Why MNCs are keen on data protection for pesticides?

Why has ‘protection of test data submitted for obtaining regulatory approval for new pesticide products become a major bone of contention between domestic and multinational crop protection chemical companies?

The Pesticides Management Bill, 2008 (PMB) – introduced but not yet passed in Parliament – allows a three-year-period of exclusivity for the test data furnished by the original registrant of any new pesticide molecule introduced into the country.

Separate data

While others wanting to manufacture or import the same product can also obtain registration, they would, however, have to generate separate data on their own. The information submitted by the original registrant “shall not be relied upon for grant of registration of the same pesticide in respect of any other person for a period of three years,” clause 12(6) of the Bill states.

Pesticide firms are required – even under the existing Insecticides Act, 1968 that the PMB seeks to replace – to get approval from a Registration Committee under the Agriculture Ministry for marketing any new product. That, in turn, is conditional upon their providing relevant data pertaining to its chemistry (including source of supply and manufacturing process), bio-efficacy (against the targeted pest), toxicity (to humans and animals) and maximum residue levels (MRL) in soil, plant and fruit.

Registered products

There are 226 pesticide products currently registered in India. In 95 per cent or more of these, the original registrants have been multinationals, who cite the absence of data protection as a disincentive for not introducing newer products.

"To obtain registration, we have to first generate bio-efficacy data from two years field trials over three different agro-climatic zones. Further, MRL data across four locations has to be submitted for one season in case of insecticides and fungicides, and two seasons for herbicides. Then, there is the need to demonstrate shelf-life stability of the product over 30 months,” said the representative of a multinational firm.

All this, according to him, involved investment of time and effort, which subsequent registrants are practically exempt from.

unprotected knowledge

Since the data generated by the original registrant has already established the efficacy and safety of the product, this ‘unprotected knowledge can be used to grant registration to ‘me-too manufacturers/importers. The latter only have to show the chemical composition of their product to be the same as that of the original registrant.

The PMB has proposed a three-year exclusivity period during which the original registrants test data “shall not be relief upon” for granting new registrations. Although lower than the ‘minimum five years protection demanded by multinationals, the provision has attracted the ire of domestic players.

"There is already a 20-year patent protection on new molecules, which provide adequate cover against me-too generic producers. Why should there be data protection over and above this?” quipped a domestic industry source.

But therein lies the nub. The 20-year protection period in India applies only with respect to product patents filed after January 1, 1995. As against this, there are some 113 pesticide products patented prior to 1995 that are still to be introduced in India.

"Though off-patent, most of these are new generation chemicals, where farmers have to spray just 5-50 grams of active ingredient compared to the 750-1,000 gm in the old organochlorine or organophosphate pesticides. Being target-specific (unlike broad-spectrum insecticides that kill even beneficial pests) makes them further environment-friendly," the multinational firm representative claimed.

Reverse engineering

There was no point in bringing these products to India “because the moment we get registration, others, too, would be given registration on the basis of the test data generated by us.” And since they are off-patent, Indian companies manage to reverse-engineer or source the technical (active ingredient) from China and outsell the original registrant.

A typical example is Imidacloprid, originally registered in 1999 by Bayer India. Today, there are many domestic manufacturers of this once-proprietary seed treatment and foliar application chemical, which was initially selling at Rs 3,800 a litre and now at Rs 700-800.

List of Pre-1995 patented pesticides not introduced in India

Pesticide / Molecule Company
1-Methylcyclopropene AgroFresh/Dow
Acebenzolar-s-Methyl Syngenta
Aclonifen Bayer
Amidosulfuron Bayer
Amitrole Bayer
Azimsulfuron DuPont
Benfluralin Dow
Benoxacor Syngenta
Bentazon Bayer
Benthiavalicarb Kumiai Chemical, Japan
Bifenox Bayer
Boscalid BASF
Brodiafacoum Syngenta
Buprimate Syngenta
Butafenacil Syngenta
Butroxydim Syngenta
Chloridazon BASF
Chlorotoluron Syngenta
Cinidon-Ethyl BASF
Clofentezine Makhteshim-Agan, Israel
Clopyralid DuPont
Cyazofamid ISK, Japan
Cyclanilide Bayer
Cyproconazole Syngenta
Cyprodinil Syngenta
Daminozide Uniroyal
Desmediphan Bayer
Dicamba Syngenta
Diethofencarb Sumitomo
Diflufenican Bayer
Dimethametryn Syngenta
Diniconazole Sumitomo
Diquat Syngenta
Dodemorph BASF
Epoxiconazole BASF
Ethofumesate Bayer
Etoxazole Sumitomo
Fenhexamid Bayer
Fenoxycarb Syngenta
Fenpropidin Syngenta
Fentrazamide Bayer
Ferimzone Sumitomo
Flazasulfuron ISK, Japan
Florasulam Dow
Fluazifop-p-butyl Syngenta
Fludioxinil Syngenta
Flumioxazin Sumitomo
Fluopicolide Bayer
Fluoxastrobin Bayer
Flupyrsulfuron-methyl DuPont
Fluroxypyr Dow
Fluazinam ISK, Japan
Fomesafen Syngenta
Formasulfuron Bayer
Fosthiazate Syngenta
Fuberidazole Bayer
Furalaxyl Syngenta
Imazalil Janssen/Makhteshim
Imazamox BASF
Imazapic BASF
Imazapyr BASF
Imazaquin BASF
Imazosulfuron Sumitomo
Isoxaflutole Bayer
Mepanipyrim Kumiai
Mepiquat BASF
Mesotrione Syngenta
Metconazole BASF
Methoxyfenozide Dow
Metrafenone BASF
Molinate Syngenta
Nicosulfuron DuPont
Oxasulfuron Syngenta
Oxolinic Acid Sumitomo
Penoxsulam Dow
Pethoxamid Arysta, Japan
Phenmedipham Bayer
Picloram Dow
Picoxystrobin DuPont
Prochloraz Bayer
Procymidone Sumitomo
Propamocarb HCl Bayer
Propoxycarbazone Bayer
Propyzamide Dow
Prosulfocarb Syngenta
Prosulfuron DuPont
Prothioconazole Bayer
Pymetrozine Syngenta
Pyroquilon Syngenta
Pyraflufen ethyl Nihon Nohyaku, Japan
Pyrasulfotole Bayer
Quinoxyfen Dow
Rimsulfuron Bayer
S-Metolachlor Syngenta
Spiroxamine Bayer
Sulfentrazone FMC
Tepraloxydim BASF
Tetraconazole Isagro
Thiabendazole Syngenta
Thifensulfuron Methyl DuPont
Thidiazuron Bayer
Tolclofos Methyl Sumitomo
Tolyfluanid Bayer
Triasulfuron Syngenta
Tribenuron DuPont
Trifloxystrobin Syngenta
Trifloxysulfuron Syngenta
Triflumuron Bayer
Trinexapac Ethyl Syngenta
Triticonazole Bayer
Tritosulfuron BASF
Uniconazole Sumitomo
Zoxamide DuPont