Providing regulatory framework in India for US-based firm developing Biologicals & coated fertilizer
Sathguru helped the company understand the current regulatory landscape in India and suggested a regulatory pathway for registration as per the FCO, 1985.
Our client, a US-based firm involved in developing and manufacturing microbial solutions, expressed interest in entering the B2B fertilizer market by assessing the associated regulations and expected timeline. The client expressed interest in registering their product(s) in India for microbial coating of inorganic fertilizers or direct application in India.
Scope and approach
Sathguru thoroughly assessed the Indian fertilizer regulations and evaluated India’s specific regulations to meet the client’s goals. Sathguru suggested the regulatory pathway for product registration according to product suitability in compliance with FCO, 1985.
To achieve this, Sathguru:
- Classified the company’s product(s),
- Studied the Fertilizer Control Order (FCO), 1985 and amendments for product(s) fitment with the existing regulations,
- Assessed the regulations to register the product for coating inorganic fertilizers with biologicals in the country, and
- Suggested the pathway for product registration and market entry into India.
Sathguru made specific recommendations based on the product classification and proposed two regulatory pathways for registration.
- Apply for commercial registration as a biofertilizer under FCO based on the product’s classification, and
- The microbial coated fertilizer category is not available in India; hence, coat the fertilizers with microbial solutions, conduct Bio efficacy studies, and submit the application to The Fertilizer Controller for review and appropriate action in collaboration with the local partner organization/company.
Sathguru helped the client understand the regulatory pathway they need to take for product registration and the expected timeline. The client is pursuing it with local partners.