Skip to main content

How to grow your Pharma Business?

  Growing a pharma business requires a strategic approach considering the specific context of your company and the pharmaceutical industry as a whole. Here are some general pointers to get you started: Market and Customer: Identify your target customer: Deeply understand the specific needs and challenges of your target audience, whether it's doctors, patients, hospitals, or other healthcare providers. This helps tailor your products, services, and marketing efforts. Focus on unmet needs: Look for gaps in the market where existing solutions are inadequate or unavailable. Addressing unmet needs can give you a competitive edge and drive innovation. Track market trends: Stay updated on regulatory changes, technological advancements, and emerging diseases to adapt your approach and anticipate future opportunities. Products and Services: Invest in R&D: Develop innovative products or differentiate existing ones through unique formulations, delivery methods, or combinations. Remember

Fixed Dose Combinations (FDCs) and their classifications

Fixed Dose Combinations refer to products containing one or more active ingredients used for a particular indication(s).

FDCs can be divided into the following groups and data required for approval for marketing is described below:

(a) The first group of FDCs includes those in which one or more of the active ingredients is a new drug. For such FDCs to be approved for marketing data to be submitted will be similar to data required for any new drug (including clinical trials)

(b) The second group FDCs includes those in which active ingredients already approved/marketed individually are combined for the first time, for a particular claim and where the ingredients are likely to have significant interaction of a pharmacodynamic or pharmacokinetic nature.
  • If clinical trials have been carried out with the FDC in other countries, reports of such trials should be submitted. If the FDC is marketed abroad, the regulatory status in other countries should be stated.
  • For marketing permission, appropriate chemical and pharmaceutical data will be submitted. In case such a combination is not marketed anywhere in the world but these drugs are already in use concomitantly (not as an FDC but individually) for the said claim, marketing permission may be granted based on chemical and pharmaceutical data. Data showing the stability of the proposed dosage form will also have to be submitted.
  • For any other such FDCs, clinical trials may be required. For obtaining permission to carry out clinical trials with such FDCs a summary of available pharmacological, toxicological and clinical data on the individual ingredients should be submitted, along with the rationale for combining them in the proposed ratio. In addition, acute toxicity data (LD 50) and pharmacological data should be submitted on the individual ingredients as well as their combination in the proposed ratio.
(c) The third group of FDCs includes those which are already marketed, but in which it is proposed either to change the ratio of active ingredients or to make a new therapeutic claim. For such FDCs, the appropriate rationale including published reports (if any) should be submitted to obtain marketing permission. Permission will be granted depending upon the nature of the claim and data submitted.

(d) The fourth group of FDC includes those whose individual active ingredients (or drugs from the same class) have been widely used in a particular indication(s) for years, their concomitant use is often necessary and no claim is proposed to be made other than convenience. It will have to be demonstrated that the proposed dosage form is stable and the ingredients are unlikely to have significant interaction of a pharmacodynamic or pharmacokinetic nature.

No additional animal or human data are generally required for these FDCs, and marketing permission may be granted if the FDC has an acceptable rationale.

Comments

Ayurvedic Medicine Company

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

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

Schedule F, F1, F2, F3, FF

Schedules:  Schedule A ,  Schedule B ,  Schedule C ,  Schedule D ,  Schedule E1 ,  Schedule F ,  Schedule G ,  Schedule H ,  Schedule H1 , Schedule I,  Schedule J ,  Schedule K ,  Schedule L1 ,  Schedule M ,  Schedule M1 ,  Schedule M2 ,  Schedule M3 ,  Schedule N ,  Schedule O ,  Schedule P ,  Schedule Q ,  Schedule R ,  Schedule S ,  Schedule T ,  Schedule U ,  Schedule V , Schedule W,  Schedule X ,  Schedule Y Schedule F: Schedule F (Rule 78 and Part X) describes requirements related to Blood and Blood Components. We are describing general heading about schedule. This will give you Idea about schedule structure and matter. Part XIIB: Requirements for the functioning and operation of a blood bank and / or for preparation of blood components. I. This section describes details about Blood Bank and Blood Components General Accommodation for a Blood Bank Personnel Maintenance Equipment Supplies and Reagents Good Manufacturing Practices (GMP’s) and Standard Operat

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