Insight

India Champions e-Governance for Pharma Industry

  • 29th December, 2016

The national e-Governance plan (NeGP) was launched in 2006 as an initiative that the Government of India has implemented to make all the government services accessible online. It has been activated in all the government departments with a vision to transform India into a digitally empowered society and knowledge economy. In this process, numerous policy have been amended to facilitate the growth of the pharmaceutical industry in India under the Ministry of Health & Family Welfare (MoHFW). The Central Drugs Standard Control Organization (CDSCO) and Drug Controller General of India (DCGI) play a vital role in the amendment of the policies. Following are some policies that were reformed to ease pharmaceutical imports:

 

1. Import & Export of Human Biological Samples Without Prior Approvals

In August, one of the first such guidelines for Biologics were published by the Central Drugs Standard Control Organization (CDSCO). No licenses are needed prior to import or export of Human Biological Samples. A Self-certified statement needs to be sent to the Customs department stating that all rules and guidelines are being followed. The department will reply with its approval for the same and the import/export can occur seamlessly.

 

2. No Permission needed for Clinical Trials intended for Academic Purposes

  • No prior approval is required for conducting clinical trials that are intended for academic purposes.
  • This is with respect to an approved drug formulation for any new indication or new route of administration or new dosage.
  • The trial shall be approved by the Ethics Committee and the data created is not intended for submission to the licensing authority.
  • The Ethics Committee shall inform the licensing authority:
    • About the cases approved by it.
    • About cases where there could be an overlap between clinical trials for academic and regulatory purposes.
    • Where the said authority does not convey its comments to the Ethics Committee within a period of thirty days from the date of receipt of communication from the Ethics Committee.
  • Hence, it shall be presumed that no permission from the licensing authority is required.

 

3. Quality Management System for Notified Medical Devices and In-Vitro Diagnostics

As per the Gazette of India, the quality policy for notified medical devices and in-vitro diagnostics must be obliged by. The top management of the manufacturer shall:

  • Ensure that the quality objectives are met at all levels of the organization
  • Plan the quality management system in order to meet the specified requirements
  • Maintain the quality management system when changes are implemented

 

4. Requirement of 50-bedded site for Clinical Trials

In the past, there have been certain issues on the conduct of clinical trials in India. In the meetings held on 20.8.2015 and 6.10.2015, respectively under the chairmanship of Secretary, Ministry of Health and Family Welfare (MoHFW) in which experts including the Secretary, D/o Health Research & Director General, Indian Council of Medical Research (ICMR) and Director General Health Services were present. It was concluded that:

  • No clinical trials will be conducted at a hospital site of less than 50-beds.
  • The Ethics Committee shall assess the need and decide whether the clinical site is suitable for the trial or not, irrespective of the number of beds.
  • In addition, all sites where clinical trials are conducted shall have an emergency rescue and care management system along with all other necessary facilities required for that particular clinical trial.

 

5. No NOC (No Objection Certificate) required for Clinical Trials

As per a circular dispatched on 3.8.16 it was concluded that:

  • The Ethics Committee shall approve proposals for the addition of sites and investigators.
  • No NOC from the DCGI in the typical course shall be required
  • However, the applicant must inform the DCGI about any addition/deletion, If no objection was received from DCGI, it would be deemed to have the concurrence of CDSCO.

 

6. Investigator can take up more than three Clinical Trials

As per the meetings held on 20.8.2015 and 6.10.2015, respectively under the chairmanship of Secretary, Ministry of Health and Family Welfare, in which experts including the Secretary, D/o Health Research & Director General, Indian Council of Medical Research (ICMR) and Director General Health Services were present the following were decided:

  • The restriction of three clinical trials per investigator has been removed.
  • The Ethics Committee, after examining the risk and complexity involved in the trial being conducted, shall decide about how many trials an investigator should undertake.

 

7. SUGAM portal

CDSCO, in order to implement e-governance in its offices, has launched the SUGAM portal on 14.11.2015. It is intended for:

  • Filing applications for the import and registration of drugs and medical devices.
  • Now the service is being extended to the online submission of applications for the grant of NOC for BA/BE studies for export purpose.
  • Moreover, applicants seeking NOC for BA/BE studies for the export purpose should register themselves and apply only before the deadline.

 

8. Permission for the Import of Drugs with less than 60% residual Shelf Life

As per a circular passed on 1st December 2015 by the Directorate General of Health Services, Office of Drug Controller General, New-Delhi to all Zonal, Sub Zonal, and Ports offices.

  • Permission for the import of drugs with less than 60% residual shelf life for the purpose of test and analysis including clinical trials is not a prerequisite anymore

 

For more information on our India Regulatory Services, please visit https://cliniexperts.com/india-regulatory-services/

 

 

References

 

  1. The Gazette of India. Extraordinary. Part II, Section 3, Sub-section (i), Regd. No. D.L.,-33004/99. New Delhi, Wednesday, January 6, 2016.
  2. The Gazette of India. Extraordinary. Part II, Section 3, Sub-section (i), Regd. No. D.L.,-33004/99. New Delhi, Tuesday, March 29, 2016/ Chaitra 9, 1938.
  3. Import/Misc./2015-DC (Shelf life less than 60%). Directorate General of Health Services. Office of Drug Controller General (India). FDA Bhawan, Kotla Road. December 1, 2015.
  4. Circular, File No. 12-01/14-DC (Pt-47). Central Drugs Standard Control Organization. Directorate General of Health Services. Ministry of Health and Family Welfare. FDA Bhawan, Kotla Road, New Delhi 11002. August 3, 2016.
  5. Notice DCGI/Misc./2016 (98). The overnment of India. Ministry of Health & Family Welfare. Directorate General of Health Services. Central Drugs Standard Control Organization. FDA Bhawan, New Delhi. August 22, 2016.
  6. Notice DCGI/MISC/2016 (97). Central Drugs Standard Control Organization. Directorate General of Health Services. Ministry of Health and Family Welfare. FDA Bhawan, Kotla Road. New Delhi 11002. August 18, 2016.
  7. Import/export policy for Human Biological Samples for commercial purposes: Amendment Schedule – 1, and Schedule – 2 of ITC (HS), 2012 Notification No. 19/2015. Government of India. Ministry of Commerce & Industry. Directorate General of Foreign Trade. Udyog Bhawan. August 4, 2016.
  8. Circular – Requirement of 50 bedded site for clinical trial. File No. 12-01/14-DC (Pt-47). Central Drugs Standard Control Organization. Directorate General of Health Services. Ministry of Health and Family Welfare. FDA Bhawan, Kotla Road. New Delhi 110002. August 2, 2016.
  9. Circular – Restriction of conducting three clinical trials per investigator. File No. 12-01/14-DC (Pt. 47) Central Drugs Standard Control Organization. Directorate General of Health Services. Ministry of Health and Family Welfare. FDA Bhawan, Kotla Road. New Delhi 110002. August 2, 2016.