52 Modern Pharmaceuticals I January 2012

Over the last decade India

has become a hub for

clinical trials and has seen

signifi cant growth in the

clinical research market. Since there is

growing demand for clinical research

we have seen mushrooming of clinical

research organisations in India in the

recent past. “Th e industry is in a growing

phase as India has been recognised as

an attractive destination for conducting

clinical trials. For this reason, specialised

organisations providing contract services

have mushroomed in India, just as they

have in other members of the BRIC nation.

A few of these are full-service providers,

some are niche players such as IT solution

companies, central laboratories, warehouses

or site management organisations. Th ere

has also been signifi cant activity in the

M&A space among Indian CROs,” says

K V Subramaniam, President and CEO,

Reliance Life Sciences. According to

Dr Shubhangi Desai, Associate Vice

President – Clinical Operations (India &

Malaysia), Siro Clinpharm, “India has made

signifi cant advances in clinical research

and currently the country has a good

infrastructure set up of investigators, sites

and patient pool.” With the establishment

of numerous CROs, adherence to quality

assumes high importance and for the

same India introduced Good Clinical

Practices (GCP) in 2005. “Th e number of

sites conducting GCP trials has increased

signifi cantly and many have gained

experience of regulatory inspections.

Th ere are many positive changes in

regulatory framework and guidelines. Th e

health authority has established GCP

guidelines for compensation for research

participants and is initiating steps for EC

and CRO registration. Post 2005, Indian

regulatory authority amended Schedule

Y and permitted concurrent global trials

and also became signatory to GATT, ie

Patent Protection Act. Many CROs saw

this as a big opportunity as MNCs would

like to conduct concurrent global clinical

trials and also conduct trials for marketing

the products,” says Dr Desai. Th is set of

guidelines has laid down a framework for

complying with high quality for clinical

practices in India and we need to explore

how GCP is being followed currently and

what are the possible changes required.

Clinical research and qualityTh is fi eld is at an advanced stage in India

as Indian fi rms have participated in

various technical domains and have been

recognised for the quality of data they

generate in clinical trials. “Clinical research

is carried out in a regulated manner in

India. Th e country continues to be a key

participant in global clinical trials. Large

pharmaceutical companies are focusing

on BRIC nations for cost-eff ective

clinical research that delivers results

as per international quality standards,”

comments Subramaniam.

Indian GCP is written keeping India in

context and it has evolved from guidelines

of WHO, International Conference on

Harmonisation (ICH), US FDA and

Insight & Outlook: Good Clinical Practices

Driving the clinical research industryThe clinical research outsourcing market is expected to grow at a CAGR of 17 per cent during 2009-2015, according to a report by ASSOCHAM. And the Indian GCP is going to further propel this growth, if followed and adhered to judiciously.

Titash Roy Choudhury

Good Clinical Practices

53January 2012 I Modern Pharmaceuticals

European GCP guidelines as well as the

Ethical Guidelines for Biomedical Research

on Human Subjects issued by the Indian

Council of Medical Research and it is

one document which gives direction to all

companies planning to conduct clinical

research in India.

“Indian GCP is based largely on

ICH-GCP. Eff orts are being made to

customise Indian GCP in key areas such

as compensation to subjects and safety

reporting. Th is shows that the industry

and regulators are actively involved in

evolving a set of guidelines that works

for all,” says Subramaniam. And these

guidelines will help ensuring the quality

of clinical research, which is the marker

for any clinical research market. “Quality

could be a potential issue with CROs

as the demand increases. However, all

serious players understand that they

cannot disregard quality in their race to

secure contracts. Th e market tends to

have a moderating eff ect on the industry;

CROs that perform to stated quality and

customer satisfaction benchmarks tend to

have better stability and market share,”

comments Subramaniam. To maintain

quality of clinical research, adherence to

GCP is not only preferable but should be

actively pursued.

Adherence to GCP and loopholesJust setting up guidelines is not suffi cient,

the question that arises is, are CROs

following the guidelines and ensuring the

quality according to the set norms. GCP

is a scientifi c and ethical quality standard

that is applied to clinical research. “It lends

itself to both theoretical and practical

aspects of clinical research. It is designed to

facilitate use of consistent methodology

in generating, monitoring and reporting

clinical trial data, to ensure that the data is

credible, accurate and reproducible.

It is oriented to meet the demands

of not just Indian CROs but all

stakeholders in clinical trials,” says

Subramaniam. “All the good and ethical

CROs follow GCP practices religiously.

Indian GCP is a part of Schedule Y and

hence is a part of law and needs to be

strictly followed, failing which it can be

punishable,” says Dr Desai. Quality is

an ongoing continuous endeavour of all

stakeholders. “In India the DCGI offi ce

is carrying out frequent inspections of

CROs to ensure compliance with GCP.

Results of these inspections have been

made public,” says Subramaniam. “Along

with monitoring the CROs the Indian

GCP has been designed keeping trials

being run in India and strict adherence

to the same has led to improvement

in ongoing research,” comments

Dr Desai.

When it comes to any loopholes, the

industry stalwarts fail to point out any.

“Indian GCP is quite in line with ICH-

GCP, it has areas which are stricter than

ICH-GCP. It all depends on adherence

and compliance,” says Dr Desai, while

Subramaniam thinks that Indian GCP

is probably more prescriptive in areas

of ethics committee composition and

functioning, timelines for serious adverse

event reporting and process of regulatory

review of clinical trial applications than

ICH-GCP. “All clinical trials that have

been conducted as per local regulations

have also been compliant to ICH-GCP

and applicable laws. Th at is, there do not

seem to be irresolvable contradictions

between Indian GCP and any of the

other internationally accepted guidelines/

regulations that pertain to clinical research,”

says Subramaniam. In spite of pointing out

loopholes or scope for improvement, the

industry believes that the guidelines are

eff ective if strict adherence and compliance

is done. Since the concerned authorities

do give the industry an opportunity to

comment on all guidelines when they are

in the draft mode, all the loopholes are

covered during that initial checking period.

As far as Indian GCP goes, they have been

laid out keeping Indian clinical trials in

mind and the guidelines are strict and

full-proof in maintaining the quality of

the various CROs. While the market

forces are driving most of the CROs

to comply with Indian GCP. Hence,

keeping the current scenario in perspective

the Indian clinical research industry as

predicted will experience unhindered

growth and progress.

(titash.choudhury@infomedia18.in)

Since the concerned authorities do give the industry an

opportunity to comment on all guidelines when they are in the draft mode, all the loopholes are covered

during that initial checking period.

K V SubramaniamPresident & CEO, Reliance Life Sciences

Large pharma companies are focusing on BRIC nations for cost-effective clinical research that delivers results as per international quality standards.

Dr Shubhangi DesaiAssociate Vice President – Clinical Operations (India & Malaysia), Siro Clinpharm

India has made signifi cant advances in clinical research and currently the country has a good infrastructure set up of investigators, sites and patient pool.