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How to start Pharmaceutical Product's Packaging Material Business?

Query: I am interested to start a small pharmaceutical packaging company and I am looking for some information. I have found your email on google when I was reading your article on how to start a pharmaceutical packaging company. Can you provide me some guidance that how can I start a pharmaceutical packaging company and how much investment require for small scale.  Response: You can start a pharmaceutical packaging printing company by setting up machinery and equipment. Unlike pharmaceutical manufacturing plants, there is no requirement of taking drug related licenses for pharmaceutical packaging companies. You can set-up a packaging company just like any other un-regulated sector. Search for premises Take GST number Purchase machinery and equipment's Tie-up with pharmaceutical finished goods manufacturing unit Supply to them But for starting a packaging company, you need to have knowledge of some skills like basic knowledge of designing, printing process and requirements of pharm

BA/BE study

Bioavailability (BA):
Bioavailability refers to the rate and extent of availability of active pharmaceutical drug in systemic circulation of our body or available at site of action. It is measurement of the relative amount of drug absorbed from administered dosage form to reach the systematic circulation and become available at site of action.

Bioequivalence (BE):
Bioequivalence refers to the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.

BA/BE studies are conducted generally for new drugs, any modification of already existing molecule/dosage form, approval of generic version of any off patent molecule etc. In case of generic drugs, BE study is required to ensure generic versions are equally safe and efficacy profile, and has same rate and extent of absorption of active ingredients as of its innovator product.

How to submit for BA/BE study data for export purpose in India?
Application has to be submitted to the office of Drugs Controller General (India) at CDSCO (HQ) FDA Bhawan, New Delhi. The applicants submit the application for BE NOC & Test Licence through online Sugam Portal in applicable checklist to meet tenets of Schedule Y of Drugs and Cosmetics Act 1940 & Rules 1945 and also Indian Good Clinical Practices (GCP) guidelines.
The application will be processed by the Assistant Drugs Inspector/Drugs Inspector (Reviewing Officer) and send to the ADC(I) (Nodal Officer) for further review. The Nodal Officer will send the application to DDC(I) (Deputy Decision Authority)/JDC(I) (Decision Authority) for recommendation for approval then DCG(I) (Licensing Authority) will grant the BE NOC & Test Licence to the applicant through Online Sugam Portal.

Read related: How to export pharmaceutical products from India?

Hope above information is helpful to you...

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