Seed Regulations – Industry Challenges

1. Seed Regulations – Industry Challenges
National Seminar, IFPRI, New Delhi
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Ram Kaundinya
Director General, FSII
26th September 2023
Regulatory Challenges for Seed Industry - IFPRI Seminar Sept 23

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FSII is an association that is committed to increased investment in seed research
to bring better products to farmers for improving farm productivity and income.
Our members represent close to Rs 10,000 crore worth of the seed industry
business, accounting for approximately 56% market share and approximately
70% of the R & D spend of the seed industry in India.
Regulatory Challenges for Seed Industry - IFPRI Seminar Sept 23

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Regulatory Challenges for Seed Industry - IFPRI Seminar Sept 23

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Key Regulatory Challenges for Seed Industry
❑ Research investments adversely affected by
o No specific recognition or incentivization of Research based
long term players
o Lack of effective IP enforcement mechanism
❑ Ease of doing business adversely affected by
o Lack of uniformity in implementation of Seed Act by states
(annual seed licenses)
o NBA related issues with movement of germplasm, products,
data and other aspects for companies covered by
Section 3(2)of Biological Diversity Act.
o Lack of time bound deregulation of GM traits (activism, politics, PILs)
o PQ related hurdles especially for vegetable seeds
o Abrupt export restrictions on grains (Rice) affecting seed exports

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FSII Recommendations
Urgent need to step up seed research to help farmers tackle existing and emerging
challenges in fields. Oilseeds and Cotton require immediate attention.
A common strategic approach required among Centre, States and Political parties
to use modern science and technology to improve yields, fight climate change and
to make farming profitable for farmer
Seed industry should be treated as a partner with Govt and ICAR
in achieving these objectives

6. Restoration of 200% income tax deduction of R&D expenditure
(existed from 2010 to 2016)
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Regulatory Challenges for Seed Industry - IFPRI Seminar Sept 23
National Accreditation of R&D companies – A national register of
R&D seed companies – with time limit, audits and renewal processes.
(will be a new measure)
Mandatory registration of seed varieties with a Central Authority
(proposed in the new Seed Bill – Pending with Parliament for long)
Encourage research in seed and biotechnology
PPV&FRA to work with States to build capacity of law enforcement agencies
to prevent / punish infringements, stealing of parent lines & copying of products
(we are working with PPV&FRA on this)
Predictable and science based deregulation of biotech traits -
need to implement law and not fall prey to activism

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Regulatory Challenges for Seed Industry - IFPRI Seminar Sept 23
National License for companies with infrastructure, people and
processes in place – for 3 years – renewal based on audits/assessment
(will be a new measure)
Decriminalization of Quality failures of seed in the field –
New Act being passed in Maharashtra & New Seed Bill (to be amended)
Improve Ease of Doing Seed Business
Harmonization of Plant Quarantine (PQ) processes with global and
regional benchmarks like STDF, NPPO collaboration across countries, full digitization
of SPS processes, e-phyto (ISPM 12) & seed health testing (ISPM 45), PRA alignment
No banning of categories of products in some states without scientific basis
– Eg. Punjab & Odisha (Centre to bring alignment among states)

8. • All accessions of the 64 crops listed under Annexure 1 of ITPGRFA be
made available for exchange and exempted from BDA (currently only
26563 accessions of only 9 crops have been listed by the DAC&FW)
• Going forward, the ABS mechanism for the seed sector should be
governed by the Ministry of Agriculture under the aegis of ITPGRFA.
• This will improve ease of doing business and will bring greater
certainty into seed operations of companies.
• NBA rules and regulations are not practical – approvals take time -
need to be reviewed to promote seed research, export, import and
eventually to benefit Indian farmer.
• European rules are more practical – benchmarking to be done
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Regulatory Challenges for Seed Industry - IFPRI Seminar Sept 23
NBA Related

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Gene Editing commercial license – complicated IP issues –
can ICAR play a role to benefit small companies?
Regulatory Challenges for Seed Industry - IFPRI Seminar Sept 23
Implementation of Notified Field Testing Sites (NFTS) system for
open field testing of GM traits
will eliminate uncertainty of obtaining NOC from states
Alignment among states and political parties on use of GM and
Gene Editing technologies – Centre to take initiative
Time bound regulatory process: GEAC may follow strict time lines of
processing applications and disposing them of within the time lines
Need for public and judiciary outreach on science behind GM & Gene
Editing, their safety & robustness of regulatory system – Govt & NAAS
Predictable & Science based deregulation of
biotech traits

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Thank you
for your attention