 Budget 2005-06: Pharma
The Indian Pharmaceutical industry is highly fragmented with about 10,000 manufacturing units (300 in the organized sector). The top ten companies make up for more than third of the market. India accounts for about 8% of the world's pharma pie in volume terms, but only 1% in value terms. Will the recently introduced Patent Regime change all that? Read more
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Corpus for the R&D fund to be increased in phases. Stable policy environment and incentives to be provided to help the two industries become world leaders |
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Units in knowledge-based industries such as pharma and biotech to be provided equity support through the SME Growth Fund |
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The exemption date for weighted deduction of 150% of in-house R&D facilities of pharmaceutical and biotechnology companies has been extended by 2 years to March 31, 2007 |
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Also, the exemption for 100% deduction of profits of companies carrying on scientific R&D, which is approved by the Department of Scientific and Industrial Research has also been extended by 2 years to March 31, 2007 |
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Custom duty for 9 specified pharma and biotechnology machinery cut to 5% |
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Corporate tax pruned to 30% from 35% |
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The extension of deduction for R&D expenditure is a positive for the big players in the domestic pharma sector. However, the industry had expected such exemption to continue upto 2010, which did not happen |
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The pruning of corporate tax too will positively impact pharma companies. |
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However, the budget was silent on span of control of NPPA's, as well as the new patent regime |
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Though the budget theme for the India pharma and biotechnology sector is a positive promising stability in policy, the industry would not be overtly satisfied with what they got. For one, though the FM did extend the exemption date on weighted deductions, he did not allow regulatory and legal expenses incurred on patent challenges to be included in this. The industry's long standing demand of 100% tax exemption on overseas earnings accruing from out licensing of IPRs, if re-invested in R&D, was also not met. The role of NPPA has also not been made clear. |
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Net, net Budget 2005-06 left much to be desired by the pharma sector. Notwithstanding this, the policy movement is clearly forward and progressive. Our outlook on the Indian pharma sector is thus, selectively positive over the next 3 to 5 years. |
Dr. Brian Tempest, CEO - Ranbaxy Laboratories Limited
"R&D should be encouraged by not only continuing fiscal incentives but by enhancing such incentives in order to make India competitive in the global market place. This will help the country leverage its scientific skills." |
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The weighted deduction for R&D expenditure should continue upto 2010 and should be enhanced from current 150% to 200%. To improve international competitiveness this must also allow expenditure incurred for regulatory and legal expenses incurred for patent challenges outside India, as well as for land and buildings for new R&D facilities. |
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100% Tax exemption on overseas earnings accruing from out licensing of IPRs, if re-invested in R&D. |
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The span of control of NPPA to be reduced. A Settlement Commission to be appointed to avoid delays in litigation. |
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Custom duty cuts for life saving drugs. |
| Budget 2002-03 |
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Budget 2003-04 |
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Budget 2004-05 |
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The Finance Minister announced a 'significant reduction in the span of control' of the DPCO.
The 150% exemption that is available on the R & D expenditure would now include the costs of filing a patent, the cost of clinical trials and the cost of bio-studies.
The budget has also hiked the allocation for the health and family welfare ministry from Rs 49.2 bn to Rs 57.8 bn for the year 2001-2002. Of this Rs 1.8 bn would be allocated to combat AIDS.
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Anti AIDS drugs to be fully exempt from excise duty.
Specific drugs used for treatment of Cancer and other critical diseases would be exempt from custom duty. Incentives earlier given on such drugs, which are now manufactured indigenously, have been charged 5% customs duty.
Customs duty on Glucometers used for diabetes reduced from 25% to 10%.
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All drugs and materials used in clinical trails to enjoy customs and excise duty exemption.
The list of life saving drugs that enjoys tax exemptions or concessional tax rates of 5% to be expanded.
Customs duty on Glucometers and Glucomteric strips reduced to 5% from existing 10%.
The government has proposed a health insurance scheme. As per this insurance plan, an individual will get a cover of Rs 30,000 in case of hospitalization for a premium of just Rs 365 a year. The government aims to bring 5m families who are below the poverty under the coverage of this scheme.
Concessions under the section 10 (23G) to be granted to institutions lending to hospital with more than 100 beds. Depreciation rate on life saving medical instruments increased from 25% to 40%
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| [Read more on Budget 2002-03] |
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[Read more on Budget 2003-04] |
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[Read more on Budget 2004-05] |
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| Key Positives |
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| Exports thrust - Indian companies are following a two-pronged approach. The first approach is weaved around looking for an opportunity to tap an existing patent viz. challenge the patent of existing products or wait for the patent to expire and then launch the generic version in the lucrative markets of US and Europe. The second revenue stream is an even more ambitious. Top Indian companies plan to offer research and development (R&D) services to global majors or carry out work on their own. Consequently, India's pharma exports have clocked a CAGR of 23% between 1993-2004 (Source: ICRA).
| Cost competitiveness - A new concept that is gaining momentum in the pharma industry is contract research apart from contract manufacturing. Given the low cost high quality advantages, Indian companies are poised to benefit from contract research business on behalf of multinationals. As for contract manufacturing, large global pharmaceutical companies are finding it profitable to outsource production. To cash in on these opportunities, many large production houses in the country are becoming US FDA compliant.
| Structural changes - The penetration of health insurance is abysmally low in the country. The entry of private players would not only bring in quantum leap in the health insurance business but also increase capital inflows into this sector. It would also bring in the concept of managed healthcare in the country. This would finally lead to overall increase in per-capita usage of drugs.
| New growth opportunities - In spite of the price war, the domestic pharma industry continues to show decent growth rates, led by the chronic therapeutic (lifestyle) segment like anti-diabetic, cardiovascular and central nervous system. Higher awareness, exposure to newer therapies and aggressive introduction of new drugs at a reasonable price has been the key driver of growth in the chronic/lifestyle segment. This trend is likely to continue going forward.
| Shift towards product patent regime - One of the positive developments has been the shift towards product patent regime from 2005 onwards. This will lead to a structural change in the industry, which will encourage innovation and greater investment in R&D. While the there would not be any impact in the short term, in longer term this will lead to strengthening and consolidation of the industry.
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| Key Negatives |
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| Lower end of value chain - Indian companies are cost competitive in manufacturing bulk drugs, which has made them an outsourcing destination for the global pharma majors. But this is lower end of the pharma value chain and is basically a commodity making skill due to low entry barriers. Also, the Indian industry still lacks facilities and resources to develop a molecule, conduct clinical trials and then launch the product. Indian companies will thus have to depend on their international peers to undertake the more expensive clinical trials and product launches.
| Weakness in domestic markets - Fierce price competition has become order of the day for the domestic pharma industry, which has restricted the ability of the domestic pharma market to grow in the value terms. Due to its highly fragmented structure, the pricing power of the players has been pruned. The Indian markets have traditionally been and continue to remain price sensitive and premium pricing of product is extremely difficult to maintain.
| Stumbling blocks - Indian companies have been trying to enter US markets through para IV filings. However, in recent times the industry has seen certain setbacks. This has reduced the companies' ability to generate strong cash flows to invest in ambitious R&D activities. This might lead to delay in the R&D plans of the pharma majors of the country.
| Patent regime - New patent regime brings in lot of promises for the industry in India, but it might not be good for the smaller players in the industry, as they will not be able to survive in the environment leading to consolidation of the industry.
| Government control - This attribute simply refuses to go away, despite all the overall moves to liberalise the industry. DPCO still continues.
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