Beginning a pharmaceutical injection business in India can be a very fruitful deal considering the increasing need for good quality injectable medicines. However, it requires thorough planning and following regulatory frameworks. In this guide, we take you through the steps and essential criteria to successfully start your pharma injection business.
Step 1: Market Research and Business Plan Formulation
Encapsulated in the word “business” is a certain sense of endeavor which necessitates adequate preliminary planning. Before you initiate the process, you need to perform an extensive market research on the existing injectable products. Create an outline covering the factors below:
- Overall business goals
- How much capital investment will be needed
- Define your target demographics and draft a marketing campaign
- The types of injections that will be in your product line
Step 2: Business Regulatory and Legal Framework
Three important state bodies comes into the picture when dealing with the placement of the business in India. To start up a pharma injections business in India, certain licenses and registrations need to be obtained.
Drug License
A Drug License is a prerequisite for the manufacturing, distribution and sale of pharmaceutical goods in India. It is issued by the State Drug Control Authority.
A Drug License is mandatory to manufacture, distribute, or sell pharmaceutical products in India. It is issued by the State Drug Control Authority.
- Manufacturing License: Required if you plan to produce injections yourself.
- Wholesale Drug License: Needed if you intend to distribute injections to pharmacies and hospitals.
- Retail Drug License: Necessary if you plan to sell directly to consumers.
Documents Required for Drug License:
- Application form
- Proof of premises ownership or rental agreement
- Proof of qualification of the competent person (Pharmacist or Registered Chemist)
- Identity and address proof of the applicant
Goods and Services Tax (GST) Registration
GST registration is essential for tax compliance.
- GST Number: Required for selling and distributing pharmaceutical products.
- Register through the official GST portal by providing business and bank account details.
Infrastructure Setup
Select a geo location that fulfills the legal requirements necessary for pharma operations of your business.
- Manufacturing Unit: In the case of production of injections, the manufacturing unit is required to be registered with WHO-GMP.
- Storage Facility: There should be proper provision of storage environment with controlled conditions for injections temperature storage.
Procurement of Machinery and Raw Materials
Purchase and raw material from recognized wholesalers alongside the dependable machinery tools for injectable products manufacturing. Ensure to consider the compliance of the equipment with industry requirements.
Quality Control and Compliance
Implementation of strict quality control measures for injectable products safety and efficacy is mandatory. Audits and WHO-GMP compliance are conducted on a regular basis to ensure this control.
Marketing and Distribution Strategy
Provide a full marketing strategy to get the necessary recognition for your injectable products. Start partnerships with local hospitals, clinics, and pharmacies. Aim for a wider crowd and make use of digital marketing services.
Injection Range Franchise and Third Party Manufacturing in India
If funding is an issue to you, then it might be worth dealing with already set up companies such as Aenor Pharmaceuticals.
Franchise Opportunities
Aenor Pharmaceuticals provides significant chances to earn through economy franchises for those willing to start a venture in the pharmaceutical injections. As a franchisee, you enjoy:
- An already established company
- Promotional campaigns
- Injectable products of superior quality
Third Party Manufacturing
If you wish to concentrate only on marketing and sales while completely ignoring the manufacturing part, Aenor Pharmaceuticals can offer you third party manufacturing services.
- Production according to your specifications
- WHO-GMP certified manufacturers
- Prompt supply and collation of products
Conclusion
Launching an injection pharmaceutical business in India requires some amount of patience and lawful compliance, as well as a significant amount of marketing. It is simple to operate and attain profits by signing a contract for franchise or outsourcing with Aenor Pharmaceuticals.
