The document outlines guidelines for registering long-lasting insecticide-impregnated mosquito bed nets and long-lasting insecticide-incorporated mosquito nets in India. The guidelines require: 1) Three-year bioefficacy trials in three locations, including two endemic areas; 2) Baseline and yearly persistence data of insecticides on nets; 3) Evaluation of fabric sustainability; 4) Toxicology data on insecticides and health monitoring of users. The toxicology data depends on whether the insecticide is already registered or a new product.
Original Description:
Long life insecticide treated mosquito nets registration requirements in India
The document outlines guidelines for registering long-lasting insecticide-impregnated mosquito bed nets and long-lasting insecticide-incorporated mosquito nets in India. The guidelines require: 1) Three-year bioefficacy trials in three locations, including two endemic areas; 2) Baseline and yearly persistence data of insecticides on nets; 3) Evaluation of fabric sustainability; 4) Toxicology data on insecticides and health monitoring of users. The toxicology data depends on whether the insecticide is already registered or a new product.
The document outlines guidelines for registering long-lasting insecticide-impregnated mosquito bed nets and long-lasting insecticide-incorporated mosquito nets in India. The guidelines require: 1) Three-year bioefficacy trials in three locations, including two endemic areas; 2) Baseline and yearly persistence data of insecticides on nets; 3) Evaluation of fabric sustainability; 4) Toxicology data on insecticides and health monitoring of users. The toxicology data depends on whether the insecticide is already registered or a new product.
insecticide impregnated mosquito bed nets and long lasting insecticide incorporated mosquito net for registration U/S 9(3) (As approved in 242 nd , 249th & 290th meetings of RC held on 11.02.2004, 08.11.2004 & 05-06-2008, respectively)
1. Three years bioefficacy trial in three locations. Out of three
locations, two locations should be in endemic areas. The bioefficacy trial has to be conducted by adopting the protocol devised by the Malaria Research Centre/VCRC (ICMR).
2. Baseline data on persistence of insecticides on the net and its
analysis for comparison on yearly basis.
3. Sustainability of fabrics.
4. (A) Toxicological Data for long lasting insecticide impregnated
mosquito bed nets
For Full package of toxicological data of the pesticide, if the
pesticide used is not already registered. The data/information shall be used for risk assessment as per WHO guidelines.
(B) Toxicological Data for long lasting insecticide incorporated
mosquito net
(i) Acute oral toxicity in rats and mice
(ii) Acute dermal toxicity (iii) Acute inhalation toxicity (iv) Primary skin irritation (v) Toxicity to birds (vi) Toxicity to fish (vii) Toxiciy to beneficial insects (viii) Health monitoring study of the user by using the long lasting insecticide net in its actual use.
Note: Toxicological data (i) to (vii) to be undertaken with
premix.
5. Other data/information as required in Chemistry and Packaging.