Agriculture Department adopts a 3D Agenda towards Crop Protection Products Regulatory Reforms in the Country

The Plant Protection Advisor had issued a notice regarding a meeting scheduled to be held on Jan-12-13, 2021 under the Chairmanship of the Joint Secretary (Plant Protection), DoAC&FW to discuss issues related to regulatory reforms in crop protection registration norms. 

A 3D Agenda ( Discuss, Decide, Deliver) has been set across involving 20 points as stated below:  

1. Focus totally on safety and efficacy 

a.Create templates for evaluation of tox, chemistry, bio-efficacy data by RC Experts 

b.Ensure same template used for each applicant and evaluation sheet be presented to RC 

c.Consider to use CIL as alternate testing lab. Outsource tox/chemistry data evaluation 

d.Ensure NMR analysis completed which are pending, and tallied with NMR submitted by applicant 

e.Enforce 5 batch analyses for TIM registrations by adopting detailed “how to verify” guidelines 

f.Accept GLP lab data only (Not GLP equivalent Lab) 

2. Outsource tox, chemistry, data evaluation 

3. Encouraging New Molecule Registration 

a.Give highest/top priority to applications for the first time in India registrations whether Tech or formulation, either for manufacturing or import 

b.Provide minimum 5 years Regulatory Data Protection for 1st time India registration 

4. Permit Toll Manufacturing by non-subsidiary on a knowhow transfer basis 

5. Refine data requirement for bio-efficacy 

6. Restrict Repeat Registrations 

a.By substantially increasing application fees 

b.Issue CR only after investment made in manufacturing facilities 

c.File FIRs for fake registrations 

7. Revisit 9(4) TIM registrations to ensure chemical equivalence established genuinely 

8. Strengthen R&D 

9. Guidelines for exports registrations for banned products 

10. Decision on dual-use insecticides 

11. Digitize all RC records and create a strong IT system for decision making 

12. Revamp Registration Committee with peer level, independent and experienced scientists in their domain knowledge 

13. a.Revamp the Organisational Structure of CIB&RC Sectt. 

b.Augment and upgrade RC Sectt. And skills of technical experts 

c. Strengthen legal and IT Department 

14.Provide RDP 

15.Process MRL applications simultaneously 

16.Reduce N-1 manufacturing, and promote import substitution of N-1 imports 

17.Weed out spurious pesticides using Rule 15(4) of the Insecticides Rules 1971 

18.Create an independent Appellate Authority 

19.Pesticides Traceability and Bar Coding 

20.Uniformity in the grant of manufacturing license by adopting a detailed checklist to be verified by an independent Technical Committee 

All interested citizens who may be interested in sharing their views on the same may write to us on this portal by end of business January 8, 2021.