In this blog, we have curated a detailed guide for starting a pharmaceutical manufacturing company in India.

Rise and rise of the Indian pharmaceutical industry

Why should you consider starting a pharmaceutical manufacturing company in India? To answer this question, we have highlighted the immense potential of the Indian pharma industry. It is presently basking in the global spotlight.

Currently, the Indian pharmaceutical industry is pegged at approximately $50 Bn. By the year 2030, the Indian pharmaceutical market is expected to be valued at $130 Bn. The Indian pharmaceutical industry can be divided into the following major segments: generic drugs, bulk drugs, vaccines, over-the-counter medicines, contract research and manufacturing, biosimilars, and biologics. Furthermore, India is the leading the supplier of diphtheria-pertussis-tetanus (DPT), Bacillus Calmette-Guerin (BCG), and measles vaccines. The availability of affordable HIV treatment in India is one of the highlights of the industry.

Notably, India is a major pharmaceutical exporter. The Indian industry caters to countries across the world. Approximately 60,000 different generic brands across 60 therapeutic categories are manufactured in India. India fulfils over 50% of Africa’s and 40% of the US’s demand for generic drugs. Thus, globally, India is the largest provider of generic drugs, holding a 20% share in global supply by volume. Moreover, it also supplies approximately 25% of all medicine requirements in the UK.

Globally, India is one of the biggest suppliers of low-cost vaccines, accounting for 60% of global vaccine production. India fulfils approximately 70% of the WHO demand for DPT and BCG vaccines and 90% of the measles vaccine requirement. Furthermore, the highest number of US-FDA compliant pharmaceutical plants outside of USA is located in India. More than 3,000 pharmaceutical companies and over 10,500 pharmaceutical manufacturing facilities drive the Indian pharma industry. Additionally, a highly skilled resource pool and low labour costs are an added advantage for India. As high-quality affordable medicines are manufactured in India, Indian has earned the name “pharmacy of the world”.

Market drivers

1. High domestic demand: India has a strong domestic demand for low-cost high-quality drugs. This is the major market driver for the Indian pharmaceuticals industry.
2. Infrastructural development: India has witnessed a rapid infrastructural development. This has fuelled the boom of the pharma industry in India.
3. Government initiative and support: The Indian government has implemented various schemes to support the Indian pharma industry. It has formulated production-linked incentive schemes to promote the domestic manufacturing capacity, including high-value products, in India. Additionally, this will increase the value addition in exports and generate employment for both skilled technicians and unskilled personnel. The government has also proposed the development of bulk drug parks for a consistent supply of bulk drug active components.
4. Booming medical tourism in India: The potential of the pharma industry in India has fuelled medical tourism. India offers quality services at costs lower than those offered in the US and Europe. This has made India a popular destination for medical treatments.
5. High drug manufacturing potential and capacity: India is the forerunner in low-cost generic patented drug manufacturing and end-to-end manufacturing. It has the added advantage of availability of highly skilled technical personnel and cheap labour. Thus, India has a high drug manufacturing potential and capacity.

Thus, the Indian pharmaceuticals industry is a major player in the global market. The aforementioned highlights are the reasons why you should consider manufacturing pharmaceuticals in India. Given the Indian market trends, starting a pharmaceutical manufacturing company in India will be profitable.

A guide to starting a pharmaceutical manufacturing company in India

Pharmaceuticals is one of the fastest growing industries in the Indian market. This industry provides an excellent opportunity for starting a business. We have already highlighted the potential of the Indian pharmaceutical industry and why you should consider manufacturing pharmaceuticals in India. We have provided some points to consider when starting a pharmaceutical manufacturing company.

First, it is important to have an idea of the various segments of the pharmaceutical industry.

Segments of the pharmaceutical industry

• Tablets
• Capsules

• Liquid
• Cream
• Injection
• Inhalers
• Parenteral (dry or liquid injections)
• Vaccines
• Ear, Eye, and nasal drops
• Powders (Supplements and Pharma powders, such as protein powders and medicated powders)
• Implants
• Blood products
• Suppositories
• Surgical
• Sprays

The aforementioned are some of the sections of the pharmaceutical industry.

Step by step guide to starting a pharmaceutical manufacturing company

1. Perform in-depth market research and identify pharmaceutical business ideas

Understand the current market trends and identify which pharmaceutical business domain will be profitable. Refer to industry reports, academic journals, and latest pharma industry news, to understand the market trends. Focus on identifying unmet needs within the healthcare system. Furthermore, determine which segment of the pharmaceutical industry do you want to start your business in. It is also important to have an idea of the major industry players and your possible competitors.

Next, decide on which of the following categories you want to focus on: generic pharmaceuticals, branded pharmaceutical firm, over-the-counter medicines, and export-based company. You may also focus on their sub-categories.

2. Formulate a detailed business plan

It is important to have a full proof business plan before starting your pharmaceutical manufacturing company. How to set up the manufacturing facility and the products to be offered have to be clear from the beginning. Also, include the company organization, customer segmentation, marketing plan, and logistics in your business plan. Fixed and running expenses that are going to be incurred also have to be worked out.

Funding acquisitions and how to utilize the funds also have to be decided.

3. Land and location selection

It is important to select an appropriate location for setting up your pharmaceutical manufacturing facility. A location with good transport links, no legal issues, easy access to talent pool will be ideal. The location plays a vital role in the success of the pharmaceutical business.

Avail the Pharmadocx Consultants land selection service. We will find you the best spot for starting your pharmaceutical manufacturing company in India.

4. Build a team of experts

Your team will be handling the day-to-day operations of your company. The team members will be driving the success of your company. Carefully handpick a team of skilled technical personnel to operate the manufacturing facility. You will need additional staff, such as unskilled assistants, accountants, supervisors, managers, etc.

5. Setting up your manufacturing facility

Various machineries, such as capsule filling machines, high-speed mixing machines, loading and capping units, and filtration machines, will be required. Other additional requirements, such as clean rooms, will have to be fulfilled. Additionally, you have to setup your pharmaceutical manufacturing factory as per applicable regulatory guidelines. Hence, setting up the pharmaceutical manufacturing facility is not an easy task.

Fret not! Avail our factory layout design service for setting up your pharmaceutical manufacturing facility in a hassle-free manner. We will design the factory as per updated Schedule M, Drugs and Cosmetics Rules, and CE guidelines. Our service includes designing civil architecture plans, clean room plans of ISO Class 7, HVAC Plans, plumbing plans, electrical plans, and equipment plans. We will visit your premises, take measurements, and design an industry-standard layout as per applicable regulatory guidelines. Our facilities are designed with the aim of efficient working with requisite cleanliness and hygiene levels.

6. Regulatory compliance, registration, and licensing

Pharmaceuticals are heavily regulated in India. Regulatory compliance is mandatory for manufacturing, distributing, and selling drugs in India. A drug manufacturing license will be required for manufacturing pharmaceuticals in India. Form 25 and Form 28 for manufacturing non-biological and biological drugs, respectively. A drug loan license will be required for companies planning to manufacture drugs without a proper manufacturing facility.  This license will permit you to manufacture drugs at a third party’s established manufacturing facility.

Pharmadocx Consultants provides regulatory support for the grant of all types of drug manufacturing licenses in India. From Form 25, Form 28, Loan license, Test license to Free Sale, WHO-GMP and COPP, and Market Standing Certificate.

In addition to the manufacturing license, you will be requiring certain other documents. Fire NOC, pollution NOC, company registration, trade license, and GST registration are some of the additional licenses you will require.

Pharmadocx Consultants: Your trusted ally for establishing a pharmaceutical manufacturing company

We provide an all-encompassing service for starting a pharmaceutical manufacturing company in India. Drop an email at [email protected] or call/Whatsapp on 9996859227.