The Parliamentary standing committee on agriculture in its 2015-16 report—Impact of chemical fertilisers and pesticides on agriculture and allied sectors in the country—has expressed serious concern over unscientific, excessive use of pesticides. It laments that associated problems have not been properly addressed by central and state governments. Even as the committee exhorts the Centre for ‘a comprehensive action plan for ensuring environment sustainable manufacturing, import, sale and use of pesticides’, review of the Insecticides Act (IA),1968 and setting up of Pesticides Development and Regulation Authority (PDRA), it has skirted an innocuous Section 9(4) in IA, which lies at the root of the mentioned problems. The Registration Committee (RC)—set up under the Act—registers every pesticide after scrutinising the formula/chemistry, verifying claims of efficacy and safety to human beings and animals, and specifying the precautions against poisoning and any other functions.
An applicant wanting to register a new product ‘first time’ in India is required to generate data to demonstrate its ‘safety’ and ‘efficacy’ in Indian conditions (costing millions of rupees) in addition to hundreds of million dollars spent globally on toxicity and chemistry studies. Once this registration is granted under Section 9(3) of IA, subsequent applicants can get registration under Section 9(4) for same product on payment of nominal fee ‘without having to submit any data’. As a result, for every registration under Section 9(3), there are multiple registrations under Section 9(4). Currently, there are over 250,000 registrations corresponding to only 280 registered pesticide molecules, i.e. close to 900 per molecule (process of issuing such registrations continues at an alarming pace). This has made way for non-serious players who have little regard for quality and standards.
Getting a manufacturing license from the state—notified authority under IA—is not difficult either, as it is by and large given without checking for basic facilities, including quality control. The result is an unmanageably large number of pesticide manufacturing units, currently over 1,400.
Juxtaposed with poor enforcement of IA and Insecticides Rules (1971), this has led to proliferation of spurious and sub-standard products. According to a FICCI study, during 2013, illegal pesticides accounted for Rs 3,200 crore or 25% of domestic market of Rs 13,000 crore. If the situation is not remedied, it can touch 40% by 2018-19.
It defies logic as to how the very objective of this law to ‘regulate’ import, manufacture, distribution, use, ‘with a view to prevent risk to human beings or animals and for matters connected therewith’ can be achieved with such proliferation of both registrations and of manufacturing units.
To compound this, lately, RC has even changed the very intent of the law by granting registrations without even verifying full chemistry data from applicants, something which is beyond the law of the Insecticides Act, 1968, and is giving undue advantage to Chinese pesticides manufacturers at the cost of domestic industry and farmers.
This sort of regulatory architecture is a losing proposition for all stakeholders. ‘Me-too’ registrants neither have any knowledge nor interest in ‘stewardship’, viz. educating farmers about proper and scientific use of new crop protection technologies. As a result, farmers are unable to utilise their full potential. Worse still, the use of spurious products (wherever these make inroads) inflict huge crop loss and damage to the soil.
The innovator/originator of new technology suffers heavy losses as with so many manufacturers (up to 100 in some cases) selling product to same set of farmers, she is unable to recoup huge investment made in developing, conducting studies (to seek registration) and ‘stewardship’. This kills her incentive to invest in R&D for bringing new products to meet farmer’s dynamic needs.
For the government, issuing and thereafter keeping track of humongous registrations and inspecting a large number of manufacturing facilities is a nightmare. The extent of consequential stress on the system is evident from the fact that CIB and RC—it issues registration certificates—decided to go for ‘digital’ signature of secretary. This seriously questions the intent of the law to regulate versus its implementation of a ‘free for all’ registration process.
Meanwhile, guidelines issued by RC in 2000 for grant of registration for ‘formulation import without registering the technical’ can help in reining in such irresponsible registrations. This is because in the absence of registration of underlying technical, imported formulation cannot be copied. It also gives an opportunity to the innovator for amortising costs incurred on getting registration and educating farmers.
This has yielded a good dividend and already 55 registrations for formulation without registering technical have been granted, leading to huge benefits to farmers. On a total spend of about Rs 10,000 crore, farmers have reaped Rs 50,000 crore (average benefit ratio of 5:1) in terms of higher yield and better quality crops.
The policy gives the desired incentive to R&D companies to bring new crop protection technologies at farmers’ doorsteps. It also enables the government exercise better regulation. The concerns expressed about safety, efficacy, health, environment, etc, are without basis, as the registrant submits full data, besides submitting complete data on the formulation to be registered.
This should be continued for the benefit of our farmers. The government needs to urgently curb such ‘me too’ registrations and make stringent guidelines for manufacturing units. A much improved regulatory architecture is needed to address the issues flagged by the Parliamentary standing committee on agriculture.
By Uttam Gupta, Policy analyst, www.uttamgupta.com