THE DIFFERENCE B/W INDIAN GCP AND ICH -GCP

In general, Indian GCP guidelines are in line with ICH-GCP. However, there are significant differences in some of the areas, which will make the task of compliance difficult for the sponsors, investigators and ethics committees. Investigator qualifications The Indian GCP (3.3.1) insists that the investigator should be qualified as per the requirement of the Medical Council of India (MCI). This means that non-medical scientists e.g. pharmacists who organise the bio-equivalence studies, cannot become investigators. Even in the medical field, several eminent investigators have medical degrees from UK or US, which are not prescribed by MCI. The qualifications of some of the senior investigators were not recognised as the medical institutions from where these investigators studied were not approved by MCI at that time. Implementation of this provision will require the monitors and auditors to ask the investigators for proof that their qualifications are in line with MCI. This provision can become a major hurdle for sponsors in selecting investigators and needs to be modified in line with ICH-GCP. Investigator and sponsor¶s SOPs The Indian guideline (3.1.3) mandates that the sponsor and the investigator should sign a copy of the Standard Operating Procedures (SOPs). Besides, the investigator and his staff have to be aware and comply with SOPs. This provision is practically impossible, as the sponsor will have to obtain signatures of all investigators in a trial on its large number of SOPs. Imagine the task of making multiple copies of hundreds of SOPs, delivering them to investigators, and obtaining their signatures! Besides, SOPs also get revised periodically and the whole cycle have to be repeated. ICH-GCP expects the investigator to comply with the protocol and leaves the task of monitoring compliance to SOPs to monitors and auditors. Investigators responsibility for data analysis As per ICH-GCP, when the trial is completed, the investigator has to provide the Independent Ethics Committee (IEC) with a summary of the outcome of trial.

as the sponsor has to provide regular feedback and interim analysis of trial data on efficacy and safety to IDMC. results and interpretations. The sponsor may consider establishing an IDMC to assess the progress of a clinical trial. This provision will increase IECs¶ troubles.6). The goal of these local trials is to confirm whether the Indian safety and efficacy results are in line with the international clinical trial data. as they will have to create space for bulky CRFs and the clinical trial reports. analyses and reports of the study from his/her centre to the sponsor and the ethics committee. are already struggling to cope with large number of bulky documents submitted for their approval. these two provisions are likely to create a conflict of responsibilities between IEC and IDMC! This provision also could become a nightmare for regulatory authorities. For most global trials. Powers of IEC According to Indian GCP (2.5). Hence.1. The IECs of major institutes. as there is scope for misuse of this provision by sponsors of local Schedule Y open registration trial. this provision makes it a responsibility of the investigator. he can submit this data to IEC to request them to stop the trial and later present the IEC recommendation to the regulatory authorities for obtaining registration. suspected fraud. increasing his burden. Usually data analysis is the function of the sponsor. they are reviewed by IDMC. the IEC has power to order discontinuation of a trial if the IEC finds that the goals of the trial have already been achieved mid-way or unequivocal results obtained. essential documents for IEC files are listed. This means the sponsor and the investigator have to provide additional copies of most documents to IEC and also ensure that . which are involved in several international trials. If a sponsor finds that the results are comparable to international data in initial 25-30 patients. As Indian centres are part of global trials. and to recommend the sponsor whether to continue. or stop a trial. IDMC is also recommended in Indian GCP (3. the sponsor establishes an IDMC in a western country.In contrast.g. Essential documents for IEC In the appendix V. However. As per ICH-GCP. This is possible. The CRFs are never sent to IEC unless the IEC asks for them for some specific purpose e. This means that Indian IECs at different sites will not be involved in this process and cannot fulfill this requirement of Indian GCP. Indian GCP demands that the investigator should sign and forward the data like Case Report Forms (CRF). modify. including the safety data and the critical efficacy endpoints at intervals.4.2. this is the responsibility of independent data-monitoring committee (IDMC).

4. as the sponsor does not have direct access to IEC documents.7). Indian GCP mandates that when a subject is withdrawn from research for medical reasons related to the study.g.4. which are as follows: Free treatment for research related injury by the investigator/ institution Compensation of subjects for disability or death resulting from such injury In addition. institution) should agree to provide compensation for any serious physical or mental injury or to provide insurance coverage Research subjects who suffer physical injury in a trial are entitled to financial/other assistance . However. etc) at any time during the conduct of the research Foreseeable extent of information on possible current and future uses of the biological material and of the data to be generated from the research and if the material is likely to be used for secondary purposes or would be shared with others.5 and 2. there is a whole section on compensation related issues (2. it could lead to issues in a clinical trial of a chronic disease in patients.4. clear mention of the same Risk of discovery of biologically sensitive information These items will make the consent form more complex to explain to the subject and may discourage him from participating in the research. bio-equivalence study. such a patient can cite this provision and insist on regular follow up and free investigations assured for the trial for the whole duration of trial! The other provisions for compensation are prescriptive: The sponsor (company.3. the subject should get the benefit for full participation. The consent has to include: Right to prevent use of his/her biological sample (DNA. adverse event. Essential items for informed consent Besides the essential items for informed consent listed in ICH-GCP.they are filed. Indian guidelines (2. While this provision seems appropriate for studies in healthy volunteers e. cell-line. If he is withdrawn because of a medical reason e.2) also cover issues of biological samples. there are also mandatory clauses on compensation. A cancer patient taking part in a long trial of a new product is assured of regular follow up and costly investigations. government. he receives free medical treatment for the event but does not receive any other benefit.g. Compensation In the essential items for consent. It will bedifficult for the monitor and the auditor to check compliance to this provision.

1. they would not have adequate medical experience and hence will not qualify as monitors! Monitor¶s responsibilities Monitor is supposed to inform the sponsor and IEC in case any unwarranted deviation from protocol or any transgression from principles of GCP.2) suggest that the monitor should have adequate medical. are an attempt to protect Indian patients.to compensate them equitably for any temporary or permanent impairment or disability subject to confirmation from IEC. their dependents are entitled to material compensation These provisions. the records will not be available. It does not include verification of informed consent. as in the case of ICH-GCP. It is desirable. Drug label In the section on protocol (2. In cases of death.6). to link the records to marketing approval. This will lead to practical difficulties in global trials where the labels are uniform with minor changes made if required by local laws and practice. As per ICH-GCP monitor has to verify that the documents provided by the investigator are legible. As most monitors are pharmacists or science graduates.5) mandates that the sponsor should make arrangements for safe and secure custody of all study related documents and material for a period of three years after the completion of the study or submission of the data to the regulatory authority (ies) whichever is later. Document retention Indian GCP (3. who are often illiterate and from lower socio economic class. Monitor¶s Qualifications Indian GCP guidelines (3. it is mentioned that drug label should include name and contact numbers of investigator and name ofinstitution. There is a glaring omission in the functions of the monitor. Monitor is also responsible for ensuring that CRFs are legible.3. This is not a global practice.1. pharmaceutical and/or scientific experience. probably. If the company does not get marketing approval within 3 years of completion of trial and if there is a need for regulator inspection after marketing approval. The monitor is not in contact with IEC and hence this requirement cannot be fulfilled. .

results and interpretations. this is the responsibility of independent data-monitoring committee (IDMC). Investigators responsibility for data analysis: As per ICH-GCP.8. EC Quorum: ICH GCP min of 5 members and Indian GCP min of 7 members. In IEC section. Powers of IEC: According to Indian GCP (2. the IEC has power to order discontinuation of a trial if the IEC finds that the goals of the trial have already been achieved mid-way or unequivocal results obtained. 7. In Informed Consent Process. As per Indian GCP.3. ICH-GCP expects the investigator to comply with the protocol. when the trial is completed. Besides. the investigator and his staff have to be aware and comply with SOPs. 8. where ICH-GCP state that Monitor has to verify that the documents provided by the investigator are legible 4. Indian GCP recommended the maximum no. (Section 2.5) but in ICH-GCP the records are linked to marketing approval. Investigator qualifications: The Indian GCP investigator should be qualified as per the requirement of the Medical Council of India (MCI).Difference Between Indian GCP & ICH-GCP 1. Investigator and sponsor s Sops: The Indian guideline mandates that the sponsor and the investigator should sign a copy of the Standard Operating Procedures (SOPs). (Section 4. 3.4. 2. analyses and reports of the study from his/her centre to the sponsor and the ethics committee. Study related documents/materials should be safe guarded by the sponsor for 3 years. Indian GCP demands that the investigator should sign and forward the data like Case Report Forms (CRF). (Section 3.2.8) but in Indian GCP Investigator should sign the form. As per ICH .GCP Not recommended. 5. the investigator has to provide the Independent Ethics Committee (IEC) with a summary of the outcome of trial. of IEC member (12-15) but ICH-GCP Maximum number is not detailed. In IEC section.GCP any one designated by the investigator to conduct and to sign the consent form.1. In contrast. 6.4. Indian GCP recommended that Member Secretary belongs to the same Institution but ICH.1). As per ICH-GCP. As per Indian GCP Monitor is also responsible for ensuring that CRFs are legible. 10. EC Members: Indian GCP gender representation at least 1 women . 9.6).