SCHEDULE Y : Download CDSCO Ammendment

See Schedule Y Presentation

Schedule Y was introduced under the Drugs and Cosmetics Act (1940-1988 -> amended 2005) to introduce requirements for countries to get permission for 1) importing 2) making new drugs 3) conducting clinical trials. Primarily in India due to large patient pool and large biopharma marketshare.

Schedule Y:

1) Depends on status of drug in country of ORIGIN

a) Approved Drugs -> Phase III

b) Not Approved Drugs -> 1 Phase earlier than current phase

c) Newly Discovered Drugs -> Safety data before trial

d) Drug of special relevance -> Trial possible

Potential of clinical research for new therapies -> added Schedule Y to the Drug and Cosmetics Rules of 1945 -> guidelines and requirements for clinical trials.

Schedule Y written with “generics industry in mind” -> lots of trials -> 2005 CDSCO revisions

1. Definitions for Phase I-IV trials, which eliminated the Phase lag.

2. Clear responsibilities for investigators; and sponsors.

3. Requirements for notifying changes in protocol.

4. Decrease the review time of application from 16 -> 10 weeks

Category A (received Approval in the U.S., Britain, Canada, Germany, South Africa, Switzerland, Australia, Japan and countries in the European Medicines Agency (EMEA)) = 2-4 week approval fast tracking in India

Category B -> 12 weeks

FYI: Nearly all global trials are in the Category A

ICH GCP

Good Clinical Practice (GCP) is an international standard set for conducting, inventing, recording, and reporting clinical trials which may involve humans as participants. It's very important to obey this standard as it offers the public the confidence that the trial subjects' rights, safety, and well-being are protected, and that data in clinical trials are plausible.

The target of the ICH GCP (International Conference on Harmonization of Good Clinical Practice) is to offer a uniform standard for U.S., European Union, and Japan to facilitate the adoption of clinical data by regulatory authorities of the stated jurisdictions. The guidelines must be followed when information from clinical trials must be submitted to regulatory authorities.

The Indian version of GCP relies on the ICH-GCP, however there are crucial differences between the two. A few of the guidelines utilized at the Indian variant lead to the tricky methodology that becomes overwhelming for sponsors and investigators.

The Indian principles state that the copy for the SOPs have to be signed by both the investigator and the sponsor.

The investigator, together with his research team, should comply with the SOPs. This could not be possible as it will grow to be a huge burden for patrons to get the SOPs signed with all the investigators of this trial. The full procedure of keeping several SOPs and making alterations are complicated enough.

The role of the investigator in data evaluation, as stated by the ICH-GCP, will be to submit a recap of this trial and its outcomes to the Sponsor and its Ethics Committee, although the Indian GCP mentions that the investigator or the institution ought to analyze the data, create a study report, and submit it to the Sponsor and Ethics Committee. Additionally, this will result in various study reports for various sites of a similar study.