Strategy to tap generic markets in

India
The environment
The responsibility
The strategy
The future

C.K.Sabharwal
Crop Health Products Ltd
-one small voice….
Generic manufacturers, products,
markets – environment..
 During 1970-1990’s, due to patent expiry,generic
pesticides became the fastest growing sector
elsewhere as in India.
 From 10% of total markets world wide in 1995,
generic producers at this time supply around 65%
of global sales of, off patent products(Anon
1999)., while 35% comes from patented
molecules.
 In India too, major share of technical
production/markets comes from off patent/generic
products. The Patent Act will now usher in new
molecules – from R&D based Companies.
Generics face substitution and regulatory
uncertainty elsewhere as in India.
Generics….down or up?
 Market for generics in India shows sure erosion in
price and value offered due to:
 Large capacity, both for actives/ formulations, at
regional/national levels – consolidation ?
 BT Cotton, changing pest/disease infestations,
transgenic crops impact on pesticide demand ?
 Imports from China etc. both legal and illegal
result in wide price difference for same molecules
between branded and generic producers.
 Local producers resorting to price discount
strategy, lowering the net value for all times..
 Availability of spurious/substandard
products,ready to sell network, and corrupt
business environment. – kill brand value chain?
Generics going down! – Who is
responsible??
 We ourselves, the fragmented industry, for failing
to look at the global picture, tolerating
illegality,partnering corrupt practices, and by an
absence of product portfolio management.
 The Government, which is unable to provide a
healthy regulatory environment/understanding.
 The network and the supply chain, who has the
last laugh at the merry bunch of jokers involved in
this game of perpetual value reduction.
 The marketers who wish to easy sell and not work
on product stewardship - <quality <price….
 The end users who buy cheap products without
thinking of consequences on the crop.
Generics – strategic issues..
 R&D companies are divesting actives,which can
be acquired by other generic producers.
 Actives registered before 1993 may not be
supported due to data generation costs by the
majors unless generic producers support use
extension for new crops. Generic producers must
produce and share data/costs and find new markets
 Allocate resources for product stewardship such as
resistance management, new usages, dose setting.
 Generic supply and demand issues, production
capacity rationalization, investment in data and
development.& exports, real challenges ahead!
 Govt. regulation will limit use of old generics.
Generics - strategy
 New solutions to crop problems to meet changing
customer needs – need of hour.
 Performance enhancement of existing active
products by improving formulations, application
methods, and combinations.(>registration).
 Offering generics as a part of crop solutions
package rather than as stand alone products.re-
launch generics – don’t write them off..
 Allowing easier route for Combinations
Registration, new formulations and export of
generics. – is the regulator listening?
 Produce newly off patent products with additional
services and performance/quality guarantees.
Generics - Strategy
 Manufacturers, distributors and dealers must stop
looking at generics as only(low) profit giving
commodities, but look at each product as a crop
specific solution provider. Large producers must
assume leadership role. Substitution must not be
automatic – it must be managed by design..
 Many off patent products outside India are
potential candidates to be examined for
manufacture – export, or domestic
development,by Indian manufacturers of actives.
This needs positive fast track registration
regulation based on reasonable data requirement.
 Parallel importers from China – eroding or adding
value? Introspection/regulation needs/partnership?
Generics – Strategic partnering
 R&D Companies in India, and large Indian
producers must look at potential partnerships,
nationally and regionally, to promote generics by
creating a value chain/brands/solutions – to
coexist(peacefully) with new (patented) products,
and biotechnology or genomic systems.
 Safer and newer formulations such as
SC/WDG/ME etc. must be encouraged to breathe
some life into generic value chain.
 Contract farming, agricultural retail, must get
involved into the generic value chain to deliver
quality to end users with monitoring capability.
 Minor use registrations must be on fast track, to
encourage precision farming.
Generics – outside India –
lessons?
 Generic products containing substances listed in
Annx. 1 of Directive 91/414/EEC cannot have a
MA granted unless the applicant has met
requirements of Annexex II and III. /consent.
 Danger that generic products may disappear from
common market according to will of the major
manufacturers/former patent holders.
 Regulations seems to protect major manufacturers
from generic competition. Is India headed this
way too? (Eco times2/1/06)
 Not only choose – Data exclusivity – data
protection & market exclusivity but share data and
implement data compensation schemes.
Regulation – generic products
 Regulation should be concerned with safety of
environment, quality, bio efficacy and MRL not
with market protection or data shields.
 Regulation should encourage sharing data,
partnerships and rules for data compensation,not
product monopoly..
 Playing with data exclusivity leads to market
exclusivity.Drives majors into investing time and
resources for minor changes rather than develop
innovative products.
 Patent protection is now 17 to 20 years.
 Generic industry has a positive role to play.
Regulators must recognize this. So must industry.
Protect the generics for
sustainable agriculture
 Manufacturers must consider with Regulators
whether an old generic meets requirements of bio
efficacy, safety and cost, before considering
replacing it with new products just because of
patent, or other considerations. – roadmap?
 Generic producers must wade through a maze of
patents, process chemistry, impurities, field trails,
toxicology and protected data, competition, costs,-
can Indian producers do this? Fast?
 Industry must forge partnerships of value. To
strike an equitable balance between generics / new
products. – SME’s – Exit or change ..Will they?
Generics – what’s coming..
 Indian Agrochemical industry in present form
unsustainable to support innovative strategies in
the future for generics.
 Food safety, environment, health, key regulatory
concerns – are these industry concerns too?
 Corporate need to better handle its image.
 Our network – partners in crime or value?
 Provide services not only products!
 Regulation must facilitate sustainable agriculture
with industry, rather than make law to fill jails..
 Generics in India …..God & Rain be with you!
They are your only support left……..unless..
THANK YOU FOR YOUR
ATTENTION