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Indian Pharmaceutical Industry Governmental Regulations And Policy Changes

The environment in which the Indian pharmaceutical industry is runing is altering at really slow rate soon, but is likely to alter well and faster in the hereafter.

The Indian pharmaceutical industry grew at really slow gait from 1947-1970, chiefly due to the deficiency of inducements and the failure of the authorities to set-up solid regulative model.

These yearss, the industry is characterized by many governmental ordinances and policy alterations, smothering monetary value controls, exact controls on preparations, and an absence of international patent protection. During 1970, the Indian Patents Act ( IPA ) and the Drug Price Control Order ( DPCO ) were approved. Although the DPCO acted as a buffer against pharmaceutical companies doing free pricing illegal, it satisfied the end of supplying quality drugs to the populace at reasonable rates.

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The debut of IPA – which did non place merchandise patents but merely procedure patents, provided a major push to the industry and its companies, which through the process of reverse-engineering, began to bring forth bulk drugs and preparations at lower costs. This led to high decomposition in the industry, due to the visual aspect of a figure of little houses.

The Indian Pharma Industry

Today about 24,000 companies – large, medium and little, skirmishing for a USD 3.9 Billion market. The Indian pharmaceutical market is ranked 12th globally. About 300 houses are in the organized sector, about 15,000 are in the little graduated table sector, and the remainder are really little without any economic systems of graduated table.

In India, manufactures over 400 volume drugs and around 60,000 preparations, which are dispersed by 5,000,000 chemists all over the state.

The Indian pharmaceutical industry is go throughing through a moving ridge of consolidation, with the aim to do stronger their trade name equity and distribution in what is fundamentally a branded-generics market.

The Indian pharmaceutical industry has come a drawn-out manner, being about non-existent before 1970 to a outstanding provider of health care merchandises, run intoing about 95 % of the state ‘s pharmaceuticals demands. The domestic pharmaceutical gross revenues have amplified from Rs. 4 bn in 1970-71 to Rs. 214 bn in 2002, at a CAGR ( Compound Annual Growth rate ) of 13.7 % per annum. The entire Indian production constitutes about 1.3 % of the universe market in value footings and, 8 % in volume footings. The per capita usage of drugs in India, stands at US $ 3, is amongst the lowest in the universe, as compared to Japan – US $ 412,

Germany – US $ 222 and USA – US $ 191.

General Features:

Human organic structure is the market place of pharmaceutical industry, but every bit long as organic structure hosts diseases. Therefore, stipulation for the growing of the pharmaceutical industry is keeping and spread outing diseases.

A cardinal scheme to carry through this end is the development of drugs that simply mask symptoms while avoiding the curring or riddance of diseases. This explains why most prescription drugs marketed have no proved efficaciousness and simply mark symptoms.

For farther enlargement of their market, the drug companies are continuously looking for new applications for the usage of drugs they already market.

Another scheme to spread out pharmaceutical market is to do new diseases with drugs. For illustration, all cholesterol-lowering drugs presently in the market are known to increase the hazard of developing cancer- but merely after the patients has been taking the drug for several old ages.

Climbing the value concatenation

InIndia, pharmaceutical industry is lifting up the value concatenation. From being a clean contrary technology industry focused on the domestic market, the industry is traveling towards basic research driven, export oriented world-wide presence, supplying broad scope of value added quality merchandises and services. Government policies will play an important function in specifying the hereafter of the pharmaceutical industry. The merchandise patent government which has come into consequence from January 2005 will take to long-run enlargement for the hereafter.

In present scenario, the growing of a domestic pharmaceutical company is critically dependent on its curative presence. The old and mature classs like anti-infective, vitamins, and anodynes are de-growing while ; new lifestyle classs like Cardiovascular, Central Nervous System ( CNS ) , Anti-AIDS, Anti-Cancer and Anti Diabetic are spread outing at double-digit growing rates.

The new tendencies

Increased generic incursion, intense competition, atomization of the industry has detrimentally impacted the overall value growing of the domestic pharmaceutical market. In this scenario, to raise in the domestic market, pharmaceutical companies are continually eyeing for invention, debut of fresh value added merchandises, merchandise life rhythm direction and enlarging their market range.

Indian companies are seting their work together to tap the generic drugs markets in the regulated high border markets of the developed states. The US market will stay the most profitable market for the Indian companies led by its market size and the power of blockbuster drugs traveling off patent. An predictable US $ 45bn of drugs expected to travel off patent by 2007 in US entirely.

Outsourcing in field of R & A ; D and fabrication is the following greatest event in the pharmaceutical industry. Strengthening costs, run outing patents, low R & A ; D cost and market kineticss are driving the MNCs to outsource both fabrication and research activities. India with its appropriate chemical science accomplishments and low cost advantages, together in research and fabrication joined with skilled work force will pull a batch of concern in yearss to come.

Indian companies have started puting more and more into R & A ; D activity at place which is bound to one twenty-four hours give birth to original merchandises invented in India and patented globally. This will heighten the bottom-line of Indian Pharmaceutical companies. Contract R & A ; D is another off-shoot of this phenomenon where MNCs set Indian companies to get down research in the specified countries of their large research undertakings. India offers cost advantages and skilled manpower for the thought.

The William claude dukenfields of Bio-technology and stem-cell Research has already produced brilliant consequences. Humuno- insulin and Hepatitis-B vaccinums are bring forthing assets for India although in its babyhood.

FMHG- ( Fast Moving Health Goods ) is fresh term introduced into advertisement universe. Many a company has taken the direct manner to the consumer ‘s place merely like consumer merchandises. This has led to an addition in the happening of self-medication and lifting gross revenues volumes for the industry.

Non-allopathic medicines is another field which is demoing good promise in footings of people ‘s taking. With new modern engineering and standardisation in the fabrication and formulating patterns, the curative consequences with alternate system of medical specialties are going more predictable. This has led to the outgrowth of a wholly new field of therapeutics. Many MNC ‘s have besides adopted these signifiers and reaped the benefit of a ready market.

Export of bulk-drugs, preparations and the API ( Active Pharma Intermediates ) have of late become the tendency. A company worth its salt has an export unit. The Government provides many financial inducements for exports such as Excise responsibility exclusion, Exports subsidy, packing credits ; export Financing, IT advantages, freedoms from Local Torahs etc. There are a figure of illustrations where the companies ongoing as a 100 % EOUs ( Export Oriented Units ) and subsequently diversified into local gross revenues.

Key Players

Key Players in the Indian Pharmaceutical Industry are:

Aarti Drugs

Abbott India

Ajanta Pharma



Anglo-French Drugs


Astrazeneca Pharma

Aurobindo Pharma

Aventis Pharma

Cadila Health



Dr. Reddy

Elder Pharma


Fulford India


German Redresss

Glaxo Smithkline

Ind Swift Lab

Ipca Labs

J B Chemical

Jagson Pharma

K D L Biotech


Krebs Biochem


Lyka Labs


Medicorp Tech


Natco Pharma

Nicholas Piramal


Orchid Chemicals


Panacea Bio




Raptakos Brett

R P G Life Sciences

Shasun Chemicals

Siris Limited

Sterling Biotech

Paces Arcolab

Sun Pharma

Suven Life Sciences

Downpour Pharma

Unichem Lab


Wyeth Ltd

Zandu Pharma


In India, medicines represent between 10 % to 15 % of entire wellness attention costs. This will non lift significantly when merchandise patents are introduced, for two grounds. First, over 90 % of the medical specialties in the Indian market are now off-patent worldwide. Second, for most of those that would be patentable, there are close options available which provide efficient competition.

The echt ground for the deficiency of entree to medical specialties and other signifiers of health care is the predominating chokehold of Governmental regulation of the Healthcare sector.

This suffering image can, nevertheless, change dramatically if the Government takes prudent stairss such as easing the DPCO and other ordinances, supply sufficient budgetary proviso for Healthcare ( Govt. spends a miserly 1 % of GDP on health care ) , allow Indian companies to purchase engineering, allows Indian companies to purchase finance, set up subordinate companies abroad, allows FDI into the sector, freely allows affiliations with MNCs, takes away limitations on exports to some states.

The industry on its ain must take stairss to increase its committedness to R & A ; D, quality, work force development, exports, market development and consolidation for economic systems of graduated table. The development of traditional system of medicine like Ayurveda, Herbal and other systems of intervention must be researched into and standardized. Documentation on their curative benefits must be generated and put unfastened for one and all to analyze and analyse. Ayurveda can give India the film editing border that the Pharma industry needs against a Patented government dominated by MNCs.

Hence, the industry has a bright hereafter.

Plague Analysis

To understand the deductions of environment on any industry it is really of import to analyze the 4 central influencers on the industry viz. Political, Economic, Social and Technological factors. It is instead unfortunate that in India these factors have a instead disproportional influence on the operation of a commercial organisation. From the yearss of independency the concern environment has been excessively regulated by a smattering of administrative officials, jobbers, business communities and politicians. Its merely a decennary since the state has seen an outgrowth of a political idea that encourages free endeavor.

Political Factors

1. These yearss there is political uncertainness in the air. A combination of diverse political idea have got jointly to cobble jointly a rag-tag alliance, that is riddle with ideological contradictions. Therefore, any consistent political or economic policy can non be expected. This muddies the investing field.

2. Minister in charge of the industry has been endangering to oblige even more rigorous Price Control on the industry than earlier. This is throwing many an investing program into the stagnation.

3. DPCO which is the bible for the industry has in consequence worked contrary to the stated aims. DPCO nullifies the market forces from promoting competitory pricing of goods dictated by the market. Now the pricing is determined by the Government based on the sanctioned costs irrespective of the existent costs.

4. In January, 2005 the state goes in for IPR ( Intellectual Property Rights ) government, popularly known as the Patent Act. This Act will impact the Pharmaceutical Industry the most. Therefore far an Indian company could get away paying a patent fee to the discoverer of a drug by fabricating it utilizing a different chemical path. Indian companies exploited this jurisprudence and used the reverse-engineering path to contrive a batch of alternate fabrication methods. A batch of money was saved this manner. This besides encouraged viing company to market their versions of the same drug. That meant that the drosss and hint elements found in different trade names of the same substance were different both in making every bit good as in quantum.

Therefore different trade names of the same medical specialty were genuinely different. Here Branding really meant quality and a purer trade name really had purer active ingredient and lesser or less toxic drosss.

Product patent government will extinguish all this. Now, a patented drug would be manufactured utilizing the same chemical path and would be manufactured by the discoverer or his licentiates utilizing the chemicals with same specifications. Therefore, all the trade names of the same active ingredient would non hold any difference in pureness and drosss. The different trade names would hold to vie on the footing of non input-related inventions such as packaging, colour, spirits, Excipients etc.

This is the biggest alteration the environment is traveling to enforce on the industry. The selling attempt would be now focused on logistics, communications, economic system of operation, extra-ingredient inventions and of class pricing.

5. In Pharma industry there is a immense PSU section which is inveterate ill and extremely inefficient. The Government puts the excesss generated by efficient units into the monetary value equalisation history of inefficient units thereby unduly subsidising them. On a long term footing this has made practically everybody inefficient.

6. Effective the January, 2005 the Government has shifted from bear downing the Excise Duty on the cost of fabricating to the MRP thereby doing the finished merchandises more dearly-won. Just for a few excess vaulting horses the current authorities has made many a life salvaging drugs unaffordable to the hapless.

7. The Government provides excess drawbacks to some units located in specified country, supplying them with subsidies that are unjust to the remainder of the industry, conveying in a skewed development of the industry. As a consequences Pharma units have come up at topographic point unsuitable for a best cost fabrication activity.

Economic Factors

1. India spends a really little proportion of its GDP on health care ( A mere 1 % ) . This has stunted the demand and therefore the growing of the industry.

2. Per capita income of an mean Indian is low ( Rs. 12,890 ) , hence, passing on the health care takes a low precedence. An Indian would see a physician merely when there is an exigency. This has led to a mushrooming of unqualified physicians and spread of non-standardized medicine.

3. The incidence of Taxes are really high. There is Excise Duty ( State & A ; Central ) , Custom Duty, Service Tax, Profession Tax, License Fees, Royalty, Pollution Clearance Tax, Hazardous substance ( Storage & A ; Handling ) licence, income revenue enhancement,

Stamp Duty and a host of other levies and charges to be paid. On an norm it amounts to no less than 40-45 % of the costs.

4. The figure of Registered Medical practicians is low. As a consequence the range of Pharmaceuticals is affected adversely.

5. There are merely 50,00,000 Medical stores. Again this affects adversely the distribution of medical specialties and besides adds to the distribution costs.

6. India is a high involvement rate government. Therefore the cost of financess is dual that in America. This adds to the cost of goods.

7. Sufficient storage and transit installations for particular drugs is missing. A survey had indicated that about 60 % of the Retail Chemists do non hold sufficient infrigidation installations and shop drugs under sub-optimal conditions. This affects the quality of the drugs administered and of class adds to the costs.

8. India has hapless roads and rail web. Therefore, the transit clip is higher. This calls for higher stock list transporting costs and longer bringing clip. All this adds to the unseeable costs. Its lone during the last twosome of old ages that good quality main roads have been constructed.

Socio-cultural Factors

1. Poverty and associated malnutrition dramatically worsen the incidence of Malaria and TB, preventable diseases that continue to play mayhem in India decennaries after they were eradicated in other states.

2. Poor Sanitation and contaminated H2O beginnings prematurely end the life of about 1 million kids under the age of five every twelvemonth.

3. In India people prefer utilizing family interventions handed down for coevalss for common complaints.

4. The usage of magic/tantrics/ozhas/hakims is prevailing in India.

5. Increasing pollution is adding to the health care job.

6. Smoke, gutka, imbibing and hapless unwritten hygiene is adding to the health care job.

7. Large joint households transmit catching diseases amongst the members.

8. Cattle-rearing encourage diseases communicated by animate beings.

9. Early kid bearing affects the wellness criterions of adult females and kids.

10. Ignorance of vaccination and inoculation has prevented the obliteration of diseases like infantile paralysis, chicken-pox, small-pox, epidemic parotitiss and rubeolas.

11. Peoples do n’t travel in for inoculation due superstitious beliefs and any kind of complaint is considered as a expletive from God for wickednesss committed.

Technological Factors

1. Advanced automated machines have increased the end product and reduced the cost.

2. Computerization has increased the efficiency of the Pharma Industry.

3. Newer medicine, molecules and active ingredients are being discovered. As of January 2005, the Government of India has more than 10,000 substances for patenting.

4. Ayurveda is a good recognized scientific discipline and it is supplying the industry with a cutting border.

5. Progresss in Bio-technology, Stem-cell research hold given India a measure frontward.

6. Humano-Insulin, Hepatitis B vaccinums, AIDS drugs and many such molecules have given the industry a pioneering position.

7. Newer drug bringing systems are the inventions of the twenty-four hours.

8. The immense unemployment in India prevents industries from traveling to the full automatic as the Government every bit good as the Labor Unions voice complains against such constitutions.

Indian Pharmaceutical Industry: SWOT analysis

It is frequently said that the pharmaceutical industry has no repeating factor attached to it. Irrespective of whether the economic system is in recession or in an upturn, the general belief is that demand for drugs is likely to turn steadily over the long-run. True in some sense. But are at that place hazards? This article gives a position of the Indian drug company industry by transporting out a SWOT analysis ( Strength, Weakness, Opportunity, Threat ) .


1. Indian with a population of over a billion is a mostly undeveloped market. In fact the incursion of modern medical specialty is less than 30 % in India. To set things in position, per capita outgo on wellness attention in India is US $ 93 while the same for states like Brazil is US $ 453 and Malaysia US $ 189.

2. The growing of in-between category in the state has resulted in fast changing life styles in urban and to some extent rural centres. This opens a immense market for lifestyle drugs, which has a really low part in the Indian markets.

3. Indian makers are one of the lowest cost manufacturers of drugs worldwide. With a scalable labour force, Indian industries can bring forth drugs at 40 % to 50 % of the cost to the remainder of the universe. In some instances, this cost is every bit low as 90 % .

4. Indian pharmaceutical industry posses outstanding chemical science and procedure reengineering accomplishments. This adds to the competitory advantage of the Indian companies. The strength in chemical science accomplishment assist Indian companies to develop procedures, which are cost effectual.


The Indian drug company companies are spoiled by the monetary value ordinance. Over a period of clip, this ordinance has reduced the pricing ability of companies.

The NPPA ( National Pharma Pricing Authority ) , which is the authorization to make up one’s mind the assorted pricing parametric quantities, sets monetary values of different drugs, which leads to take down profitableness for the companies. The companies, which are lowest cost manufacturers, are at advantage while those who can non bring forth have either to halt production or bear losingss.

2. Indian drug company sector has been marred by deficiency of merchandise patent, which prevents planetary drug company companies to present new drugs in the state and discourages invention and drug find. But this has provided an upper manus to the Indian drug company companies.

3. Indian drug company market is one of the least penetrated in the universe. However, growing has been slow to come by. As a consequence, Indian big leagues are trusting on exports for growing. To set things in to perspective, India accounts for about 16 % of the universe population while the entire size of industry is merely 1 % of the planetary drug company industry.

4. Due to really low barriers to entry, Indian drug company industry is extremely fragmented with approximately 300 big fabricating units and about 18,000 little units spread across the state. This makes Indian pharma market progressively competitory. The industry witnesses monetary value competition, which reduces the growing of the industry in value term. To set things in position, in the twelvemonth 2003, the industry really grew by 10.4 % but due to monetary value competition, the growing in value footings was 8.2 % ( monetary values really declined by 2.2 % )


Migration into a merchandise patent based government is likely to transform industry lucks in the long term. The new patent merchandise government will convey with it new advanced drugs. This will increase the profitableness of MNC drug company companies and will coerce domestic drug company companies to concentrate more on R & A ; D. This migration could ensue in consolidation every bit good. Very little participants may non be able to get by up with the disputing environment and may yield to giants.

2. Large figure of drugs traveling off-patent in Europe and in the US between 2005 to 2009 offers a large chance for the Indian companies to capture this market. Since generic drugs are trade goods by nature, Indian manufacturers have the competitory advantage, as they are the lowest cost manufacturers of drugs in the universe.

3. Opening up of wellness insurance industry and the expected growing in per capita income are cardinal growing drivers from a long-run position. This leads to the enlargement of health care industry of which drug company industry is an built-in portion.

4. Bing the lowest cost maker combined with FDA approved workss, Indian companies can go a planetary outsourcing hub for pharmaceutical merchandises.


1. There are definite over the patent government sing its current construction. It might be possible that the new authorities may alter certain commissariats of the patent act formulated by the preceding authorities.

2. Menaces from other low cost states like China and Israel exist. However, on the quality forepart, India is better placed comparative to China. So, distinction in the contract fabricating side may decline.

3. Short-run menace for the drug company industry is the uncertainness sing the

execution of VAT. Though this is likely to hold a negative impact in the short-run, the deductions over the long-run are positive for the industry.

Poter ‘s 5 Forces Analysis:

Business environment in today ‘s universe is highly competitory and in economic sciences paralance where perfect competition exists, the net incomes of the houses runing in that industry will go zero.

However, this is non possible because, no company is a monetary value taker, they strive to make a competitory advantage to boom in the competitory scenario.

Industry Competition:

This one of the most competitory industries in the state with every bit many as 10,000 different participants contending for the same pie. Competition in the industry can be measured from the fact that the top participant in the state has merely 6 % market portion, and the top mulct participants together have approximately 18 % market portion.

Therefore, concentration ratio for this industry is really low. High growing prospective market it attractive for new participants to come in in the industry.

Fixed cost turnover, which is one of the gages of fixed cost demands, tell us that in bigger companies this ratio is in the scope of 3.5 to 4 times. For smaller companies, it would be even higher.

Players that are focused on a peculiar part, have a better bent of the distribution channel, doing it easier to win.

Product distinction is one key factor, which gives competitory advantage to the houses in any industry. In pharmaceutical industry, merchandise distinction is non possible since India has followed procedure patents till day of the month, with jurisprudence favoring impersonators. The cost fight is a driver non merchandise distinction. However, companies like Pfizer and Glaxo have created large trade names in over the old ages, which act as a merchandise distinction tools.

Dickering power of purchasers:

Alone characteristic of pharmaceutical industry is that the terminal user of the merchandise is different from the physicians. Consumer has no pick but to purchase what physicians say.

In this industry, the purchasers are scattered and they as such does notwield much power in the pricing of the merchandises. However, authorities with its policies, plays an of import function in modulating pricing through the NPPA ( National Pharmaceutical Pricing Authority ) .

Dickering power of providers:

Pharmaceutical industry depends upon several organic chemicals. Chemical industry is once more really competitory and disconnected. Chemicals used in pharmaceutical industry are mostly a trade good.

Suppliers have really low bargaining power and pharmaceutical companies can exchange from their providers without incurring really high cost. However, providers can travel frontward integrating to go a pharmaceutical company. Companies like Orchid chemicals and Sashun chemicals were fundamentally chemical companies, who turned themselves into pharmaceutical companies.

Barriers to entry:

This industry is one of the most easy accessible industries for an enterpriser in India. Capital demand for this industry is really low, regional distribution web is easy, since the point of gross revenues is restricted in this industry in India.

Making trade name consciousness and franchisee amongst physicians is really of import for endurance.

Quality ordinance by the authorities may set some hindrance for set uping new fabrication operations.

Impending new patent government will raise the barriers to entry. But it is improbable to deter new entrants, as market for generics will be as immense.

Menace of replacements:

Pharmaceutical industry has one of the greatest advantages. Whatever happens, demand for pharmaceutical merchandises continues and the industry thrive. One of the grounds for high fight in the industry seems to hold an infinite hereafter.

However, in recent times, the progresss made in the field of biotechnology, can turn out to be a menace to the man-made pharmaceutical industry.


This industry is dynamic in nature.

Form of competition will be different. It will be between big participants.

In India, companies like Cipla, Ranbaxy and Glaxo are likely to be cardinal participants.

Entry barriers will increase traveling frontward.

Economies of graduated table will play an of import function.

Last but non least, in a huge state of India ‘s size, authorities excessively will hold bigger function to play.

Environment of the industry is besides good, and industry has a bright hereafter.


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