PHARMACEUTICAL INDUSTRY IN INDIA: HISTORICAL PERSPECTIVES, RECENT ISSUES AND FUTURE TRENDS

International Journal of History and Research (IJHR) ISSN (P): 2249–6963; ISSN (E): 2249–8079 Vol. 12, Issue 1, Jun 2022, 77–88 © TJPRC Pvt. Ltd.

PHARMACEUTICAL INDUSTRY IN INDIA: HISTORICAL PERSPECTIVES, RECENT ISSUES AND FUTURE TRENDS MALIKA BASU (GHOSH) Assistant Professor in History, Kalna College, University of Burdwan, West Bengal ABSTRACT Since the colonial period, the issue of the pharmaceutical industry was an important area of concern. The Indian pharmaceutical sector has grown steadily over the last three decades to become a profitable, high-tech enterprise. It has been impacted by a variety of institutional and regulatory challenges since its establishment, including patents, foreign exchange legislation, pricing controls, industrial licensing, and research and development.

With this context in mind, the purpose of this article is to investigate a problem that has impacted the Indian pharmaceutical business and how the situation is changing. The goal will be emphasised for the following reasons: I The impact of intellectual property rights on India's pharmaceutical sector (ii) understanding integration and acquisition in the Indian medical field (iii) what will be the future research and development in Indian medicine and finally (iv) understanding trends futures of the Indian pharmaceutical industry in this era of globalization.

has influenced the choice of technologies and trends of Indian pharmaceutical companies over time which has contributed to the growth and evolution of this industry in India on a large scale.

KEYWORDS: Pharmaceutical, Industry, Intellectual Property Rights, Foreign Investment & Globalisation

Original Article

Research shows that the emergence of co-operative policy and technological changes in public policy principles

Received: Jan 11, 2022; Accepted: Feb 01, 2022; Published: Mar 26, 2022; Paper Id.: IJHRJUN202210

INTRODUCTION During the colonial era, in western drugs, the people of the country relied heavily on foreign purchases. At that time, drug production was at an alarming level (Singh, 2011). There was an error in the drug trade. Both the hot weather and the wrong storage system were major drug storage problems. As a result of these conditions, substandard drugs continued to be sold on the market. The whole situation was very disappointing. The situation was evident at the government level. In March 1927, the State Council commended the General Council of Councils to urge all Provincial Governments to take action regarding drug abuse. Other than that, to make a law to stop the production and sale of drugs, but no results emerged from that action. On the other hand, after World War I, traditional medicine faced a decent colonial empire. Although some efforts are being made to improve the chemical industry in India. The strategies are also designed by the Indian Munitions Board, but nothing is being done to help the production of home remedies. In such a scenario, in the face of inequality, the Indian Chemical Industry demanded tax protection in 1929. The Tax Board was established and overseen by Mr. Padamji P Ginwala.

The board recommended that the government be careful when making chemicals. But the Medical Sector remained insecure. As a result, before World War II, India relied heavily on foreign trade. During this time, in the field of Pharmaceuticals, Britain was facing stiff competition from Germany. To address this, the Indian and British governments agreed at the 1932 Regional Economic Summit in Ottawa. This agreement provided for exchange

www.tjprc.org

editor@tjprc.org

78

Malika Basu (Ghosh)

rates in Britain for key categories of goods including drugs and drugs (Singh, 2011).

Prior to coming to the Drug Act or the Inquiry Committee, a brief reference to some of the things that endanger the health of the community was illegal. There has been an uncontrolled and unlimited publication of drug and drug advertisements as well as prescription drugs. Counterfeit and counterfeit drugs proliferated with the support of advertising agencies. All of these issues had a direct impact on public health. In March 1929, local governments applied for the formation of a sub-committee for this purpose. Finally, the Government of India issued Declaration No. 1637 dated 11 August 1930, he appointed a committee (Drug Research Committee) under the leadership of Lieut-Col. R.N. Chopra, looking at the problem of adultery and drug addiction. This was a really long campaign for traditional and international drug companies. In other words, the most important event in the early twentieth century was the establishment of the Drug Research Committee in 1930. In a government resolution of August 1930, we had given the Committee the power to summon members where necessary. This arrangement has enabled the Committee to seek the assistance of specialized professionals with experience in local experience and problem-solving experience. The work of the Committee was very well organized. As a result, a number of comments and discussions appeared in professional newspapers regarding drug abuse and drug trafficking. The Committee Report was taken by the Chairperson to Delhi and forwarded to the Government of India on Tuesday 31 March 1931. The report was published on December 1, 1931. It was recommended that the Drug and Pharmacy Control Act be enacted. The Committee recommended that all copyrighted goods and goods with ‘confidential formula’, manufactured in India or imported, require registration on the patents of the Canadian Patent and Proprietary Medicine Act. With regard to traditional medicine, it was recognized that a single or combination drug should be administered. The administration of these drugs should be different from that of drugs and western arrangements. Recommendations are made for the promotion and development of the drug industry in the country. The import duty on manufactured drugs should be increased by 5%. The construction of Government Depot Pharmacies should be gradually reduced and thus available goods from local manufacturers as much as possible. It was also recommended that steps be taken to integrate Indian Pharmacopoeia without delay. Overall, the Report was received with great respect.

Important features of the recommendations were published in several journals in the country and abroad. At the government level, the app went very slowly but eventually many of the Committee's recommendations came into effect.

In fact, in India, there was no law that could directly prohibit drug abuse or ensure compliance with proper standards of hygiene and power. However, certain provisions of the Indian Penal Code, the Indian Trademarks Act, 1889, and the Maritime Code of Conduct, 1878, had an effect on it. Deliberate adultery, illegal drug trafficking, quality or consumer demand, can be punished under certain sections of the Indian Penal Code. The Opium Act, 1878, Poisons Act, 1919, and the Dangerous Drugs Act, 1930, regulated the production, importation and sale of certain drugs, but they did not have a direct effect on adultery or power standards. Basically, these actions were designed to meet the tax and property requirements and to prevent the illegal use of certain dangerous drugs. An indication of a visit to India in the winter of 1936-37 may be suggested by Dr. G.C. Anderson, Secretary of the British Medical Association. Upon his return, he reported the condition of the medical profession to the BMA (British Medical Association). He also reported on drug and drug control. He pointed out that the medical profession in India was disrupted because, there were no organized or independent specialists.

Impact Factor (JCC): 5.5584

NAAS Rating: 2.90

Pharmaceutical Industry in India: Historical Perspectives, Recent Issues and Future Trends

79

1.1 PHARMACEUTICAL INDUSTRY IN THE POST-INDEPENDENCE PERIOD After gaining independence in 1947, the Government of India stated that it had a special interest in government and the progress of the drug industry. At that time, the drug industry was in its infancy. The total production of drugs in our country was estimated at Rs. 10 million. Multinational corporations (MNCs) exploited the drug market in our country by using the colonial Patents and Designs Act of 1911. They were too preoccupied with purchasing drugs in their home nation. Even ten years after independence, these multinational corporations controlled 99 percent of India's nearly 1700 pharmaceuticals and patents. However, major multinational corporations (MNCs) never come forward with investment or technical aid to set up drug manufacturing units in India. Under the Department of Chemicals and Fertilizers, five medication manufacturing units have been constructed. Indian Drugs and Pharmaceuticals Limited (IDPL), Hindustan Antibiotics Limited (HAL), Bengal Immunity Limited (BIL), Bengal Chemical and Pharmaceutical Limited (BCPL), and Smith Stanistreet Pharmaceutical Limited were the companies in question (SSPL). These institutes are responsible for India's ability to obtain pharmaceuticals and medicines at very inexpensive costs. At the end of the colonial fag, drug laws began to change. However, their use really started in free India. In independent India, the Drug Investigation Committee has recommended a pharmacy regulation law. To regulate the work of the pharmacy, the Bill was released at the end of 1945 and was officially introduced to the Legislature in January 1946. Finally, the Pharmacy Bill was approved by the Governor-General on 4 March 1948. This is a red-letter day in the history of Pharmacy in India. However, the publication of India's first official Pharmacopoeia in 1868 was a milestone. On the other hand, in gaining the independence of the country, the long-awaited day came on November 23, 1948. The Ministry of Public Health of India formed a committee of Indian Pharmacopoeia. Early in 1956, Pharmacopoeia of India (The Indian Pharmacopoeia), 1955, appeared. The next milestone was the unification of the Indian Pharmacopoeia, 1955. The supplement was prepared in 1960. Pharmacopoeia was revised and the 'Second Edition' of Pharmacopoeia of India appeared in 1966. Gradually Pharmacopoeia was revised and updated. Even in 2007, Indian Pharmacopoeia was organized by the Indian Pharmacopoeia Commission. Several reviews and updates on testing methods, reference data, dosage forms, vaccines, blood and brightly related products, biotechnology products etc.

In the early 1950s, there were seventy-five large doses and one thousand five hundred and sixty-eight measures of medical anxiety. There were state-owned factories (11), large corporations under foreign control (28) and large corporations under Indian rule (54). In 1951, the Industrial Act was enacted which gave the Central Government the power to regulate industries (development and control) including the Medical industry. In 1953, the Government of India established a Medical Research Committee under the chairmanship of Major General SL Bhatia to conduct an in-depth investigation into the scope and development of the pharmaceutical industry, basic equipment and packaging industry, suspension, quality control and management, research work, distribution and marketing, technical training etc. to develop the entire pharmaceutical industry. In order for the pharmaceutical industry to thrive rapidly, it was suggested that each production concern should try to produce as much chemical and chemical products as possible at that time. There may be reference to the Drugs and Magic Remedies Act 1954 (objectionable advertisements) (Drugs and Magic Remedies, 1986).

The law has made provisions to regulate drug advertising in certain circumstances, to prohibit advertising for certain purposes of suspected magical remedies and to deal with related matters. The laws under this Act were published in 1955.

In 1955, the Pharmaceutical Inquiry Committee, formed the Development Council for Drugs and Pharmaceuticals in terms of the Industrial Act, 1951. It was felt that the country should be free from foreign exploitation and cheap

www.tjprc.org

editor@tjprc.org

80

Malika Basu (Ghosh)

medicines should be given to the people. In 1956, the Russian delegation visited India and made recommendations for the development of the pharmaceutical and other industries. Over time, various companies gradually joined the drug manufacturers. In 1960, there were about 2,800 large, medium and small producers. India has met the full requirements for the manufacture and packaging of imported or semi-finished drugs. A report (1959) by Judge Rajagopala Ayyangar (1959) on the review of the Copyright Act may also be noted. In line with Justice Ayyangar's views on the pharmaceutical industry, the Mudaliar Committee (1951-61), recommended that copyright should be a process and not a product. Patent application should be reduced to between five and ten years, although the extension has not been granted as usual. The Mudaliar Committee also recommended that shops and depots be modernized, expanded and operated as state-owned enterprises for the production and supply of drugs, not only to meet the needs of community development, but also to security services. It can be said that the Indian Pharmaceutical Delegation traveled to Russia and other Eastern European Countries in 1956. In line with the recommendations of the Council on Drug and Drug Development, in 1963, Indian Pharmaceutical Delegation visited several drug laboratories in Italy, Switzerland, West Germany, the United Kingdom, the United States of America and Japan. The Indian team identified basic and intermediate drugs, experimental plants, pharmaceutical processing, product development laboratories, modern contraceptive methods, basic and applied research, quality control, drug patents, drug prices and exports. The visit provided adequate information and expert advice to the Government of India which assisted him in making policy decisions regarding drug production and related matters.

Another important development was the patent law. In British India, the First Copyright Act was passed in 1856. After independence, the situation changed with the promulgation of the Copyright Act of 1970. The law provided for a process patent only to be provided with chemicals. Medicines and food with a protection period of five to seven years and a Right License after three years of patenting. This legislation has been a huge success in the national field of the pharmaceutical industry.

In the 1970s, the Indian government took a number of policy steps to attain independence in the pharmaceutical industry. The first move was to update colonial patent legislation and renounce the pharmaceutical product's patent protection. As a result, the Patents Act of 1970 limited patent protection to medical inventions. As a result, Indian companies will be allowed to create new pharmaceuticals that have been approved for use on the worldwide market but were previously unavailable to India's needy patients. This has allowed for the production and sale of novel pharmaceuticals at affordable prices. Second, the government enacted legislation restricting foreign ownership, prohibiting foreign corporations from owning more than 50% of the company. Third, the government imposed direct price limits on all 347 medication formulations. Fourth, international pharmaceutical companies (MNCs) are forced to start producing both synthetic drugs and bulk drugs in India (Abrol, Prajapati and Singh, 2011). Fifth, mass production of public sector drugs has encouraged small and medium enterprises (SMEs) to begin production.

In February 1974, the Government of India appointed a Drug Committee under the leadership of Jaisukhlal Hathi.

The Committee conducted an in-depth study of the industry and related factors. The report was first released in April 1975.

The Committee noted that the public sector has achieved full production of high energy, especially in synthetic drugs. The drug industry was full of external units that set the pattern for the industry. The Committee commended the establishment of the National Drug Authority (NDA) to facilitate the implementation and achievement of the basic objectives and to distribute the essential drugs to as many economic people as possible. However, comprehensive recommendations focus on drug industry development, bulk drug production facilities, technology development and flow, drug and drug prices, quality control, essential drug supply measures and common home remedies for the general population, especially in rural Impact Factor (JCC): 5.5584

NAAS Rating: 2.90

Pharmaceutical Industry in India: Historical Perspectives, Recent Issues and Future Trends

81

areas. Undoubtedly, the Report of the Hathi Committee (1975) was an important milestone in the development of the Indian pharmaceutical industry. The period 1971-95, was crucial in strengthening the foundation of the drug industry. In January 1995, India became a founding member of the World Trade Organization (WTO) and complied with the requirements of the WTO intellectual property agreement, Trade Related Aspects of Intellectual Property Rights (TRIPS).

In order to meet the basic requirements of TRIPS, the Copyright Act was amended in 1999. In 2002, India enacted its patent law to grant TRIPS a 20-year patent on all inventions, which must be applied to patents at the end of the transition period. An important step in India’s implementation of its TRIPS commitment must be covered by the Patent Act 2005 in order to provide product ownership. With the advent of the patent regime from January 2005, the Indian Pharmaceutical Industry was at high risk for opportunities and risks. This has enabled local pharmaceutical companies to pursue various business strategies and R&D (research and development) forward aimed at achieving long-term sustainable growth under the new regime. There is the emergence of a new industrial structure due to the gradual integration of Indian factories with the international pharmaceutical industry, the increasing exchange of new pharmaceutical methods worldwide and job creation opportunities (Abrol, 2005).

All of these governmental actions have combined to make India not only self-sufficient but also a general producer of generic medications over the last two decades. In terms of production capacity, India's pharmaceutical industry is now rated third (10 percent of the global share). Profits increased from $ 0.3 billion in 1980 to around $ 21.73 billion in 2009-10. There are around 5,000 small, medium, and major producers in the business. In several worldwide medical systems, India's pharmaceutical industry plays a critical role in providing pharmaceuticals. The Global Fund to Fight AIDS, Tuberculosis, and Malaria and the US President's Emergency Plan for AIDS Relief (PEPFAR), for example, both acquire a significant portion of their drugs from Indian manufacturers. While the Indian pharmaceutical sector grew rapidly from 1991 to the first half of the 2000s, its adequacy and competitiveness in the generic pharmaceutical market are now under threat. The Indian pharmaceutical sector faces numerous obstacles from both internal and external sources. The most significant concern is multinational corporations' (MNCs) expanding dominance of the Indian pharmaceutical industry and marketplaces, as well as their harsh exploitation and abuse of copyright products afforded under the current Indian patent system (Chaudhuri, 2005). The Indian government's two policy moves may be viewed as pivotal in the formation of the industry's current predicament. The first was a shift in government policy toward foreign investment, and the second was a significant shift in state intellectual property policy to meet with WTO responsibilities. Both of these measures, taken together, are currently setting the globe on a course to ruin.

1.2 FOREIGN ACQUISITIONS AND STRATEGIC ALLIANCES The pharmaceutical business in India was opened to foreign investment (FDI) in 2001. As a result, the 'automatic way' (i.e., without prior approval) was used to allow 100 percent FDI in medication production. The FDI policy made no distinction between new and existing institutional investments (Bhaumik, Beena, Bhandari and Gokran, 2003). However, over the last twelve years, multinational corporations have made little effort to invest in new ventures in India, preferring instead to focus on current interests, such as the acquisition of Indian firms. At the same time, MNCs and Indian pharmaceutical businesses have formed a number of strategic alliances. These strategic partnerships are most commonly seen in the domains of research and development (R&D), marketing, and contract manufacturing. The field of contract production is the main form in these three periods. In the light of shifting global pharmaceutical market dynamics, MNC acquisitions and strategic alliances should be understood and assessed. However, in order to fully benefit from such

www.tjprc.org

editor@tjprc.org

82

Malika Basu (Ghosh)

seizures and international bindings, it is vital to take into account the extensive modifications made by the Indian government to the country's intellectual property laws.

1.3 PRODUCT PATENT PROTECTION To comply with the obligations of the WTO Convention on Trade-Related Intellectual Property Rights (TRIPS) Agreement, India re-launched the product patent system in 2005. This takes the place of one of the most important policy tools for the growth of the Indian pharmaceutical industry. Prior to 2005, the Indian medical industry was able to introduce new pharmaceuticals to the Indian and international markets in a short period of time for a fraction of the startup cost due to the lack of patent protection. In addition, competition among Indian pharmaceutical producers arose as a result of product patents and the introduction of identical medicines to the market by a number of enterprises. The competition resulted in the availability of medications at cheaper prices, which coincided with the price regulation of critical medicines until the mid-1990s. Because NCEs generally come with product patent protection, the reintroduction of a product patent restricts Indian pharmaceutical companies' ability to release standard versions of new chemical companies (NCEs) in a timely manner.

Professor Sudip Chaudhuri of the Indian Institute of Management (IIM, JOKA, Kolkata) recently published a study that shows how MNCs are increasingly controlling the Indian medical industry. According to a study, India has eighty NCEs and new biological organisations (NBEs) between 1995 and 2010. MNCs sell ninety-two of the eighty new medications to India and control the market for the other thirty-four. Thirty-four of these medications are used to treat cancer (11), heart (7), anti-infectives (5), analgesics (3), nerves (4), anti-diabetes (3), and ophthalmology (3). (1). Professor Chaudhuri also thought about direct price regulation for patented pharmaceuticals. 'Price control is not forbidden under TRIPS or any other WTO agreement,' he claims. The 2006 Draft National Pharmaceuticals Policy (page 15) suggested mandatory pricing discussions before patenting the market and underlined the value of research experiences from Canada, Australia, France, and other nations with a good system. When comparing pricing restrictions to compulsory licensing, Chaudhuri claims that price controls "make medications more inexpensive when done correctly but do not allow mainstream corporations any space." However, MNC acquisitions of Indian pharmaceutical companies and strategic alliances pose the greatest danger to the future usage of CL (compulsory licences). This could eliminate opportunities to exploit the Indian Patents Act's flexibility to assure access to medicines. Due to MNCs' dominance of the Indian pharmaceutical business as a result of acquisitions and strategic alliances, variables such as forced licensing will be used less frequently (Chaudhuri, 2011).

The pharmaceutical sector is undergoing significant changes around the world. The 'blockbuster drug model,' as used by drug MNCs, is currently under fire. The field of research and development is parched, and the number of NCEs has plummeted. Patents on existing compounds are also projected to expire, putting MNCs at a disadvantage. In reality, in the not-too-distant future, practically all blockbuster pharmaceuticals for drug MNCs will be copyrighted. In addition, mainstream Indian firms began challenging blockbuster patents. As a result, the worldwide generic market is quickly expanding, particularly in regulated areas. Another significant issue for the business is that, as a result of the global financial crisis, industrialised countries have begun to cut social security spending as part of their fiscal austerity measures.

This is expected to affect out-of-pocket drug purchases as well as public drug purchases. MNCs have used a range of ways to address these issues, one of which is controlling the generic medication industry. In this perspective, the acquisition and partnership of strategies with ordinary businesses should be understood. In India, issues such as drug misuse and excessive Impact Factor (JCC): 5.5584

NAAS Rating: 2.90

Pharmaceutical Industry in India: Historical Perspectives, Recent Issues and Future Trends

83

medicine pricing have spurred controversy and discussion among policymakers and analysts. Another source of concern was a legislative health committee, which noted in a July 2010 report on the acquisition of Indian pharmaceutical companies: 'These developments may result in MNCs acquiring market strength and essential medications becoming more expensive.' The Committee would like to express its gratitude to the Department of Health and Family Welfare for working quickly with the Department of Chemicals and Fertilizers to develop policy solutions to keep Indian drug companies in Indian hands.' As a result, the Departments of Health and Trade and Industry were opposed to such acquisitions. In a report released in October, the High Level Experts Group on International Health Management in India stated unequivocally that "we also need to revise India's FDI rules to amend the current rules for the automatic route of 100% foreign players in the Indian industry to -49 percent, in order to maintain India's leading pharmaceutical companies and our independence in drug production." Many community-based organisations, such as the All-India Drug Action Network, the Center for Trade and Development, and the Delhi Science Forum, have expressed similar concerns. The issue is currently being examined in depth by the parliamentary trade committee.

In response to these concerns, the Prime Minister hosted a high-level conference in October that adopted the recommendations of the Arun Maira Committee created to explore the policy response to the FDI issue in the Indian medical industry, with minor changes. This judgement modifies the present policy, which allows for 100 percent FDI in the sector via the default route, and differentiates between new and existing investments. Existing investments will also be referred to the External Investment Promotion Board on a six-month interim basis. The Competition Commission of India (CCI), which oversees mergers and acquisitions, is also in charge of such deals. A six-month transition period is also given for amending the Competition Act and Rules so that the CCI can work properly. This demonstrates that the government has decided to only use competition law to address concerns about MNCs acquiring Indian generic enterprises. As a result, the Commission is concentrating its efforts on resolving the problem from a competitive standpoint. However, one significant problem in the competitive legal system is that the Commission's decisions will not be challenged by the courts and will not be overturned. As a result, the government must implement a policy-based strategy as well as suitable measures to address the policy concerns raised by the acquisition of Indian pharmaceutical businesses.

As a result, any improvements affecting the Indian pharmaceutical industry could help underdeveloped countries expand their medical reach. The patent system has taken away Indian pharmaceutical businesses' previously unrestricted ability to introduce generic medications. Only TRIPS modifications incorporated in India's Copyright Act allow standard versions of copyrighted pharmaceuticals to be made. However, these scenarios are only used by a few Indian pharmaceutical companies to introduce conventional versions of NCEs. To make the best use of these conditions, legal provisions should be carefully crafted. Furthermore, through policy tools and capacity building, the government should encourage the use of this flexibility. Importantly, there is a need to address MNCs' increasing regulation of the Indian pharmaceutical sector, which poses a substantial risk to TRIPS flexibility and could jeopardise access to pharmaceuticals.

The Indian government's policy response to these concerns has so far fallen short of expectations, particularly when it comes to procurement and strategic relationships. The urgent need to devise regulatory solutions at several levels to avoid direct and indirect acquisitions of ordinary domestic enterprises, with the goal of keeping the generic industry in operation and raising the price chain. Access to inexpensive medicines must constantly be preserved as a result of this (Pradhan, 2006).

In the pharmaceutical industry, the Indian market offers enormous growth potential. Companies would need to

www.tjprc.org

editor@tjprc.org

84

Malika Basu (Ghosh)

rethink how they do business if the industry is to achieve a robust growth rate of 15-20 percent by 2020. Co-operatives and partnerships will help pharmaceutical firms flourish in a healthy way. They'll keep working to improve efficiency and production. They will, however, need to apply new business models and come up with new ideas to serve their growing clients faster and better in order to satisfy the demands of a changing business climate. By removing financial and physical barriers to getting health care in India, advancements in the health insurance sector, medical technology, and mobile phones could help the pharmaceutical industry thrive. Overall, the pharmaceutical industry must carefully assess the many regulatory actions. In the years ahead, it will be fascinating to witness how corporations adapt to the regulatory framework as they seek to capitalise on the prospects given by the Indian market. As emerging markets become more important, and India's role as a bridge between them grows, both local and medical MNCs will need to alter their business models, organisations, and procedures, as well as develop customised strategies (Saberwal, 2009). The pharmaceutical business, on the other hand, will have to compete in the worldwide marketplace. The main focus should be on research, drug development and development. Industry, authorities and institutions must understand the challenges and needs of the market to develop skilled, management and business personnel. Pharmaceutical industries will need to risk and strengthen their organization by focusing on bringing in talents and skills from outside the industry rather than traditional methods that focus on developing talent in internal departments to focus more on achieving industrial goals.

1.4 INTELLECTUAL PROPERTY RIGHTS AND INDIAN PHARMACEUTICAL INDUSTRY Intellectual Property Rights (IPR) in the pharmaceutical business have become a contentious topic around the world.

Previously, IPR conflicts were frequently between high-priced pharmaceutical firms and low-priced generic pharmaceutical companies. India was not immune to the IPR dispute, and due to the high number of poor people in need of basic health care, the Indian government first refused to offer stronger IPR protection. However, over time, Indian authorities have become more aware of the necessity for and relevance of IPR protection for the sector's long-term success.

The Patents Act of India, passed in 1970, includes laws relating to patents for the manufacture of pharmaceuticals, among other things. The passing of the Copyright Act (Amendment), 2005, which brought India's copyright rules into compliance with TRIPs, was a significant reform in copyright laws.

Prior to the 2005 amendment, only procedures may be patented; no final product could be patented. As a result, if a company wants to create the same product but using a different process, it won't be breaking India's copyright regulations. Various companies, particularly renowned manufacturers, have expressed concern about the regulation because it did not fully safeguard their production and permitted others to build the same product, which could be protected under copyright elsewhere. Product and method patents have been approved for a term of 20 years, as amended by the 2005 amendment, and additional provisions have been implemented to avoid patent persistence. The 2005 modification was regarded as a significant shift in India's defence structure. However, copyright issues are common in India, and have recently been exacerbated by mandatory authorization. Although India's copyright protection has improved dramatically, recent challenges such as compulsory licensing (CLS) techniques have sparked debate. CLS can be awarded under the Indian Copyright Act if, for example, adequate public standards surrounding patent institutions are not reached, copyrighted inventions are not publicly available at a reasonable price, and patented inventions are not done on the Indian subcontinent.

CL distribution conditions, in the context of a pharmacy, are meant to prevent a situation in which public health is discriminated against by only receiving a patented product. The Supreme Court of India has dismissed Nacto Pharma's Impact Factor (JCC): 5.5584

NAAS Rating: 2.90

Pharmaceutical Industry in India: Historical Perspectives, Recent Issues and Future Trends

85

motion for Special Restrictions CL. The case of Nacto Bayer was the first against CL, and Nacto was awarded a CL drif of Bayer's Patent Nexavar since all of the conditions for granting CL under the Copyright (Indian) Act, 1970 were met.

Although CLs are regarded as a necessary evil in developing countries, they are a source of concern in the industry due to the financial losses they frequently inflict. In a recent Copyright Order, it was stated that issuing CL should be the last choice and that efforts should be made first to secure a voluntary license. This order gives the industry some relief, as it underlines the legal position that a patent holder's patent will not be infringed upon if he does not meet the CL grant conditions under the Copyright Act of 1970. While short-term decisions that benefit society are appealing, such decisions should not upset the pharmaceutical business as a whole. There is a pressing need to strike a cautious balance between community and industry interests.

1.5 MERGERS AND ACQUISITIONS IN INDIAN PHARMACEUTICAL SPHERE: GENERAL OUTLOOK TOWARDS FOREIGN INVESTMENTS India's population is large, and it has limited access to inexpensive health care. In this regard, assuring I continuous availability and supply of medications (ii) continued critical medicines (iii) enhanced supply of medicines over time are some of the primary issues in approving foreign investment in the Indian pharmaceutical business. As a result, a policy that authorises foreign investment in the Indian medical sector must strike a balance between addressing people's demands and the industry's major needs. Currently, up to 100 percent FDI is permitted for brownfield investment with previous approval from the Foreign Investment Promotion Board (FIPB), and up to 100 percent FDI is approved in excess of FIPB prior clearance for green investment. The pharmaceutical business in India has one of the highest levels of foreign direct investment (FDI). The question of whether such investments have benefited the Indian pharmaceutical business has been disputed. Certain parts of the government have recently called for a complete ban on foreign investment. Although more access to capital is necessary for any industry to thrive, in the medical field, increased investment should be accompanied by increased technology transfer and increased productivity. FDI accompanied with such escorts could help India achieve long-term prosperity and protect world-class institutions. FDI-driven growth is critical, and it should act as a catalyst for the creation of a world-class pharmaceutical industry that serves the majority of the country's needs.

1.6 RESEARCH AND DEVELOPMENT DESTINATION During the 1990s, the Indian government's private labour and trade policy provided R&D incentives in the medical industry. New products were removed from pricing constraints, a variety of financial systems were made available to R&D enterprises, technical cooperation was put through an automated approval process, and patents on products and processes were awarded for a 20-year period. Only with new technologies has this incentive resulted in a significant increase in productivity. Owing to its faulty engineering industry, India was traditionally known as the world's capital; however, this is changing, and Indian firms have begun to research and establish pharmaceuticals. Since 1985, more than 870 international businesses have opened R&D offices in India, with Texas Instruments being the first. The following are the primary reasons why R&D in India is considered profitable: Cost-effectiveness: In India, the cost of establishing world-class R&D services is a fraction of what it costs in the West. The entire cost of R&D is around one-eighth of what it is in the West, and the cost of clinical trials is about onetenth. Intelligence: A wide collection of English-speaking technical capabilities, as well as highly developed R&D skills, is offered at a moderate cost. Pre-established R&D Centers: Pre-established R&D Centers are simple to utilise and

www.tjprc.org

editor@tjprc.org

86

Malika Basu (Ghosh)

inexpensive. Growing biotechnology industry: India's biotechnology industry has experienced rapid growth and now includes world-class businesses. Market access: India is one of the world's fastest expanding economies. Companies may engage in this new and growing industry by investing in R&D in India. Domestic Income Growth: India's increasing middle class is a promising drug market. The market for non-essential pharmaceuticals will rise substantially as a result of the increase in revenue available. Government Grants: Since India's independence, the Indian government has provided numerous incentives for R&D in the country; including Biodiversity: Some drugs aimed at the Indian market require some type of research and development as well as clinical testing. India's genetic diversity provides a wide range of R&D and clinical trials opportunities. Pharmaceutical R&D is predicted to increase rapidly in India in the near future, and with the country's growing economy and pharmaceutical sector, the introduction of new products is gaining new economic relevance in the industry.

1.7 CONCLUSIONS India's medical industry has come a long way in terms of infrastructure development as well as technical and R&D capabilities. The business is facing new problems as the Indian pharmaceutical sector becomes more integrated with the global market. Other long-standing issues include intellectual property rights (IPR) and market pricing issues. The trend of increasing foreign interest in the sector and increasing R&D expenditure is projected to continue. The pharmaceutical business in India may confront new assets and challenges as a result of increased electricity and a growing consumer segment, but it is predicted to grow consistently and remain an attractive investment destination. Overall, the pharmaceutical industry must carefully assess the many regulatory actions. In the next years, it will be fascinating to witness how corporations adapt to the regulatory environment as they strive to take advantage of the opportunities given by the Indian market. Both local and NN pharmacists will need to alter their business models, organisations, and processes, as well as build specific strategies, as emerging markets become increasingly essential and India's position between these markets develops tremendously. The pharmaceutical business, on the other hand, will have to compete in the worldwide marketplace. Focused should be given on research and drug development. Industry, authorities and institutions must understand the challenges and needs of the market to develop the skills, managers and employees of the business. The pharmaceutical industry will need to take risks and strengthen their organization by focusing on bringing in talents and skills outside the industry rather than the traditional methods focused on developing talent in internal departments to focus more on achieving industrial goals. Finally, it can be said that India is slowly entering the world markets and competing with international quality standards and prices. While R&D is an important factor in ensuring competitiveness in the international arena, the future of the Indian pharmaceutical industry depends on patent protection.

REFERENCES 1.

Abrol, D. (2005). Post-TRIPs Development Strategies of Indian Pharmaceutical Industry. Proceedings of the National Seminar on Drug Policy, JSA, Kolkata, 16-17 April.

2.

Abrol, D., Prajapati, P & Singh, N. (2011). Globalisation of the Indian Pharmaceutical Industry: Implications for Innovation.

International Journal of Institutions and Economies, 3, 2, 327-365.

3.

Bhaumik, S.K., Beena, P., Bhandari, L.,& Gokarn, S. (2003). Survey of FDI in India, Centre for New and Emerging Markets.

London: Business School.

4.

Chaudhuri, S. (2005). The WTO and India’s Pharmaceuticals Industry: Patent Protection, TRIPS and Developing Countries New Delhi: Oxford University Press.

Impact Factor (JCC): 5.5584

NAAS Rating: 2.90

Pharmaceutical Industry in India: Historical Perspectives, Recent Issues and Future Trends 5.

87

Chaudhuri, S. (2011). Multinationals and Monopolies: Pharmaceutical Industry in India after TRIPS. Working Paper Series, WPS No. 685, November.Indian Institute of Management, Kolkata.

6.

Harkishan Singh. (2011). Pharmaceutical History of India. Delhi: Vallabh Prakashan.

7.

Saberwal, G. (2009). Drug Development in India: What Does the Future Look Like? Contemporary Perspectives: History and Sociology of South Asia, 3, 293-309.

8.

Singh, H. (2011).The Overseas Drug Trade of Colonial India. Pharmaceutical Historian, 31,4-9.

9.

The Drugs and Magic Remedies (Objectionable Advertisement) Act, Government of India, Ministry of Health and Family Welfare,1986.

FROM WEBSITES 1.

Centre for Trade and Development (Centad). New Delhi. (2010). Competition Law and Indian Pharmaceutical Industry.

Retrieved from https://www.cci.gov.in/sites/default/files/PharmInd230611_0.pdf

2.

Joseph, R.K. (2011). The R & D Scenario in Indian Pharmaceutical Industry. DiscussionPaper # 176. RIS: Research and Information System for Developing Countries. Retrieved from https://www.ris.org.in/images/RIS_images/pdf/dp176_pap.pdf

3.

Prakash,A.,

Sarma,P.,

&

Medhi,B.

(2018).

Retrieved

from

https://www.researchgate.net/publication/326298520_Intellectual_property_rights_and_Indian_pharmaceutical_industry_Pre sent_scenario 4.

Rani,N.,

Yadav,S.,

&

Jain,P.K.

(2011).

Retrieved

from

https://www.researchgate.net/publication/255697506_Impact_of_Mergers_and_Acquisitions_on_Shareholders'_Wealth_in_Sh ort-Run_An_Empirical_Study_of_Indian_Pharmaceutical_Industry 5.

Sharma, B., & Singh, S. (2021). Retrieved from https://www.mondaq.com/india/trademark/1082800/pharmaceutical-industryand-intellectual-property-rights-an-indian-perspective

6.

Sharma, R. (2020). Future of Pharmaceutical Industry in India. Retrieved from https://www.orfonline.org/expert-speak/futureof-pharmaceutical-industry-in-india/

7.

Trends and Opportunities for Indian Pharma. Retrieved from https://ficci.in/spdocument/22944/india-pharma-2018-ficci.pdf

8.

Zacharias,

N.,

&

Farias,

S.

(2002).

Retrieved

from

http://www.nishithdesai.com/fileadmin/user_upload/pdfs/Patents_and_the_Indian_Pharmaceutical_Industry.pdf 9.

Ahmad, I. M. R. A. N., et al. "Checklist of some medicinal plants of district Lower Dir, Pakistan." IASET: Journal of Agricultural & Bio-Chemical Science 1 (2016): 15-22.

10. Illesinghe, Amal, and Sellappan Palaniappan. "Towards Predicting Credit Risk in Sri Lanka’s Banking Sector." International Journal of Financial Management (IJFM) ISSN(P): 2319-491X; ISSN(E): 2319-4928 Vol. 7, Issue 3, Apr-May 2018, 15-20 11. Din, Towseef Mohi UD. "Handicraft Entrepreneurship: Tool for Economic Development In Rural Economy." IASET: Journal of Humanities and Social Sciences (IASET: JHSS) ISSN(P): Applied; ISSN(E): Applied Vol. 3, Issue 1, Jan - Jun 2017; 1-4

www.tjprc.org

editor@tjprc.org