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India CIBRC issued new regulation decisions on biopesticides
Sep. 8, 2015
The Indian Central Insecticides Board and Registration Committee (CIBRC) has issued some decisions on biopesticide during the 357th Meeting of RC held on 10th August, 2015. These decisions were made based on recommendations of the “Expert Group” constituted by RC in its 354th RC held on 31st March, 2015 under the chairmanship of Dr. S. N. Sushil, PPA on “Harmonization of data of bio-pesticide of already registered strain”. The Hon’ble Chairman stated that these recommendations shall work as a boon for establishing new biopesticides units. After detail discussion the committee decided as under:
1. It was informed that so far, as per the available records appx. 57 strains of different biopesticides are registered under section 9(3) & 9(3B). The list is annexed as Annexure – I.
2. APPA & Secretary (CIB&RC) should write to the earlier registrants of the strain/inventor of the strain to deposit one sample of at least 01 kg with the Sectt. of CIB&RC of the product/strain within a period of one month. The samples thus obtained shall be sent to NBAIM, Mau for getting 16 SR-DNA/Gene code sequencing/finger printing for creating data bank of all the strains. NBAIM, Mau may be requested to finish the work within one month of receipt of sample.
3. Registration of already registered strains to other applicants:
Requirement of the data/information to be submitted by the subsequent applicant for getting registration under section 9(3) /9(3B) of already registered strain:-
a.) Form-I duly filled in along with requisite registration fee of Rs. 100 as per existing requirement.
b.) Already approved Label leaflets of the product/strain
c.) Testimonial/documents about the company as per existing requirement.
d.) Undertaking about the strain from the inventor of the strain OR first registrant OR subsequent registrant of the strain OR the applicant.
e.) One sample (01 kg.) for pre-registration verification (PRV) through Central Insecticides Laboratory as per already approved product specification by RC.
f.) Another sample (01 kg) for pre-registration verification (PRV) of Gene code sequencing/16 SR-DNA/finger printing along with a demand draft (as per invoice obtained as testing fee from NBAIM, Mau) in favour of NBAIM, Mau as testing fee for Gene code sequencing/16 SR-DNA/finger printing.
g.) Invoice for testing fee for Gene code sequencing/16SR-DNA/finger printing has to be obtained from NBAIM, Mau by the Sectt. of CIB&RC.
4. Registration of new strain of the biopesticides:
It was decided that the applicants for registration of new strain has to submit all the data as per existing guidelines for registration under section 9(3)/9(3B) for all the disciplines. Two samples have to be submitted to the Sectt. of CIB&RC; one for pre-registration verification (PRV) from Central Insecticides Laboratory as per product specification requirement & another sample to be used for pre-registration verification (PRV) of Gene code sequencing/16 SR-DNA/finger printing along with a demand draft (as per invoice obtained as testing fee from NBAIM, Mau) in favour of NBAIM, Mau as testing fee for Gene code sequencing/16 SR-DNA/finger printing.
5. Minimum infrastructure required for production & registration of biopesticides:
It was felt that flight-by-night manufacturers are available in the market and other products are sold in name of Bio Pesticides. Many of the manufacturers don’t have proper and adequate infrastructure required for quality production of the biopesticides, as many samples of the biopesticides are failing in the test, which is affecting the quality of the produce. Therefore, verification of the infrastructure and technical competency of the applicants already registered under section 9(3B) and applying for registration u/s 9(3) and/9(3B) extension has to be conducted by a team constituted by the Secretary (CIB&RC) for the purpose.
6. Minimum CFU count and nominal concentration strength of the formulation to be continued as per existing guidelines.
7. Verification of Shelf life of strain and verification of product: This aspect needs more conclusive information, hence the existing procedures may be continue.
8. Grant of registration of biopesticides under section 9(4) category: - The committee agreed to the recommendations of the Sub-committee that it is not feasible to allow 9(4) for biopesticides registration. However, the decision of RC at S. No. ‘3’ above will immensely simplify and expedite the registration process of biopesticides.
9. Submission of photographs for veracity of research, test and trails: - the committee accepted the recommendations of the Expert Group.
10. The above said decisions of RC shall come into force from 01st January, 2016.
Source: CIBRC
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