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Registration of LLINs in India

DIRECTORATE OF PLANT PROTECTION, QUARANTINE & STORAGE


http://ppqs.gov.in/divisions/cib-rc/guidelines?page=2

1.14

Guidelines for registration of long lasting


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.

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