长江之歌简谱殷秀梅:CDSCO issues Guidance document for import & registration of APIs, formulations

来源：百度文库编辑：九乡新闻网时间：2024/04/30 03:56:41

CDSCO issues Guidance document for import & registration of APIs, formulations (25/7/11)

Mumbai, 25 July: The Central Drugs Standard Control Organization (CDSCO) has issued Guidance document on common submission format for import and registration of Active Pharma Ingredients (APIs) and finished formulations in India.

The main purpose of the document is to provide guidance for submission of application in Form 40 to the CDSCO for registration certificate and issuing license for import of drugs into India. The document is intended to provide non-binding guidance for use in the import and registration of bulk drugs and finished formulations in India.

The scope of the guidance is applicable to those drugs manufactured outside India, and the import registration to be issued (under Form 41) by the CDSCO.

As per the 82-page guidance document, an application shall be made to the licensing authority in Form 40, either by the manufacturer himself, having a valid wholesale license, for sale or distribution of drugs or by his authorized agent in India either having a valid license to manufacture for sale of a drug or having a valid wholesale license for sale or distribution of drugs.

In India, import, manufacturing, sale and distribution of drug is regulated under Drugs and Cosmetics Act 1940 and Drugs and Cosmetic Rules 1945 made thereunder. At present, bulk drugs and finished formulations are regulated under the said Act. Any substance falling within the definition of drug (Section 3b of the Act) required to be registered before import into the country. Not only drugs but the manufacturing site also need to be registered for import.

If the drugs fall within the definition of New Drug (Rule 122 E of the Act), the new drug approval is the pre-requisite for submission of application for registration and or import of drug. The application for registration and import can be made to the licensing authority under the Act, i.e. to the Drugs Controller General of India (DCGI) by the local authorized agent of the foreign manufacturer having either manufacturing or sale license or by the foreign manufacturers?having a wholesale license in the country.

The CDSCO has asked all the stakeholders likely to be affected by the proposed Guidance document to make their comments on the document within 20 days.

CDSCO issues Guidance document for import & registration of APIs, formulations New PIC/S Document on GMP for APIs The evolution of the registration of medical devices CONTEMPORARY MANAGEMENT ISSUES: GENETIC MODIFICATION OF FOOD China issues rules on management of military ... Second decade of 21st century provides import... Housing and social security top issues of Chinese people 10 Biggest Issues for Developers Migrating 32-bit Applications to 64-bits Chavez leaves for Cuba for 4th session of che... Guidelines for Specification of Turbulence at... Official calls for stronger monitoring of res... For the Two of Us 情浓两依依 []Official calls for stronger monitoring of res... President Hu calls for training of high The Age of Outrage...for The West Imminent fall of Qaddafi poses challenge for ... Preparation underway for launch of Tiangong A Quality Scorecard for the Administration of... be ashamed for，be ashamed of Chinese people toast for a better Year of the Rabbit Money charged for private use of govt vehicles International Legal Implications of Climate Change for the Polar Regions Attention to the work of working methods and techniques for People mourn for martyrs of 1911 Revolution i...