History of Pharmaceutical Industry in India

Table of Contents

Pharmaceutical industry in India

The Indian pharmaceutical industry is the world’s 3^rd largest by volume and 14th largest in terms of value. Total Annual Turnover of Pharmaceuticals was Rs. 2,89,998 crore for the year 2019-2020. Total pharmaceutical exports and import were to the tune of Rs. 1,46,260 crore and Rs. 42,943 crore respectively in the year 2019-20.

Major Segments of the Pharmaceutical Industry are Generic drugs, OTC Medicines and API/Bulk Drugs, Vaccines, Contract Research & Manufacturing, Biosimilars & Biologics.
India has the second-highest number of US FDA-approved plants outside the US. India is a global leader in the supply of DPT, BCG, and Measles vaccines. India accounts for 60 percent of global vaccine
production, contributing 40 to 70 percent of the WHO demand for Diphtheria, Tetanus and Pertussis (DPT) and Bacillus Calmette–Guérin (BCG) vaccines, and 90 percent of the WHO demand for the measles vaccine.
India is the largest provider of generic drugs globally. Access to affordable HIV treatment from India is one of the greatest success stories in medicine. India is one of the biggest suppliers of low-cost vaccines in the world. Because of the low price and high quality, Indian medicines are preferred worldwide, thereby rightly making the country the “Pharmacy of the World”. The Pharma sector currently contributes to around 1.72% of the country’s GDP.
India’s pharmaceutical sector forms a major component of the country’s foreign trade, with attractive avenues and opportunities for investors. India supplies affordable and low-cost generic drugs to millions of people across the globe and operates a significant number of United States Food and Drug Administration (USFDA) and World Health Organization (WHO) Good Manufacturing Practices (GMP)-compliant plants. India has occupied a premier position among pharmaceutical manufacturing countries of the world.
India is 3rd largest market for APIs globally, 8% share in the Global API Industry, 500+ different APIs are manufactured in India and it contributes 57% of APIs to prequalified list of the WHO.

Pharmaceutical is one of the top ten attractive sectors for foreign investment In India. 100% foreign investment is allowed under automatic route in Medical Devices. Foreign investments in pharmaceutical greenfield projects are allowed up to 100% under the automatic route and for brownfield pharmaceutical projects, foreign investment beyond 74% to up to 100% Government approval is required.

Department of Pharmaceuticals

The Department of Pharmaceuticals was created on the 1st July, 2008 under the Ministry of Chemicals & Fertilizers with the objective to give greater focus and thrust on the development of pharmaceuticals sector in the country and to regulate various complex issues related to pricing and availability of medicines at affordable prices, research & development, protection of intellectual property rights and international commitments related to pharmaceuticals sector which require coordination with other Ministries.

Bureau of Pharma PSUs of India (BPPI)

Bureau of Pharma PSUs of India (BPPI) – set up on 1st December, 2008 by the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Government of India, with the objective to have focused and empowered structure to implement the Jan Aushadhi Scheme launched by Department of Pharmaceuticals.

Public Sector Undertakings manufacturing units of Govt of India

Central Public Section undertakings- the Department has 5 Central Public Section undertakings under its Administrative control, they are-
(a) Indian Drugs & Pharmaceuticals Ltd. (IDPL), Dundahera Industrial Complex, Dundahera, Gurgaon, Haryana,
(b) Hindustan Antibiotics Ltd, Pimpri, Pune, Maharashtra,
(c) Karnataka Antibiotics & Pharmaceuticals Limited, Bangalore-560010,
(d) Bengal Chemicals & Pharmaceuticals Ltd, Kolkata, West Bengal and
(e) Rajasthan Drugs and Pharmaceuticals Limited, Road NO.12, V.K.I. Area, Jaipur-302013.

PRADHAN MANTRI BHARTIYA JANAUSHADHI PARIYOJANA (PMBJP)

The branded (Generic) medicines are sold at significantly higher prices than their un-branded generic equivalents, though are identical in the therapeutic value.

With an objective of making quality generic medicines available at affordable prices to all especially for the poor and the deprived ones, Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) was launched by the Department in the year 2008. Under this scheme, dedicated outlets known as Pradhan Mantri Bhartiya Janaushadhi Kendras (PMBJK) are opened all over the country to provide generic medicines to the masses.

Salient features of the Scheme
The Scheme has been approved for continuation with the financial outlay of Rs. 490 crore for the period from 2020-2021 to 2024-2025. The target is to open 10,500 PMBJP Kendras in all over the country by March 2025. It has also been decided to enhance the product basket of PMBJP up to 2,000 medicines and 300 surgical by March 2025.

Pharmaceutical industry today
The number of purely Indian pharma companies is fairly low. Indian pharma industry is mainly operated as well as controlled by dominant foreign companies having subsidiaries in India due to availability of cheap labor in India at lowest cost. 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 market are small-to-medium enterprises; 250 of the largest companies control 70% of the Indian market. Thanks to the 1970 Patent Act, multinationals represent only 35% of the market, down from 70% thirty years ago.

Most pharma companies operating in India, even the multinationals, employ Indians almost exclusively from the lowest ranks to high level management. Homegrown pharmaceuticals, like many other businesses in India, are often a mix of public and private enterprise.

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 US 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 are expected to be filed by Indian companies. Growth in other fields notwithstanding, generics is still a large part of the picture.

Patent
As it expands its core business, the industry is being forced to adapt its business model to recent changes in the operating environment. The first and most significant change was the 1 January 2005 enactment of an amendment to India’s patent law that reinstated product patents for the first time since 1972. The legislation took effect on the deadline set by the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, which mandated patent protection on both products and processes for a period of 20 years. Under this new law, India will be forced to recognise not only new patents but also any patents filed after 1 January 1995.t13l Indian companies achieved their status in the domestic market by breaking these product patents, and it is estimated that within the next few years, they will lose $650 million of the local generics market to patent-holders.

In the domestic market, this new patent legislation has resulted in fairly clear segmentation. The multinationals narrowed their focus onto high-end patients who make up only 12% of the market, taking advantage of their newly bestowed patent protection. Meanwhile, Indian firms have chosen to take their existing product portfolios and target semi-urban and rural populations

Product Development
Indian companies are also starting to adapt their product development processes to the new environment. For years, firms have made their ways into the global market by researching generic competitors to patented drugs and following up with litigation to challenge the patent. This approach remains untouched by the new patent regime and looks to increase in the future. However, those that can afford it have set their sights on an even higher goal: new molecule discovery. Although the initial investment is huge, a company is lured by the promise of hefty profit margins and has a legitimate competitor in the global industry. Local firms have slowly been investing more money into their R&D programs or have formed alliances to tap into these opportunities.

Small and medium enterprises
As promising as the future is for a whole, the outlook for small and medium enterprises (SME) is not as bright. The excise structure changed so that companies now have to pay a 16% tax on the maximum retail price (MRP) of their products, as opposed to on the ex-factory price. Consequently, larger companies are cutting back on outsourcing and what business is left is shifting to companies with facilities in the four tax-free states – Himachal Pradesh, Jammu & Kashmir, Uttaranchal and Jharkhand. Consequently a large number of pharmaceutical manufacturers shifted their plant to these states, as it became almost impossible to continue operating in non-tax free zones. But in a matter of a couple of years the excise duty was revised on two occasions, first it was reduced to 8% and then to 4%. As a result the benefits of shifting to a tax free zone were negated. This resulted in, factories in the tax free zones, to start up third party manufacturing. Under this these factories produced goods under the brand names of other parties on job work basis.

As SMEs wrestled with the tax structure, they were also scrambling to meet the 1 July deadline for compliance with the revised Schedule M Good Manufacturing Practices (GMP). While this should be beneficial to consumers and the industry at large, SMEs have been finding it difficult to find the funds to upgrade their manufacturing plants, resulting in the closure of many facilities. Others invested the money to bring their facilities to compliance, but these operations were located in non-tax-free states, making it difficult to compete in the wake of the new excise tax.

Relationship between pharmaceuticals and biotechnology
Unlike in other countries, the difference between biotechnology and pharmaceuticals remains fairly defined in India. Bio-tech there still plays the role of pharma’s little sister, but many outsiders have high expectations for the future. India accounted for 2% of the $41 billion global biotech market and in 2003 was ranked 3rd in the Asia-Pacific region and 11th in the world in number of biotech. In 2004-5, the Indian biotech industry saw its revenues grow 37% to $1.1 billion. The Indian biotech market is dominated by bio pharmaceuticals; 75% of 2004 -5, revenues came from bio-pharmaceuticals, which saw 30% growth last year. Of the revenues from bio-pharmaceuticals, vaccines led the way, comprising 47% of sales. Biologies and large-molecule drugs tend to be more expensive than small-molecule drugs, and India hopes to sweep the market in bio-generics and contract manufacturing as drugs go off patent and Indian companies upgrade their manufacturing capabilities.

Most companies in the biotech sector are extremely small, with only two firms breaking 100 million dollars in revenues. At last count there were 265 firms registered in India, over 75% of which were incorporated in the last five years. The newness of the companies explains the industry’s high consolidation in both physical and financial terms. Almost 50% of all biotech are in or around Bangalore, and the top ten companies capture 47% of the market. The top five companies were homegrown; Indian firms account for 62% of the bio-pharma sector and 52% of the industry as a whole.[4,46] The Association of Biotechnology-Led Enterprises (ABLE) is aiming to grow the industry to $5 billion in revenues generated by 1 million employees by 2009, and data from the Confederation of Indian Industry (CM) seem to suggest that it is possible.

Comparison with the US
The Indian biotech sector parallels that of the US in many ways. Both are filled with small start-ups while the majority of the market is controlled by a few powerful companies. Both are dependent upon government grants and venture capitalists for funding because neither will be commercially viable for years. Pharmaceutical companies in both countries have recognised the potential effect that biotechnology could have on their pipelines and have responded by either investing in existing start-ups or venturing into the field themselves. In both India and the US, as well as in much of the globe, biotech is seen as a hot field with a lot of growth potential.

Relationship with IT
Many analysts have observed that the hype around the biotech sector mirrors that of the IT sector. Biotech colleges have been popping up around the country eager to service the pools of students that want to take advantage of a growing industry. The International Finance Corporation, the private investment arm of the World Bank, called India the “centerpiece of IFC’s global biotech strategy.” Of the $110 million invested in 14 biotech projects investment globally, the IFC has given $43 million to 4 projects in India. According to Dr. Manju Sharma, former director of the Department of Biotechnology, the biotech industry could become the “single largest sector for employment of skilled human resource in the years to come”.
British Prime Minister Tony Blair was similarly impressed, citing the success of India’s biotech industry as the reason for his own country’s own biotech opportunities. Malaysia is also looking to India as an example for growing its own biotech industry.

Indian Government Support
The Indian government has been very supportive. It established the Department of Biotechnology in 1986 under the Ministry of Science and Technology. Since then, there have been a number of dispensations offered by both the central government and various states to encourage the growth of the industry. India’s science minister launched a program that provides tax incentives and grants for biotech start-ups and firms seeking to expand and establishes the Biotechnology Parks Society of India to support ten biotech parks by 2010. Previously limited to rodents, animal testing was expanded to include large animals as part of the minister’s initiative. States have started to vie with one another for biotech business, and they are offering such goodies as exemption from VAT and other fees, financial assistance with patents and subsidies on everything ranging from investment to land to utilities.

Foreign investment
The government has also taken steps to encourage foreign investment in its biotech sector. An initiative passed earlier this year allowed 100% foreign direct investment without compulsory licensing from the government. In April, a delegation headed by the Kapil Sibal, the minister of science and technology and ocean development, visited five cities in the US to encourage investment in India, with special emphasis on biotech. Just two months later, Sibal returned to the US to unveil India’s biotech growth strategy at the BI02005 conference in Philadelphia.

Challenges
The biotech sector faces some major challenges in its quest for growth. Chief among them is a lack of funding, particularly for firms that are just starting out. The most likely sources of funds are government grants and venture capital, which is a relatively young industry in India. Government grants are difficult to secure, and due to the expensive and uncertain nature of biotech research, venture capitalists are reluctant to invest in firms that have not yet developed a commercially viable product.

The government has addressed the problem of educated but unqualified candidates in its Draft National Biotech Development Strategy. This plan included a proposal to create a National Task Force that will work with the biotech industry to revise the curriculum for undergraduate and graduate study in life sciences and biotechnology. The government’s strategy also stated intentions to increase the number of PhD Fellowships awarded by the Department of Biotechnology to 200 per year. These human resources will be further leveraged with a “Bio-Edu-Grid” that will knit together the resources of the academic and scientific industrial communities, much as they are in the US.

Mutation & Its Types | Microbiology

Medical Devices Act 2017 | Pharmacy Notes