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The Indian Pharmaceutical Industry

Info: 5409 words (22 pages) Essay
Published: 3rd May 2017 in Economics

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The Indian Pharmaceutical Industry today is in the front rank of Indias science-based industries with wide ranging capabilities in the complex field of drug manufacture and technology. A highly organized sector, the Indian Pharmaceutical Industry is estimated to be worth, $4.5 billion, growing at about 8 to 9 percent annually. It ranks very high in the third world, in terms of technology, quality and range of medicines manufactured. From simple headache pills to sophisticated antibiotics and complex cardiac compounds, almost every type of medicine is now made indigenously.

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The number of purely Indian pharmaceutical companies is fairly low. Indian pharmaceutical industry is mainly operated and controlled by dominant foreign companies having subsidiaries in India due to availability of cheap labour in India at lowest cost.

Most pharmaceutical companies operating in India, even the multinationals, employ Indians almost exclusively from the lowest ranks to high level management. Mirroring the social structure, firms are very hierarchical.

Homegrown pharmaceuticals, like many other businesses in India, are often a mix of public and private enterprise.

Although many of these companies are publicly owned, leadership is passed from father to son and the founding family holds a majority share.

In 2002, over 20,000 registered drug manufacturers in India sold $9 billion worth of formulations and bulk drugs. 85% of these formulations were sold in India while over 60% of the bulk drugs were exported, mostly to the United States and Russia. Most of the players in the Indian market are small-to-medium enterprises. It has been estimated that 250 of the largest companies control 70% of the Indian market. The 1970 Patent Act., made the multinational companies to represent only 35% of the market, down from 70%, thirty years ago.

In terms of the global market, India currently holds a modest 1-2% share, but it has been growing at approximately 10% per year. India gained its foothold on the global scene with its innovatively engineered generic drugs and active pharmaceutical ingredients (API), and it is now seeking to become a major player in outsourced clinical research as well as contract manufacturing and research. There are 74 U.S. FDA-approved manufacturing facilities in India, more than in any other country outside the U.S, and in 2005, almost 20% of all Abbreviated New Drug Applications (ANDA) to the FDA were filed by Indian companies. Growths in other fields notwithstanding, generics are still a large part of the picture.

As such, the Indian pharmaceutical industry has now become the third largest producer in the world and is poised to grow into an industry of $ 20 billion by 2015, from the current turnover of $ 12 billion.

As a result, manufacturing expertise and efficiency were the only requirements to participate in this industry, creating low barriers of entry. The most critical challenge facing the global pharmaceutical industry today is the increasing cost of drug discovery and development and the increasing time to market. This is further compounded by:

Impending patent expirations of blockbuster molecules

Pricing pressures

Low public opinion

Challenges to intellectual property by increasingly aggressive generic companies.

Re-importation pressures

Medicare/Medicaid reform

Increasing regulatory hurdles

This scenario is forcing the multinational pharmaceutical companies (MNCs) to rethink their strategic options in order to exploit their core competencies across the globe. In this situation, India stands to a gain a lot because of its inherent advantages like stability, culture, cost, and educated workforce. This has led to increased alliances and collaborations as a result; the leading Indian pharmaceutical companies have become some of the most efficient manufacturing units in the world. In fact, India has the highest number of US FDA (Food and Drug Administration) certified manufacturing facilities outside USA.

The overall phenomenal progress made by the industry in the last three decades has instilled a strong belief in the government and the pharmaceutical companies in India that the country has a competitive strength and it should be enhanced by suitable policy measures and firm specific actions with regards to export, innovation, strategic alliances and investment.

The pharmaceutical policy 2002 echoes the same sentiments and has shifted focus of the policy from self reliance in drug manufacturing to the objective of enhancing global competitiveness. The introduction of policy says: “The basic objectives of the government’s policy relating to drug and pharmaceutical sector were enumerated in drug policy of 1986. These basic objectives still remain largely valid, however, the drug and the pharmaceutical industry in the country today faces new challenges on account of liberalization of the Indian economy the globalization of the world economy and on account of new obligations undertaken by India under the WTO agreements. These challenges require a change in current pharmaceutical policy and the need for new initiatives beyond those enumerated in drug policy 1986, as modified in 1994, so that policy inputs are directed more towards promoting accelerated growth of the pharmaceutical industry and towards making it more internationally competitive.

The need for radically improving the policy framework for knowledge-based industry has also been acknowledged by the government. The Prime Minister’s Advisory Council on Trade and Industry has made important recommendations regarding knowledge-based industry. The Pharmaceutical industry has been identified as one of the most important knowledge based industries in which India has a comparative advantage.”




Bengal Chemicals & Pharmaceuticals Limited (BCPL), established in 1901, is a Public Sector Undertaking (PSU) of the Government of India and is India’s first pharmaceutical company. The company was started by Prafulla Chandra Roy in Kolkata (then known as Calcutta) and has since manufactured such household Indian products as “Hospitol”, “naphthalene balls”, and “Phenol”. The company is headquartered in Kolkata and reported aggregated revenues of Rs 6,199 lakhs (US$ 138.2 million) in fiscal 2006.

The Nascent industry, however, received setbacks in the post world war-II period as a result of new therapeutic developments in the western countries that triggered natural elimination of older drugs from market usage by newer drugs like sulpha ,antibiotics, vitamins, hormones, antihistamine, tranquilizers, psycho pharmacological substances etc. This culminated in the discontinuation of local production based on indigenous materials and forced the industry to import bulk drugs meant for processing them in to formulations and for selling in the domestic market.

Figure- 2.1: stages of Growth of Indian Pharmaceutical Industry


Source: ISID Working Paper, 2006/05.

The government started to encourage the growth of drug manufacturing by Indian companies in the early 1960s. In the post independence period, Indian pharmaceutical industry exhibited four stages of growth (see Figure 2.1& 2.2). In the first stage during 1950s-60s, the industry was largely dominated by foreign enterprises and it continued to rely on imported bulk drugs notwithstanding its inclusion in the list of ‘basic industries’ for plan targeting and monitoring. Foreign firms, enjoying a strong patent protection under the Patent and Design Act 1911, were averse to local production and mostly opted for imports from home country as working of the patent. Given the inadequate capabilities of the domestic sector to start local production of bulk drugs and hesitation of foreign firms to do so, the government decided to intervene through starting public sector enterprises. This led to the establishment of the Indian Drugs and Pharmaceuticals Ltd. (IDPL) plants at Rishikesh and Hyderabad in 1961 and the Hindustan Antibiotics at Pimpri, Pune, in 1954, to manufacture penicillin. The starting of the public sector enterprises has been an important feature in the evolution of the pharmaceutical industry as it assumed initiative roles in producing bulk drugs indigenously and led to significant knowledge spillovers on the private domestic sector.

The second growth stage, of the industry took place in the 1970s. The enactment of the Indian Patent Act (IPA) 1970 and the New Drug Policy (NDP) 1978 during this stage are important milestones in the history of the pharmaceutical industry in India. The IPA 1970 brought in a number of radical changes in the patent regime by reducing the scope of patenting to only processes and not pharmaceutical products and also for a short period of seven years from the earlier period of 16 years. It also recognizes compulsory licensing after three years of the patent. The enactment of the process patent contributed significantly to the local technological development via adaptation, reverse engineering and new process development.

As there exits several ways to produce a drug, domestic companies innovated cost-effective processes and flooded the domestic market with cheap but quality drugs. This led to the steady rise of the domestic firms in the market place. The NDP 1978 has increased the pressure on foreign firms to manufacture bulk drugs locally and from the basic stage possible. Foreign ownership up to 74 per cent under the Foreign Exchange Regulation Act (FERA) 1973 was permitted to only those firms producing high technology drugs. Foreign firms that are simply producing formulations based on imported bulk drugs were required to start local production from the basic stage within a two year period. Otherwise were required to reduce their foreign ownership holding to 40 per cent. New foreign investments were to be permitted only when the production involves high technology bulk drugs and formulations thereon.

In the third growth stage or phase of evolution Indian pharmaceutical industry developed modern technology for manufacturing of all dosage forms like tablets, capsules ,liquid ,oral, injectables etc.. This domestic industry based on large scale reverse engineering and process innovation achieved near self sufficiency in production of bulk drugs belonging to various major therapeutic groups resulting in lasting impact on competitive position of Indian pharmaceutical firms in national and international markets.

During , 1980-90’s ,Indian pharmaceutical industry had emerged as one of the most export oriented sectors in Indian pharmaceutical industry with more than 30% of the production being exported to the foreign market. In 1991, domestic firms contribute about 70-80% market share in case of bulk drugs and formulations respectively. The trade deficits of seventies had been replaced by trade surpluses of 1980’s. (FIG-2.1).

The fourth stage of evolution of industry during 1990’s witnessed dramatic changes in the policy regime governing the pharmaceutical industry. The drug de-licensing, hundred percent foreign investments is permitted through automatic route and price control has been significantly reduced. One of the major factors that have increased the confidence of foreign multinationals looking for local opportunities in India is the adoption of a new product patent regime in January 2005, before that India had already carried out three amendments in march-1999, June2002 and April 2005, in the patent act of 1970 to bring to bring Indian patent regime in harmony with the WTO agreement on Trade Related Intellectual Property Rights (TRIPs). The third and the final one, known as the Patents (Amendment) Act, 2005 came into force on 4th April 2005 and introduced product patents in drugs, food and chemicals sectors. The term of patenting has also been increased to a 20 year period. The number of pharmaceutical units has also increased to over 23,000 in 2002, further more

Fig: 2.2: Growth phase of Indian pharmaceutical industry



The fifth stage is in progression (Fig.2.2), in which we are observing investment in innovation and research, with enactment of new IP laws and investments in biotechnology aided companies. There is promising growth in production of bulk drugs and formulations (Table: 2.1) from Rs 10 crores in 1947-48 to Rs 21100 crores in 2002-03 in formulations and almost nil in 1947-48 to Rs 5400 crores in 2002-03 in bulk drugs production. The drug industry also becomes capable to spent 497crores in 2002-2003 from almost nil in 1947-48 on research and development of new molecules.

All in all Indian drug sales are expected to rise by an annual 8% to nearly $26.59 bn between 2006 and 2015 and further is the matter of wait and watch depending up on conditions prevailing in international and domestic markets. In the UNIDO-classification of developing countries, according to the “state of art” in the pharmaceutical sector India is ranked among the top and today India manufactures over 400 bulk drugs and around 60,000 formulations.

2.2 Drug industry-growth

As shown in, Table: 2.1 and table2.2, depicts the growth progress in production of bulk drugs and finished formulations. India produces bulk drugs related to various therapeutic areas. Indian pharmaceutical industry, manufactures over 400 bulk drugs and roughly 60,000 finished medicines used in different formulations.


India’s US $ 3.1 billion pharmaceutical industry is growing at the rate of 14 percent per year. It is one of the largest and most advanced among the developing countries.

Domestic Demand

The industry has enormous growth potential. Factors listed below determine the rising demand for pharmaceuticals.

• The growing population of over of a billion

• Increasing income

• Demand for quality healthcare service

• Changing lifestyle has led to change in disease patterns, and increased demand for new medicines to combat lifestyle related diseases.

More than 85 per cent of the formulations produced in the country are sold in the domestic market, there has also been a record increase in consumption of drugs worldwide. India with its large population has recorded the therapeutic segmentation in healthcare market with changes in pattern of drug consumption in turn affecting its production.Fig:2.3 shows the percentage increase in sales in various therapeutic segments. India is largely self-sufficient in case of formulations. Some life saving, new generation under-patent formulations continue to be imported, especially by MNCs, which then market them in India. Overall, the size of the domestic formulations market is growing strongly at 10 percent per annum (Table, 2.4), with rs23047crores in 2006-07, from rs2350crores in 1987-88.

Fig: 2.3: Percentage Increase therapeutic segments.


Table 2.4 shows demand for drugs as per therapeutic segments, showing categories, for treatment of lifestyle-related diseases such as diabetes, cardiovascular diseases, and central nervous system are on the increase. Health scenario is also changing. There are around 700,000 new cases of cancer each year and total of around 2.5 million cases. It is estimated that there are around 40 million people in India with diabetes and the number is rising, 5.1 million HIV/AIDS patients, and 14 million tuberculosis cases. According to industry reports, while the Indian pharmaceutical industry witnessed a growth of 7 to 8 percent, the cardio-vascular segment recorded 15 to 17 percent growth and anti-diabetes segment of over 10-12 percent growth. So, with the increase in diseases and various ailments, consumption of medicines is on increase day by day (refer, Fig: 2.3).

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As per estimates, Over 20,000 registered pharmaceutical manufacturers exist in the country. The domestic pharmaceuticals industry output is expected to exceed Rs260 billion in the financial year 2002, which accounts for merely 1.3% of the global pharmaceutical sector. Of this, bulk drugs had accounted for Rs 54 bn (21%) and formulations, the remaining Rs 210 bn (79%). Table: 2.5, shows the 16.98% CAGR for bulk drugs amounting to rs17, 307.02 crores in 2009-10.



The export market growth has been one of the most outstanding features of the Indian pharmaceutical industry (Table-2.5). Negligible before the 1970s, exports started picking up after the abolition of product patents in 1972, accelerating in the 1980s and then growing rapidly since the mid-1990s. In recent years, exports have been increasing annually at more than 20%. The proportion of exports in net sales for the studied 120 companies was 44%. The export market was found to be larger than the domestic market not only for large companies, such as Ranbaxy (Now owned by Japanese Daichi Sankyo Corporation), Dr. Reddy’s or Cipla , but also for smaller companies such as Granules , Shilpa Medicare, Kopran , Transchem, and Pure Pharmaceutical etc. The period between 2000 and 2010 witnessed India’s top 10 drug companies growing in their sales turnovers, ranging between Rs 500-Rs 800 crores, to professionally-run MNC generics manufacturing companies with turnovers ranging from Rs 3,500 crores to over Rs 7,000 crores. India is among the top 20 pharmaceutical exporters world-wide.

Most of these exporting firms earlier dependent on bulk drug supplies, small exports to unregulated markets in Africa and Asia and formulation sales in the domestic market, the last 10 years saw them aggressively tapping regulated markets of the US and Europe and penetrating into newer and emerging market Exports

Over 60 per cent of India’s bulk drug production is exported. India’s pharmaceutical exports are to the tune of Rs 87 billion, of which formulations contribute nearly 55 per cent and the rest 45 per cent comes from bulk drugs. In financial year 2005, exports grew by 21 per cent.

Domestic pharmaceutical export, growing at 30 per cent per annum, touched a new height of US $ 4.8 billion in the financial year 2006-07. The year’s exports will push the drug sectors contribution to India’s Forex earnings to 7.75 per cent from the current 5 per cent. The growth in drug exports, despite the pressing generic competition in the global markets, is attributed to increased Abbreviated New Drug Applications (ANDAs) approvals in the US market and contribution from unconventional markets in Latin America, Australia and the emerging markets in the Middle East and African Region. The formulations and exports are largely to developing nations in CIS, South East Asia, Africa and Latin America. In the last 3 years generic exports to developed countries have picked up.In the coming years, opening up of US generics market and anti AIDS market in Africa will boost exports.

India’s pharmaceutical sector has seen unprecedented changes in the past decades ensuing for a remarkable growth in its exports (pharmaceutical exports occupy a share of 4.4% to 5.2% of India’s total exports over the last 6 years) and exports grew at a CAGR of around 22% in the 6 year period of 2004-05 to 2009-10( Fig:2.4). India’s growth story in itself vindicates its potential; it had a $ 333.33m turnover in 1980 to around $22.30 bn. by 2010-11


pharmaceutical industry in the country today faces new challenges on account of LIbralisation of the Indian economy graph2.JPG

SOURCE: Indian pharmaceutical export industry@scribd.com

2.5 Revenue from Export

As earlier discussed India accounts for less than two per cent of the world market for pharmaceuticals, with an estimated market value of US $ 10.4 billion in 2007 at consumer prices, or around US $ 9 per capita but has the potential to reach more than 2% by 2020.

India currently represents just US $ 6 billion of the $ 550 billion global pharmaceutical industry but its share is increasing at 10 percent a year, compared to 7 percent annual growth for the world market overall. Also, while the Indian sector represents just 8 percent of the global industry total by volume, putting it in fourth place worldwide, it accounts for 13 percent by value, and its drug exports have been growing 30 percent annually. Cipla, Nicholas Piramal, Ranbaxy, Zydus Cadila, Dr. Reddy’s are the few Indian pharmaceutical companies, which are known at the global level due to their quality products.

The Indian market for over-the-counter medicines (OTCs) is worth about $940 million and is growing 20 percent a year, or double the rate for prescription medicines. The industry’s exports were worth more than $3.75 billion in 2004-05 and they have been growing at a compound annual rate of 22.7 percent over the last few years, according to the government’s draft National pharmaceuticals Policy for 2006, published in January 2006. The Policy estimates that, by the year 2010, the industry has the potential to achieve $22.40 billion in formulations, with bulk drug production going up from $1.79 billion to $5.60 billion.


Imports have registered a CAGR of only 2 per cent in the past 5 years. Import of bulk drugs have slowed down in the recent years as per DGIC reported data in the year 2010-11. The value of export was Rs 10,937 Crores, recording a declining growth of 9.82% as compared to 15.15% in 2009-10. The situation is advantageous and good sign, as the industry is becoming self reliant in production and less dependent on foreign markets.

Based on the retrospective data, USA, Germany, Russia, UK, China, Brazil, Canada, South Africa, Nigeria, Netherlands, Spain, Turkey, Ukraine, Vietnam, Israel, Italy, Mexico, UAE, Singapore, Iran had been potential importers of Indian Drugs. Countries like South Africa, Israel, Turkey, Kenya, Singapore, UK, China, Russia, Italy and Vietnam etc. have been identified to be potential prospective markets with high growth rates of imports from India. Africa, Latin America, ASEAN and CIS countries with huge demands deem them to be put in the category of focus countries as these are the emerging markets and have a huge potential with day in day out incremental growth rates of per capita drugs consumptions supported by treaties like SAFTA (with SAARC), treaties with GCC, EU, Japan, Korea etc. As shown in table: 2.10, based on such estimates, it has been predicted that the 17% export growth of Rs 248,000 crores would be achieved in 2019-20 with a domestic growth of 22% amounting to Rs 233,000crores.




The health-care costs are rising world-wide. Leading companies across the world are merging. Strategic alliances and collaborations are taking place in order to meet the increasing R&D budgetary requirement that exceed billion dollars each for many leading global pharmaceutical players. Indian Drug manufacturers are pursuing foreign acquisitions due to their need to:

Improve global competitiveness

Move up the value chain

Create and enter new markets

Increase their product offering

Acquire assets (including research and contract manufacturing firms, in order to further boost their outsourcing capabilities) and new products

Consolidate their market shares

Compensate for continued sluggishness in their home market.

Often there is a significant overlap of expenditure in creating manufacturing assets or investing in R&D either in generics or in basic research resulting into wastages at national level. Consequently corporate have indulged either in acquisitions or mergers to avoid duplication of investments and capture larger market share at global place.

Table 2.7 shows the data of number of overseas acquisitions by Indian pharmaceutical Industry. We can conclude that the year 2005 witnessed the maximum number of overseas acquisition due to paradigm change in pharmaceutical policies and enactment of certain new laws which are later discussed in this chapter. Indian companies had gained a lot by these cross border acquisitions and details of which has been given in table 2.8 Many Indian companies are seeking to expand their distinctive capabilities by acquiring specific skills, knowledge and technology abroad that are either unavailable or of inadequate quality at home. By mergers and acquisitions they get advantage of acquiring new resources and gain entry to new markets for better profitability. Table2.8 shows the number of cross border acquisitions by Indian companies with their focus areas.



The period between 2000 and 2010 witnessed India’s top 10drug companies growing in their sales turnovers, ranging between Rs 500-Rs 800 crore, top professionally-run MNC generics manufacturing companies with turnovers ranging from Rs3,500 crore to over Rs 7,000 crore. India is among the top 20 pharmaceutical exporters world-wide. Most of these exporting firms earlier depended on bulk drug supplies, small exports to unregulated markets in Africa and Asia and formulation sales in the domestic market, the last 10years saw them aggressively tapping regulated markets of the US and Europe and penetrating into newer and emerging markets. The Indian industry had filed only 3 marketing applications with the USFDA in 1998, the number swelled to 148 in 2009. Approximately $123bn of generic products is at risk (subject to patent renewal approvals by regulators) of losing patents by 2012.Even at a conservative estimate of 15% opportunity this translates into $18.4bn opportunity for India. However the figures need to be appropriately deflated since Indian opportunity will lie in generics equivalent of branded drugs, which would be cheaper. Ageing populations of the US (plus the 2010 US Healthcare Reforms in action), China & European economies leading to the more and more expenditure on medicines and appreciation in the per capita consumption value of the drug products with cheaper rates.

As global markets such as North America, Europe and Japan continue to slow down (graphical representation below), pharmaceutical companies are scanning markets for new growth opportunities to boost drug discovery potential, reduce time to market and squeeze costs along the value chain. The Industry is beginning to realize that some of the most promising opportunities will come from emerging markets (Asia/Australia/Africa & Latin America). IMSHealth and other sources suggest that emerging markets (China, India, Brazil, Russia, Turkey, Mexico and South Korea) will contribute to over 40% of the incremental growth of the global Pharmaceutical industry over the next decade.

With its enormous advantage ,including a large well educated ,skilled and English speaking workforce, low operational costs and improving regulatory infrastructure, India has the potential to become the region’s hub for pharmaceutical and biotechnology discovery research, manufacturing, exporting and health care services within the next decade. However, in order for this to happen, it is imperative that the regulatory environment continues to improve . otherwise ,India will have to face tough competition from china leading to capture of market shares by china as their government strong commitment and pro industry policies have produced a favorable and protective environment for not only product patent but also for crucial data protection so while developing an Indian collaborative R&D strategy, pharmaceutical MNCs should keep in mind certain issues like data and IP security, performance metrics, and quality standards, and address and evaluate these upfront to ensure a successful relationship. Although the major factor that has increased the confidence of foreign multinationals looking for local opportunities in India is the adoption of a new product patent regime in January 2005. This already had facilitated concurrent global phase II and III clinical trials. A new patent regime has changed the dynamics of the Indian pharmaceuticals industry in other respects, too. Several leading domestic producers have begun to conduct original research into new chemical entities (NCEs) and novel drug delivery systems. However, these companies are likely to license most of these drug candidates to Western pharmaceutical companies, because few Indian companies can afford the high costs and failure rates associated with developing an NCE. In this context, several Indian firms have already entered into research partnerships with multinationals. Some pharmaceutical MNCs like AstraZeneca have opened their own captive research centers in India to take advantage of the low costs as well as availability of high quality intellectual work force.

Russia 2013, marketing insight estimates.

(ASSOCHAM). IMS estimates the healthcare market in India at $31.59 bn. by 2020, whereas the global management consulting major, McKinsey & Co. predicts that the Indian pharmaceutical market is expected to touch $40 by 2015. The industry has given employment to approximately 2.86 mn people and has around 20,053 units. Globally, India is 4th in terms of volume (8% of world’s production), 13th in terms of value, and 17th in terms of pharmaceutical export value. The drugs and pharmaceuticals exported are worth over $3.8 bn.




The pharmaceutical industry in India meets around 70% of the country’s demand for bulk drugs, drug intermediates, pharmaceutical formulations, chemicals, tablets, capsules, orals and injectibles. There are about 250 large units and about 8000 Small Scale Units, which form the core of the pharmaceutical industry in India (including 5 Central Public Sector Units). These units produce the complete range of pharmaceutical formulations, i.e., medicines ready for consumption by patients and about 350 bulk drugs, i.e., chemicals having therapeutic value and used for production of pharmaceutical-formulations.

As discussed in earlier chapters about the Indian Pharmaceutical sector which is highly fragmented with more than 20,000 registered units. It has expanded drastically in the last two decades. The leading 250 pharmaceutical companies control 70% of the market with market leader holding nearly 7% of the market share. It is an extremely fragmented market with severe price competition and government price control. North Indian states & UT’s are also engaged in production of pharmaceutical products, few states like Himachal Pradesh, Uttaranchal, are also providing tax holidays so as to motivate the pharma companies to enhance their production facilities, more over the climatic conditions and other macro factors are suitable for the growth of pharma and especially biotech., Industries in these two states. Table2.14 shows the state wise distribution in north India.


Source: Annual report: 201


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