India released the fifth draft of the Chemical (Management and Safety) Rules (ICMSR) on August 24, 2020. The ICMSR will regulate Substances, Substances in Mixture, Substance in Articles and Intermediates that are manufactured, imported, or placed in the Indian Territory. ICMSR is also known as India REACH.
Notification is required for all substances that are in quantity above 1 Tonne Per Annum (TPA). Additionally, only substances that are listed in "Priority Substances Required to be Registered" in Schedule II of the ICMSR need to be registered.
The ICMSR (India REACH) is expected to be notified to WTO in 2022 and come into force after 60 days of notification. India REACH will require Indian manufacturers and importers to comply with the regulation which includes notification and substance registration. For foreign manufacturers, they may appoint an Authorized Representation (AR) on their behalf to comply with the ICMSR (India REACH).
The BIS in BIS Certification stands for Bureau of Indian Standards. The establishment of a national standards body in India is based on the Bureau of Indian Standards Act established in 2016.
The aims of the BIS Act include harmonious development of the activities of standardization, conformity assessment and quality assurance of goods, articles, processes, systems, and services. The responsible authority is the Bureau of Indian Standards
BIS certification is required by every manufacturer (Indian or foreign) of those who are manufacturing products under Compulsory Certification.
Product certification includes two schemes:
The list of products that requires BIS certification is constantly being extended. See our summary on BIS Mandatory Product list: for Scheme II and Scheme II.
For non-Indian manufacturers to comply with BIS certification, Authorized Indian Representative (AIR) can be appointed to assist the application process, including:
Pesticide is a substance, which is used for destroying insects or other organisms harmful to cultivated plants or to animals. India is the 4th largest country in the production of pesticides next to USA, Japan and China. Indian pesticide act 1968, an Act that regulates the import, manufacture, sales, transport, distribution, and use of insecticides with a view to prevent risk to human beings or animals. The preliminary set of rules for the registration of chemicals in India was described in the Insecticide rules, 1971. The above-said rules have been amended and made more stringent to prohibit or restrict the usage of toxic chemicals in India.
There are mainly three types of registrations.
9(4)”Me Too” Registration – Min 180 Days.
9(3) and 9(3b)- fresh registration – Min 365-1095 days
The regulatory agency responsible for the registration of insecticide & pesticide is the Central Insecticides Board & Registration Commitee (CIBRC). Central Insecticides Board & Registration Committee (CIBRC) under the Directorate of Plant Protection, Quarantine & Storage, and Department of Agriculture & Cooperation was set up by the Ministry of Agriculture in the year 1970. The Central Insecticides Board (CIB) advises the Central Government and State Governments on technical matters arising out of the administration of this Act and to carry out the other functions assigned to the Board by or under this rules.
Click here to view more on:
Type and depth of data requirements depends on category of pesticide (Category I-IX).
|I||Technical grade pesticide, which is not registered for manufacturer/ Import and use in india|
|II||Technical grade pesticide, which is registered for manufacturer/ Import and use in india|
|III||Indigenous manufacturer of technical grade pesticide, which is not registered use in india|
|IV||Indigenous manufacturer of pesticide already registered for use in india|
|V||Indigenous manufacturer of new pesticide formulation(s), not registered for manufacturer and use in india|
|VI||New combination pesticide formulation, not register for use in india|
|VII||Import of new formulation of pesticide, not registered for import/manufacturer and use in india|
|VIII||Indigenous manufacturer of registered/unregistered formulation of microbial bio pesticles.|
|VIII(a)||Bio-pesticides : non-Bt & Bs based|
|VIII(b)||Bio-pesticides : Bt & Bs based|
|IX||Indigenous manufacturer of bio-pesticides-Botonical-Technical/Formulation|
The Insecticide Act (1968) is not applicable to:
(a) the use of any insecticide by any person for his own household purposes or for kitchen garden or in respect of any land under his cultivation;
(b) any substance specified or included in the Schedule or any preparation containing any one or more such substances, if such substance or preparation is intended for purposes other than preventing, destroying, repelling or mitigating any insects, rodents, fungi, weeds and other forms of plant or animal life not useful to human beings.
The Central Government may, by notification in the Official Gazette, and subject to such conditions, if any, as it may specify therein, exempt from all or any of the provisions of this Act or the rules made thereunder, any educational, scientific or research organisation engaged in carrying out experiments with insecticides.
Insecticide inspector does surveillance for minimum of 3 times in a year, and send’s the samples of insecticides for analysis.
There is no standard measure for chronic toxicity studies. OGen the length of the experiment is in days, months, or years and the amount of each dose is stated. As per the CIB RC classiﬁcation there are four types of classiﬁcations.
The Ministry of Environment, Forest, and Climate Change formed the National Coordination Committee and proposed new pesticide management bill 2017. It is expected that the pesticide act will be replaced by this new proposed bill. The PESTICIDES MANAGEMENT BILL will regulate the import, manufacture, export, storage, sale, transport, distribution, quality and use of pesticides. This bill takes necessary measures to continue, restrict or prohibit the use of pesticides with a view to prevent its risk on human beings, animals or environment. This bill was proposed by the NCC in august 2017, and the bill was draGed on 19/02/2018. It is expected that this new management bill come into force by the end of 2019 or early 2020.
The Insecticides Act of 1968 and the Insecticides Rules of 1971 regulate the import, registration, manufacturing, sale, transportation, distribution, and use of insecticides (pesticides) in India, as well as other related matters. Before being made available for use or sale, all insecticides (pesticides) must go through the Central Insecticides Board & Registration Committee (CIB & RC) registration process.
India plant protection product registration is intricately challenging task due to various categories of registration.
Identifying a suitable category for your product needs to be established and it some time happens with the conformity of regulatory authority.
Indian authorities many a take a product-to-product approach basis for the initial evaluation.
Study management and monitoring is one of the most robust tasks in the whole application process.
Best GLP certified labs in India for data generation.
Testing laboratory selection, the study placement, monitoring studies, and proofreading the report.
A constant check with the labs that the studies must fulfil the regulatory requirement. And can be used for registration purpose.
The data requirements are set out in respective Regulation for the active substance and for the product formulation.
Writing regulatory dossiers is one of the most important tasks.
Data must be provided via online portal yet coordination with authorities must be maintain to check that all data is being submitted.
1. Study of guidelines displayed on official website of CIB&RC.
2. Generation of chemistry, toxicological, packaging, bio-efficacy data as per latest guidelines.
3. Submission of online form 1 along with required data.
4. Preliminary scrutiny by CIB&RC for application and data completeness.
5. Sampling and verification of manufacturing site by government authorities.
6. Testing of collected samples if same are as per specifications.
7. Scrutiny of submitted data by concerned sections of CIB&RC.
8. Approval in CIB&RC monthly meeting.
9. Issuance of Registration certificate.
10. Application for manufacturing license from state government.
11. Issuance of manufacturing license.
12. Application for stock and sale of Insecticides.
13. Approval by state governments if to be sold and distributed in India.