he Sanskrit synonym for drug is "Oshadhi’, references of which are abundant in the most ancient scriptures of the Hindus, the ‘Rigveda’. But the term has been used in it for wheat sprouts as well. Oshadhi simply ment any substance that could make a person healthy. Indian medicine conventionally attributes its fatherhood to Twin-Gods or ‘Ashvini-kumars’.

Indian ancient medical treaties comprise of ‘Charak’ and ‘Sushrut’ samhitas. In these, we find a mention of surgery also. Form the beginning of the Christian era, Indian medicine started an exchange of knowledge with the Greek and Chinese civislsations. After the tenth century AD, this exchange was extended to Arab scientists who were actively involved in achieving ‘Alchemy’. Even thought the dream of Alchemy never came true, the related experiments laid the foundations of modern chemistry. Salsts of metals like iron, copper, lead, silver and gold became common very soon as an integral part of medical practice.

It’s All Greek

Modern medicine owes its legacy to the Greeks whose physicians developed various methods of preparing’extracts’ form crude drug. The human race cannot forget the name of the veteran physician, Galen. His knowledge and method of preparation alcoholic extracts of crude drugs was precise and accurate. He was the person who, for the first time in human history, devised a method for standardizing the extracts of crude drugs. Hence today, extracts of crude drugs are rightly named after him as ‘Galenicals’.

Renaissance of Medicine

During and after the Renaissance in Europe, every branch of science started developing and flourishing. Medicine was no exception. Two examples can be quoted here, fox-glove and cinchona. Fox-glove was indigenous to England and cinchona was imported form Latin America, after discovering its potent anti-malarial activity. Dioxin form fox-glove and quinine form cinchona are used as medicines even today. Scientists started exploring the active principles of crude drugs and tried to isolate and purify them.

In the first five decades of the nineteenth century, scientists could isolate and purify most of the active principles from crude drugs which were known to medical practice. Later, all these active principles were collectively termed as alkaloids : quinine, quinidine, cinchonine, digitoxigen, morphine, colchicine, codeine and strychnine, etc. The list became unending! The isolation and urification of alsalodids was and excellent groundwork for later scientists, for their’ synthetic’ activities. For example, heroin was prepared form morphine with the simple process of acetylation.

The Modern Era

The modern pharmaceutical industry began in Th 19^th century, with the discovery of highly active medicinal compounds that could be manufactured most efficiently on a large scale. As these compounds replaced the herbal medicines of earlier times, the occurrence and severity of such diseases as pernicious anemia, rheumatic fever, typhoid fever, lobar pneumonia, poliomyelitis, syphilis and tuberculosis were greatly reduced. Pharmaceutical industrial research ha greatly aided medical progress. Of the 66 valuable drugs introduced since aspirin in 1899, as many as 57 were discovered and then produced in industrial laboratories.

What Exactly Is a Drug ?

The medical jurisprudence of every nation defines the term ‘drug’with a minor difference, here and there. The definition of ‘drug’ given by the World health organization(WHO) is the best guideline : ‘nay substance or mixture of substances manufactured, sold, offered for sale, or represented for use in the diagnosis, treatment, mitigation, or prevention of disease, abnormal physical state, or the symptoms thereof in man or animal; [and for use in ] restoring, correcting, or modifying organic function in man or animal’.

Form this definition, it is clear that virtually everything has been included in defining a ‘drug’.

Pathbreaking Discoveries

The history of drug development in the 20^th century is very elaborate, featurijhng thousands of milestone discoveries of which, three are particularly noteworthy :

1. The discovery of sulfonamides (foundation of modern chemotherapy)
2. The discovery of penicillin, which led to discovery of hundreds of poten antibiotics.
3. The discovery of prostaglandins and endorphins (the beginning or our understanding of various endogenous molecules nad processes which then became the foundation of modern medicine).

The world-wide pharmaceutical industry is relatively young. It began to emerge as a major industry only in the mid-1930s. The introduction of the first sulfonamide in 1935, Prontosil, introduced by G. Domagk, stimulated interest in pharmaceutical research and set the stage for the successful development of penicillin. During World War II, leadership in new drug discoveries shiffed form Europe to the USA. American and Japanese companies substantially increased their research and development efforts. Many prescription drug firms began to produce other health-related products such as Over-The_Counter(OTC) drugs, veterinary products and agricultural chemicals. Some also started manufacturing medical equipment's, medical devices, diagnostic, diagnostic products and hospital supplies.

Extending The Frontiers Of Progress

The world pharmaceutical industry has shown tremendous progress during the last three decades. This Progress has been multi-faceted. It has made its presence felt in all fields of the pharmaceutical industry, like process technologies, discovery and synthesis of new drugs, novel drug delivery systems, biotechnology's, etc,.Consequently , newer, better and safer drugs are available for a wide spectrum of diseases. The total world-wide annual sales of Pharmaceutical Manufactures Association (PMA) grew from $4.9 billion in 1967 to $50.1 billion in 1989 to $247.9 billion in 1994 and is projected at $342.0 billion in 1999.

The World View

Germany is the largest exporter and importer of pharmaceutical products. The USA, Japan, France and the UK are the other important exporters and importers of pharmaceutical products. The market is dominated by multinational corporations (MNCSs). The predominate positions and status of MNCs in the market can be gauged from the fact that the 50 largest companies not only product 66% of the world’s output of drugs and pharmaceuticals but also supply 50% of the pharmaceutical requirement of the developing countries.

The Indian Pharmaceutical Industry

The Indian Pharmaceutical Industry is now about a century of. At the beginning of the present century, the drug industry was practically non-existent in India, and almost all the requirements of pharmaceuticals were imported form abroad, mainly form the UK, France and Germany. The indigenous production of these medicines was, however, started in 1901 with the establishment of the Bengal Chemical and Pharmaceutical Works by Acharya P.C. Roy in Calcutta with a capital of Rs. 25,000. The unit started with the production of simple galenicals. In 1907, Alembic Chemical Works was established by T.K. Gajjar and Raj Mitra B.D. Amin. But these nits faced several problems like competition form overseas producers, lack of support form the Government and the prejudice against indigenous allopathic medicines. The pharmaceutical industry that existed in India hten was based on traditional, Ayurvedic and Unani medicines.

Alopathy Mkes Inroads

The allopathic system soon became popular as it offered immediate relief to patients. Nder its influence, the indigenous system virtually lost ground. This expanded the market of western pharmaceutical manufactures. Nine western firms had been in existence before 1915. Almost all of them started as branches, selling the products of heir parent firms. It was basically in industry comprising small and medium sized plants engaged in making formulations based on imported bulk drugs. Between 1904 and 1907, four research institutes viz. the Haffkine Institute, King Institute , Central Research Institute and Pasteur Institute were established which undertook research in tropical diseases like malaria, typhoid and cholera.

On The Battlefront

The real stimulus for domestic production of pharmaceuticals came during World War I (1914-1918), when there was a steep rise in demand and a drastic reduction in imports. The production of quininie salts registered a substantial increase. Besides, the production of new items like urea-stilbamine, caffeine form tea waste and surgical dressings was taken up for the first time. The industry also took up the production of biological products like sera and vaccines, anesthetics like ether and chloroform and coal tar distillation products like naphthalnce and cresol.In 1930, Benagal Chemical and Pharmaceutical Works started the production of Tetanus Antitoxin, basic drug.

World War II (1939-1945), was another significant landmark. By 1941, the industry took up[ the manufacture of new drugs like Indochlorhydroxy quinolone as well as a number of other alkaloids. Besides, the industry also made a a beginning in the production of chemotherapeutic drugs like arsenicla, anti-leprotic drugs and colloidal preparations of calcium, silver, mangagneses and iodine. The production of formulations based on imported bulk drugs also recorder a significant expansion during this period.

Post World War II Scenario

Post-War developments in the West which witnessed the replacement of many 9lder drugs by antibiotics and new chemotherapeutic agents placed the Indian industry at a great disadvantage. As a result, Indian companies had to stop the production of items that were manufactured during the war years, Instead, they started manufacturing formulations based on imported bulk drugs and the extraction of therapeutic agents from plant sources.

At the dawn of Independence, the pharmaceutical industry in India comprised such manufacturing units which were engaged only in the production of formulations based on imported bulk drugs. A few drugs wee, however, producted form late intermediates. The Indian Govsernment set up the Pharmaceutical Enquiry Committee to9 examine the structural imbalances of the industry which submitted its report in 1954. Its recommendations covered various aspects like licensing, foreign collaborations, pro duction of bulk drugs and selling and distribution of drugs and medicines.

The Foreign ‘Invasion’

Recognising the international character of this industry and the urgent need to develop a strong production base in the country for manufacturing drugs and medicines on a scale required in the country, the Government of India permitted the entry of transanational companies to set up units in India, to make drugs of high quality standards. Aided by the pragmeatic policies of the Government, Indian and foreign enterprises established manufacturing facilities for producing a large numbers of bulk drugs. Leading pharmaceutical form the West(notably form the USA, UK, Germany and Switzerland) came to India with their technology and resources. As a result, a wide range of products were manufactured which included antibiotics, vitamins, sulfa drugs, synthetic hormones and corticosterisds, analgesics, anti-pyretics, anti-TB, anti-dysentery, anti-diabetics and anti-malaria's, etc.

Building Blocks of growth

50 years ago, it was not sufficiently realized that basic chemicals and pharmaceuticals are two different industries. The latter depends, by an large, on the former for its growth. Unfortunately, in India, while the pharmaceutical industry had grown, the chemical industry has lagged behind. The setting up of penicillin factory at Pimpri,Pune in the early 50’s and the construction of the Indian drugs and pharmaceuticals limited (IDPL) plants at Rishikesh and Hyderabad in the 60s have been the milestones in the history of the pharmaceutical industry in the country.

These have been the foundation on which the structure of the pharmaceutical industry in India has been built. The public sector investment in the pharmaceutical industry has been the catalytic engine for the growth and distribution of drugs and medicines.

R&D to Innovate and Liberate

It is now imperative for the Indian Pharma industry to give greater emphasis to basic research for the discovery and the development of new drug molecules, as against R n D activities which have so far been mainly devoted to formulation and development. In the context of product patent protection in GATT and in order to be globally competitive, investment in research and Development by the pharmaceutical industry will have to be substantially step up to increase the focus on the discovery and development of new drug molecules. This would require a quantum jump in the investment in R and D from the present level of one to two percent of the industries turn over . The modifications in the drug policy have recognized the need for encouragement of R n D efforts . It has been decided that a new drug which is not been produced else where, if developed through indigenous R n D , would be put outside price control for a period of 10 years from the date of commercial production, in favor of the company which undertook the R n D and produced the drug.

Exporting Health

Export activity in the field of finished pharmaceuticals is comparatively recent. The industry which began as an importer of finished preparations and which, before independents, was engaged mainly in processing imported bulk material into formulations, switched over rapidly to basic manufacture. Considerable progress has been made in this direction with the result that in 1996-97, India exported finished formulations worth as much as Rs. 3509.20 crores, making pharmaceuticals an important foreign exchange earner. The export of pharmaceuticals consists mainly of basic drugs, intermediates and fine chemicals (Including quinine salts exported exclusively by the government ) and finished formulations.

Emerging as a largest International Resource

The number of bulk drugs and pharmaceutical chemicals manufactured in the country by the Indian sector today has risen to more than 600 these are produced by total of 400 companies. During the last three years, new items have been added to this list and a large number of new companies have come into the field of bulk drug manufacturing. As a sequel to this remarkable growth of output and a change in the pattern of production, India is now perhaps the largest manufacturer of the maximum number of drugs in the world.

Pharmacy as a profession

Pharmacy has been defined as the profession concerned with the art and the science of preparing from natural and synthetic sources suitable and convenient materials for distribution and use in the treatment and the prevention of disease. The word "pharmacy" has been derived from the Greek word "Pharma-con" meaning medicine or drug and a pharmacist is the person concerned with drugs or the expert on the drugs.

The physician, dentist and veterinarian may prescribe drugs and be primarily interested in the effect of those drugs on the patient, their therapeutic value and toxicology.
The nurse may administer drugs and be concerned with dosage forms, roots of administration and toxic manifestations ,but the pharmacist is the real expert on drugs. It is his legally granted responsibility to handle drugs. It is his professional responsibility to know all about those drugs. No educational program other than one in pharmacy provides the background to understand completely all about drugs.

Pharmacy as all other professional and sciences, had a common origin in primitive civilization. Upto a point in time, pharmacy and medicine were not separate occupations. The German emperor Frederick II, made the first attempt in 1240 to recognize pharmacy officially as a profession, separate from medicine the edict of Fredrick II contain regulations which provided the legal basis for the separation of pharmacy as an independent branch of health service. The separation of pharmacy from medicine did not occur early or by direct edict or regulation. It evolves slowly through much conflict, much negotiation, civil suits and finally regulation and legislation.

At present, academic programs in pharmaceutical sciences are organized at various centers of learning in India. These include colleges, institutes and departments, etc. The courses are run at the diploma,degree,masters and doctoral levels. The institutions operates under the broad framework prescribed by the statutory bodies like the All India Council for Technical Education (AICTE) and the Pharmacy Council of India (PCI) . They control the quality of pharmaceutical education in the country. The examining authority-the University – co-ordinates the academic programs of cognate subjects. Recently, health ,medical and technical universities have been constituted in various states and pharmacy education programs have been brought under their jurisdiction.