The Pesticides Manufacturers & Formulators Association of India (PMFAI) has formally requested the Ministry of Agriculture and Farmers Welfare to omit Regulatory Data Protection (RDP) and data exclusivity for agrochemicals from the upcoming Pesticide Management Bill (PMB) 2025. 

PMFAI's representation on Data Protection in Pesticide Management Bill 2025 

The Pesticides Manufacturers & Formulators Association of India (PMFAI) has appealed to the Ministry of Agriculture and Farmers Welfare not to grant any Data Protection or Data Exclusivity for agrochemicals or include provision for Regulatory Data Protection for Agrochemicals in the Pesticide Management Bill (PMB) 2025. 

1) Regulatory Data Protection is demanded for Off Patent Generic molecules which has completed its patent period of 20 years or nearing expiry of its patent period. 

2) Data Protection I Data Exclusivity is a TRIPS plus measure that will delay introduction of generic pesticides (affordable off patent agrochemicals) for Farmers in the country. 

3) India Agriculture is predominately of small land holding farmers with 1-5 acres of land. Availability, accessibility and affordability of new agrochemicals are critical factors that directly influence the farms' productivity, profitability and overall livelihood of small Farmers. Experience shows that Data Exclusivity failed to ensure this. 

4) MNCs abuse of patent rights in India: For every ten patents granted since 2010 to the western MNCs for new pesticide chemistries/molecules, six have not been commercially introduced in India though they were promptly commercialized in other countries. 

5) The western MNCs who failed to commercialize all their patented molecules are the ones who actively now lobbying for Data Exclusivity to bring their old off patent pesticide molecules to the Indian market.  

6) In the last two years, as many as 36 new pesticides molecules were registered in India- @ 1.5 new molecules per month. This a record high, and it is higher than the registrations in countries that have granted data exclusivity such as Brazil, Malaysia, Thailand etc. 

7) Presently, India is third largest exporter of agrochemicals in the world, up from sth position a decade ago, ahead of France and Germany. Rate of growth of exports from India is much higher than the growth of global exports in agrochemicals. Govt. of India shall ideally introduce policies that further facilitate manufacture and export of generic agrochemicals. Data Exclusivity would not achieve this. 

8) Unlike the global Pharmaceutical industry, the agrochemical market is dominated by generics. Around 90% of the global agrochemicals market consists of generics. In fact, all the top 10 selling agrochemicals in the world are generics. India is a leader in producing and supplying generic agrochemicals worldwide. Therefore, contemporary regulatory policies shall be required to encourage rapid introduction of generics in the country.

9) Regulatory Data Protection for Agrochemicals, for further period of protection beyond Patent period of 20 years, will only result in - ( 1) depriving Farmers getting Agrochemicals at lower and affordable prices; (2) preventing Indian MSMEs entering business with generic version; and (3) thus avoiding competition in market. 

10) Life of a Pesticide is about 30-35 years and if Regulatory Data Protection is granted beyond 20 years' patent period, there will not be any scope for entry of Generic version. 

11) If additional protection granted by way of Regulatory Data Protection or protection beyond existing patent period, MSMEs who are major contributors to nation's GDP will not be able to enter into business and compete in the market, directly affecting Indian Agriculture and Farming community. 

12) The issue of Data Protection for Agrochemicals also discussed at length by Parliamentary Standing Committee during consultation held with stakeholders on "The Pesticide Management Bill 2020 (PMB 2020)". Considering and analyzing the suggestion of stakeholders, Parliamentary Standing Committee convinced that Patent period of 20 years is sufficient for inventors to gain benefits and investments made in discovery of new molecules, provided that new molecules are introduced within patent period in India. Thus, Parliamentary Standing Committee has not accepted Data Protection for Agrochemicals. 

13) The Parliamentary Standing Committee considering and analyzing the suggestions from all stakeholders was convinced and observed that as India is a very large and growing market for Agrochemicals and with huge arable land, it will be able to attract introduction of new molecules from foreign as well as domestic companies even without provision for any Data Protection. 

14) Considering of any provision for Regulatory Data Protection or TRIPS plus measures would be detrimental to India's socio-economic interests and would adversely impact nation's ambitious plans of "Make in India" and "Aatmanirbhar Bharat". 

15) If the protection is given beyond patent period, our exports will also suffer as we will not be able to export patent expired molecules where the requirement of regulatory is minimal (2 years).