Skip to main content

Is medical representative a good career?

A career as a medical representative can be a great choice for many people. There are many advantages to this career, including the potential to earn a good income and the opportunity to work in a variety of settings. Of course, like any career, there are also some downsides to being a medical representative. For example, you may find yourself working long hours or traveling frequently. Overall, though, a career as a medical representative can be a good choice for many people. If you're interested in this field, be sure to research it thoroughly to make sure it's the right fit for you.

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...

Comments

Send Distribution/Franchise Query

Name

Email *

Message *

Register your business at

Find pharmaceutical, cosmetics, nutraceutical, ayurveda and alternative medicine's distributors, franchise, suppliers query for free.

If you want to take distribution, franchise or associates with any pharmaceutical, cosmetic or ayush company then you can find it here...

Popular posts from this blog

How to Register as a Pharmacist in India?

Who is a Pharmacist: Pharmacist is a person having educational qualification in pharmacy profession i.e. Diploma in Pharmacy or Bachelor in pharmacy or Pharma D etc. Who is a Registered Pharmacist: Registered Pharmacist is a person having educational qualification in pharmacy and his/her name is registered under state pharmacy council  of state in which person reside or want to conduct his/her profession or business . How to become a Registered Pharmacist? For becoming pharmacist in India, a person has to fulfill criteria as per Pharmacy Act. A person want to register himself/herself as a pharmacist should have at least minimum of Diploma in Pharmacy or Bachelor in Pharmacy or Pharma D. After completing above mentioned qualifications, you become eligible for registering as a pharmacist. If you have only Diploma in pharmacy, then 500 hours practical training spread over a period of not less than 3 months is also required to become eligible. download pdf After registering your name in s

State Pharmacy Council, Its Constitution and Composition and Functions

State Pharmacy Council: State Pharmacy Council is constituted as per the Pharmacy Act, 1948 & State Pharmacy Rules, 1951. State Pharmacy Council is an authoritative council to regulate Pharmacy Act, 1948 & State Pharmacy Rules, 1951. What is state pharmacy council? State Pharmacy Council means a State Council of Pharmacy constituted under section 19, and includes a Joint State Council of Pharmacy constituted in accordance with an agreement under section 20 under the Pharmacy Act, 1948 & State Pharmacy Rules, 1951. State Pharmacy Council constituted and work under  Pharmacy council of India . Composition of State Pharmacy Council: The State Pharmacy Council consists of the following: i) Six members, elected from amongst themselves by registered pharmacists of the State; ii) Five members, of whom at least three shall be persons possessing a prescribed degree or diploma in pharmacy or pharmaceutical chemistry or registered pharmacists nominated by the State Governme

What are the Schedules under Drug and Cosmetic Act, 1940 & Rules 1945?

Schedules are the set of provisions for classifications of drugs, forms, fees, standards, requirements and regulations related to pharmaceutical, Ayurvedic (including siddha), unani and tibb system of medicines, homeopathy, blood and realted products etc under Drug and Cosmetic Act, 1940 and Rules, 1945. The schedule to the drugs and cosmetics act are Schedule A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, U, V, W, X, Y. Drug and cosmetic rules are divided into schedules alphabetically and named also alphabetically like Schedule A, Schedule B etc till Schedule Y. The schedules to the drugs and cosmetics act are important part. Every schedule contains specific information as discussed below. Schedule A:  Schedule A  describes application forms and licenses types. Download Schedule A Pdf Schedule B:  Schedule B  describes Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories. Download Schedule B Pdf Schedule B1: Schedule B1 describes