Ethical issues: biosafety, patents and biopiracy

What are the ethical issues of biotechnology?

In plain words: changing living things can help or harm, so it needs rules. Two kinds of question arise: is a genetically modified organism safe to release, and who owns, and who should profit from, plants and knowledge that farmers and local people developed over centuries?

Why regulation is needed

• Some ethical standards are required to evaluate the morality of all human activities that might help or harm living organisms (page 184).
• Beyond the morality, the biological significance matters too: genetic modification of organisms can have unpredictable results when such organisms are introduced into the ecosystem (page 184).
• So the Indian Government has set up organisations such as GEAC (Genetic Engineering Approval Committee), which makes decisions on the validity of GM research and the safety of introducing GM organisms for public services (page 184). Judging whether a GM organism is safe to release is the biosafety issue that the NEET (UG) 2026 syllabus lists.
• Beyond the NCERT text: the committee’s current name is the Genetic Engineering Appraisal Committee, still shortened to GEAC (Wikipedia, “Bt brinjal”, facts in our words). In an exam, expand GEAC as NCERT does.

Patents on biological resources

• Using living organisms for public services, for example as sources of food and medicine, has also created problems with patents (page 184).
• There is growing public anger that certain companies are being granted patents for products and technologies that use the genetic materials, plants and other biological resources that have long been identified, developed and used by farmers and indigenous people of a specific region or country (page 184).

The Basmati rice patent

• Rice is an important food grain whose presence goes back thousands of years in Asia’s agricultural history. There are an estimated 200 000 varieties of rice in India alone, and India’s diversity of rice is one of the richest in the world (page 185).
• Basmati rice is distinct for its unique aroma and flavour, and 27 documented varieties of Basmati are grown in India. Basmati is referred to in ancient texts, folklore and poetry, as it has been grown for centuries (page 185).
• In 1997, an American company got patent rights on Basmati rice through the US Patent and Trademark Office. This allowed the company to sell a ‘new’ variety of Basmati in the US and abroad (page 185).
• The ‘new’ variety had actually been derived from Indian farmers’ varieties: Indian Basmati was crossed with semi-dwarf varieties and claimed as an invention or a novelty. The patent extends to functional equivalents, so other people selling Basmati rice could be restricted by it (page 185).
• Several attempts have also been made to patent uses, products and processes based on Indian traditional herbal medicines, such as those from turmeric and neem. If we are not vigilant and do not counter such patent applications immediately, others may encash on our rich legacy (page 185).

Biopiracy

• Biopiracy is the use of bio-resources by multinational companies and other organisations without proper authorisation from the countries and people concerned and without compensatory payment (page 185).
• Most industrialised nations are rich financially but poor in biodiversity and traditional knowledge. The developing and underdeveloped world is rich in biodiversity and in traditional knowledge related to bio-resources (page 185).
• Such traditional knowledge can be exploited to develop modern applications, and can save time, effort and expenditure during their commercialisation (page 185).
• There is growing realisation of the injustice, inadequate compensation and benefit sharing between developed and developing countries, so some nations are developing laws to prevent unauthorised exploitation of their bio-resources and traditional knowledge (page 185).

The Indian Patents Bill

• NCERT notes that the Indian Parliament has cleared the second amendment of the Indian Patents Bill, which takes such issues into consideration, including patent terms, emergency provisions, and research and development initiatives (page 185).

Solved examples

Common mistakes to avoid

Quick revision summary

• Manipulating living organisms needs regulation: ethical standards, and caution because GM organisms released into the ecosystem can have unpredictable results.
• GEAC (Genetic Engineering Approval Committee; now named Appraisal Committee, beyond the NCERT text): decides on the validity of GM research and the safety of introducing GM organisms for public services, the biosafety question.
• Patents: public anger at patents on products and technologies that use biological resources long developed by farmers and indigenous people.
• Basmati: India has about 200 000 rice varieties and 27 documented Basmati varieties; in 1997 an American company patented a ‘new’ Basmati derived from Indian varieties. Turmeric and neem uses also faced patent attempts.
• Biopiracy: using bio-resources without authorisation and without compensatory payment. India cleared the second amendment of the Indian Patents Bill.

Questions students ask

What is the difference between biopiracy, a biopatent and bioprospecting?

Biopiracy is a kind of misuse, a biopatent a legal right and bioprospecting a search: biopiracy is “the use of bio-resources by multinational companies and other organisations without proper authorisation from the countries and people concerned without compensatory payment” (NCERT page 185). A biopatent is, by our reading, a patent on a biological resource or on a product or process using one, as in NCERT’s Basmati case (pages 184–185). Bioprospecting is “exploring molecular, genetic and species-level diversity for products of economic importance” (NCERT Chapter 13, page 223); by our reading, it turns into biopiracy when that authorisation and payment are missing.

Under which law was GEAC set up, and what does RCGM do?

Beyond the NCERT text, GEAC was set up under India’s Rules for hazardous micro-organisms and genetically engineered organisms, notified in 1989 under the Environment (Protection) Act, 1986, and it works under the Union environment ministry, MoEFCC (the ministry’s Annual Report 2019–20). The same Rules provide for the Review Committee on Genetic Manipulation (RCGM), which sits in the Department of Biotechnology and oversees research with GM organisms (Ministry of Environment and Forests, India’s 2008 national report on the Cartagena Protocol on Biosafety). In NCERT, which does not name RCGM, GEAC itself makes decisions on “the validity of GM research” (page 184).

Is Bt brinjal approved in India like Bt cotton?

Beyond the NCERT text, Bt brinjal cannot be grown commercially in India, unlike Bt cotton, because its release is on hold: GEAC concluded on 14 October 2009 that Bt brinjal, which carries a Bt cry gene against the fruit and shoot borer, was safe for environmental release, but the environment ministry then held public consultations and in 2010 imposed a moratorium until the concerns raised by the public, scientists and states were resolved (Ministry of Environment and Forests, Annual Report 2009–10). A 2026 country report of the Indian Council of Agricultural Research (ICAR) says Bt brinjal is still under that moratorium.

Practice questions

Try each question first, then open the answer to check your working.

1. Q1. What does GEAC stand for, and what does it decide?

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   Genetic Engineering Approval Committee; it makes decisions on the validity of GM research and the safety of introducing GM organisms for public services (NCERT page 184).

2. Q2. Besides ethics, why must the release of GM organisms be regulated?

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   Genetic modification of organisms can have unpredictable results when such organisms are introduced into the ecosystem (NCERT page 184).

3. Q3. Name two traditional herbal medicines whose uses, products and processes have faced patent attempts.

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   Turmeric and neem (NCERT page 185).