TOPIC: General Studies 3
- Science and Technology – developments and their applications and effects in everyday life
- Different types of irrigation and irrigation systems storage, transport and marketing of agricultural produce and issues and related constraints
Bayer-Monsanto deal- How it affects India
In news: German firm Bayer’s acquisition of US seeds company Monsanto, if approved, would create the world’s largest agribusiness. But the deal has drawn criticism in India and sparked concerns among the nation’s farmers.
Bayer and Monsanto in India
- Bayer Group in India comprises the Crop Science and Pharmaceuticals divisions.
- Crop Science is the largest division for Bayer in India. It has two units: Crop Protection / Seeds and Environmental Science.
- Crop Protection / Seeds markets high-value seeds along with innovative chemical and biological pest management solutions.
- Environmental Science focuses on non-agricultural applications, with a range of pest control products and services for areas ranging from the home and garden sector to forestry.
- Bayer is a market leader in the crop protection business in India.
- Monsanto India Ltd. (MIL) has been operating in India for six decades. This company focuses on maize, agriculture productivity and herbicide.
- Monsanto Holdings Pvt. Ltd. holds 26% stake in Mahyco which focuses on marketing Paras cotton hybrid seeds, BT cotton technologies and Vegetable Hybrid seeds.
- Mahyco Monsanto Biotech India Pvt. Ltd. sub-licenses BT technologies to 28 Indian seeds companies.
In short, Monsanto focuses on seeds and biology, Bayer on chemicals.
Why does the deal matter?
- The merger will propel the merged entity (Bayer-Monsanto) into a leading player in the seed sector.
- If the deal is approved by regulators, the new company would become the largest agribusiness in the world selling 29% of the world’s seeds and 24% of its pesticides.
- This will put it in the commanding position vis-à-vis food supply.
- Through their subsidiaries and joint ventures in India, the two firms will garner a major share in paddy, maize, vegetables and cotton and agrochemicals.
Worries for India
- Less choices: In the past, first Dow Chemical and DuPont merged, then there was Syngenta’s acquisition by China National Chemical Corporation. With the Bayer Monsanto merger, stakeholders worry that the global consolidation will narrow choices for farmers.
- Monopolisation: This will leave only three players in the global market in agribusiness and will have a cascading impact on Indian agriculture. It will lead to concentration of power and will result in market distraction. It will also result in further consolidation of the monopoly over agricultural inputs.
- Slow innovation: The reduced competition could shrivel up innovation, leading to slower improvements in crop yields.
- Global agricultural slump– Commodity prices have fallen sharply, and farmers have less to spend on supplies. This has reduced their profits and eroded the capacity to buy costly biotech seeds.
- Increased food prices: If firms can corner key markets in seeds and chemicals, they might be able to raise prices of their products on farmers, which in turn could make food more expensive.
- Strong lobbying power: The new entities will have stronger lobbying power with government which would force shaping up of unfavourable policies at the cost of consumers and farmers’ interests.
Present situation in India
- Bayer’s takeover of Monsanto comes at a time when public resistance to genetically engineered crops has been spreading across India. This is a consequence of the growing number of reports about the negative impact of GM crops on human health and the environment.
- Moreover, GM seeds are increasingly blamed by activists for causing financial hardship to farmers and driving them to commit suicides.
- Monsanto recently withdrew an application for its next-generation GM cotton seeds in India due to intellectual property concerns. It opposed the Indian government proposal that would force it to share its technology with local seed companies.
- Another problem between Monsanto and the Indian government involves a cut in the royalty the company gets paid from local seed companies for using its patented technology.
- There are two ways to deal with situation
- Engage in the usual MNC-bashing. But it will not be too useful as farmers need and have right to new technologies that help boost crop yields, cut losses from pest and disease or save labour and time.
- A more constructive response is to actively engage with the current realities of international agri-business and constantly evolve new means to protect farmers’ interests as well as allow new technology to come to India.
- The new entity is expected to take a fresh look at the issues between Monsanto and the Indian seed industry. Also, the domestic seed industry is hopeful that the merged entity can bring some state-of-the-art technologies to India when Bayer is currently focusing on digital farming, which can benefit Indian farmers.
Connecting the dots:
- Recently, a crucial merger took place between a seed and chemical company dominant in the agri-business. How is this merger expected to affect India? Explain.
- Should Indian farmers be encouraged and incentivised to undertake organic farming or continue with high value seeds? Determine the pros and cons of the same.
General Studies 2
- Issues relating to development and management of social sector/services relating to Health , Education, Human Resources
General Studies 4
- Ethics and human interface
- Probity in governance
Clinical Trials: Ethics Vs Economics
- The notion that medical research is guided by a beneficent hand – an honourable impulse for the betterment of humanity. In reality, research and development of drugs is driven by markets rather than moral concern.
- As the demand grows for newer and better drugs for an expanding range of conditions, so too does the need for clinical testing. Health as a commodity, repositions ethics within an economic framework, and human experimentation is no exception. Profits, rather than people, become the prime consideration
- As the death toll from the African Ebola crisis peaked, World Health Organization (WHO) Director-General Margaret Chan delivered ascathing attack on the “profit-driven” pharmaceutical industry and its unwillingness to develop a vaccine “for markets that cannot pay”.
- Just as many global companies have moved their manufacturing and call centres offshore, the cheapest way to conduct clinical trials is to outsource them to the developing world.
Factors leading to Clinical trials to Global South
The human experiments have rapidly migrated to the global south because:
- Regulations have become more stringent in the developed world. A major justification for moving clinical trials to global south has been the greater availability of “naive” participants – drug-free bodies that allow for unadulterated test conditions.
- The vulnerability of subjects that can make them more attractive. Fewer regulatory safeguards, high levels of poverty and illiteracy, combined with an almost blind faith in Western medicine, provide an almost endless supply of “willing” volunteers in countries such as Africa, China, India and parts of Eurasia.
- The once booming clinical trials in India came under the Supreme Court scrutiny in 2013, after at least 370 deaths were attributed to Serious Adverse Events (SEAs) during such trials.
- Between 2005 and 2012 the deaths of 2,644 Indian subjects werelinked to unethical clinical trials. A number of Indian school girls were alleged to have died after taking part in trials of the Human Papilloma viruses (HPV) vaccine.
- In response to campaigns from groups such as Swasthya Adhikar Manch (Health Right Forum) and media exposure of the exploitation of Indian subjects, in 2013 the Indian governmenttightened its regulatory regime. This included the mandatory registration and accreditation of ethics boards, and better compensation schemes for the injured and families of deceased victims.
- In September 2013, the apex court ruled that no new clinical trials be permitted until the regulatory mechanism was reformed.
- The Indian government’s tightening of regulations for clinical trials was met by criticism from many in the industry, including the Association of Clinical Research Organizations (ACRO), based in the United States, whose vice president of public relations threatened to transfer business “to more hospitable countries to mitigate the economic damage”.
- With the aim to speed up innovation and research in India, the Health Ministry has amended (March 2016) the Drug and Cosmetics Act, exempting clinical trials conducted at academic institutions from taking the hitherto mandatory permission from the Drug Controller General of India (DCGI).
- The latest amendment to the Drug and Cosmetics Act follows recommendations by the Professor Ranjit Roy Choudhury Committee, which had suggested that academic research should be approved by the Institutional Ethics Committees.
Unfortunately regulatory bodies, designed to protect the vulnerable, often fall short of their remit.
- Public health experts say amendment to the Drug and Cosmetics Act is a setback for those working towards a safer, more transparent clinical trials regime.
- With the latest amendment chances of misuse are also higher. The only defence for this decision can be that this is academic, not commercial, research.
- Injury or death as a result of misconduct is hard to prove and even harder to prosecute.
Trials conducted in various parts of the country had violated patient rights as informed consent was not taken, and the patients subjected to clinical trials included newborns, children, pregnant women and mentally challenged persons are often exploited.
- Efforts should be made for a safer, transparent and continuous monitoring mechanism.
- The line should be drawn for this, that the trials on the name of academic should not be misused and diverted for commercial purposes.
- Local activism and human rights agendas can effectively challenge, to some degree, the harmful outcomes of the market and to protect, against the exploitation of vulnerable people in clinical trials.
Connecting the dots:
- Before a drug is approved, it is required to be supported by clinical trials conducted by medical experts. Critically discuss the various issues involved.
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