印度毒品总监(DCGI)已指示州药物监管机构采取必要的行动,并指导所有制造商如何在Sugam Portal上上传其制造地点和配方数据这将通过提高透明度,问责制以及该国药物的可及性来加强药物调节系统。
这DCGI’s direction came after a gazette notification vide G.S.R. 19(E) issued by the Union ministry of health and family welfare on January 10, 2019 amending the Drugs and Cosmetics Rules, 1945 by inserting Rule 84AB – data to be transferred by the licensee on online portal Sugam. As per the inserted rule, all the licensee shall register with Sugam and upload information, as per the format provided in the said portal, pertaining to the licences granted for manufacture for sale or distribution of drugs and the information so provided shall be updated from time to time and such information uploaded by the licensee shall be verified by the concerned licensing authority. The rule is effective from January 29, 2019.
去年7月,卫生部早些时候发布了对1945年毒品和化妆品(D&C)规则的修正案。
这中央药物标准控制组织(CDSCO)已在Sugam门户网站下启动了一个模块,以上传与制造地点,配方,配方生产,产品生产能力有关的数据。在这方面,CDSCO还开发了用户手册。
根据手册,申请人必须首先在门户网站上分别注册其所有制造地点。如果已经注册了SUGAM门户,则登录到Sugam门户,如果不是,请先注册并验证该帐户。一旦完成了注册程序,申请人就可以登录Sugam门户网站以发送制造地点和配方信息。在此之后,应输入制造地点,因此将要求申请人在此制造网站上输入所有许可证细节。
申请人需要进一步输入他选择的许可证的配方详细信息。他/她可以输入相同许可证的多种配方。申请人提交申请后,它将进入状态FDA批准。所有接受的应用程序将在经过验证的公式详细信息部分中可见。
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Contact Us WhatsApp申请人还需要进入生产details for each formulations quarterly/yearly basis. Finally, he/she is required to submit the volume of products that are generated by the manufacturing site.
已提交和批准的信息将在Sugam Portal的制造商仪表板上获得。
In case applicant wants any amendment in the formulation detail, he/she can communicate to the state FDA through the option ‘reply to official’ and asked for the amendment. The official can also reply back to the applicant.
Further, DCGI appealed to state food and drug administration to verify the data uploaded by the manufacturers for compliance of the provisions of the rules.
截至目前,还没有数字化的制造地点和配方数据。与制造厂和药物配方有关的详细信息与州FDA有关。有时,州毒品管理局发现很难与CDSCO共享实时数据。Sugam Portal将被证明是共享有关国内制药行业的全面信息的灵丹妙药。
药品制造商欢迎政府的倡议,以使所有许可在印度制造毒品的单位强制使用数字宣言机制。
Said Nipun Jain, chairman of Small & Medium Pharma Manufacturers Association (SMPMA), “We have welcomed the health ministry’s notification paving the way for digitization of manufacturing plants and formulation data. It will help CDSCO access real time-data on domestic drug units without depending on state drug authorities.”
Echoing Jain’s view, the Federation of Pharma Entrepreneurs (FOPE) co-chairman Vinod Kalani said, “Industry has extended its support to the government’s digitization endeavor. A significant number of drug manufacturers have already started uploading requisite data on plants and formulations on the portal.”