are required to review th,e applications and submit bboratories or insidA, laboratory areas notified for
their recommendations and reports to RCGM. this purpose under the EPA. 1986.
RCGM review and gives its recommencbtion for • Any p,erson operating or using GMOs for scale up
large scale activities, field t:rws and environmental or pilot operations shall have to obtain permission
release to GEAC. DLCs are also required to from GEAC.
regularly submit its report to the SBCC/GEAC. • Expcrimt"nts for the purpost' of education involving
GMOs can be undrrtaken with the oversight
In addition to th,e above, various 1ub-committees and of l SSC..
expert committees are constituted by RCGM and GEAC • Deliberate or unintentional relras,e of GMOs
on • cue by case basis. Such commlucn comprise or not allowed,
experts from various dlsdplines drown from public sec· • Production in which GMO, arc generated or used
tor lnstltutlons to prepare and =icw v.arious guidelines shall not be commrnced except with th.c approval of
and bio..fety data. Central Compliance Committees are GEACAII approvals shall be for • period of 4 ycan
also set up for monitoring of confined fi<ld Uia1c on case at first insw,ce renewable for 2 years at a timr.
by case basis. An example of functioning of regulatory • GEAC shall have po..-ers to revo1u, approwls in case of:
system for confined 6eld trials and environmental re- i Any new information on harmful effects
lease of a GE plant is illustrated in F',g. I. ofGMOs.
 iL GMO! ,caiue sudi damage to the environment as
mnld .oot he envisaged when approval wa given._
iii Noo..,rompliance of any omditions s.tipibted
byGEAC.

SupuvlsiDn and p,1nalli&:1

GEAC ~ ~ implementarinn of the terms and
mnrlitiorw .bid dow:m in nmnediun with the appmwls
acroroed by it GJEAC moay cam:, out s u ~ n through
SBCC1 DLC or any authomed persom.. If mders are not
complied, SBCC/J])LC may 1rake suitahle measlll'es at the
expenses of~ _person who is n:spnns~ lo caw of im-
mediate ~ to prevent any dam~, SBCC and
DLC cm tale !im•itahle measures and the ~ in-
curred \ri.lill be recovered frum die peman res1x1mibR.
Variou :oo1Jii6ca.t ioos bwe also i'SSlaed 11 ndK Rwes. 1989

Seed his- .. _ . ,..

from time to tbn-e to ~ iSS1JeS S1lf:h as empo\Ne.r iog
-~11.3,ir:IJmries notified uo~
Seed .Art ,nvl,er ~ (~ o ) AdJ 1986~
exempting eertaio ca:regpries of reamib:imm pham:mc:ent-
iclll products. GM. food •i~ iogrifdienrs in mod m,li:~
and additives Imm the punriew of Rules. 1919..

Odl8 rl!Jevant IIIH!ii and pdPl!i

[n addiwin to Rnlrs.. l 98 Olhn AdE aid Rules. also
1~

refer to Bpecilic ~ lpmdncl:5 mmmhing GMOs [2)a

These ioclude Plant Quarantime Order. 200l~ Biological
Diveffi.ty A.ct, 2002 and food Sa&!J and St.an-cmds .~
2006. Tah'.le 2 ~ relevatd: Aro/Rules regnlatlog
GMOs in .klrliiL
Risk Asses.<ment or Gffletic:ally Engi"""""1 Plants: A To date. Bt cotton is the only GE plant approved for
Guide foe Stalreholders and Risk An2lysis fr.untowork, commercial cultn-ation in India.
2016 (8). The Risk Analysis Framt'WOrk is hosed oo the In addition to the above. research involving GM micro•
problem formulation approach. Coocrpt and principles of organisms fur heaJtllare and iJ>dustrial application under
Risk Assessmen~ Risk Managanent and Risk Communic>• conlllined conditions is underway in several organizations.
lion have been explairu!d in the Risk Analysis Framewod<. lodian companies an, actively involved in products of
Guidelines foe ERA or GE plants t,a..., beeo prepared in similar biologics (also refared as biosimilars).

Biosafoty, to which India is a signatory. 11<

oonsonance with Annex ID to the C:utagena Protocol on Regarding research in GE insects, limiied efforts have
been made by an Indian company for taking forward
from technology from male sterile mosquitoes developed
by Oxitec. The company bas completed mating compati•
Status of researdii and commercialiution al GMOs in bility experiments with Indian strains and set up fucil•
India ities for coolllined ttials.
India has a very rich and innovative R&D pipeline, 1lS Development or GE silkworms is being actively pur•
evident from the fuct that tlw,re are more than 500 active sued and field trials have been undertaken. All these ap•
IBSCs in the country. Sever.,! public and private sector plications are being dealt with on a case by case basis
institutions are involved in the rese;u-ch and develop- and no separate guidelines bav,, been issued so far by
ment or GE plants in India. In one or the sur,eys COO• the regulators.
ducted by MoEFCC in 2014 under the Phase D Capacity
Building Project on Biosafety, over 85 different plant Regulmon of genome ,uginl!l!ring Tl!chnologil!S in India
species were identified as currently being used in expert• RA,rognis:ing the global advances in the area of genome
mental work, in.eluding plants used for food, U-ock engineering technologies and huge potential for practical
reed, fiber fuel and dietary or medicinal purposes (9). A applications in healthcare and agriculture, initiatives have
comprehensive list of all of the aop species idcnlilied by hem lllm1 in India by leading researdl institutions. In
respondents in tine survey is placed in Table 3. :2014. DBT bas coostituted a dedicated Task For
Out or the above, more than 20 plants with varying "Genome Enginttring T ecbnologjes and their A ppli
traits such as hybrid seed production, insect resistance, with a vision to foster innovation and promote
herbicide toleraace, abiotic stress tolerance, nunitional opment of Genome-wide Analysis and Engi
enhancement. etc. are under various stages of field trials Technologies to make them accessible and affordable for
(10). A list or GE plants for which confined field trials wider use in life sciences. It is proposed to strengthen
have been approved in the past 4 years is placed below facilities oo emerging technologies such as gene editing
Table 4. and suooort research omiects. Effons are al1so underu-av
to develop human resource to atch up with the growth in BiotedUlology Regulatory Au1hocity of India in 2013. How•
this are• •nd harness the 1,.,ne6ts of thole !«hnologies for .--..; the bill was lapood and further action on the same Is
t.ulc or •pplled use In larger conwct and dri,.., ....earch •waked.
for technology development towards basic and applied use. In view of the present definition, it is expected that
Reg,mling regulation of genome engineering technolo- regulatory considerations for new and emerging tech ..
gles, there Is sdU • dcb•te In the country, l11C definition of nologles will t,., on a cue by cue bas is based on the
GE technology •• In Rul<s, 1989 Is very brood hued and existing regulatory framework i.e. Rules. 1989 In the
include "modificalion. deletion or removal ol paru of her· near fuwre.
itable matecial". This implies that all nc,w technologjes will
t,., subject to r,gulation under provision of Rules, 1989. Adu< 1 f; •••Cl
l'h,\ wo,l 11, (W1 ol ,1 i,prc.1,11 n1.u~ Ol lhl~ joum.sl produced•~ !M'1 ol h
~ MOoed 'fn\'\.JOnmerttal Re-IN~ of Eng.-wred Peil~ Bu!ldlng 11n
Conclusions lntcmou:llf\ol Co.-emarci!' Fran·~•i\~:nk.' honed a,; North Carolru State
As India i.< a sign,atory to Cartagt,m PrOOXDI on Biosiai,ty, UM--m.ty on OcmbN 5-6, 2016 an::I organized by die Gerieac Engineering &
5ooecy Centi!'! Md CSIRO. The worluhop ac;.ie-nda ard presenl.ition ~ei
the deftnltion of modem biotechnology as in the Procoool f10ff'I thP tnr'Mr,g C,10 bf b.,'ld Al h Up-,,//rNNICll-nCMJ r r1u/Qt'w'ftl!,('1WCh l
was proposed to t,., adopted In the Bill lor .....ing up of PCfL"'(.Ulcr«.d~t~tng/.