2. What is ICH :
• The International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use (ICH) is an
initiative that brings together regulatory authorities and
pharmaceutical industry to discuss scientific and technical
aspects of pharmaceutical product development and
• US, Europe and Japan formed the International Council for
Harmonization in 1990 with Canada, Australia, and the Nordic
countries as contributors, the WHO as the facilitator, and the
International Federation of Pharmaceutical Manufacturers'
Associations (IFPMA) provided the secretariat.
• The ICH guidelines were finalized in 1996.
3. What is GCP :
• Good clinical practice (GCP) is an international quality
standard that is provided by ICH (international body) that
defines standards, which governments can transpose into
regulations for clinical trials involving human subjects.
• GCP enforces tight guidelines on ethical aspects of a
clinical study and aims to ensure that the studies are
scientifically authentic and the clinical properties of the
investigational product are properly documented.
4. Role Of ICH-GCP:
• GCP enforces tight guidelines on ethical aspects of a clinical study and
aims to ensure that the studies are scientifically authentic and the
clinical properties of the investigational product are properly
• High standards are required throughout the study such as in
documentation like for the clinical protocol, record keeping, training,
and facilities, including computers, hardware and software.
• Quality Assurance (QA) and inspections ensure that these standards are
• GCP guidelines standards for conducting clinical trials, defines the roles
& responsibilities of clinical trial sponsors, clinical research investigators,
5. ICH topics are divided into four categories:
• Quality (Q) guidelines: Harmonisation
achievements in the Quality area include
important areas like the conduct of stability
studies, defining relevant thresholds for impurities
testing and a more flexible approach to
pharmaceutical quality based on Good
Manufacturing Practice (GMP) risk management.
• Safety (S) guidelines: Include potential risks like
carcinogenicity, genotoxicity and reproductive
Efficacy (E) guidelines: Include the design, conduct, safety and reporting
of clinical trials. It also covers novel types of medicines derived from
biotechnological processes and the use of pharmacogenetics/genomics
techniques to produce better targeted medicines.
Multidisciplinary (M) guidelines: Topics that do not fit into the above-
mentioned guidelines are included here.
It includes the ICH medical terminology (MedDRA), the Common
Technical Document (CTD) and the development of Electronic Standards
for the Transfer of Regulatory Information (ESTRI).
In November 2005, the ICH Steering Committee adopted a new
codification system for ICH Guidelines.
The purpose of this new codification is to ensure that the numbering /
coding of ICH Guidelines is more logical, consistent and clear.
7. Indian GCP :
• Indian GCP guidelines are given by an Expert Committee set
up by Central Drugs Standard Control Organisation (CDSCO)
in consultation with clinical experts for generation of clinical
data on drugs.
• It was set in line with multiple other guidelines such as
ICH-GCP, Schedule Y and ICMR guideline.
• It was developed to ensure uniform quality of clinical
research throughout the country and to generate data for
registration for new drugs before use in the Indian
8. Differences between ICH GCP & Indian GCP:
Investigator qualifications: According to the section 3.3.1 of
Indian GCP, investigator must be qualified as per the
requirement of the Medical council of India (MCI) So
pharmacists cannot become investigator for the BA/BE
studies. Also knowledgeable investigators having medical
degree of the foreign university are not approved by Medical
council of India.
Investigator and sponsor’s SOPs: The Indian guideline (3.1.3)
put forth that the copy of the Standard Operating
Procedures (SOPs) should be signed by Investigator as well as
by Sponsor. The investigator along with his research staff has
to acknowledge and comply with the SOPs.
• Informed consent: Along with the essentials for Informed
consent mentioned by ICH-GCP, Indian version added new
headings (220.127.116.11) about biological samples (Genetic material
– DNA, RNA, etc.)
• It offers the patients the right to prevent use of such samples
collected during the trial for possible current and future
uses; considering its sharing or secondary uses is anytime
• Investigators role in data analysis: According to ICH-GCP the
Investigator has responsibility to submit a summary of trial
to Sponsor and its Ethics committee where as Indian GCP
states that Investigator/Institution should analyse the trial
data, create a study report and submit it to Sponsor and
• Monitor’s responsibilities: According to ICH-GCP monitor
should verify the legibility of documents provided by
investigator or site. It does not state any mandate to verify
the revisions of ICF (Informed Consent Form). The Indian
GCP states that its monitor’s responsibility to inform sponsor
and Ethics committee about the deviation, violations from
protocol, including ICF process or any such guidelines
• Authority of Ethics Committee: As per section 18.104.22.168 of
Indian GCP the EC has authority to stop the a trial if ethics
committee finds that the objective of the trial has been
achieved midway or unrelated results have been obtained.
According to ICH GCP it is the duty of the Independent data-