National e-Governance plan (NeGP), launched in 2006 as initiative that Government of India has implemented to make all government services accessible online.
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:
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.
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:
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:
As per a circular dispatched on 3.8.16 it was concluded that:
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:
CDSCO, in order to implement e-governance in its offices, has launched the SUGAM portal on 14.11.2015. It is intended for:
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.
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