Ethics Committee Registration Services India

As per New Drug and Clinical Trial Rules, 2019, whoever intends to conduct clinical trial or bioavailability study or bioequivalence study shall be required to have approval of an Ethics Committee for clinical trial. The Ethics Committee selected for this purpose shall be registered under Rule 8 of the New Drug and Clinical Trial Rules, 2019.

Constitution of Ethics Committee: The Ethics Committee shall have a minimum of seven members from medical, non-medical, scientific and non-scientific areas with at least:

(i) one lay person;

(ii) one woman member;

(iii) one legal expert;

(iv) one independent member from any other related field such as social scientist or representative of non-governmental voluntary agency or philosopher or ethicist or theologian.

The Ethics Committee shall consist of at least fifty percent of its members who are not affiliated with the institute or organization in which such committee is constituted. One member of the Ethics Committee who is not affiliated with the institute or organization shall be the Chairperson, and shall be appointed by such institute or organisation.

One member who is affiliated with the institute or organization shall be appointed as Member Secretary of the Ethics Committee by such Institute or organization. The committee shall include at least one member whose primary area of interest or specialisation is non-scientific and at least one member who is independent of the institution. The members of the Ethics Committee shall follow the provisions of new drug and clinical trial rules, Good Clinical Practices Guidelines and other regulatory requirements to safeguard the rights, safety and well-being of trial subjects.

The members representing medical scientists and clinicians shall possess at least post graduate qualification in their respective area of specialisation, adequate experience in the respective fields and requisite knowledge and clarity about their role and responsibility as committee members.

Functions of Ethics Committee:

Review and accord approval to a clinical trial, bioavailability or bioequivalence study protocol and other related documents, as the case may be, and oversee the conduct of clinical trial to safeguard the rights, safety and wellbeing of trial subjects;
Make at appropriate intervals, an ongoing review of the clinical trials for which it has accorded approval;
Indicate the reasons that weighed with it while rejecting or asking for a change or notification in the protocol in writing;
where any serious adverse event occurs to a trial subject or to study subject during clinical trial or bioavailability or bioequivalence study, the Ethics Committee shall analyse the relevant documents pertaining to such event and forward its report to the Regulatory Authority and comply with the other applicable legal provisions;
where at any stage of a clinical trial, it comes to a conclusion that the trial is likely to compromise the right, safety or well-being of the trial subject, the committee may order discontinuation or suspension of the clinical trial and the same shall be intimated to the head of the institution conducting clinical trial and the Regulatory Authority;

As per law, each of the ethics committee has to be registered with CDSCO.

API First is a team of regulatory experts who are well versed with the nuances of the regulatory filing and subsequent approval processes of drugs in India as well as other regulatory countries. The team of experts have a vast experience with the drug approval process in India.