From the Agrochemicals market report:
Unprotected Knowledge
â Currently, under the existing Insecticides Act, once a pesticide is registered in favor of an entity based on test data
(demonstrating its bio-efficacy and safety) generated by it, this information can be used to grant approval to others
wanting to market the same product
The âme-too’ registrant does not have to submit any fresh data for the purpose
â Such unprotection of data generated by multinationals as original registrants has proved to be a major disincentive for
them to not introduce newer products in India
âMoreover, this exempts the subsequent registrants from investing the required time and effort
Reverse engineering
â It is also found that once a manufacturer gets registration for a product, others too are given registration on the basis
of the test data generated by them
Since they are off-patent, Indian companies manage to reverse-engineer or source the technical (active ingredient) from China and
outsell the original registrant
â For e.g. âImidaclopridâ was originally registered in 1999 by Bayer India, however today there are many domestic manufacturers of it and as such its price has
come down to INR 700-800/litre from the initial price of INR 3,800/litre
Flaws in the registration process (2/2)
Source: JM Financial Services âSABERO ORGANICS GUJARAT Ltd.â; SBI Cap Securities âSabero Organics Gujarat Ltd.â, Mar 2010; Business Line âWhy MNCs are keen on data
protection for pesticides?â, May 2010
However, on the demand of multinationals functioning in India, The Pesticides Management Bill, 2008 (PMB) has been introducedbut not yet passed in Parliament which allows a 3 year period of exclusivity for the test data furnished by the original registrant ofany new pesticide molecule introduced into India
Mahesh - Any idea on the status of this Bill?