1. Please tell us about the field of regulatory toxicology, research in this field and its implementation for risk management.

Toxicology as a subject is still underrepresented in Indian academia, with very few universities offering it formally. Regulatory toxicology, a more specialised branch, is even less understood. I was introduced to it at CDRI. Those working in pesticides, and human or veterinary drugs engage more with regulatory toxicology, but regulatory requirements vary across these sectors. For instance, pesticide regulators demand near-zero tolerance, given the potential harm to humans and ecosystems. In contrast, drug toxicology balances safety with therapeutic benefits — since no drug is completely non-toxic. Regulatory toxicologists must evaluate how much risk is acceptable for the expected benefit. 

In India, long-term studies and risk management research are limited due to funding, infrastructure, and awareness gaps. Most data still come from Western sources. Despite limited manpower and resources, Indian institutes like CDRI are making earnest efforts to bridge this gap. Moreover, academia and industry differ — academia focuses on mechanisms, while industry emphasises proving safety and efficacy quickly for regulatory approval.

2. Who are the key role players in formulating and implementing regulatory norms and what is the role of researchers/​scientists in this?

The key players in regulatory implementation are government authorities such as Drugs Controller General of India (DCGI) for pharmaceuticals, the Central Insecticides Board for pesticides, FSSAI for food, and the Ministry of AYUSH for traditional products. Each sector has a dedicated regulatory body that frames guidelines and oversees their enforcement. These authorities constitute expert committees that include pharmacists, physicians, academicians, toxicologists, and pharmacologists. In my experience serving on over 100 such committees, I’ve observed that many members began as researchers or academicians. Over time, through in-depth research and hands-on experience across various domains of regulatory science, they became subject matter experts. Thus, researchers and scientists play a crucial role, not only in generating data but also in shaping and applying regulatory norms based on their deep understanding of safety, efficacy, and risk assessment.

3. What are the key focus areas and associated issues when we look from a regulatory compliance perspective?

Regulatory compliance is essential across all sectors — pharma, veterinary, agriculture, food, and more. In the veterinary sector, animals are often treated with hormones for increased milk production, which may harm humans, as some cancers are now linked to such milk. For pesticides, although minimum and maximum dose guidelines exist, untrained users in rural areas often exceed recommended levels, leading to self-exposure and environmental harm. In pharmaceuticals, compliance issues extend beyond use; improper disposal of antibiotics, for instance, contributes to antimicrobial resistance (MDR/XDR), posing long-term public health risks. Regulatory bodies exist, but implementation often lags due to economic constraints, lack of awareness, or urgency in production. 

As the saying goes, ​“if it is ati (excess), then it will be iti (end).” Hence, regulation is not just necessary — it’s critical for sustainability and safety across sectors.

4. What is the present Indian scenario with respect to education, implementation and ways to overcome challenges in the field?

In India, toxicology, especially regulatory toxicology, is rarely included in academic curriculum. I believe it should be introduced as a core subject within biological sciences to build foundational understanding. Without proper education, effective implementation is not possible. Currently, decisions are often made without fully understanding ground realities, or based only on outdated documentation. To overcome these challenges, we need to revisit the basics and align top-level policies with actual field conditions. India has three toxicology societies — two in the South and one national body, the Society of Toxicology (India), which is among the oldest. However, these platforms sometimes drift from their core mission, and regulatory discussions remain limited. While seminars are regularly held, there’s a need for unified efforts to actively involve both young and experienced professionals to bridge knowledge gaps and foster meaningful dialogue in regulatory toxicology.

5. A piece of advice to young minds.

My simple advice: Be good and do good. 

Be good by building a strong foundation of knowledge, especially if you’re a biologist, don’t shy away from learning toxicology, pharmacology, or regulatory science. Stay ethically grounded and aim for a holistic understanding. Today, we have access to abundant information, but without proper application, it’s of little value. Don’t get lost in data-focus, learn deeply, and apply wisely. If you’ve chosen biology, explore both its strengths and risks, and think about how harmful aspects can be regulated, because we ourselves are biological beings. Our duty is to care for ourselves, society, and the environment. I believe change is coming.