Indian Regulatory Update: January-December 2017.

This document provides updates in regulatory requirements regarding conduct of clinical trials in India.

PROPOSAL FOR MAKING SEPARATE RULES FOR NEW DRUGS AND CLINICAL TRIALS AGREED IN DRUGS' TECHNICAL ADVISORY BOARD MEETING

Minutes of the 75th meeting of Drugs Technical Advisory Board (DTAB)[1] held on January 3, 2017, at DGHS Nirman Bhawan, New Delhi, are uploaded on Central Drugs' Standard Control Organization (CDSCO) website

In agenda no. 6, there is consideration of the proposal for making separate rules under the Drugs and Cosmetic Act, 1940, for new drugs and clinical trials including stem cell and cell-based products

DTAB further recommended that earlier decisions taken by DTAB in respect of clinical trials should be expedited for notification.

GOOD CLINICAL PRACTICES INSPECTION CHECKLIST

CDSCO office in January 2017 has issued Good Clinical Practices inspection checklist.[2]

This 10-page checklist contains sections such as General, Legal and Administrative aspects, Organization and Personnel, Conduct of Trial, Sponsor, Investigational Product, Ethics Committee, Pathology Laboratory, Quality Assurance, Record Keeping, and Data Handling.

HANDBOOK FOR APPLICANTS AND REVIEWERS OF CLINICAL TRIALS OF NEW DRUGS

CDSCO in collaboration with Indian Council of Medical Research (ICMR) has released this handbook[3] in January 2017

Toward capacity building for regulatory submissions and review, ICMR and CDSCO jointly set up an Expert Group for preparation of a handbook as guidance for applicants and reviewers

This handbook is developed to increase efficiency and quality of review and highlights regulatory, administrative, and scientific review processes that should be followed by applicant and reviewers if new drugs/clinical trials

The handbook has emphasized the critical elements of pharmaceutical, preclinical, toxicological, clinical, and prescribing information data to be submitted. It focuses on evaluation of the application for risk vis-a-vis benefit, innovation vis-a-vis existing therapies, unmet medical need, ethical aspects of patient safety, and India-specific concerns.

MEDICAL DEVICES RULES 2017-GSR 78 (E) RELEASED

Medical devices Rules 2017[4] has been released in the form of G. S. R. 78 (E) dated January 31, 2017

Chapter VII of the said rules describes a clinical investigation of medical device and clinical performance evaluation of new in vitro diagnostic medical device. The seventh schedule has listed requirements for permission to import or manufacture investigational medical device for conducting a clinical investigation.

VALIDITY OF LICENSE TO IMPORT STUDY DRUGS EXTENDED FROM 1 TO 3 YEARS-GSR 103 (E) RELEASED

DRAFT of 4th amendment to Drugs and Cosmetic (D and C) Rules as per G. S. R. 103 (E)[5] has been released dated February 2, 2017

This Gazette extends the validity of license to import study drugs from earlier 1 year to 3 years.

AMENDED DRUGS AND COSMETIC ACT AND RULES RELEASED

In February 2017, a revised version of The Drugs and Cosmetic Act and Rules[6] is released by CDSCO. This version is amended to incorporate all updates up to December 31, 2016

This revision is useful as a reference document of all recent regulatory updates.

BIOPHARMACEUTICAL CLASSIFICATION SYSTEM ISSUED - G. S. R. 327 (E) RELEASED

9th Amendment to Drugs and Cosmetic Rules has been released in the form of G. S. R. 327 (E)[7] dated April 3, 2017, which included “Biopharmaceutical classification system”

The Ministry of Health had earlier issued G. S. R. 102 (E) dated February 2, 2017, containing a draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945, inviting comments/suggestions within 45 days from the date on which the notifications are made available to the public. It was explained that “biopharmaceutical classification system” means a system used to classify drugs on the basis of solubility and permeability, classified as category I – high solubility and high permeability, category II – low solubility and high permeability, category III –high solubility and low permeability, and category IV – low solubility and low permeability”

Different clauses in Rules 74, 74 (B), 76, 78, 78 (A) are revised in the said G. S. R. 327 (E) released on April 3, 2017.

3-TIER REVIEW PROCESS SIMPLIFIED

Minutes of the 34th meeting of the APEX committee held on June 2, 2017, are published on CDSCO website[8]

In this meeting, UNDER ITEM NO. 2, it was decided that proposals relating to Global Clinical Trials (GCTs) should be placed before the Subject Expert Committee (SEC) and where these are accepted/rejected by the SEC, no further approval of Technical Committee or Apex Committee will be required

It was clarified that cases where Drug Controller General of India office is not in agreement with the recommendations of SECs, the proposal may be placed before the Technical Committee for a final decision within a month of the recommendation of the SEC

It was further clarified that, in case, an applicant has grievances in cases of rejections by the SEC, such proposals may also be placed before the technical committee for consideration, and the decision of the technical committee will be considered final

This decision of simplification of the 3-tier review process is expected to establish the predictability of review/approval timelines for GCTs.

THREE IMPORTANT GUIDELINES PUBLISHED BY INDIAN COUNCIL OF MEDICAL RESEARCH

ICMR in October 2017 has published three guidelines[91011] on their website which are as mentioned below

National Ethical Guidelines for Biomedical and Health Research Involving Human Participants

National Ethical Guidelines for Biomedical Research Involving Children

National Guidelines for Stem Cell Research

These guidelines are very useful reference documents for biomedical and stem cell research and are expected to be widely referred toward achieving high quality of conduct of ethical clinical research in India. They can be accessed at the following URL, respectively

http://www.icmr.nic.in/guidelines/ICMR_Ethical_Guidelines_2017.pdf

http://icmr.nic.in/guidelines/National_Ethical_Guidelines_for_BioMedical_Research_Involving_Children.pdf

http://icmr.nic.in/guidelines/Guidelines_for_stem_cell_research_2017.pdf

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Conflicts of interest

There are no conflicts of interest.