Bis Certification
| Target Location | Pan India |
BIS stands for “Bureau of Indian Standards” and emerged in 1986 from the “Indian Standards Institution” (ISI). The ISI had been in existence since 1947 and was the responsible agency for certifying production quality in India, but had limited authority in writing and enforcing standards. In order to strengthen the ISI in its function, it was therefore elevated to the status of “Bureau of Indian Standards” (BIS) in 1986 and from then on was also responsible for the formulation of standards.
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| Type Of Industry | Commercial |
| Import / Export Location | Pan India |
Import licence means either a licence in Form 10 to import drugs excluding those specified in Schedule X, or a licence in Form 10-A to import drugs specified in Schedule X.
In India import, manufacturing, sale and distribution of drug is regulated under Drugs and Cosmetics Act 1940 and Drugs and Cosmetic Rules 1945. At present, bulk drug (Active Pharmaceutical Ingredients) and finished formulations are regulated under the said Act.
An application for an import License is made to the licensing authority in Form 8 for drugs excluding those specified in Schedule X, and in Form 8-A for drugs specified in Schedule X, either by the manufacturer himself having a valid wholesale License for sale or distribution of drugs under these Rules, or by the manufacturers agent (Importer) in India either having a valid License under the Rules to manufacture for sale of a drug or having a valid wholesale License for sale or distribution of drugs under these Rules and an undertaking in Form 9 duly signed by or on behalf of the manufacturer.
The grant of import licence of an application for an import licence in the form and manner prescribed in Rule 24, the licensing authority shall, on being satisfied that, if granted, the conditions of the licence will be observed, issue an import licence in Form 10 or From 10-A.
An Import licence unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue.
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