Indian drugs and pharmaceutical industry has advanced perceptibly and is getting ready  for the new patent regime and  to withstand global competition, which is expected to be unleashed by new winds of liberalisation - a new era of liberalisation - much different from what was ushered in since the conclusion of the Uruguay Round and the establishment of the World Trade Organisation.

The industry has been expanding at annual rates ranging between 8 to 10% (against global growth rate of 6%).  According to a study  by McKinsey, Vision 2010, the domestic pharmaceutical industry could attain a size of  $25 billion (Rs 1200 billion) by 2010 by focusing on two areas: first, innovation-led research, development and new drug discoveries; and second, information technology-led remote sales and marketing.  The market for bulk drugs and formulations had increased from about Rs 103  billion in 1990-91 to an estimated Rs 435  billion at the end of 2003-04.  The prices of Indian essential drugs are among the lowest in the world. Apart from strides made by the industry in the last half-a-century, lower production cost due to reverse engineering and low R&D outlays has been a major factor in keeping the prices under check.

The global pharmaceutical industry is estimated at $ 300 billion, not all representing cross-border trade.  India's measly share of $ 1.5 billion in global trade represents an untapped potential. Under the regime of economic liberalisation underway since early 1990s, the drugs and pharmaceutical sector witnessed initiatives at fresh investment in the sector. Nearly 1735 investment proposals of the order of around Rs 166  billion were initiated. The foreign collaboration proposals approved numbered around 425 with a foreign direct investment  (FDI) component of over Rs 25 billion. The pharmaceuticals have figured high on the export front. In 2001-02,  the sector was  estimated to have registered a growth of 17.6% at around Rs 20.3 billion.

In the wake of economic liberalisation, many a  overseas players  returned or contemplated returning to India. These include Ivox Corp (USA),  Taro Pharmaceuticals (Israel) and Merck (USA). These are out either to set shop or looking for acquisitions in India. Hexal AG of Germany has established a liaison office in India. MILLIONCs like Rocha, Bayer, Aventis and Chiron are making India a regional hub for bulk drugs. 

The Export Import Bank of India (Exim Bank) had  doubled its corpus for the pharmaceutical industry to Rs 2 billion as a result of increased activity in the industry, especially in the external sector. The fund is used for the development and commercialisation of the new products and applications, significant improvement in the existing design of  products, setting up and expansion of pilot plants, research studies for obtaining regulatory approvals, cost of filing and managing international patent and R&D Centres.

It needs, however, to be recognised that the presence  of small scale manufacturers has resulted, on the one hand,  in a highly fragmented industry, and on the other, it has made it possible to supply a near 100,000 drugs including vitamins, antibiotics, antibacterials, cardio-vascular and other essential drugs. These account for nearly 37% of the market.  While each of about 80% of the manufacturers has annual sales below a billion rupees, top ten companies are known to control over 30% of the market. At present there are more than 20,000 players in the country.

The major players are: Alembic Chem, Aurobindo Pharma, Cipla, Dr. Reddy's, FDC, IPCA Labs, Jagsonpal Pharma, J.B. Chemicals, Kopran, Lupin Labs, Lyka Labs, Morepan Labs, Nicholas Piramal, Ranbaxy Labs, Sun Pharma, Themis Medicare, GlaxoSmithkline, Astrazeneca, Aventis, E-Merck, Torrent Pharma, TTK Healthcare, Unichem Labs,  Wockhardt  and  Zandu Pharma.  Until recently, only a few of the Indian companies had gone into any serious R&D activity. Much of the effort was directed to affordable analogue research. The R&D level in the country is low with even well-placed pharma companies spending less than 2% of turnover on R&D. MILLIONCs are known to contribute as much as 10% or more of their turnover to R&D.  While India is very strong in process chemistry, biology and applied bio-chemistry, initiatives at all levels - government, academia, private sector - involving heavy financial outlays, are called for.

Ayurveda continues to remain a preferred system of medicine for a vast segment of population in the country. The country has over 400,000 registered practitioners of the Indian system of medicine. Around 170 institutes properly affiliated to various universities impart under- or post-graduate courses each year. These institutes churn out some 5,500 fresh practitioners. The practitioners are supported by 12,000 dispensaries and 2,100 beds available for ayurveda treatment countrywide. The emerging biotechnology sector has already taken by storm and is offering sops to states to make these as the thriving ground for the highly potential segment in medicare.

How to Prepare Project Report on Pharmaceutical Processing Industry?

Drug manufacturing companies work under strict laws and regulations. Their processes need to comply with relevant drugs act in their respective countries.

Therefore, if you are planning to invest in pharmaceutical processing, a good project report will be necessary. Besides the prominent aspects of a project report, you should pay close attention to the following issues in a pharmaceutical processing report.

1. Marketing

This industry is very competitive. I need not stress the value of detailed market analysis. You need to understand the status of market competition and the demand for pharmaceutical products. A proper market analysis will additionally help you prepare an excellent pharmaceutical business plan. Given your market analysis report, you will develop a marketing plan.

2. Government approval

In almost all countries, there are laws and regulations for the manufacture, distribution, and administration of drugs. Consider giving a status report on these requirements when making the final project status report.

3. Manufacturing Process

It would help if you had a picture of the process you will employ in making your drugs. Outline the quality checks and balances in the process. State the required pharmaceutical intermediates and their corresponding active pharmaceutical ingredients.

4. Machines and Equipment

You need to identify the equipment you will need, such as homogenizers, spectrophotometer, tabulating machines, etc. to ensure the machines meet quality specifications. You may also need to put down a plan to train workers on their operations.

How Does the Drug Manufacturing Process Work?

If you are an aspiring drug manufacturer, you should know how the bulk drug manufacturing process works. This is a complicated process and requires professional skills in molecular biology, medical microbiology, and pharmacy.

The process involves four steps, namely:

• Milling
• Granulation
• Coating
• Tabulation

Milling is important because it makes the drug powder uniform. It ensures uniform distribution of the active pharmaceutical ingredients. Additionally, milling makes it easier to formulate the drug into a syrup or emulsion.

After milling, you can use wet or dry granulation to form granules. You then coat them and compress the drugs using a tabulating machine. Alternatively, you can fill the granules into capsules.

For any chemical industry business ideas, prioritize the security of your staff. Ensure workers have sufficient PPEs. Have plans to protect them from chemical poisoning. Install eyewashes and emergency showers in both production units and laboratories.

Pre-Feasibility Report on Bulk Drug Manufacturing Process

Before you set up a feasibility report or start making a business plan, you first need to do a pre-feasibility study. It is the conclusions of this study that will make you decide whether to proceed to the project feasibility report or not.

Implementing a pharmacy business plan is an expensive affair. Please do not put any investment into a business plan of this magnitude without looking at its feasibility study report.

Considering the variety of pharmaceutical products, a feasibility plan will help you decide on the most relevant product for your target market. The results of pre-feasibility and feasibility studies will inform your marketing strategy plan. At the pre-feasibility stage, you get to review the technical skills required for the bulk drug manufacturing process. You also assess the knowledge level and determine whether you have the knowledge and skills.

Lastly, this report looks at the financial demands of a chemical project report on bulk drug processing. From here, you will decide on the feasibility of the project.

How to Grow Pharmaceutical Intermediates Market?

The pharmaceutical industry relies on pharmaceutical intermediates. We use these chemicals to produce active pharmaceutical ingredients (API). 

To grow the pharmaceutical intermediates market, therefore, we should focus on the drug manufacturing industry. Here are some tips on how we can grow this industry.

1. Investment in Research and Development

We should encourage governments and established drug manufacturers to invest in research and development of new medicines. New drug development will increase the need for pharmaceutical intermediates. Consequently, this will cause the growth of the industry.

2. Boost Generic Drug Manufacturing

Feasibility study reports for project ideas in pharmaceuticals show a growing demand for generics. This demand is particularly high in developing countries. More investment in generic drugs will result in increased demand for pharmaceutical intermediates.

3. Collaborations

It is quite expensive to run a pharmaceutical intermediate processing company. If you look at a project summary example for the local industry and you will notice the huge investment. One way of cushioning the industry is to encourage collaborations, mergers, and acquisitions. Working together gives small-scale companies a competitive advantage. It lowers their operation costs and improves revenue.

How to Set Up a Chemical Industry Business Plan?

Writing a chemical industry business plan begins with a pre-feasibility study. Here, you look at the various business ideas in chemical manufacturing. You then evaluate each of these ideas based on:

1. Skills and Knowledge

If you are interested in the chemical manufacturing industry, I assume that you have some skills or knowledge in this sector. If so, look at the skills required for each idea you have. Which of these ideas marches your skills and knowledge?

2. Financial Resources

Different chemical processes have different cost implications. Try to review each idea against the expected financial input. You can examine some business plan examples on the internet to get a hint on required inputs. Once you have a convincing pre-feasibility report, you can proceed to make a feasibility report meaning the idea is profitable and viable.

The next step in setting up a chemical industry business plan is to prepare a small business marketing plan. The results of your feasibility report will help do this.

Chemical manufacturing is not only expensive, but it is also strictly regulated by law. It would be best if you had an innovative marketing strategy to break even. It would be best if you did an accurate market analysis.

A project report on the pharmaceutical industry helps you assess the dynamics of the industry. You will want to know who the major chemical manufacturers are. You will also assess the availability of raw materials and machinery for your pharmaceutical industry.

In your project report, you will also address the technical aspects of the pharmaceutical manufacturing process. You need to draw a flow diagram for the process. Lastly, sit down and draw a business plan for your chemical industry business. You will need the information from all the above processes. Additionally, a business plan will consider the financial implications of your pharmaceutical industry project report.