Pharma Industry in Ahmedabad and Vadodara

A mention may be made here of a pioneering unit, namely, Sri Krishna Keshav Laboratory in the much younger medical disposable manufacturing sector. In 1970, this firm formed a joint venture with a US based Company, McGaw Private Limited. The new company was named McGaw Ravindra Laboratories India Ltd. This Firm was in the production of medical disposable and I.V. fluids, and by now, this firm has created many entrepreneurs in the field, including the founder of Core Parenterals, the largest firms in the sector now. War Provided the Impetus During the early decades of the twentieth century, there were hardly any manufacturing facilities within India and there was near total dependence on imports. Even importation of drugs was jeopardized as the World War (1914-1918) broke out. The Indian entrepreneurs rose to the occasion. The persistent efforts by a few enthusiasts and also the pressure of popular demand for quality drugs for the Indians, did effect a series of developments, especially during the momentous decades of 1930s and 1940s that substantially transformed the Indian pharmaceutical industry from a state of ailing infancy. A Visionary Makes the Difference Again, during the formative years of the pharmaceutical industry, a special mention needs to be made of one individual whose contribution and commitment to the promotion of the local industry was phenomenal. B.V. Patel, an internationally acclaimed authority on pharmacy legislation and a Drugs Controller par excellence, was instrumental in the survival and growth of the Drugs Laboratory in Vadodara. Soon after Independence, it was to be decided as to the laboratory, then "a small link in a chain of State Laboratories and a one-room one-bench-affair with two technicians", be shifted or be merged with the State of Bombay. Patel, the then Drugs Controller of Bombay, not only favoured its existence but also advised developing it as a nodal facility for future development of the north of Bombay area. "This very instance shows his visionary capacity...but for the preservation of that nucleus, the Gujarat State would not have a laboratory of the dimension it has now." Patel continued his support and made notable efforts in promoting a healthy atmosphere for the industry, whereby entrepreneurs, policy makers, technicians and a host of support service providers could interact and build up a remarkably advanced pharma industry in Gujarat. Another instance of the entrepreneurial farsightedness is the founding of CADMACH Machinery, the pharma machine manufacturing unit at Vatva in Ahmedabad in 1967, by Ramanbhai B. Patel. CADMACH started as an R and D outlet in 1966. He, along with I. A. Modi and Khambatta, was instrumental in starting this vital link in the pharma industry and free the growth path from import dependence of such a critical sector. Further, particularly in Ahmedabad, the substantial presence and vitality of CADMACH and other similar units encouraged diversification towards manufacturing packaging machines also. Even the later development of the medical disposables industry, a highly related sector, in Ahmedabad may be linked to the early emergence of a strong pharma machinery base in the region. This also refers to the advantages of industrial clustering, whereby setting up of related industries in the locality becomes a viable and cost effective proposition. An important turning point in the growth of the industry can clearly be linked to the Indian Patent Act of 1970. As explained, the Act provided the domestic industry with the much-needed stimulus by opting for a process patents system and specifying a short duration of seven years for patents. It also provided for automatic compulsory licensing without the patent holder being heard. The innovative entrepreneurs took utmost advantage of the process patent and there was phenomenal growth of small firms during the 1970s and 1980s. This phase of euphoria was also sustained due to heightened exports to many countries, mainly Russia and Africa countries. Birth of the B. V. Patel PERD Centre There was a strong and long standing need by both the pharma units as also other concerned intelligentsia for having a technical cum training centre in Gujarat State. Thus, the B.V. Patel Education Trust, Ahmedabad and the Gujarat Branch of Indian Pharmaceutical Association (IPA) established the B.V. Patel Pharmaceutical Education and Research Development (PERD) Centre in Ahmedabad in 1989. The New Patent Regulation The pharma industry is at the threshold of another major turning point in its recent history. Certain fundamental changes are envisaged in the Indian Patent Act 1970 if the provisions of the World Trade Organization (WTO) are to be met and to make it TRIPs complaint. These are to be put in place before 2004. The Government of India has already taken the first step towards incorporating the proposed changes by notifying the Patents (Amendment) Rules 1999. This would enable granting of exclusive marketing rights. (EMR) for items, which qualify under the eligibility criteria, set out in the proposed Act. The operationalisation of the new patent regime in 2005 will bring in fundamental changes in the composition of the industry. The booming generic market will be a major solace for pharma companies in this situation. But as explained earlier, the generic market game is going to be tough even for the most accomplished of Indian Pharma majors because of the complexities involved in getting clearances and the enormous costs that are involved. Growth in Gujarat Gujarat has been playing a major role not only in the sphere of production of drugs and pharmaceuticals, thus catering to the growing domestic demand, but also in earning valuable foreign exchange. At present, the state accounts for about 46 per cent of the total national production and 17 per cent of exports. As explained above, the industry has grown substantially over the last two decades deriving inspiration from the splendid performance of units such as Alembic and Sarabhai Chemicals in the pre-Independence period, and cashing in on the policies and facilities available. A number of young entrepreneurs of Gujarat have taken to this industry in the subsequent years. A major factor that helped the industry in the state is an early development of certain crucial linkages. Thus, technical training institutions like LMCP since 1947 and the Bombay College since 1960s groomed pharmacists with a professional approach. Machinery manufacturers like CADMACH took care of the industry''s need for crucial capital goods. Apart from such specific factors, the overall industrial scenario of Gujarat continues to provide impetus to the pharma industry. The Bombay-Ahmedabad route is well endowed with excellent physical infrastructure. Ahmedabad and Vadodara are fairly well developed; the two cities are connected by both state and national highways that link both Gandhinagar (the state capital) and Mumbai. The railways passing through Ahmedabad, Vadodara, Ankleshwar, Vapi, Valsad and Mumbai have historically been regarded as the catalyst for the urban-industrial growth and vibrancy of the so-called ''golden corridor'' that extends between Ahmedabad and Mumbai. Further, Gujarat already has a well developed chemicals and fertilizer industry, which has partly helped the pharma industry to stabilize. The industrial labour here is not aggressive and, hence, he wage cost is not a constraint to the producer. After the decline of the textile mills in Ahmedabad, quite a few entrepreneurs have diversified in to chemicals and pharma products. The state policies have been overtly pro-industry, and SSIs, particularly received considerable state support tin the 1960s and 1970s. All these factors have contributed to the growth of pharmaceutical industry in the sate. Number of Units It is estimated that there are round 75-100 bulk drug producers and 1000 manufacturing units mostly in formulations and other areas including excipients, disposables, homeopathic, ISM and miscellaneous products under the purview of FDCA. Of these ten are large, 100 are medium and the rest are small units20. Every pharmaceutical unit is required to hold a license from the Food and Drugs Control Administration (FDCA), Government of Gujarat. The licensees could be actual producers with own manufacturing facilities or loan licensees with a permit to manufacture, but not in possession of the facility. They use the facilities available with the actual units on a rate contract basis and produce and market drugs under their own brand name. Actual (own) licensees too can be loan licenses for those. For size classification, firms with turnover of Rs. 1000 million or more have been termed large, those with turnover range of Rs. 100 to Rs. 500 million has been termed medium and turnover range of less than Rs. 10 million is termed small products for which they do not have any manufacturing facility. It is estimated that there are 7-8 big firms (Cadila Pharma, Zydus Cadila, Sun Pharma, Torrent, Core, Alembic, Sarabhai, etc.), 50 medium sized units and the rest are small units in Ahmedabad and Vadodara. Investment The structural characteristics of the pharma sector in the state have undergone significant changes over the here decades between the 1970s and 1990s. The statistics published in the Annual Survey of Industries (hereafter ASI) relating to the organized sector pharma units in Gujarat shows and increase in the capital output ratio by about three times between 1980-81 and 1994-95. The ratio of invested capital to labour increased during the same period nearly six times indicating a significant rise in capital intensity in this sector. Production, Trade and Market There was a commensurate rise in pharma production too. During the period between 1979-80 and 1997-98, the share of the state''s production in that of all India has increased from around 26 per cent to close to 46 per cent. Despite fluctuations, there has been a secular increase in the state''s exports. It may be observed that exports, as a promotion of turnover was much higher in the nineties as compared to that in the previous decade. The state''s share in all India exports was 16 per cent in 1997-98. This clearly substantiates the relative dominance of Gujarat in the Indian market. It commanded around 50 per cent of the total domestic market in 1997-98. Medical Disposables in Ahmedabad As mentioned earlier, the medical disposables industry originated in Gujarat with the establishment of the I.V. fluid manufacturing industry in the 1970s, particularly, Shree Krishna Keshav Laboratories (formerly Macgaw Ravindra Laboratories) followed by some more I. V. fluid manufacturers. The growth of this industry was supported by the easy availability of plastics raw materials and also plastics processing capacities and skills available in Gujarat. Till 1989, the medical disposables were not covered under the Drugs and Cosmetics Act. In March 1989, the Ministry of Health and Family Welfare, Government of India, by a notification made it mandatory to manufacture the following three products only after obtaining license under the Drugs and Cosmetics Act, 1948. 1. Disposable perfusion sets 2. Disposable syringes 3. Disposable hypodermic needless By this time, a number of units had already been installed in the small-scale sector for the manufacture of I.V. sets and other medical disposables, However, since the units were mostly promoted by either skilled workers or traders directly or indirectly working in the industry with limited investments, most of the units needed improvements to meet he requirements of Drug Control regulations. Since almost three decades, the units in Gujarat have been contributing more than 70 per cent requirements of the country. A number of units are exporting their products. The production process and value addition in I.V. sets appear as Annex 6. Business Linkages of Pharma Clusters In simple terms, an industrial cluster represents the spatio - sectoral concentration of manufacturing activities and services, in similar and related spheres. The accrual of benefits of scale and scope, even when such clusters are dominated by small firms, bears testimony to the potential of collective action. A significant advantage of industrial clustering is its potential to remarkably reduce the transaction costs, which directly benefits the units and, in turn the consumers. Whereas the nature of the market, i.e., the demand for products, largely determines the growth of a certain industrial cluster, there are a number of supportive structures and policy factors that also contribute to the process. Additionally, clusters do not function in isolation. The growth of a cluster induces related industries and other service providers to come closer and grow in tandem. Mapping the pharma cluster The pharma industry has grown over the years in Ahmedabad and Vadodara by developing linkages along its supply and distribution chains as also with a variety of support service providers. We will list out and describe the major elements in the pharma cluster including agencies, institutions, and associations. The inclusion of an element does not imply that its linkage with the industry is strong. In fact, the industry''s linkages with many of the elements are rather weak. The core of the cluster At the core of the cluster there are the drug manufacturers, who fall broadly under two categories - bulk drug producers and formulators. Formulators manufacture the end product that is finally consumed, whereas bulk drug manufacturers produce the input for formulators. In Ahmedabad and Vadodara there are hardly any bulk drug manufacturer. Most of the own and own -cum - loan licensees deal in formulations. Some of the firms are run by second-generation entrepreneurs. They have done well during the early period, i.e., mid-seventies to early-nineties and are cushioned. The first generation units that came into existence during the late eighties to early nineties are comparatively small and are struggling. Besides, as stated earlier, there are also manufactures of medical disposables. Backward Industry Linkages The suppliers of raw material and capital goods form the most prominent backward linkages. It is important to note that the links between the industry and these suppliers spread beyond the geographical limits of the cluster. However, the industry is in no way dependent on import of either raw materials or machinery. The major input suppliers are as follows: Bulk drugs: Bulk drugs are not generally available locally, i.e. in Ahmedabad and Vadodara. It is generally sourced through commission agents form Vapi and Ankaleshwar in Gujarat and also from other pharma units situated in Maharashtra, Tamil Nadu, Andhra Pradesh and North India. However, some big units in The entrepreneurs as also others directly or indirectly concerned with the industry emphasized the critical role networking would play in the emerging eventuality of globalization of business and markets. In Table 4.5 a glimpse into the perception of pharma entrepreneurs regarding the likely effects that networking would have on long-term competitiveness of firms may be had. The major responses highlight a potential improvement in both management practices and the quality of the product; these are the crucial requirement sin a highly competitive global market. By recognizing the importance of networks being catalytic in the firms'' quest for acquiring higher levels of technology and also benefiting through strategic planning, the local manufactures did point to the substantial scope for collective efforts. Institutions A number of institutions/bodies, both public and private, have been playing a major role in eh growth of the industry. These include: 1. Central level institutions 2. State level institutions 3. Global regulatory mechanisms 4. Private sector network 5. Other support institutions Central Level institutions At the central level the Drug Control Authority of India under the Ministry of Health and Family Welfare controls the area of introduction of new drugs in India. The department also handles subjects related to GMP and its up gradation. The office of the Deputy Drug Controller (Western Zone) controls the issuance of the WHO-GMP certification. The Department of Chemicals and Petrochemicals under the Ministry of Chemicals and Fertilizers also performs both regulatory as well as development roles. The Drug Price Equalization Account (DPEA) of this department regulates matters related to excess drug prices charged by firms. An export promotion cell in the pharmaceutical division of the department has been created with the objective of boosting pharmaceutical exports and to act as a nodal centre for consultation and providing support on various aspects concerning pharmaceutical exports. The cell also undertakes promotional activities for accelerating pharmaceutical exports and considers suggestions for modifications in EXIM Policy from the industry. The cell has also been entrusted with the organization of seminars and workshops on standards, quality control requirements etc. of important countries so as to prepare the domestic companies for exporting their products. The National Pharmaceutical Pricing Authority (NPPA), constitutes in 1997, implements the drug policy of the government through the Drugs Prices Control Order (DPCO). The NPPA also advises the Central Government on changes/revisions on the Drug Policy. The chairman of NPPA, in his capacity as the member secretary to the Pharmaceutical Research and Development Committee, Government of India, advises the Central Government regarding the support required by Indian pharma companies to undertake domestic R and D. State Level The single most prominent regulatory authority at he state level is the Food and Drugs Control Administrative (FDCA) under the Ministry of Health and Family Welfare, Government of Gujarat based in the state capital, Gandhinagar. This body issues drug licenses, monitors quality control, issues State GMP certificate, undertakes periodic inspection of units, and, overall, keeps a close watch over ht industry, especially with respect to quality. The FDCA has a wide network of activities all over the estate. At the level of officers, its has a commissioner, two joint commissioners, 20 assistant commissioners, 16 senior drug inspectors and 24 drug inspectors. The Gujarat FDCA office also plays a promotional role. Its major strength is that it can convince and motivate both the government and the industry leaders to dialogue. This office is also taking the lead to create an optimum proactive work force to champion the cause of Gujarat as a leader in the Indian pharma industry. Global Regulatory Mechanisms In the emerging business scenario that would result from the complete operationalisation of WTO norms and conditions, the regularly environment and institutional mechanisms will undergo dramatic chances. Though the domestic administrative set up may continue to be the same, the industry will have to face a greater degree of trade regulation when it is exposed to the possibility of being subjected to the imposition of non-tariff and technical barriers to trade. In short, the hub of the regulatory measures is slowly being shifted form local institutional set up toward global bodes. This shift will have significant impact on the conduct and performance of pharma industry in the coming years. How capable are the indigenous units in understanding and coping with the changes in the business environment and establishing and maintaining effective linkages with the changed institution forms is what would determine the future course of growth of the industry. Linkages with Technical and Business Support providers Pharmaceutical production being a knowledge intensive industry, it needs to have organic links with educational institutors and R and D centres for the supply of up-to-date and viable processes and trained manpower. This is all the more true for the units in the small and medium category, as they lack the financial capability to do basic research activities in-house. It may also be noted that educational and research institutions serve as major sources of supply of pharma entrepreneurs for the local industry. Another crucial linkage is the one with testing laboratories due to regulatory requirements. LM College of Pharmacy (LMCP) The oldest and the most prestigious institution in the area of pharmacy education in the region, LMCP, was founded in 1947 by the Ahmedabad Education Society. Incidentally, it was the first full-fledged pharmacy college to have been established in India. The college was set up with the aim to rain students, encourage and direct R and D in pharma science, and act as a catalyst for the growth of the industry. In addition to Bachelor''s, master''s and doctoral programmes in pharmacy science, it offers diploma programmes for retail pharmacists. It has research programmes on medicinal chemistry, pharmacology, and pharmaceutical technology. The alumni of LMCP are serving in drug industry, community pharmacy and hospital pharmacy, regulatory agencies, R and D laboratories, government policy-making bodies and academic intuitions, both within and outside the country. PERD Centre, Ahmedabad Among R and D centres, the B. V. Patel PERD Centre in Ahmedabad ahs a significant place. In fact, it is a unique intuition in that it has the government, industry and academia as its stakeholders. The PERD Centre was established in 1989 as a trust and society. The B.V. Patel Education Trust of Ahmedabad and the Gujarat Branch of the Indian Pharmaceutical Association have promoted it. It is the first and only private multi-disciplinary postgraduate research and service institution India to promote advanced research, services and training in the pharmaceutical sciences and industry. There are four major divisions in PERD: (1) Contract and consultation on all aspects of basic and applied industrial research projects; (2) drug discovery research centre; (3) drug quality testing facilities; and (4) advanced training, research and educational centre. It has well equipped labs and trained technical staff. Research facilities are available in analytical instrumentation, cellular and molecular biology, clinical testing, biostatistics, formulations, pharma technology, pharmacokinetics and biopharmaceutics, pharmacology and toxicology, phytochemistry and pharmacognosy, radiation and radioisotope, synthetic and medical chemistry et. The centre also has an array of analytical equipments and machineries. The PERD Centre has so afar developed about 15 formulations for commercialization. It offers a range of services to the industry including toxicological evaluation, development of animal models for evaluation of pharmacological evaluation of drugs, phytochemical evaluation and standardization of medicinal plants used in traditional medicines, development of synthetic process for bulk drugs and intermediates et. The Food and Drug Control Laboratory (FDCL), Vadodara The FDCL was established as early as in 1947 in the erstwhile princely state of Baroda. When Gujarat became a separate state in 1959, the FCDL became the testing laboratory for Gujarat State Drug Control Administration. The FDCL is capable of analyzing all categories of drugs (except sera and vaccines) with a capacity to test 8000 drug samples. There are divisional laboratories sin pharmaceutical chemistry, immunology, pharmacology, pharmacognosy and ayurveda. The staff is drawn from various disciplines like pharmacy, chemistry, microbiology and botany. Private Laboratories There are 11 approved testing laboratories in the state approved by the office of FDCA, Gujarat. These do various statutory tests of bulk drugs and formulations as per law. Only one firm does bio-equivalence and bio-availability test. CIPET The Central Institute of Plastic Engineering and Technology (CIPET) is a Government of India organization working under Ministry of Chemicals and Fertilizers. CIPET is having diversified activities in the field of plastics like mould design, product testing, plastic processing and mould manufacturing. In Ahmedabad, CIPET is also having a plastic testing equipment fabrication cell where various types of testing equipments to control the quality of plastic materials and products are being developed. These equipment are as per various national and international standards. The price of the equipments has been kept very competitive in comparison to the may global suppliers of testing equipment so that the plastic units, which are in small sector, can afford to procure these equipments. The equipments have already been supplied to reputed industries, training institutes, various central and state government organizations and some of the equipments have been exported also. CIPET does manpower training (managerial and supervisory) through structured as well as tailor-made courses. It also provides technical services in the flowing areas: - Consultancy and advisory services to plastic industries - Testing and standardization - Application development - Design and development of moulds and dies - Material selection for new product substitution - Machinery and equipment selection - Setting up of testing laboratories Linkages with Industry and Business Networks Peer networks like business associations are an important part of the industry environment. In the pharma sector there are three prominent entrepreneurial networks - Indian Drug Manufacturers Association, Indian Pharmaceutical Association and the organization of Pharmaceutical Producers of India (OPPI), Bulk Drug Manufacturers Association (BDMA), besides there is a separate organization of medical disposable units called the Medical Disposable Manufacturers Association (MDMA). Besides there are also small local associations of pharma manufacturers like Rakanpur Santhej Pharma Manufacturers Association. A new lobby of large firms has also been formed. There is also very powerful lobby of chemists and druggists that control the prescription distribution channel - all India Organization for Chemists and Druggists (AIOCD). Being a technocrat dominated industry there is Chemist and Druggists (AIOCD). Being IDMA Founded in 1961, Indian Drug Manufacturers'' Association (IDMA) describes itself as the voice of the national sector of the pharma industry as its members represent the Indian manufactures only. It has 513 members (as in 1998) - 90 per cent of them being small firms. IDMA has been in the forefront analyzing and disseminating the likely impact of a product patent systems on domestic industry. IDMA organizes and takes part in national and international seminars/workshops relating to key issues of the pharma and health care industries. It plays a very active role in policy consultations and dissemination of information to its members. It brings out two publications - one general and the other technical. IDMA has three state level bodies in Tamil Nadu, West Bengal and Ahmedabad. The Gujarat chapter called the IDMA-Gujarat State Board (IDMA-GSB) has 150 member firms, 80 per cent of whom are in the small sector. IDMA-GSB plays a crucial role with respect to government liaison and enhancing the industry''s knowledge base. OPPI Organisation of Pharmaceutical Producers of India(OPPI) is an organisation of pharma manufacturers established in 1965, four years after IDMA was launched. Currently, it has a membership of around 67. This includes 59 members from the drugs and pharmaceutical sector. Around 66 per cent of them are companies of foreign origin. Only a couple of Ahmedabad and Vadodara based firms are members of both OPPI and IDMA. The organisation takes initiative in organizing seminars and workshops to discuss the key issues in the area. It brings out technical publications including Quality Assurance Guide and Safety, Health and Environmental Guide. OPPI is an active member of International Federation of Pharmaceutical Manufacturers (IFPMA) and has developed operational guidelines for interpretation and implementation of IFPMA code of Ethical Marketing Practices. OPPI has been lobbying vigorously for the amendment of the Indian Patent Law to make it TRIPS compliant. It has been actively advocating rationalization of duty structure and a revision of drug pricing policy. Efforts have been made by this body to make suppliers (of bulk drugs, excipients, packaging materials, equipments that go in for manufacturing these etc) more responsive to the needs of the pharmaceutical industry in terms of quality, price stability and delivery schedules. Indian Pharmaceutical Alliance The Indian Pharmaceutical Alliance represents research based national pharmaceutical companies. It consists of the following members: - Alembic Ltd - Nicholas Piramal India Ltd - Cipla Ltd - Ranbaxy Laboratories Ltd - Dr Reddy''s Laboratories Ltd. - Sun Pharmaceutical Industries Ltd - Lupin Laboratories Ltd - Wockhardt Limited These companies annual R&D spend at Rs 250 crore account for 90 per cent of total private sector spending in pharmaceutical research and development. These companies contribute one-fourth of the country''s export of drugs and pharmaceuticals and share over 23 per cent of the domestic market. The main aims of the Indian Pharmaceutical Alliance are: - Partnering the government in the evolution of a patent regime that will on the one hand meet the TRIPS obligation and on the other serve national interest; - Engaging the government in constructive dialogue to move to price management from price control regime for the benefit of the consumer; and - Working with the government in progressively upgrading regulatory provisions, procedures and standards for harmonization with those of the developed markets. The IPA, working closely with Government on policy related matters, will seek to imbibe the experiences of the generic pharmaceutical industry internationally. It will seek affiliation with the International Generic Pharmaceutical Association (IGPA) located at Brussels, which represents Generic Pharmaceutical Industry of Europe, Canada and the US. The association of more than 500 international companies collectively represents a significant cross-section of the global pharmaceutical industry. The main objective of the IGPA is to promote international pharmaceutical harmonization and regulatory decisions in a way that will benefit the public and strengthen the industry. AIOCD All India Organisation of Chemists and Druggists (AIOCD) was formed in 1975 with the aim to bring together chemists, distributors, and stockists and bring them under one association. The association has a three-tier system with taluka, district and state level associations. The current membership strength of AIOCD is 550,000 that control an estimated business of around Rs 260,000 million. About a decade back, agreements were made between the AIOCD, IDMA and OPPI where by all the India margins for retailers and wholesalers for non-scheduled category drugs was fixed for 20 per cent and 10 per cent respectively, and 16 per cent and 8 per cent for scheduled category drugs respectively. The association offers protection to the trade fraternity. In case of breakage, leakage and expired products, cent per cent replacement of the product is guaranteed. The change over from 50 per cent to 100 per cent replacement of defective goods was accomplished only recently. The AIOCD has one or more offices in every state. The AIOCD bulletins are published regularly to increase awareness. Pharma manufacturers generally publish their formulations through AIOCD bulletins. At least two to three times a year, workshops are held at state, district and zonal level to increase awareness among the trade. Topics relating to new rules and regulations, introduction of new products, new trading policy, banking, finance and various other aspects relating to the trade and pharma industry are discussed. A convention is held every two years, where greater exchange of information is facilitated. AIOCD does not agree with the governments move for opening up of retail sector to foreign investment. Indian Pharmaceutical Association (IPA) IPA was established in 1939. It is the national professional body of pharmacists. Many industrialists and government officers with pharmacy background are members of IPA. The major areas of activity of IPA are training, research, publications, organization of workshops and changes in legislation. IPA has created specialized divisions to impart training, disseminate information and education related to various professional aspects of pharmacy including industrial pharmacy, education, regulatory affairs, community, hospital and clinical pharmacy. MDMA Medical Disposables Manufacturers Association (MDMA) was formed in 1991 with a view to work together for the emerging technical and commercial needs of the member units. At present, there are 36 member units of the MDMA. The annual turnover of these units ranges from Rs 3 million to Rs 20 million. The major activities include: -Exchange of information regarding changing government regulations -Undertaking common interest development programmes -Representing the requirements of the industry to the government and other regulatory bodies. With the globalisation and other challenges being faced by the industry, the association has now been activated and is working for the growth of the member units, which have the state-of-the-art technology in manufacturing of medical disposables. Other Support Agencies It needs to be noted that though there is a fairly important base of pharma machine manufacturing in Ahmedabad, there does not exist any formal effective body of entrepreneurs. During the interviews, some expressed keen interest to form an association of machine manufacturers. Even if the total number of entrepreneurs is around 40-50, an association could be of much use in a variety of ways, especially, in terms of liaison with government, consulting on procedural matters exports and other sector specific policies, and organizing /participating in state/national level technical exhibitions. As a number of problems faced by this industry are not the same as encountered by the drugs and pharma enterprises, the role of association was envisaged to be vital in furthering the interests of the industry. This specific instance highlights the need for collective action. National Productivity Council (NPC) One prospective specialized support institution in this linkage is the National Productivity Council (NPC). NPC is a national level organization to promote productivity culture in India. NPC offers consultancy and training services in various fields with a focus on shop floor improvement. It has Post Graduate Engineers who offer services in industrial engineering, quality management, maintenance management, environment management and human resource development. It has significant experience in consulting services in most industry sectors including pharmaceuticals. NPC can offer the following specific services to the pharma units; -ISO 9002 Consultancy Service -Productivity Improvement: (Waste Reduction, Good House Keeping and Manpower Productivity) -Cleaner Production -Solid Waste Management -Energy Audits -Training (for Workers, Supervisors and Executives) Apart from the above, there are significant service providers like banks and financial institutions, consultants and training institutes, who are linked to the industry all along its supply and distribution chains. SIDBI is the major term-lending and development oriented financial institution for the small and medium enterprises. Banks and Gujarat State Financial Corporation help them with short-term working capital. Industrial Extension Bureau (iNDEXTb) also plays a major promotional role. The Indian Institute of management (IIMA) and the Entrepreneurship Development Institute of India (EDII) are prominent training institutes in the area of management. They conduct both general and industry-specific training programmes periodically. They also carry out in-house tailor made programmes for firms. Gujarat Industrial and Technical Consultancy Organisation Ltd (GITCO) is a potential technical consultancy provider. The Cluster map that follows explains the existing business and institutional linkages.