ndia: At Indian Habitat Center, agriculture association CropLife India has enabled agriculture scientists, medical fraternity, toxicologists, chemists, academicians, government officials of Ministry of Agriculture & Co-operation, regulators, of Central Insecticides Board & Registration Committee (CIB & RC), ICAR (Indian Council of Agricultural Research) and global industry experts to align the country’s Regulatory environment with global practices through a two-day workshop on “Equivalence Procedure and Data Bridging Concepts for Registration of Crop Protection Products”.
This exercise would enable faster registration of safer and greener crop protection products leading to quality manufacturing processes thus enabling farmer access to safer technologies in the country. Indian farmers lose 20-30% of its agricultural output, with crops valued at above Rs. 40,000 crore every year to pests like pests, insects, diseases and rodents.
Some of the significant forward looking regulations are harmonization with OECD protocols in major disciplines, crop grouping concept, minor changes regulation to enable innovation at a faster pace and many more. CropLife India in its continuous engagement efforts, have organized policy workshops in collaboration with regulators and policy makers that has paved the way towards progressive regulations in the country, Crop Grouping principles of Residue data generation and MRL (Maximum Residual Levels) setting for manufacture of crop protection products in the country.
Dr J.S. Sandhu, DDG, ICAR (Crop Science & Chairman of the Registration Committee), while inaugurating the workshop mentioned that “Such workshops help us to interact with Global regulatory systems while helping us to make the “Make in India” concept stronger for crop protection products (pesticides/agrochemicals) in the country. It is always good to generate ideas and adopt the best.”
India has 18 Agro-climatic zones with multiple crops with farmers facing multiple challenges of 15-25% potential crop production due to pests, diseases, insects, weeds, water shortages, irregular irrigation facilities, shortage of pulses, oil seeds, maize and labour. These are enabling factors for farmers to have access to quality products.
Significantly, due to continuous engagements with global regulatory practitioners, India became a signatory to the Mutual Acceptance of Data (MAD) as per GLP (Good Laboratory Practices) principles of OECD (April 6, 2011), which is a major success story for the Indian Regulatory environment for the crop protection industry.
Key recommendations from the earlier held workshop in 2014, enabled the Indian crop protection regulatory environment to harmonize with globally accepted principles of equivalence and data bridging while assessing and implementation in the Indian context.
This augmented strengthening domestic manufacturing of agrochemicals at par with international standards, which moved towards facilitating the “Make in India” initiative of the Government, while harmonizing Bureau of Indian Standards (BIS) specifications with FAO/WHO including export registrations.
“Crop protection is not just about using chemicals to manage pests – we must have holistic, environmentally safe “Greener crop protection & crop health solutions”, says Sarjiwan Manhas, Vice Chairman of CropLife India.
The way forward for the Indian crop protection industry, valued at $ 4.2 Billion would be to concentrate on delivering Specialty Formulation, develop regulatory capacity and regulatory data development apart from market Research for enhancing reach and distribution of the industry.
The agrochemical sector faces multiple challenges but with collaborative work between various stakeholders can facilitate India becoming a global manufacturing hub of quality crop protection solutions and adopt best practices to increase the country’s agricultural productivity while making it a food and nutrition secured nation.
Crop Protection & Regulatory guidelines: The approval and use of commercial crop protection products in all contexts is highly regulated all over the world, including India. Strengthening the existing guidelines enables supporting both the domestic industry as well as International players to ensure farmers have the best choice of products and latest innovations on par with farmers across the world. Progressive regulations indicate there is an urgent need to reduce timelines of regulatory protocols.
“CropLife India and its members of both Indian bred and global companies has been at the forefront to strengthen domestic manufacturing at par with global standards and facilitate the Make in India initiative of the Government. The Indian regulatory system concerning the Crop Protection Industry which is very robust and knowledgeable has adopted the OECD guidelines which is a step towards global acceptance of regulatory norms.”, says Dr Vasant Patil-Director Scientific & Regulatory Affairs- Crop Life Asia.
Global MNCs invest about 8-10% of their revenues in Research & Development, while Indian bred crop protection manufacturers spend 1-2% of their revenues in R&D, which makes them less competitive to compete in the global market in developing specialty molecules.
Ease of introduction of latest pest control solution technology is the key to some of the challenges faced by Indian farmers like spurious products, low focus on R&D by domestic manufacturers, inefficiencies in the supply chain etc. which need to be addressed on priority.
Discovery of new molecules is a highly specialized R&D activity- it is significant to note that, on an average, only one molecule out of 100000 screened chemical compounds gets finally identified and selected, for full development while going through the rigorous R&D process and Regulatory approvals.
From discovery in the labs to the introduction in a country regulatory level, it takes more than 8-10 years and involves an investment of more than 1600 Crores. Further, in India to provide access at the farm level, the product must undergo 3-4 years of stringent evaluation on efficacy, safety, MRLs and other parameters as per guidelines established by CIB&RC (Central Insecticide Board & Registration Committee) and another 1-2 years for review of data and final registration approval.
CropLife India, the 14-member association of the technology driven crop science industry has introduced more than 243 molecules out of the 260 registered in India until 2014-15. It extensively engages with close to 7.3 million of farmers throughout India, as part of its “Stewardship” activity, while imparting knowledge and education to farmers, detailers and retailers on scientific application, responsible use of crop protection solutions, pesticide container management, usage of PPE (Personal Safety Equipment).
It promotes the benefits and responsible usage of crop protection products, as well as sound science based regulatory system to protect people and the environment, timely access to crops, usage of new pesticides to support a sustainable agriculture system in India.
A unit of CropLife International, a global federation of the plant science industry present in over 91 countries, CropLife India believes in a strong and science-based regulatory system to protect people and the environment such that timely access to new crops, new crop protection solutions or new uses for existing crop protection products are promoted.