How to Start Pharmaceutical Business

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 Licensing authority: means the authority appointed by the Central Government to perform the duties of the licensing authority under these Rules and includes any person to whom the powers of a licensing authority may be delegated under Rule 22 of Drug and Cosmetic Act & Rules/. Licence for examination, test or analysis: means a licence in Form 11 to import small quantities of drugs the import of which is otherwise prohibited, for the purpose of examination, test or analysis Manufacturer: includes a manufacturer of drugs, who may be a Company or a unit or a body corporate or any other establishment in a country other than India, having its drugs manufacturing facilities duly approved by the National Regulatory Authority of that country, and who also has a free sale approval of the drugs approved by the said aut...

Medicines and pharmaceutical products are life saving products and sensitive also. Pharmaceutical marketed is regulated all over world through different act & rules of specific countries. In India, pharmaceutical products are regulated through Drug and Cosmetic Act & Rule, 1940. Import, Export, manufacturing, distribution, retail and dispensing all are regulated under this act. For every activity, one has to take license and approval for it. You are eligible to export pharmaceutical products from India if you are a pharmaceutical manufacturer or pharmaceutical marketing company or wholesaler/distributor. Along with these specific licenses, you will also need to complete general requirements for exporting any goods from India. For exporting pharmaceutical products , you should have following requirements and licenses: Pharmaceutical Manufacturing License Number , pharmaceutical marketing company or Wholesale Drug License Number Goods and Service Tax Identification Number ...

In India import, manufacturing, sale and distribution of drug is regulated under Drugs and Cosmetics Act 1940 and Rules 1945. At present, bulk drug (Active Pharmaceutical Ingredients) and finished formulations are regulated under the said Act. Any substance falling within the definition of drug required to be registered before import into the country. Not only drug but the manufacturing site needs to be registered for import. The application for Registration Certificate and import License can be made to the Licensing Authority under the Act i.e. to the Drugs Controller General (I) at CDSCO, FDA Bhawan, Kotla Road, Near Bal Bhawan, New Delhi by the Local Authorized Agent of the foreign manufacturer having either manufacturing or sale License or by the foreign manufacturers having a whole sale License in the country through online application system “SUGAM” Requirements: Pharmaceutical Manufacturing License or Wholesale Drug License Importer Exporter Code Number Import Reg...

In India import, manufacturing, sale and distribution of drug is regulated under Drugs and Cosmetics Act 1940 and Rules 1945. At present, bulk drug (Active Pharmaceutical Ingredients) and finished formulations are regulated under the said Act. Any substance falling within the definition of drug required to be registered before import into the country. Not only drug but the manufacturing site needs to be registered for import. The application for Registration Certificate and import License can be made to the Licensing Authority under the Act i.e. to the Drugs Controller General (I) at CDSCO, FDA Bhawan, Kotla Road, Near Bal Bhawan, New Delhi by the Local Authorized Agent of the foreign manufacturer having either manufacturing or sale License or by the foreign manufacturers having a whole sale License in the country through online application system “SUGAM” Requirements: Pharmaceutical Manufacturing License or Wholesale Drug License Importer Exporter Code Number Import Licen...