The excipient manufacturing market in India is still at a nascent stage. More than 90 per cent of its market requirements are met by imports from countries like USA, Germany and Europe. According to Dr. P.V. Appaji, Director General of Pharmexcil, not many are in the field of manufacture of excipients in India. Even if there are any, they have not reached up to the export capacity.
“At present there are no components relating to excipients being exported from India. The Indian excipient industry is still at a nascent stage and there is a need for the industry players to venture into this niche area and must explore potential export markets apart from meeting the domestic needs,” he added.
Excipient scenario in India
India’s leading names in pharmaceutical excipients have joined hands to set up its first ever excipient council. Leading pharmaceutical companies viz. ACG Worldwide (serving the pharmaceutical industry for five decades and is the second largest manufacturer of empty hard capsules in the world), Colorcon, Indchem International, Micro Labls, Dow Chemicals, Lubrizol India, BASF India, SPI Pharma and Merck Groups are the founder members of the International Excipient Council (IPEC). IPEC has launched its Indian chapter, IPCEA India. IPEC India is the fifth member of the IPEC Federation, the others being the Americas, Europe, Japan and China.
Internationally, the IPEC Federation is the leading federation of the pharmaceutical excipients industry and has over 250 members across all affiliates. The IPEC Federation provides a unified voice that promotes the proper use of excipients in medicines as a means of improving patient treatment.
IPEC India’s primary objectives are to promote the excipient industries in India which aims to be a knowledge base and resource centre for the Indian excipients industry. It conducts workshops and seminars, organize conferences where training are being given regarding best practices and provides other suitable forums in which knowledge and best practices can be institutionalized in member companies.
“In India the excipients also have the same kind of regulations as that of the pharmaceutical ingredients. Drug control regulators have devised standard regulatory norms to be abided by the pharma and food industry with regard to use of excipients. And of course the regulatory standards are evolving day by day,” informed Ravi Udaybhaskar, Additional Executive Director of Pharmexcil and a senior officer from drugs control department.
In India a lot of starch based excipients of different commercial grades are produced from starch plants after chemicals or physical processing. Commercial grade micro-crystalline cellulose is available from cellulose powder manufacturers, which by chemical and processing are converted to excipients. However, Indian excipient manufacturers need to depend on import components and the manufacturing of excipients, which must follow the good manufacturing practice requirements.
Global excipients market
Europe and North America account for about 75 per cent of the global excipients market. Manufacturers from India and China are also contributing to market significantly and their market share increases every year, because both countries already have a strong presence in API and intermediates manufacturing.
According to the latest available data on market statistics, the total global market for excipients was estimated at $4.5 billion in 2013, with an average annual growth of seven per cent to eight per cent in volume and four to five per cent in value. This means that, the global excipient market is approximately 0.4-0.5 per cent of the global pharmaceutical market, which is evaluated at $ 850 billion.
North America and Europe, as the main pharmaceutical producing areas, consume approximately 70 per cent of excipient output. Japan takes another estimated 15 per cent and India, Brazil and China have become major single markets in recent years and are expected to increase to $7.2 billion (4.9 billion Euros) by 2016. This represents a five-year Compound Annual Growth Rate (CAGR) of 6.5 per cent. It is reported that approximately 5 billion kg of excipients were used in 2011, globally.
The largest segment of the market, organic chemicals, was valued at $3.8 billion in 2008; this is expected to increase to $4 billion in 2009, and is projected to reach $5.5 billion in 2014, for a five-year CAGR of 6.4 per cent. Whereas, the estimated Indian pharmaceutical market in 2009 was Rs. 40,000 crore and the present value is about Rs.90,000 crore with a growth of 10 per cent per year.
The estimated share value for excipient in market in this is about 10 per cent of the total market of Indian pharmaceutical industries. Indian excipients are also widely used in cosmetic and other health care products, which contribute about another Rs. 10,000 crore market.
Role of excipients
Excipients play a vital role in the pharmaceutical and food industries as they are inactive non-reactive edible substances which are used for coating the medicines and their ingredients to give aesthetic look.
In other words, an excipient is a substance formulated alongside the active ingredient of a medication, included for the purpose of long-term stabilization, bulking up solid formulations that contain potent active ingredients (thus often referred to as "bulking agents", "fillers" or "diluents"), or to confer a therapeutic enhancement on the active ingredient in the final dosage form, such as facilitating drug absorption, reducing viscosity, or enhancing solubility.
Excipients can also be useful in the manufacturing process, to aid in the handling of the active substance concerned such as by facilitating powder flowability or non-stick properties, in addition to aiding in vitro stability such as prevention of denaturation or aggregation over the expected shelf life. The selection of appropriate excipients also depends upon the route of administration and the dosage form, as well as the active ingredient and other factors.
Pharmaceutical regulations and standards require that all ingredients in drugs, as well as their chemical decomposition products, be identified and shown to be safe. Often, more excipient is found in a final drug formulation than active ingredient, and practically all marketed drugs contain excipients. As with new drug substances and dosage forms thereof, novel excipients themselves can be patented. Sometimes, however, a particular formulation involving them is kept as a trade secret instead or else it could be easily reverse-engineered.
The Federation of IPEC, a pharmaceutical regulatory non-profit, develops, implements, and promotes global use of appropriate quality, safety, and functionality standards for pharmaceutical excipients and excipient delivery systems. IPEC-America, along with their counterparts in Europe, China, and Japan serves as a primary international resource on excipients for its members, governments, and public audiences.
Though excipients were at one time assumed to be "inactive" ingredients, it is now understood that they can sometimes be "a key determinant of dosage form performance. In other words, their effects on pharmacodynamics and pharmacokinetics, although usually negligible, cannot be known to be negligible without empirical confirmation and sometimes are important. For that reason, in basic research and clinical trials they are sometimes included in the control substances in order to minimize confounding, reflecting that otherwise, the absence of the active ingredient would not be the only variable involved, because absence of excipient cannot always be assumed not to be a variable. Such studies are called excipient-controlled or vehicle-controlled studies.
Currently there are more than 1,200 different kinds of excipients available in the market. They are categorized based on the need they fulfill, particularly in the finished pharmaceutical products.