The Parliamentary Standing Committee on Agriculture in its report for the year 2015-16 entitled “Impact of chemical fertilizers and pesticides on agriculture and allied sectors in the country” has expressed serious concern over un-scientific and excessive use of pesticides. It laments that associated problems have not been addressed properly by the Government of India [GOI] and State Governments.
Even as the committee exhorts GOI 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 scrutinizing the formula, 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 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 u/s 9(3) of IA, subsequent applicants can get registration u/s 9(4) for same product on payment of nominal fee ‘without having to submit any data’.
As a result, for every registration u/s 9(3), there are multiple registrations u/s 9(4). Currently, there are 200,000 registrations corresponding to over 200 registered pesticide molecules in India [process of issuing such registrations continues at an alarming pace]. A wonderful opportunity to ride piggy back on innovator has made way for non-serious players who have little regard for quality and standards.
Getting manufacturing license from the state – notified authority under IA – is not difficult either. True, before giving a license, it is expected to do inspection to check for basic facilities including quality control. But, that is rarely done! The result is an unmanageable large number of pesticide manufacturing units, currently over 1250.
Juxtaposed with poor enforcement of IA and Insecticides Rules [1971], this has led to proliferation of spurious and sub-standard products. According to FICCI study, during 2013, illegal pesticides accounted for Rs 3200 crores or 25% of domestic market of Rs 13,000 crores. If, situation is not remedied, it can touch 40% by 2018-19.
The registration under 9(4) [or ‘Me-Too’ as it is known in common parlance] was introduced in 1968 under a scenario when country was facing huge foreign exchange shortage; there was no R&D and tox data generation facility and overriding objective was to reduce import and save foreign exchange. But, in present globalized economy and all those constraints a thing of the past, there is no justification to continue with this section. Yet, it stays!
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 utilize their full potential. Worse still, use of spurious products [wherever, these make in-roads] inflict huge crop loss and damage to the soil.
The innovator/originator of new technology suffers heavy loss as with so many manufacturers [up to 100 in some cases] selling the product to same set of farmers, he/she is unable to recoup huge investment made in developing, conducting studies [to seek registration] and ‘stewardship’. This kills his/her incentive to invest in R&D for bringing new products to meet farmer’s dynamic needs.
For government, issuing and thereafter keeping track of such humongous registrations and inspecting/monitoring a large number of manufacturing facilities is a nightmare. The extent of stress on the system caused by huge numbers may be gauged from the fact that some time ago, CIB&RC – body that issues registration certificates – decided to go for ‘digital’ signature of Secretary.
Clearly, there is an urgent need for reining in ‘Me too’. One of the ways is to defer such registrations u/s 9(4) for a specified period from the date of original registration by innovator u/s 9(3). Termed ‘data protection [DP]’, this gives a reasonable opportunity to innovator for amortizing huge cost incurred on getting registration as also in educating farmers. Already, the government had recognized the need for it by making a provision for 3 years DP in Pesticide Management Bill [PMB] (2008) which is stuck in the parliament.
Meanwhile, the guidelines issued by RC in 2000 for grant of registration for ‘formulation import without registering the technical’ also serve the same purpose as in the absence of registration of underlying technical, the imported formulation cannot be copied. In 2007, RC allowed “deemed” registration of the technical after 3 years from the date of registering the formulation import. In 2009, it also allowed registration for ‘indigenous manufacture of formulation without registering technical’.
This has yielded good dividend and already, 55 registrations for formulation without registering the technical have been granted leading to huge benefits to farmers. On a total spend of about Rs 10,000 crores, farmers have reaped Rs 50,000 crores [average benefit ratio of 5:1] in terms of higher yield and better quality crops.
Without doubt, this policy gives the desired incentive to R&D based companies – domestic and MNCs – to bring new crop protection technologies farmers doorsteps. It also enables the government exercise better regulation. The concerns expressed about safety, efficacy, health, environment etc are without any basis as the registrant submits full data on the Technical besides submitting complete data on the formulation to be registered.
The policy should be continued till such time a law is enacted to grant DP. The government needs to expedite passage of PMB [2008] which promises a much improved regulatory architecture and will address the issues flagged by parliamentary committee.