A Risk-Based Ladder for India’s Biotech Approvals
| AUTHOR | Arindam Goswami |
| DATE | November 13, 2026 |
| CATEGORIES | High Tech Geopolitics Biotech Advanced Biology |
On 12 October 2026, petitioners urged the Supreme Court to hear a contempt plea against the release of herbicide-tolerant basmati and two genome-edited rice varieties. The petition treats these varieties as a single problem, but Indian law handles them under different rules, and a rice plant carrying a gene from another species would go down a different route again. The case is a good illustration of how India regulates biotechnology. The rules decide how closely to examine a product based on the technique scientists used to make it. Whenever India has relaxed its rules over the past five years, in agriculture as well as in medicine, it has looked at two practical questions instead. The first is whether the product contains something new that can survive or spread. The second is how close the product gets to people and to open fields. Writing these two questions into a single rule would give a useful four-step ladder for deciding how much checking a product needs. Let’s examine the current system, the cases where India has already eased its rules, and the ladder that follows from those cases.
How the current system is set up
India regulates genetically engineered organisms under rules framed in 1989 under the Environment (Protection) Act, 1986. Their full name is the Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro-organisms, Genetically Engineered Organisms or Cells. In other words, the rules label an engineered organism hazardous from the start, before even looking at what it actually does.
A number of bodies share the work under these rules. Institutional Biosafety Committees (IBSCs) oversee research inside individual labs. The Review Committee on Genetic Manipulation (RCGM), which sits under the Department of Biotechnology (DBT), reviews research and development work. The Genetic Engineering Appraisal Committee (GEAC), under the environment ministry, decides whether a product can be released into the environment. The Food Safety and Standards Authority of India (FSSAI) looks after GM food, and ICAR runs the trials that new crop varieties go through. An agriculture ministry roundtable earlier this year described this as a multi-tier set-up and called for reforms grounded in science. Medicines go through a separate system altogether, under the Drugs and Cosmetics Act, 1940 and the New Drugs and Clinical Trials (NDCT) Rules, 2019, which the Central Drugs Standard Control Organisation (CDSCO) runs.
On paper, this division of labour looks orderly. Once one looks at specific products, though, the system starts to produce some strange results.
Where the current system produces odd results
Herbicide tolerance in rice is a good place to start. The trait lets farmers sow seeds directly and control weeds with a spray, which saves water and labour. India now has this trait through three different breeding methods, but if one looks at the rules, they treat them very differently. IARI bred Pusa Basmati 1979 and Pusa Basmati 1985 by altering a gene with a chemical called ethyl methanesulfonate. The 1989 Rules do not cover this kind of mutation breeding, so ICAR launched the varieties commercially without any GEAC approval. If scientists made a similar change through genome editing, the plant would need clearance from the biosafety committee at their own institute. If they inserted a gene from another species to get the same result, the plant would have to go through the full GEAC process. In all three cases the farmer ends up with a rice plant that tolerates the same weedkiller, yet the regulatory burden ranges from no biosafety review at all to several years of appraisal.
Food crops with foreign genes have had a particularly hard time, even after regulators approved them. GEAC recommended Bt brinjal, but the government put it under an indefinite moratorium in 2010. GEAC also recommended the release of GM mustard, DMH-11, in 2022. The Supreme Court gave a split verdict on it in July 2024, and the case is still pending. As a result, Bt cotton, approved in 2002, remains the only GM crop Indian farmers can legally grow. At the same time, a field study commissioned by the seed industry estimated that between 24 and 30 per cent of India’s cotton area in 2025–26 carried unapproved herbicide-tolerant or newer Bt traits. So while formal approvals stay stuck, many farmers have already gone ahead and planted unapproved seed.
Soybeans show how much the answer can depend on the form a product takes. India has allowed imports of oil from certain GM soybean and canola varieties for years. In 2021, when feed prices hit record highs, poultry farmers asked to import GM soymeal. The environment ministry said it had no objection, since the meal contained no living organism. The commerce ministry then allowed imports of 12 lakh tonnes of de-oiled GM soya cake, but only through two named entry points and only until 31 October 2021. Imports of GM soybean seed remain banned. India therefore accepts GM soy as oil, accepted it as animal feed for a few months after several ministries weighed in, and still refuses it as seed.
Medicines have had their own version of this problem. Until January 2026, a drug company needed CDSCO’s permission just to make small, non-commercial batches of a new drug for testing or analysis, and the law gave CDSCO up to 90 days to decide. Until August 2024, a medicine already approved by strict foreign regulators usually also needed a fresh phase 3 trial in India on about 200 to 300 people before it could go on sale.
India has not ignored these problems. Over the past five years, it has relaxed its rules in several of these areas, and the reasons it gave for doing so are worth looking at closely.
The cases where India eased its rules
The biggest change came for genome-edited plants. On 30 March 2022, the environment ministry exempted SDN-1 and SDN-2 genome-edited plants that contain no foreign DNA from Rules 7 to 11 of the 1989 Rules. DBT then issued safety-assessment guidelines in May 2022 and standard operating procedures in October 2022. A government official described the outcome as a regulatory system that had come after a decade of deliberation. The exemption still keeps some checks in place. An IBSC has to confirm that the plant carries no foreign DNA, and the plant still goes through the usual variety trials. ICAR announced two genome-edited rice varieties under this route in May 2025, and DBT has since issued revised 2026 procedures for importing such planting material.
The soymeal decision described above was a smaller relaxation, but it rested on a similar kind of reasoning. Meal that cannot grow cannot spread its genes into Indian fields, so the environment ministry saw no reason to put it through the GEAC process.
On the medicines side, the NDCT (Amendment) Rules, 2026 replaced the test licence with an online prior intimation to CDSCO. Companies can now start making small test batches once they have informed the regulator. The amendment kept the licence for a short list of high-risk categories: sex hormones, cytotoxic drugs, beta-lactam antibiotics, biologics containing live micro-organisms, and narcotic and psychotropic substances. For those categories, it cut the processing time from 90 to 45 working days. Low-risk bioavailability and bioequivalence studies also no longer need prior permission.
Two other changes dealt with evidence that already exists. In August 2024, under Rule 101 of the NDCT Rules, CDSCO named the US, UK, Japan, Australia, Canada and the EU as reference jurisdictions. For drugs approved there, it allowed waivers of local trials for orphan drugs, gene and cell therapies, pandemic drugs, defence drugs and drugs that offer a significant therapeutic advance, with CDSCO deciding on a case-by-case basis. In 2025, CDSCO’s draft guidelines on similar biologics proposed letting developers skip animal toxicity studies when laboratory analysis already shows that their product matches the original.
These decisions, read side by side, seem to share a logic. In these cases the regulator first asked how familiar the product was. A plant with no foreign DNA, a biosimilar that matches its reference product in lab tests, and a drug already approved by a trusted foreign regulator can reasonably be called familiar. The regulator then asked how far the product would reach into people or the environment. Soymeal that cannot sprout, small test batches and research inside a lab reach very little. Where a product was familiar and contained, India relaxed the rules. Where it involved live micro-organisms or hazardous chemistry, India kept the full checks. The 2026 drug rules make this especially clear, because they leave out of the relaxation exactly those high-risk categories.
There are two problems with the way India has gone about this, though. First, it made these decisions one at a time, through separate memos and amendments and often after years of debate. A developer with a new kind of product still has no general rule that tells them which route they will face. Second, the crop rules still look only at the breeding method, while the public debate and the petitions in court are mostly about traits. The Supreme Court’s Technical Expert Committee recommended in 2013 against herbicide-tolerant crops, especially in crops such as rice for which India is a centre of genetic diversity. Under the current rules, however, a herbicide-tolerant rice made through chemical mutation skips biosafety review altogether, while a transgenic insect-resistant brinjal has been waiting since 2010. How risky the product actually is doesn’t feature into these decisions.
The logic India has already used in these scattered decisions can, however, be turned into a general framework that fixes both problems.
A framework built from these decisions
The two questions that India’s regulators have been asking give a simple grid. One axis measures novelty, meaning whether the product is familiar or new. The other measures exposure, meaning whether the product stays contained or reaches open fields and people’s bodies. The table below places the products discussed above on this grid.
| Contained (lab, non-living, non-food, small quantity) | Open (field release, living seed, food, given to patients) | |
|---|---|---|
| Familiar (no foreign DNA, matched to a reference, or approved by a trusted regulator) | Notify. SDN-1 lab work; test batches of ordinary drugs; non-living GM feed meal | Institutional check plus normal testing. SDN-1/SDN-2 crops entering variety trials; biosimilars with a strong analytical match; Rule 101 drugs with post-marketing studies |
| Novel (foreign genes, live micro-organisms, hazardous chemistry, untested mode of action) | Central review with a fixed deadline. Transgenic research in containment; test batches of cytotoxic drugs or live biologics | Full appraisal. Transgenic food crops such as DMH-11; first-in-world gene therapies |
Read from the top left to the bottom right, the grid works as an escalation ladder with four rungs. India already runs each of these rungs somewhere in its system:
Rung 1, notification. The developer files an online intimation and can start work, as the 2026 drug rules now allow for test batches.
Rung 2, institutional check. The IBSC or an ethics committee confirms which category the product falls in, and the usual variety trials or clinical testing follow. This is how the genome-editing route already works.
Rung 3, central review with a deadline. RCGM or CDSCO reviews the file within a fixed period, in the way the 45-working-day limit now applies to high-risk test batches.
Rung 4, full appraisal. GEAC or CDSCO carries out a complete biosafety and efficacy review, publishes the data and decides by a set date.
A product can also move between rungs. Good prior evidence, such as approval by a trusted foreign regulator or a close analytical match, should move a product down a rung, as Rule 101 and the biosimilar draft already accept. A trait that raises a specific concern should move a product up. Herbicide tolerance in a crop for which India is a centre of genetic diversity, for example, would sit at Rung 3 or above, whichever breeding method produced it.
Applying this ladder to the problems described earlier points to five concrete changes.
What India can do, based on these findings
The first step is to frame these two questions into a single notified rule. So far, India has needed a separate memo or amendment for each relaxation, and in the case of genome editing the process took about ten years. A general rule publicly known in advance that places products on the ladder by novelty and exposure would let developers of a new technology know which route they would face from the start.
The second step is to create a standing notification route for non-living GM-derived inputs such as feed meal. The 2021 soymeal approval came with a tonnage cap, two named ports and an end date, and poultry farmers would have to go through the same process again the next time feed prices spike. Since meal that cannot grow carries the same low risk every year, a standing Rung 1 route suits it.
The third step is to add a trait check to the crop rules. At the moment, the same herbicide-tolerant trait can face no review, a light review or a full review, depending only on how scientists bred the plant. Looking at the trait as well as the method would give a consistent answer for a given risk. It would also put regulators on firmer ground in court, since the petitions there already argue about traits.
The fourth step is to give every rung a deadline, including GEAC’s full appraisal. The 2026 drug rules show that a fixed timeline can work even for high-risk products. Bt brinjal and DMH-11 show what tends to happen without one: a favourable recommendation and then years of uncertainty. A statutory deadline, together with published biosafety data, would require GEAC to say yes or no by a known date.
The fifth step is to let good prior evidence move products down a rung across agencies, and not only in the drug regulator. Rule 101 and the biosimilar draft already accept evidence generated elsewhere. Writing that principle into a general rule would save Indian developers and patients from repeat studies that do not add any new information.
India’s recent reforms in 2022, 2024 and 2026 already matched the level of scrutiny to the level of risk, even if they did so case by case. Turning them into a single ladder would let regulators clear familiar, contained products quickly and spend their time on new products headed for open fields and hospital wards. It would also help with the problem of illegal seeds. Farmers turn to unapproved cotton hybrids partly because the formal route has stayed closed for years, and a predictable route would give them a legal option.