In this highly regulated world, the services of toxicological data generation are important in making sure that products of agrochemical and pharmaceutical industries are safe to be used by humans or to the environment.
A product has to pass a profound series of toxicity tests before the product can be registered, sold or exported to evaluate the vulnerability of health hazards of the product.
These assessments are not scientific necessities but rather regulatory necessities required by various authorities, including the Central Insecticides Board & Registration Committee (CIB&RC), the Drug Controller General of India (DCGI) and outside the country, the EPA (USA) and EFSA (EU).
The tests in toxicology vary and to mention some, they involve acute toxicity, reproductive toxicity, chronic exposure and carcinogenicity.
They are carried out to establish the safety limits of a product, and all those types of studies have to be carried out under Good Laboratory Practice (GLP) to gather an accurate result, provide transparency and replicate the results.
Toxicological studies that are GLP compliant are not just needed to meet regulatory requirements but are needed to uphold the health of the population.
India has emerged as a center in generating GLP-compliant toxicological data as it has the latest infrastructural facilities, skilled toxicologists and reasonably priced services. India houses Contract Research Organizations (CROs) supporting all aspects of a study like study design, data generation and submission-ready dossiers fitting the demands set by both the internal and external regulations of the regulatory bodies.
Introducing a new pesticide, importing an agrochemical, or even creating a drug product therapeutically, you can significantly accelerate the approval schedule when using the help of a trusted toxicology laboratory or CRO.
Amid concerns on product safety, regulatory toxicology services no longer support compliance, rather than forming a reputation that the company cares about brand safety and has a sustainable market exposure.
What Is Toxicological Data Generation and Why Is It Vital for Product Registration?
The generation of toxicological data is a science-based process wherein a substance is tested in an ordered way to determine its safety profile and is needed to analyze its impact on human health and the environment. These studies are the foundation of the regulatory filings in countries around the world—pharmaceuticals and, more so agro-chemicals.
Regulatory authorities like the Central Insecticides Board & Registration Committee (CIB&RC), the Drug Controller General of India (DCGI), or the international bodies like the EPA (USA), the EFSA (EU), or the OECD have no means of evaluating the risk-to-benefit ratio of a product where no sound toxicology data is available. Therefore, it is not optional that on product registrations, toxicological data be provided.
Pharmaceutical companies and agrochemical companies must early on invest in services offering toxicological data generation in order to reduce the time taken to get approval (licenses to market the products) of their products and be ready with legislation in both local and foreign markets.
GLP-Compliant Toxicological Data Generation in India: Standards, Scope, and Benefits
India has become a provider of GLP toxicological information across the world with a growing grid of toxicology laboratories in India which are certified to generate toxicological information. The Department of Science & Technology has the National GLP Compliance Monitoring Authority (NGCMA), which makes sure that OECD principles are followed.
Good Laboratory Practice (GLP) is a set of quality system requirements relating to the methods by which safety studies intended to support non-clinical safety assessment must be planned, conducted, monitored, recorded, and archived as well as how the safety studies are to be reported. All the toxicological studies that have been involving GLP are done within this framework so as to maintain data integrity, its traceability and its acceptability by regulators across the world.
Clients also have the advantage of:
- Regulatory toxicology services that are global standards
- Competitive pricing
- Regional availability of skills in preclinical toxicology studies
- Efficient mandates of submission of toxicity testing units, to Indian and international authorities
GLP certification is particularly important in companies that have their export as a major business target since non-GLP results are usually rejected at the first instance.
Toxicology Study Requirements for Pesticide and Pharma Product Registration
When introducing a new pesticide or a new pharmaceutical formula it is of great essence to satisfy the set toxicology studies benchmarks in order to have the new product registered. Both the authorities contain sound safety evaluation procedures:
For Agrochemicals:
According to the CIB&RC guidance, one is expected to submit the acute toxicity study (oral, dermal, inhalation), the chronic toxicity protocol, and the genotoxicity results.
There must also be environmental fate and ecotoxicological data.
For Pharmaceuticals:
Before the initiation of clinical trials, the DCGI demands preclinical toxicology tests of the agent (reproductive toxicity, mutagenicity, and carcinogenicity).
The studies are to be GLP, ICH, and OECD compliant.
The requirements of a toxicology study depend on the intended use of the product, dosage, and exposure frequency. The availability of structured regulatory toxicology services, which respond to the local and international requirements, minimizes the chances of rejection of applications.
Types of Toxicological Studies: Acute, Sub-Chronic, Chronic and Preclinical Testing Explained
The knowledge of the scope and aim of various toxicological assays should be a priority when it comes to designing the product development roadmap and regulatory navigation strategy.
The following is the description of the key types of studies:
Acute Toxicity Studies: When a single dose exposure is utilized to assess short-term toxic reactions. Incorporates oral, dermal, and aerosol.
Sub-Chronic Studies: Re-exposure for 28 to 90 days to determine the accumulative toxicity of an organ.
Chronic Toxicity Testing: long-term exposure of a major part of the lifespan of the test subject. Needed on products that are exposed to long durations.
Preclinical Toxicology Studies: These are done prior to human studies and include reproductive toxicity, carcinogenicity and immunotoxicity and in particular with pharma products.
These toxicity testing services are performed under rigid GLP procedures, and they are set to meet the target expectation of the regulating body. The type of study to be selected depends on the chemical nature of a product to be exposed, the route used and population characteristics.
How to Generate Toxicological Data for Agrochemicals and Pharmaceuticals: Step-by-Step
This is a simplification of the process to create GLP-compliant data in a situation where manufacturers/importers intend to register a product with the authorities:
- Product Profiling: What is the composition of the product and what is it used for?
- Toxicology Study Design: Reconcile regulatory requirements with test plans (OECD/ICH/CIB&RC).
- Choose a GLP-certified lab: Pick one of the well-established toxicology laboratories in India or elsewhere.
- Conduct studies: Conduct acute, chronic, and preclinical toxicology studies as necessary.
- Data Reporting and Validation: Reports data in GLP-formatted form, including raw data.
- Dossier Submission: Submission to CIB&RC, DCGI or to international regulators as appropriate.
Professional toxicological data generation will make the process efficient and compliant using professional services. Additionally, there are some CROs that can provide a toxicity data submission service to accelerate the schedules.
Choosing the Right Contract Research Organizations for Toxicology Studies in India
India has an increasing number of highly capable contract research organizations to carry out toxicology studies, which cater to both Indian and foreign clients.
In considering CROs, you should look into the following aspects:
- GLP Accreditation: Required in most jurisdictions to be accepted.
- Experience: Work experience in the fields of agrochemicals and pharmaceuticals.
- Infrastructure: All the necessary toxicological capacities of agrochemicals and pharma are in-house.
- Turnaround Time: Fastness without losing the data integrity.
- Compliance Record: History of successful experience with authorities such as CIB&RC, DCGI, USFDA, etc.
Contracting the appropriate CRO can assist you in decreasing risk in development and duplicate avoidance and provide you with assurances that the generated GLP toxicological studies will be acceptable globally.
There are also a number of major CROs in India, such as integrated packages providing services in preclinical toxicology studies, to toxicity testing programs of agrochemical registrations.
Cost, Timelines, and Compliance: What to Expect from Toxicological Data Generation Services
The cost to invest in toxicological data generation services is typically very wide-ranged because it does not only depend on the type of product but also on the provision of how many studies the company needs to conduct and according to which regulations the company wants to target.
Approximate Pricing Range (India):
- Acute Toxicity: 2.5-5 lakhs per study
- Sub-Chronic Studies: 8-15 lakhs
- Chronic Studies: 20-50 lakhs+
- Complete Preclinical Solution of Pharma: RS.40 lakhs to 1.5 cr
Timelines:
- Acute research: 1-2 months
- Sub-chronic/chronic 3 to 9 months
- Complete preclinicals: 6 months to a year
Compliance Tips:
- Start early—the time can delay your go-to-market plans.
- Work with CROs offering services in submitting data on toxicity, and work with such companies to minimize mistakes.
- Prevent having to repeat studies or risk them being rejected; ensure GLP compliance.
In case of agrochemical firms with the orientation to exports it is very crucial to assure that all toxicological data generation work which is compliant to the GLP in India should be globally acceptable.
Why You Need Expert Consultancy for GLP Toxicological Data Generation and Regulatory Submissions
Managing the decision to develop and supply GLP-compliant toxicological data is not a straightforward exercise; whatever the compound, the solution is neither simple nor straightforward. That is why it is important to have consultants specialized in toxicology and regulatory affairs.
A professional toxicology and regulatory consultancy may mean the difference between a smooth product registration process and the unnecessary drags caused by missing information or violation of regulatory standards.
The majority of companies, particularly startups, importers, and first-time applicants, do not have the in-house means of interpreting regional and international regulatory requirements. A consultant is of help in filling that gap as they plan their studies specific to the type of product and the target markets.
Consultants make sure that no steps in the process are missed, such as the applicability of the OECD guidelines or the choice of the most suitable toxicology studies in the case of agrochemicals or drugs.
Also, the regulatory requirements are not fixed and can change depending on a nation. A study that is acceptable in India (at the CIB&RC or DCGI level) may fail to be acceptable to users in the United States (EPA) or in the European Union (REACH).
Consultants give transparency on these country-specific peculiarities, with GLP-certified CROs to streamline the scope and format of the toxicological data generation services in line with each other’s specifications.
Such a consultant will also assist in laboratory communications, monitoring of studies, reviewing draft reports of errors, and preparation of submission-ready regulatory dossiers. With products that are under stringent launch schedules, it can save a lot of back-and-forth with authorities, and the product can enter the market a lot sooner.
In other words, consultancy services do not only provide support, but they are strategic. Deployment of knowledge and technical expertise can help companies solve the GLP toxicological study investment dilemma: What to invest in and why? To produce data that has global regulatory acceptance, a quality GLP toxicological study program ensures that companies regain their investment in GLP toxicological studies.
Frequently Asked Questions
It is the process of conducting safety studies to assess the toxic effects of a substance on humans or animals.
It demonstrates product safety and is a regulatory requirement for approval.
These are studies conducted under Good Laboratory Practices ensuring data integrity and regulatory acceptance.
A single dose of the substance is administered orally to test animals to observe toxic effects and determine LD50.
Agrochemicals, pharmaceuticals, industrial chemicals, and cosmetics typically require such studies.
It ranges from ₹2.5 lakhs to ₹1.5 crore depending on the type and number of studies.
Acute, sub-chronic, chronic, reproductive, carcinogenicity, and genotoxicity studies.
Typically between 3 to 12 months based on study complexity.
CIB&RC, DCGI, EPA, EFSA, OECD, and other national and international regulatory bodies.
Preclinical toxicology supports early drug development, while regulatory toxicology ensures compliance for market approval.
