Registration of Biopesticides under Section 9(3B) of the Insecticides Act, 1968

The registration of biopesticides under Section 9(3B) of the Insecticides Act, 1968 has been examined in detail based on decisions taken in earlier meetings of the Registration Committee. Simplified guidelines have been approved for the registration of already registered strains of biopesticides.

Simplified Registration Guidelines for Already Registered Strains

Applicants are required to submit one consolidated folder containing the following documents and materials:

• Duly filled and signed Form I with complete details, along with the applicable registration fee.
• Notarized copy of:
  • Board of Directors Resolution (for companies)
  • Affidavit (for proprietorship)
  • Partnership deed (for partnership firms)
• Verified composition of the biopesticide strain consistent with earlier registration granted under Section 9(3) or 9(3B).
• Notarized copy of the Permanent Account Number (PAN).
• Certificate of Incorporation issued by the Registrar of Companies (for companies).
• Authorization letter from the inventor of the strain or undertaking specifying the source of the strain (Annexure II).
• Requisite number of duly stamped envelopes.
• Copies of approved label and leaflet authorized for the registered strain.
• Copy of the accession number of the strain or relevant supporting information.
• Undertaking declaring the product is free from chemical and botanical pesticides (Annexure III).
• One sample of 500 g / 500 ml for DNA fingerprinting and gene sequencing, along with prescribed testing fee.
• Original receipt of the testing fee.
• Undertaking declaring the product is free from GMO (Annexure V).
• Undertaking on composition of the biopesticide (Annexure VI).

Toxicology Data Requirements

Toxicology data generated from non-GLP laboratories shall also be accepted to encourage registration of new strains, as well as repeat or additional studies for existing strains. This provision applies to all categories of biopesticide registrations.

Applications currently under scrutiny are also covered under this decision.

Sample Submission and Scrutiny

An additional sample of 500 g / 500 ml shall be submitted along with the application file for provisional review. The application will be examined by the Chemistry Division of the Secretariat.

No preliminary scrutiny is required for applications pertaining to already registered biopesticide strains.

DNA Fingerprinting and Laboratory Studies

The Secretariat may coordinate directly with the concerned laboratory to obtain DNA fingerprinting reports confirming that the submitted strain matches the originally registered strain.

Government laboratories willing to conduct such studies may apply for approval through the Secretariat in accordance with prescribed terms and conditions.