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REGULATORY UPDATES
Year : 2018  |  Volume : 9  |  Issue : 3  |  Page : 149-150

Indian regulatory update: January – March 2018


Head Regulatory Affairs, Global Drug Development India, Novartis India Limited, Mumbai, Maharashtra, India

Date of Web Publication12-Jul-2018

Correspondence Address:
Amita Bhave
Novartis India Limited, Sandoz House, 5th Floor, Shivsagar Estate, Dr Annie Besant Road, Worli, Mumbai - 400 018, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/picr.PICR_50_18

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How to cite this article:
Bhave A. Indian regulatory update: January – March 2018. Perspect Clin Res 2018;9:149-50

How to cite this URL:
Bhave A. Indian regulatory update: January – March 2018. Perspect Clin Res [serial online] 2018 [cited 2019 Oct 15];9:149-50. Available from: http://www.picronline.org/text.asp?2018/9/3/149/236482


   Introduction Top


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



   Notice Regarding Applications of R-Dna Derived Products to Be Submitted on Sugam Top


  • A notice [1] was issued by Central Drugs Standard Control Organization (CDSCO) dated January 15, 2018 regarding SUGAM
  • Vide this notice, applicants were notified that applications pertaining to clinical trials, marketing authorizations, registration certificate, and import license for r-DNA derived drugs will only be accepted through online SUGAM portal effective February 1, 2018. It was further clarified that no offline applications will be accepted thereafter.



   Office Memorandum-List of Clinical Trials to be Inspected in 2018 Top


  • CDSCO has issued an office memorandum dated January 17, 2018[2] wherein a tentative central inspection plan for 2018 for inspections of clinical trial permitted with reference to r-DNA products has been prepared as a process of clinical trial oversight
  • Clinical trial inspections, of 27 listed trials, will be conducted by a team comprising of the team trained in good clinical practices, along with subject expert and an officer from CDSCO-HQ, drug inspectors from respective states may also join the inspection team.



   Amended Drugs and Cosmetic Draft Rules– Gsr 104(E) Released Top


  • The draft amendment of drugs and cosmetic rules as per GSR 104(E) has been released [3] dated February 1, 2018. Objections and suggestions if received from any stakeholders within specified period of 45 days from the release date will be considered by the central government
  • Amended rules contain 12 chapters and 8 schedules
  • Newer aspects introduced in amended rules include a definition of orphan drug, posttrial access, and accelerated approval process. The validity of clinical trial permission is limited to 2 years
  • Further, there is a change in fee structure for all applications including clinical trial applications. Provision for formal presubmission and post–post submission meetings with CDSCO has been included, and a written response is expected
  • Timelines for permission to conduct a clinical trial of a new drug already approved outside India have been specified as 90 days
  • There are changes with respect to rules for compensation and medical management as compared to existing rules. A further new aspect of interim compensation has been included in this revised draft.



   Office Orders-Observance of Grievance Redressal/pendence Disposal Week Top


  • To address the grievances received from stakeholders, CDSCO had issued an office order [4] dated February 1, 2018 announcing the week of February 5, 2018–February 9, 2018, as grievances redressal/pendency disposal week in CDSCO (HQ)/Zonal offices
  • To address the grievances/dispose of pending issues, senior officers at HQ and in Zonal offices were to be available in second half of the day during that week
  • A division-wise and zone-wise report on the status of grievances was to be submitted to the office of Drugs Controller General of India (DCGI) by February 12, 2018
  • This order was further followed by another office order dated February 13, 2018.[5] Vide this notice; all stakeholders were informed that public hearings are held every day in CDSCO office. Further DCG(I) conducts fortnightly hearings to address grievances of all stakeholders. In case of grievances still not redressed, stakeholders were requested to approach the concerned DDC(I)/JDC(I) or secretariat of DCG(I) for early redressal.



   Office Order Regarding Setting up of Public Relation Office at Cdsco (Hq) Top


  • An office order [6] was issued dated March 7, 2018 by CDSCO announcing setting up of Public Relation Office at CDSCO FDA Bhawan, New Delhi functioning from 10 am to 5 pm on all working days
  • This office shall act as “Single Window” for disposal of grievances of stakeholders and is expected to provide information to innovators regarding regulatory requirements and provide clarifications pertaining to Drugs and Cosmetic Act 1940 and Rules thereafter. The office will also guide investors in various business phases as per the current focus on “Invest India/Make in India.”
  • Stakeholders visiting Public Relation Office will not require any prior appointment. PRO will seek requisite information from various CDSCO officials viz-DDC(I)/ADC(I) of all divisions of CDSCO HQ as needed.


Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
   References Top

1.
Notice issued by CDSCO (X- 11026/08/2018-BD); 15 January, 2018.   Back to cited text no. 1
    
2.
Office Memorandum issued by CDSCO (F no. QA/02/Central Inspection Plan/CT/rDNA/2018); 17 January, 2018. Available from: http://www.cdsco.nic.in/writereaddata/rDNA%20CT.pdf. [Last accessed on 2018 Apr 02].  Back to cited text no. 2
    
3.
The Gazette of India. New Delhi: Ministry of Health and Family Welfare; 01 February, 2018. G.S.R. 104(E). Available from: http://www.cdsco.nic.in/writereaddata/GSR%20104(E)%20dated%2001_02_2018_New%20Drugs%20 and %20CLinical%20Trial%20Rules,%202018.pdf. [Last. [Last accessed on 2018 Apr 02].  Back to cited text no. 3
    
4.
Office Order Issued by CDSCO dated (No D.21013/75/2017-DC); 01 February, 2018. Available from: http://www.cdsco.nic.in/writereaddata/office%20order2_1_2018.pdf. [Last accessed on 2018 Apr 02].  Back to cited text no. 4
    
5.
Office Order Issued by CDSCO (No D.21013/75/2017-DC); 13 February, 2018. Available from: http://www.cdsco.nic.in/writereaddata/NOTICEdated13_2_18.pdf. [Last accessed on 2018 Apr 02].  Back to cited text no. 5
    
6.
Office Order Issued by CDSCO (No. A.32029/01/2018-D); 07 March, 2018. Available from: http://www.cdsco.nic.in/writereaddata/order7_3_2018.pdf. [Last accessed on 2018 Apr 02].  Back to cited text no. 6
    




 

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   Introduction
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