REGULATORY UPDATE

Year : 2018  |  Volume : 9  |  Issue : 1  |  Page : 48-50

Indian regulatory update: January-December 2017

Amita Bhave
Department of Regulatory Affairs, Global Drug Development India, Novartis India Limited, Mumbai, Maharashtra, India

Correspondence Address:
Ms. Amita Bhave
Novartis India Limited, Sandoz House, 5th Floor, Shivsagar Estate, Dr. Annie Besant Road, Worli, Mumbai - 400 018, Maharashtra
India

Source of Support: None, Conflict of Interest: None

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DOI: 10.4103/picr.PICR_176_17

Abstract

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

Keywords: Amendments, CDSCO, D and C Rules, gazettes, ICMR, revision, updates

Proposal for Making Separate Rules for New Drugs and Clinical Trials Agreed in Drugs' Technical Advisory Board Meeting

• Minutes of the 75^th 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 4^th 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

• 9^th 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 34^th 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

1. National Ethical Guidelines for Biomedical and Health Research Involving Human Participants
2. National Ethical Guidelines for Biomedical Research Involving Children
3. National Guidelines for Stem Cell Research

• 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

References

1.	Minutes of the 75th Meeting of Drugs Technical Advisory Board (DTAB) Dated 03rd January, 2017. Available from: http://www.cdsco.nic.in/writereaddata/Minutes%20of%2075t h%20DTAB%20held%20on%2003_01_2017.pdf. [Last accessed on 2018 Jan 12].
2.	GCP Inspection Checklist; January, 2017. Available from: http://www.cdsco.nic.in/writereaddata/GCPInspChecklist16.pdf. [Last accessed on 2018 Jan 12].
3.	“Handbook for Applicants and Reviewers of Clinical Trials of New Drugs in India”. Issued by ICMR and CDSCO in January, 2017. Available from: http://www.cdsco.nic.in/writereaddata/Scan1.pdf. [Last accessed on 2018 Jan 12].
4.	The Gazette of India, New Delhi: Ministry of Health and Family Welfare. Notification, 31-Janurary, 2017. G.S.R. 78 (E). Available from: http://www.cdsco.nic.in/writereaddata/Medical%20Device%20Rule%20gsr78E.pdf. [Last accessed on 2018 Jan 12].
5.	The Gazette of India, New Delhi: Ministry of Health and Family Welfare. Notification, 02-February, 2017. G.S.R. 103 (E). Available from: http://www.cdsco.nic.in/writereaddata/Charitable%20Drugs%20&%20Test%20Licence%20Extension_103E_02-Feb-2017.pdf. [Last accessed on 2018 Jan 12].
6.	Ministry of Health and Family Welfare. The Drugs and Cosmetic Act and Rules, as Amended Upto 31-December, 2016. Available from: http://www.cdsco.nic.in/writereaddata/2016Drugs%20and%20Cosmetics%20Act%201940%20 and %20Rules%201945.pdf. [Last accessed on 2018 Jan 12].
7.	The Gazette of India, New Delhi: Ministry of Health and Family Welfare. Notification, 03-April, 2017. G.S.R.327 (E). Available from: http://www.cdsco.nic.in/writereaddata/GSR%20327(E)%20Dated%2003_04_2017.pdf. [Last accessed on 2018 Jan 12].
8.	Minutes of 34th Apex Committee Meeting Held on 02-June-2017. Available from: http://www.cdsco.nic.in/writereaddata/Minutes%20of%2034th%20Apex%20Committee%202%20june%202017%20.pdf. [Last accessed on 2018 Jan 12].
9.	National Ethical Guidelines for Biomedical and Health Research Involving Human Participants. Available from: http://www.icmr.nic.in/guidelines/ICMR_Ethical_Guidelines_2017.pdf. [Last accessed on 2018 Jan 12].
10.	National Ethical Guidelines for Biomedical Research Involving Children. Available from: http://www.icmr.nic.in/guidelines/National_Ethical_Guidelines_for_BioMedical_Research_Involving_Children.pdf. [Last accessed on 2018 Jan 12].
11.	National Guidelines for Stem Cell Research. Available from: http://www.icmr.nic.in/guidelines/Guidelines_for_stem_cell_research_2017.pdf. [Last accessed on 2018 Jan 12].

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