India’s new Pesticide Bill should incentivize R&D company to introduce new products

India’s new Pesticide Management Bill should incentivise introduction of new and safer products by R&D based companies, as against fly-by-night operators, according to an article written K C Ravi, vice-president (Business Sustainability), South Asia, at Syngenta India Limited. 

 

The R&D based crop sciences industry has, moreover, been launching new molecules with increased efficacy and reduced application rates over time. The application rates, in the case of insecticides such as organophosphates (malathion, chlorpyrifos, etc) and carbamates (carbaryl, aldicarb, etc) during the 1960s and 1970s, were as high as 1,000-3,000 grams of active ingredient per hectare. By the eighties, with the advent of cartap and synthetic pyrethroids, the rates came down to 50-500 grams per hectare. From the nineties to the early 2000s, there was further advancement through moderate toxicity chemicals like triazoles and neonicotinoids, having dosages of 25-200 grams per hectare. Since the mid-2000s, the active ingredient application has fallen to well below 100 grams; in some cases of very low toxicity chemicals — such as sulfonylureas and diamides — it is as less as 4 grams per hectare. The pursuit towards greener chemistries continues.

 

That pursuit needs encouragement in order to make our agriculture both economically viable (through reduced crop losses) and sustainable (by lowering the environmental load). It calls for the creation of a policy environment that incentivises a steady flow of the latest and safer products. This applies even more so in crop protection chemicals where the R&D based companies are mostly multinationals. But instead of recognising the reality of there being very little indigenous investment in discovery of newer molecules, the whole debate around pesticides has unfortunately taken the usual colour of MNCs-versus-domestic companies. At the end of the day, any innovator, be it an MNC or a domestic firm, needs an environment that promotes and protects innovation.

 

For any new crop protection molecule to reach the market, it takes more than 11 years of intensive R&D efforts and an average investment of around $ 300 million. The long gestatation period and heavy development cost is precisely why, in many countries, innovators are given an “exclusivity period” for the test data on a new product that they submit in confidence to regulators. Such exclusivity period — during which the regulator would not divulge the test data to any subsequent/“me-too” applicants for the same molecule/formulation, or rely on it for granting marketing approval to anybody other than the original applicant/innovators – extends from 6 years in Malaysia to 7 years in Turkey; eight years in Taiwan; 10 years in China, Brazil, Chile, US, Canada and the European Union; 11 years in Australia; and 15 years in South Korea.

 

The logic behind regulatory data protection is to ensure that the innovator is able to recover his R&D costs, at least partially, and also steward the correct usage of the product by farmers, before grant of registratation approval to “me-too” applicants for the same molecule/formulation. India is currently in the process of finalising a new Pesticide Management Bill. It is necessary that the proposed law incorporates regulatory data protection provisions, with an exclusivity period of not less than 10 years, in line with globally accepted standards. This, apart from encouraging R&D based companies to bring new crop protection products for the benefit of our farmers, will also help curb the menace of spurious pesticides.

 

The draft Pesticide Management Bill put up for comments by the Union agriculture ministry, unfortunately though, makes no reference to data exclusivity for new crop protection products. That may be like throwing the baby (innovator companies) along with the bathwater (of the spurious pesticide menace)!