“The success of the pharmaceutical industry in India has brought work to large numbers of the population and made affordable life-saving medication available to millions..”
The Pharmaceutical Industry in India is at the forefront of the country’s scientific industries. The industry’s scope is very wide and embraces the challenging demands of pharmaceutical production and development. This highly structured sector of the economy is approximately valued at more than $20 billion, butanding at a rate of almost 10% a year. Of all third world pharmaceutical industries, India’s is amongst the leaders in terms of scientific development, standards and range of medication produced. This ranges from straightforward medicine for headaches to complex antibiotics and sophisticated medication for heart conditions. Nearly every kind of medication is now produced within the domestic Indian pharmaceutical industry.
The industry plays its part in sustainable development through the production of critical drugs and medication, the quality of much of it being recognized and passed for use by the standards-setting agencies of America and Britain. Led and guided by assistance from foreign companies, in just half a century the Indian Pharmaceutical Industry has truly made its mark in the international market place.
The Indian Pharmaceutical Industry is made up of predominantly small-scale manufacturers, of which there are in excess of 20,000. This is the result of phemomenal expansion during the past 20 years. The top 250 enterprises control more than two-thirds of the industry and the foremost company has secured more than 6.5% of the market. The market suffers not only from excessive fragmentation, but also aggressive pricing and strict controls on pricing by the government.
The Indian Pharmaceutical Industry meets more than two-thirds of the domestic requirement for wholesale and retail medicines, medications, pills, and medicines taken by mouth or intravenously. At the heart of the industry – which includes 5 nationalised enterprises – are approximately 250 large-scale and 8,000 smaller producers. Together, they produce a whole spectrum of medicines and medications – that is to say, preparations ready to be taken by patients themselves and some 350 compounds that provide the bulk raw material for the manufacture of further drugs.
Following the de-licensing of the pharmaceutical industry, industrial licensing for most of the drugs and pharmaceutical products has been done away with. Manufacturers are free to produce any drug duly approved by the Drug Control Authority. Technologically strong and totally self-reliant, the pharmaceutical industry in India has low costs of production, low R&D costs, innovative scientific manpower, strength of national laboratories and an increasing balance of trade. The Pharmaceutical Industry, with its rich scientific talents and research capabilities, supported by Intellectual Property Protection regime is well set to take on the international market.
Thanks to de-regulation of the pharmaceutical industry, production of most medicines and medications is now free of all such restriction and producers are able to manufacture any drug that meets the approval of the Drug Control Authority. Scientifically capable and domestically self-sufficient, the Indian pharmaceutical industry has low overheads for manufacturers, minimal research and development needs, skilled personnel, government research facilities and strengthening trade balances. It’s skills and knowledge base in science and research is supported the protection of Intellectual Property rights, as the industry competes in the international arena.
INDIA’S COMPETITIVE EDGE
Skilled labour: The country has a skilled and trained workforce, that is well-educated and widely conversant in English. Competitive production of chemical compounds: Its record is second to none, especially with respect to its cost efficiency in synthesizing medical molecules. The industry both manufactures and exports complex raw materials for drug production.
Regulatory and Fiscal Infrastructure: A democracy for more than half a century, India has a sound regulatory and fiscal infrastructure, with a settled environment of foreign manufacturers and commerce.
IT: India has an excellent IT network, supported by world-reknowned colleges and universities.
The World Economy: The country’s commitment is to a laissez-faire world economy. It’s middle class of more than 69 million consumers continues to expand.
Mergers: Foreign pharmaceutical industries are finally finding big opportunities in India. Corporatisation has been widespread throughout the international industry and is finally taking place in India, too.
The pharmaceutical industry is valued at more than US$3,000 million in India and continues to expand at almost 14% annually. It is one of the biggest and most forward-looking in the third world.
With more than 20,000 approved producers, the country’s pharmaceutical industry could pass the Rs260,000 million for the year 2002, or less than 1.4% of world output. Appoximately 21% of Indian output was in raw materials of chemicals for drug production and 79% in manufactured medicines. In 2001, exports reached Rs87,000 million and imports Rs20,000 million.
The pharmaceutical industry in India is subject to strigent controls. Government price controls are imposed on a large proportion of all drug production and the potential for profit is aqffected accordingly.
The Home Market
The home market accounts for more than 84% of all drugs produced in India. The country’s producers are able to meet almost the entire domestic demand, with the exception of some new, patented medicines which still need to be imported. The value of the domestic market is currently some Rs160,000 million and expanding at about 10% annually.
Over 59% of India’s production of the raw materials for medicine production is sold overseas. The remainder is sold domestically. Exports are worth some Rs87,000 million, with approximately 56% in made-up medicines and 44% in raw chemicals. Foreign shipments are growing at an astonishing 20% or so each year, while imports are rising by less than 3% a year.
In accordance with international agreements, India now grants product patent status to medicines developed and manufactured in the country. Growth of the pharmaceutical sector is also boosted by the government allowing wholly-owned direct investment in the industry by foreign corporations.
Indian drug companies have seen recent successes in the sale of patent rights to foreign manufacturers and the domestic industry is rapidly recognizing the value of compliance with US Food and Drug Agency requirements in order to tap the North American market for its non-branded products..
R&D will secure the future growth and success of the Indian Pharmaceutical Industry. Advances in health and life-expectancy have all largely been the result of successful R&D. Research and Development is a particular area in which India’s skilled and talented scientists can collaborate with and work alongside colleagues in the international community.
Research and Development is especially important in the Indian sub-Continent, where certain diseases are rife and some health needs remain unsatisfied.
Currently, the pharmaceutical industry in India spends around 2% of turnover on research and development – considerably less than its foreign competitors, who spend around 15%. As India also joins the patent protection regime, however, the picture is likely to change and domestic expenditure on research and development is set to increase.
India is ideally placed to participate in medical trials requiring several test centers, thanks to the ready availability locally of all medical treatments and preparations to treat many conditions. Such partnerships would bring benefits to both parties. According to representative organizations of the industry, chemo-medical companies are using the resources of contracted-out research agencies.
Thanks to its abundance of medical talent, the Pharmacy Industry in India provides a competitive base for medical trialing, for which it has a great record and many overseas manufacturers are already making good use of these facilities.
Both pharmaceutical and biotechnological industries qualify for government grants and incentives of up to 150%, with research coporations qualify for tax-breaks of up to 10 years. In addition, the Indian Government has established an R&D fund to promote excellence of R&D in the development of the pharmaceutical sectoir.