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
Post a Comment

Steps for starting Pharmaceutical manufacturing company.

Pharmaceutical sector is regulated under Drug and Cosmetic Act & Rule, 1940. From manufacturing to retailing, every activity is regulated under this act and separate license is required for conducting every type of activity.

For setting up pharmaceutical manufacturing unit, you will require to take manufacturing license number for it. If you want to manufacture medicines then you will require medicine manufacturing license. If you want to manufacture medical device then you will require manufacturing license for medical devices. If you want to manufacture pharmaceutical raw material/ Bulk Drugs and active ingredients then you will require related license. Similarly separate licenses will be required for cosmetics, surgical equipments, disposable syringes etc.

Manufacturing licenses is granted by State Drug Control Office generally situated at capital region of concern state. You have to apply for manufacturing license to State Drug Control Office. But before applying for granting of manufacturing license, you have to fulfill all criteria and requirements required for setting up pharmaceutical manufacturing unit.

Requirements for Setting-up pharmaceutical manufacturing unit: 
  • Building and Plant
  • Two Technical Persons (One is approved for Manufacturing process and One is for Analytical Operations)
  • Machinery and Equipments for manufacturing processes and analytical operations
Building and Plant: The building(s) used for the factory shall be designed, constructed, adapted and maintained to suit the manufacturing operations so as to permit production of drugs under hygienic conditions. They shall conform to the conditions laid down in the Factories Act, 1948. Plant should compile with the specification describe under Schedule ‘M’ of Drug and Cosmetic Act & Rule.

Technical Persons: Technical persons shall possess desired qualification and experience in specific manufacturing type i.e. medicine, medical device, active ingredients etc.

The manufacture shall be conducted under the active direction and personal supervision of competent technical staff consisting at least of one person who is a whole-time employee and who is:
  • A graduate in Pharmacy or Pharmaceutical Chemistry of a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose] and has had at least eighteen months practical experience after the graduation; or
  • A graduate in Science of a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose who for the purpose of his degree has studied Chemistry as a principal subject and has had at least three years practical experience after his graduation; or
  • A graduate in Chemical Engineering or Chemical Technology or Medicine of a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose with general training and practical experience, extending over a period of not less than three years after his graduation; or
  • Holding any foreign qualification the quality and content of training of which are comparable with those prescribed in above three and is permitted to work as competent technical staff under this Rule by the Central Government.
Provided that the Licensing Authority may, in the matter of manufacture of disinfectant fluids, insecticides, liquid paraffin, medicinal gases, non-chemical contraceptives, plaster of Paris and surgical dressings, for the manufacture of which the knowledge of Pharmaceutical Chemistry or Pharmacy is not essential, permit the manufacture of the substance under the active direction and personal supervision of the competent technical staff, who, although not having any of the qualifications included above , in the opinion of the Licensing Authority, adequate experience in the manufacture of such substances.

The analytical operations shall be conducted under the active direction and personal supervision of competent technical staff consisting at least of one person who is a whole-time employee and who is:
  • A degree in Medicine or Science or Pharmacy or Pharmaceutical Chemistry of a University recognized for this purpose and shall have experience in the testing of drugs, which in the opinion of the licensing authority is considered adequate.

Machinery and Equipments: Each type of manufacturing requires different type of machineries. Medicine manufacturing unit require different type of machineries where as bulk drugs manufacturing requires different types of machinery. Medical device manufacturing will require different types of machinery and equipments.
Licenses required for setting up pharmaceutical manufacturing unit: 
Read about procedure, details and documents required for particular license, click at particular license type above. 

Important Links:
Hope above information is helpful to you…

Read Related: 
लेबल:

Comments

Post a Comment

Ayurvedic Medicine Company

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
2 comments
Read more

How to calculate Price to retailer (PTR) and Price to Stockist (PTS) from any given Maximum Retail Price (MRP)?

Download: PTR/PTS Calculator Download by clicking here You have fixed Maximum Retail price for your product. You have also fixed profit margin, you want to give to retailers, stockists and other distribution channel business partners. But you don’t have knowledge how you can calculate at what price you will bill to stockist and stockist will be to retailers. Then this article is going to be very useful for you...  In this article, we will calculate price to stockist (PTS) and Price to Retailers (PTR) with any given MRP and margin percentage. Also we will provide a PTR/PTS calculator along with how you can make your own PTR/PTS calculator in excel format and we will also provide link to download PTR/PTS calculator in excel. Check related article: profit margin in pharmaceutical industry (Manufacturer to retailers) Have a look at important definitions related to this topic: Distribution Channel: Distribution channel is a group of businesses involved in process of delivery a product/s
3 comments
Read more

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
Post a Comment
Read more