India’s lack of Regulatory Data Protection discourages innovators from introducing new molecules
Recently, Union Agriculture Minister Shivraj Singh Chauhan expressed concern over the "poor quality" pesticides and seeds available in the market, hinting at the introduction of stricter laws to tackle this issue. The proposed Pesticide Management Bill (PMB) 2020 calls for replacing the Insecticides Act of 1968 to address substandard crop protection chemicals and enforce harsher penalties, including criminalization, to safeguard farmers.
Substandard products across any sector have damaging effects on economic growth, harm consumers, and tarnish the reputation of legitimate businesses. However, quality control does not necessarily require punitive measures—it demands investment in infrastructure, skilled labor, and a commitment to high standards from manufacturers. It also requires a robust, transparent regulatory system for product registration, market sampling, and reliable lab analyses.
The pharmaceutical industry offers a useful blueprint. In 2003, the introduction of QR codes and strict implementation helped curb the sale of counterfeit drugs. Consumers were encouraged to verify quality by scanning the codes. Similarly, agencies like Maharashtra’s FDA have proactively trained drug inspectors and recruited more officers via the MPSC (Maharashtra Public Service Commission) ensuring that inspectors undergo proper training to strengthen enforcement.
Another key development in pharma is the Ministry of Health’s partnership with the Quality Council of India (QCI) to upgrade the Central Government Health Services (CGHS) over the next five years. This collaboration aims to help CGHS facilities achieve NABH and NABL accreditation and improve quality monitoring mechanisms. In a major reform, CGHS has revised Good Manufacturing Practices (GMP) norms, with compliance required by December 2024. These changes are pushing many pharma units to invest heavily in manufacturing, testing, and skilled personnel—underscoring the importance of consumer safety. As per media reports, almost 40% of the existing pharma units are now at a high risk of shutting down business because the compliance requirements to GMP needs substantial investment in manufacturing, testing, skilled manpower and documentation.
A similar overhaul is needed in the agrochemical industry. First, registration should only be granted to companies with the necessary manufacturing infrastructure. The evaluation guidelines should be uniform and transparent. Furthermore, updating the Central Insecticides Laboratory with NABL and GLP accreditation, along with improving state-level agrochemicals testing labs, should be prioritized. A fully digitized registration system would also improve reliability.
The Department of Biotechnology and the Food Safety and Standards Authority of India (FSSAI) have promulgated a detailed Guidance Document/Gazette to spell out the role, responsibilities, functioning and detailed guidelines for approvals to ensure transparency, consistency and accountability. A similar Guidance Document for the Central Insecticide Board & Registration Committee (CIB & RC) would go a long way to strengthen the registration processes.
The CIB&RC has already made progress by enforcing the path-breaking Know Your Company (KYC) requirements, resulting in the de-registration of over 7,000 non-compliant firms. This action, which aims to weed out fake manufacturers according to government sources, will leave around 2,500 legitimate companies in the industry. Additionally, the digital registry of genuine companies through the Integrated Pesticide Management System (IPMS) will help streamline registration and offer transparency on manufacturing infrastructure, production, and exports. This is indeed a most welcome step for the clean sweep of the reforms agenda.
In line with the pharma sector, an independent body like QCI could audit manufacturing units to ensure compliance with quality standards. QCI should also oversee market sampling and product analyses through state labs. This process would ensure equitable access to high-quality products across the market.
Another critical reform is to encourage innovation and the introduction of newer agrochemical molecules. Currently, India has registered only about 350 agrochemical molecules, compared to 1,250 globally. India’s lack of Regulatory Data Protection (RDP) discourages innovators from introducing new molecules, as the registration process is costly and risky. Implementing a 3-5 year RDP would incentivize innovation, benefiting farmers by providing access to a broader range of effective and safe products.
The farmer remains the most affected by substandard products, often forced to choose from a limited and low-quality range of pest crop protection products. For this reason, the Government of India’s Satwant Reddy Committee recommended RDP to protect innovators. Without it, new products face the risk of being copied and marketed at lower prices with questionable quality. This Committee, comprising of more than 10 Government Departments held extensive consultations with leading scientists, patent attorneys, and industry, based on which it recommended a minimum 3 year (if not 5) RDP for any product registered for the first time in India, irrespective of its patent status.
Given the impact of climate change, changing cropping patterns, emergence of newer pests, diseases, and weeds, the farmers need a wider and newer range of products to protect their crops. A policy decision for a 3-5 year RDP shall definitely encourage introduction of newer molecules at a much faster pace, and bring in innovations. As can be seen historically, once the newly registered molecule gains market, it invariably gets manufactured in India, as also becomes the base for its global sourcing.
Currently, "Make in India" has led to over 3,000 registrations for technical pesticides, but fewer than 20% of these companies are operational. This highlights the need for confidentiality in the registration process to protect the interests of genuine manufacturers and avoid copycat registrations.
It’s encouraging to see the Ministry of Agriculture and CIB&RC take proactive steps toward reforming the industry. These reforms will ensure a stronger, more transparent agrochemical industry, benefiting Indian agriculture and the farmers who rely on high-quality crop protection solutions. By tackling substandard products, we can boost farm productivity, ensure better product stewardship, and increase the availability of innovative and safer options for crop protection.
These reforms, implemented in mission mode, will not only elevate the quality of products for Indian farmers but also help position India as a global hub for agrochemicals, with the potential to increase exports from US $4 billion to US $11 billion by 2030.
(Salil Singhal is Chairman Emeritus, PI Industries and Dr. K. C. Ravi is Chief Sustainability Officer, Syngenta India. Views expressed in the article are personal views of the authors.)
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