• The chemical industry is an indispensable and integral constituent of the growing Indian  The wide range of chemical products play a vital role in catalyzing not only the economy of the country, but also making the life-style of human beings comfortable and sophisticated. Apart from the above, chemicals are essentially contributing in several other fields, viz., health, agriculture, environment, forest, communications, pharmaceutical, transport, power, textile, infrastructure, housing, defense, etc.
• The chemical Industry, 3rd largest producer in India and 6th by output in the world, is critical to the economic development of any country and has played an important role in India's ongoing metamorphosis from an agrarian economy to an industrialized This industry occupies a pivotalposition in meeting basic needs & improving quality of life and is one of the most diversified sectors covering thousands of commercial products. The chemical industry is the mainstay of the industrial & agricultural development of the country & provides building blocks for several downstream industries, such as textile, paper, paint, soap, detergent, pharmaceutical, varnish, etc.
• The Indian Chemical Industry has the major advantage of being extremely diverse in the range of productsthat it manufactures and going forward, the industry can build on this base
• The chemical industry in India is a key constituent of Indian economy, accounting for 11 of the GDP.
• The Indian chemical industry comprises small, medium and large-scale units, and presently, there are about 70,000 chemical manufacturing units. Indian chemicals industry comprises a wide range of chemical products including pharmaceuticals (29%), petrochemicals (21%), specialty chemicals (19%), fertilizers (17%), agrochemicals (3%) and other base chemicals constituting -11 % of the total Indian chemicals
• Indian chemical industry exports dyes, pesticides and specialty chemicals which form about 3% share in the global market and contributes significantly to foreign exchange
• India accounts for approximately 16 % of the world production of dyestuff and dye intermediates, particularly   for reactive acids and direct
• Indiais 3rd largest consumer of polymers and 3rd largest producer of

The Department of chemicals & petrochemicals (DCPC) has undertaken formulation of a National Chemical Policy in line with hon’ble Prime Ministers vision of Make in India with zero defect in quality and Zero effect on environment.
The National Chemical Policy of India is in final stages and as a part of this, the Government is planning to launch Indian Bureau of Corrosion Control and setting up National Chemical Centre that could prevent losses from corrosion and act as a repository information Centre for the chemical industry.

The Vision for the Indian Chemical Industry is : “To facilitate the accelerated growth and development of the chemical industry to meet local and global requirements, in an environment friendly manner, with focus on innovation, sustainability and green technologies, so as to enable it to become a globally competitive major player."

AIMS and OBJECTIVES :

The principal policy objectives are to create an enabling framework to meet the growing demands in all areas to foster innovation, catalyze manufacturing, addressing environmental concerns and adopting green technologies, encourage HRD and R&D through academic institutions & industry that not only cater to the growing domestic needs but also take advantage of global export opportunities as a logical expansion of the industry. The chemical Industry, 3rd largest producer in India and 6th by output in the world, is critical to the economic development of any country and has played an important role in our country's ongoing metamorphosis from an agrarian economy to an industrialized economy.

Chemical industry Imperatives :

India envisages the future growth of its chemical industry by successfully utilizing its inherent strengths while effectively addressing the key challenges. The following challenges need to be addressed to achieve the aspirational growth target defined in the Vision

• .Infrastructure
• Feedstock
• R& D Technology
• Sustainability
• Regulations

There is strong Government support towards R and D In 2016, Department of Chemicals and Petrochemicals, Ministry of Chemicals and Fertilizers, Govt. of India and Federation of Indian Chambers of Commerce and Industry (FICCI) launched, “India-Chem 2016” to develop Indian Chemical and Petrochemical Industry The Ministry of Environment, Forest & Climate change has formed the national coordination committee to prepare a national action plan for chemicals for India.

At present, there are multiple Act/Rules in India governing the chemicals industry that fall under the purview of different Ministries/Departments. An illustrative list for reference is given below: FUTURE FOCUS AREAS : Specialty chemicals as a focus area :

In view of the importance and bright prospects of specialty chemicals, including their export potential, this segment deserves special attention and incentives in the policy. Special focus needs to be provided to the specialty chemicals industry by the following measures:
1. By setting up capacities in PCPIRs through demarcating special zones to aggregate feedstock demand.
2. Encouraging the anchor tenant of PCPIRs to set up an Ethylene Oxide (EO) plant with stringent manufacturing standards to meet the demand of this important feedstock for specialty chemicals.
3. Setting up of chemical clusters and consolidation of Acts/Rules would be another initiative in this direction.
4. Considering the sun-rise nature of the sector, adequate R&D support needs to be provided.
5. Specialty chemicals market has expanded at a CAGR of about 12% over FY 07-11. This figure is expected to rise by 9.43% from FY14 to reach USD90 billion by FY23.
6. The Indian middle class household is expected to grow from 31 million in 2008 to 148 million by 2030, leading to a huge demand for specialty chemicals in automotive, water treatment and construction
7. India’s construction chemical sector consists of a variety of products ranging from admixtures to sealants. Admixtures form the largest segment with a 42% share, followed by 18% share of adhesives and sealants
8. The construction chemical market stood at USD573.2 million in 2014, which grew to USD649375 million in 2015. By 2019, the construction chemical sector is set to touch USD1146.4 million.

• India is currently the world’s 3rd largest consumer of polymers behind China and the US. India’s  polymerconsumption is 2 million tones which constitutes 3% of the global consumption.
• The sector is expected to grow at a higher rate due to growth in plastic demand resulting from increasedusage in packaging, construction and automotive
• Polymerproduction in India is around 9 million tones and imports stands at 8 million tons.

• Indiais the 3rd largest producer of agrochemicals, globally and ranks 4th in terms of production of crop protection chemicals. The market for crop protection chemicals in India is expected to reach to USD7.5 billion by FY9 and register exports of about 50% of value of Indian crop protection

The 7 states including Andhra Pradesh (AP), Maharashtra, Punjab, Madhya Pradesh (MP) and Chhattisgarh, Gujarat, Tamil Nadu and Haryana account for over 70% usage of crop protection chemicals in India. Andhra Pradesh (AP) is the leading consumer of agrochemicals with a market share of 24%.

• Carryingout technology and product development
• Evolvingand periodically updating the national program for technology/product
• Acting as a nodal agency to monitor and ensure the implementation of various recommendations made for promoting indigenous R&D, IPR creation, Confidential Business Information (CBI) protectionand manufacturing and deployment of products and
• Collaborating with the Ministry of Science & Technology, and specifically with Department of Science & Technology (DST), Department of Scientific & Industrial Research (DSIR) and leading national laboratories
• A centralized R&D Technology Park (R&DTP) should be created to provide "plug in" facilities for MSMEs so that they can have access to the world class R&D facility to develop and enhance their customerofferings
• All the expertise R&D, including laboratory research, pilot facility and scale-up expertise would be madeavailable in this R&D TP to facilitate world class innovation at a competitive cost for
• Formulating the road map for innovation 2022
• Anyother area relevant to the chemical sector.

Drug and Cosmetics Act, 1940

Cosmetic is defined under section 3(aaa) of the Drugs and Cosmetics Act, 1940 as, any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance, and includes any article intended for use as a component of cosmetic. 

Under the provisions of Drugs and Cosmetics Act, 1940 and Rules made there under, the manufacture of cosmetics is regulated under a system of inspection and licensing by the State Licensing Authorities appointed by the respective State Governments, while the import of cosmetics is regulated under a system of registration by the Central Licensing Authority appointed by the Central Government. The Drugs Controller General (India) functions as the Central Licensing Authority who grants the Import Registration Certificate and regulates the import of cosmetics into India vide Gazette notification G.S.R 763(E) under the provisions of Drugs and Cosmetics Act, 1940. 

The Cosmetics Rules, 2020

With the recent increase in awareness about safety and healthcare regulatory bodies around the globe started improving and advancing their regulations and policies to safeguard the health of their citizens. Following the trend Indian regulatory body who watch-over the safety of the cosmetics in the country – Central Drug Standard Control Organization (CDSCO) came up with new Cosmetics Rules. The Cosmetics Rules have been published through an official gazette notification on 15th Dec, 2020 and are effective since the same date in the whole country.

In the Cosmetics Rules, 2020, the cosmetics' definition remains the same.However, the concept of "New cosmetic" is introduced for the first time. It is defined as ‘a cosmetic that contains a novel ingredient that has not been used anywhere in the world or is not recognized for use in cosmetics in any national or international literature’.

These new rules mandate importers/ manufactures of a ‘new cosmetic’ to make an application and seek an approval from the Central Licensing Authority (CLA) before such a ‘new cosmetic’ could be imported or manufactured in India.The application should be accompanied with requisite data on safety and effectiveness. Further, the manufacturer must comply with IS 4011:2018 standards for testing the safety of the ‘new cosmetic’. 

The Cosmetics Rules, 2020 streamline the process of import registration of cosmetics. Along with the rules, the CDSCO (Central Drug Standard Control Organization) has issued frequently asked questions (FAQs) and guidance document for grant or retention of registration certificate (RC) or license for import or manufacture of cosmetics in the country.

To guide manufacturers in the formulation and labelling of their cosmetics, the Cosmetics Rules, 2020 includes the Ninth Schedule which defines the Indian Standards that cosmetics (in their finished forms) need to respect and the Tenth Schedule which list the colorants permitted in cosmetics (Part I - IS 4707) and in soaps.

Form	Purpose
Cos-5	Application to obtain cosmetics manufacturing license
Cos-7	Self- certificate compliance for GMP
Cos-8	Cosmetics Manufacturing license
Cos-10	Form for sampling
Cos-12	Application for new cosmetics
Cos-15	Seizure Form
Cos-16	Fair-price Form
Cos-17	Memorandum to Govt. Analyst
Cos-18	Non-Disposal Form
Cos-19	Govt. Analyst Test Report
Cos-22	Application for grant of testing of cosmetics
Cos-23	License for testing laboratory for cosmetics

 

The cosmetic products need to be registered on the SUGAM portal. To help the manufacturers, the authorized agent or the importers gather the right information to upload on the portal, an Excel sheet listing all the information needed is available to download on the portals’ website. Registration submission requires :

• Product's category
• Name of the product
• Brand
• Size
• Variants
• Bulk (yes or no)
• Kit (yes or no)
• Name of the kit
• Address of the premises of the manufacturer
• Name of the country where the product has been manufactured
• Instructions

GPC can :

• Review your formulation
• Test the physic-chemical properties of your product
• Test the microbiology of your product
• Review your label
• Review your claims
• Perform a safety assessment
• Register your product
• Perform regulatory monitoring
• Give regulatory consulting

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.

• Provisional Registration under sections 9(3b) : Provisional registration is done for the chemical/molecule which has been introduced for the first time in India.The registration is usually granted for a period of 2
• Regular Registration under section 9(3) : It is a regular registration of the chemical, wherein the producer or importer needs to register an already existing pesticide with different impurities, and applicantneed to submit the complete data as per
• “Me-Too”Registration under section 9(4) : AGer 9(3) registration of a molecule, any other person can join/apply for

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: 

Insecticides / Pesticides Registered under section 9(3) of the Insecticides Act, 1968 for use in the Country (updated on January 2021) 

Pesticide and Formulations Registration for Use in India (updated on January 2021) 

List of Pesticides that are banned, refused registration and restricted in use (updated on January 2021) 

Source of Import and list of Indigenous Manufactures of Insecticides (updated on January 2021) 

List of approved Pesticides for control of Desert Locust 

 

Type and depth of data requirements depends on category of pesticide (Category I-IX).

Category	Desciption
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.

Classification of Insecticides based on toxicity level:

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 Pesticides Management Bill, 2017.

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. 

1. India plant protection product registration is intricately challenging task due to various categories of registration.  

2. Identifying a suitable category for your product needs to be established and it some time happens with the conformity of regulatory authority.  

3. Indian authorities many a take a product-to-product approach basis for the initial evaluation. 

4. Study management and monitoring is one of the most robust tasks in the whole application process.  

5. Best GLP certified labs in India for data generation.  

6. Testing laboratory selection, the study placement, monitoring studies, and proofreading the report.  

7. A constant check with the labs that the studies must fulfil the regulatory requirement. And can be used for registration purpose.  

8. The data requirements are set out in respective Regulation for the active substance and for the product formulation.  

9. Writing regulatory dossiers is one of the most important tasks.  

10. 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. 

Chemicals	Indian Standards	Title of Indian Standards	Date of Notification - WTO	Final date for comments	Reason / objective	Description
(1).	(2).	(3).
Acrylonitrile	IS 12540:1988	Specification for Acrylonitrile	2020-07-07	2020-09-05	other	This order seeks to ensure conformity to Acrylonitrile listed in the schedule to the specified Indian Standard
Maleic Anhydride, Technical	IS 5149:2020	Specification for Maleic Anhydride, Technical	2020-07-07	2020-09-05	other	This order seeks to ensure conformity to Maleic Anhydride (Quality Control) Order, 2020 listed in the schedule to the specified Indian Standard
Methyl Acrylate	IS 14707: 1999	Methyl Acrylate -Specification	2020-07-07	2020-09-05	other	This order seeks to ensure conformity to Methyl Acrylate, Ethyl Acrylate, n-Butyl Acrylate (Quality Control) Order, 2020 listed in the schedule to the specified Indian Standard.
Ethyl Acrylate	IS 14708:1999	Ethyl Acrylate - Specification	2020-07-07	2020-09-05	other	This order seeks to ensure conformity to Methyl Acrylate, Ethyl Acrylate, n-Butyl Acrylate (Quality Control) Order, 2020 listed in the schedule to the specified Indian Standard.
n-Butyl Acrylate	IS 14709:1999	n-Butyl Acrylate - Specification	2020-07-07	2020-09-05	other	This order seeks to ensure conformity to Methyl Acrylate, Ethyl Acrylate, n-Butyl Acrylate (Quality Control) Order, 2020 listed in the schedule to the specified Indian Standard.
Styrene (Vinyl Benzene)	IS 4105:2020	Specification for Styrene (Vinyl Benzene)	2020-07-06	2020-09-04	other	This order seeks to ensure conformity to Styrene (Vinyl Benzene) (Quality Control) Order, 2020 listed in the schedule to the specified Indian Standard.
Vinyl Acetate Monomer	IS 12345:1988	Specification for Vinyl Acetate Monomer	2020-07-06	2020-09-04	other	This order seeks to ensure conformity to Vinyl Acetate Monomer (Quality Control) Order, 2020 listed in the schedule to the specified Indian Standard.
Sodium Tripolyphosphate	IS 6100: 1984	Sodium Tripolyphosphate specification	2020-02-27	2020-04-27	Protection of Human Health or Safety  Protection of Environment	STPP is used as a preservative for poultry, meat, and seafood. It is also added, along with other sodium polyphosphates, to processed cheeses as an emulsifier. It is also used in the manufacture of detergent, water treatment chemical, purification china clay, conditioning of oil drilling mud, in paper making and textile processing etc. The locally manufactured or imported Sodium Tripolyphosphate shall conform to the Indian standard (IS 6100: 1984) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) . The use of standard mark is governed by the provisions of Bureau of Indian Standards Act 1986 and the Rules and Regulations made there under. Bureau of Indian Standards shall be the certifying and enforcing authority
Precipitated Barium Carbonate	IS 3205:1854 (reafirmed 2015)	Specification for Precipitated Barium Carbonate Technical	2020-02-17	2020-04-17	other	Barium Carbonate is one of the important raw material widely used in the manufacture of different types of ceramic dielectric capacitors for high frequency application and for hard ferrites. The other important use is as an ingredient for the manufacture of ceramic glaze frits and fluxes, optical and ophthalmic glasses and special cut glasses. It is also used in other electro ceramic materials used a resistors, circuit breakers etc. The standard of Barium Carbonate for ceramic and glass industry prescribes minimum purity and impurity profile in maximum covering iron, sodium oxide and other metal sulphates etc. Barium Carbonate Technical is used for removing of sulfates in phosphoric acid production and chlorine alkali electrolysis. Barium Carbonate Technical is also used in the manufacture of various Barium compounds like Barium Chloride, Barium Nitrate, Barium Sulphide etc. The standards prescribe minimum content of Barium and Carbonate, besides impurity profile. The locally manufactured or imported Barium Carbonate shall conform to the Indian standard (IS 3205:1984, reaffirmed 2015 and IS 12928: 1990, reaffirmed 2017) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) . Bureau of Indian Standards of the State Governments shall be the enforcing authority.
Precipitated Barium Carbonate	IS 12928:1990 (reafirmed 2017)	Specification for Precipitated Barium Carbonate for Ceramic and Glass Industry	2020-02-14	2020-04-14	other	Barium Carbonate is one of the important raw material widely used in the manufacture of different types of ceramic dielectric capacitors for high frequency application and for hard ferrites. The other important use is as an ingredient for the manufacture of ceramic glaze frits and fluxes, optical and ophthalmic glasses and special cut glasses. It is also used in other electro ceramic materials used a resistors, circuit breakers etc. The standard of Barium Carbonate for ceramic and glass industry prescribes minimum purity and impurity profile in maximum covering iron, sodium oxide and other metal sulphates etc. Barium Carbonate Technical is used for removing of sulfates in phosphoric acid production and chlorine alkali electrolysis. Barium Carbonate Technical is also used in the manufacture of various Barium compounds like Barium Chloride, Barium Nitrate, Barium Sulphide etc. The standards prescribe minimum content of Barium and Carbonate, besides impurity profile. The locally manufactured or imported Barium Carbonate shall conform to the Indian standard (IS 3205:1984, reaffirmed 2015 and IS 12928: 1990, reaffirmed 2017) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) . Bureau of Indian Standards of the State Governments shall be the enforcing authority.
Sodium Formaldehyde sulfoxylate	IS 4505: 2015	Sodium Formaldehyde sulfoxylate - Specification	2020-02-14	2020-04-14	other	Sodium Formaldehyde sulfoxylate is a power full reducing agent. It also finds extensive applications in textile industry for printing and stripping dyed textiles prior to redying and discharge printing. It is used in bleaching sugar cane juice for making jaggery, as a redoxs catalyst in emulsion of polymers and as a stabilizer/anti-oxidant in Pharmaceutical drug formulations. It also has a niche use as a water conditioner, reducing the amount of chlorine. The standard of the product stipulates minimum purity and maximum permissible content of heavy metals like lead, iron, copper and zinc etc. The locally manufactured or imported Sodium Formaldehyde Sulphoxylate shall conform to the Indian standard (IS 4505: 2015) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) . The use of standard mark is governed by the provisions of Bureau of Indian Standards Act 1986 and the Rules and Regulations made there under. Bureau of Indian Standards shall be the certifying and enforcing authority
Phosphorous Trichloride	IS 4581:1978, reaffirmed 2015	Specification for Phosphorous Trichloride , Pure and Analitical Reagent	2020-02-13	2020-04-13	other	Phosphorous Trichloride is used as a chemical intermediate to produce a variety of products which are used in several applications including agricultural products, surfactants and metal extractants, flame retardants, additives for lubricants etc. The Indian standard prescribes minimum purity of Phosphorous Trichloride and maximum content of heavy metals. The locally manufactured or imported Phosphorous Trichloride shall conform to the Indian standard (IS 4581:1978, reaffirmed 2015) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) . Bureau of Indian Standards of the State Governments shall be the enforcing authority.
Potassium carbonate	IS 7129: 1992, reaffirmed 2015	Specification for Potassium Carbonate Anhydrous	2020-02-13	2020-04-13	other	Potassium carbonate is used as a dehydrating agent and for making other potassium salts, such as chlorates and chromates. It also finds its use in ceramics, explosives, fertilizers, mineral water, tanning electroplating, shampoo preparations, process engraving and soft soaps, textile dyeing, bleaching and finishing oil, and photography. The Indian standard of Potassium Carbonate prescribes minimum purity and the percentage of heavy metal content such as lead, iron etc. The locally manufactured or imported Potassium Carbonate Anhydrous shall conform to the Indian standard (IS 7129: 1992) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) . The use of standard mark is governed by the provisions of Bureau of Indian Standards Act 1986 and the Rules and Regulations made there under. Bureau of Indian Standards shall be the certifying and enforcing authority.
Pyridine	IS 8058: 2018	Pyridine - Specification	2020-02-13	2020-04-13	other	Pyridine is used as solvent in dyestuff industry, pharmaceutical industry and as a laboratory reagent. It is also used in the manufacture of drug intermediates like 2- aminopyridine, 2, 6-diaminopyridine, pheniramine, vitamins, adhevies, food flavouring agent etc. it is also used in the manufacture of pesticides. The Indian standard of pyridine stipulates minimum purity content, and maximum limit of impurities such as copper content, ammonium compounds, chlorides and sulphates etc. Since pyridine finds application in the manufacture of pharmaceuticals, its quality need to conform to the BIS standards otherwise impurities present in Pyridine enter the animal & human chain. The locally manufactured or imported Pyridine shall conform to the Indian standard (IS 8058: 2018) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) . The use of standard mark is governed by the provisions of Bureau of Indian Standards Act 1986 and the Rules and Regulations made there under. Bureau of Indian Standards shall be the certifying and enforcing authority.
Sodium Sulphide	IS 297: 2001, reaffirmed 2017	Sodium Sulphide, technical - specification	2020-02-13	2020-04-13	other	Sodium Sulphide is widely used in paper and pulp industry, in tanneries, dyestuff and textile industries, and ore beneficiation. The solution being caustic, it needs proper care in handling. The standard prescribes purity of Sodium Sulphide and maximum content of impurities such as iron, aluminium and sodium compounds. The locally manufactured or imported Sodium Sulphide shall conform to the Indian standard (IS 297: 2001) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) . The use of standard mark is governed by the provisions of Bureau of Indian Standards Act 1986 and the Rules and Regulations made there under. Bureau of Indian Standards shall be the certifying and enforcing authority
Gamma Picoline	IS 16113: 2013	Gamma Picoline specification	2020-02-10	2020-04-10	other	Gamma Picoline is used in polymer industry for making 4-vinylpridine which is used for manufacture of polymers and pharmaceutical intermediates. It is also used in pharmaceutical industry for the manufacture of Isoniazid, an anti-TB drug. Since Gamma Picoline finds application in the manufacturing of Pharmaceuticals, its quality need to conform to the BIS standards otherwise impurities of Gamma Picoline may enter the animal & human change. The India standard of Gamma Picoline prescribes minimum purity of Gamma Picoline and impurities which need not to exceed the maximum content mentioned there in. The locally manufactured or imported Gamma Picoline shall conform to the Indian standard (IS 16113: 2013) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) . Bureau of Indian Standards of the State Governments shall be the enforcing authority
Hydrogen Peroxide	IS 2080:1984, reaffirmed 2016	Specifications for Stabilized Hydrogen peroxide	2020-02-10	2020-04-10	other	Hydrogen peroxide is mainly used as an oxidizing and bleaching agent in industry and also as disinfectant. The standard specifies acidity of the product and maximum percentage of impurities like iron, copper, lead and arsenic etc. The locally manufactured or imported Hydrogen Peroxide shall conform to the Indian standard (IS 2080:1984, reaffirmed 2016) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) . Bureau of Indian Standards of the State Governments shall be the enforcing authority.
Morpholine	IS 12084:2018	Morpholine - Specification	2020-02-10	2020-04-10	other	Morpholine is an extremely versatile chemical with many important applications. It is used as an intermediate in the manufacture of rubber chemicals, optical brighteners, resin and dyes. It is also used extensively as a corrosion inhibitor in steam boiler systems. Indian standard of Morpholine prescribes minimum purity, metalic impurities such as copper, iron, nickel in parts per million (maximum) . The locally manufactured or imported Morpholine shall conform to the Indian standard (IS 12084:2018) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) . Bureau of Indian Standards of the State Governments shall be the enforcing authority.
Phenol	IS 538: 2000	Phenol (Carbolic Acid) - Specification	2020-02-10	2020-04-10	other	Phenol is used as an antiseptic, germicide and disinfectant. It is also used in the manufacture of dyes, picric acid. It finds industrial applications such as Phenol Formaldehye resins, poly carbonates, laminates, plywood, expoxides, phonexy herbicides and numerous pharmaceutical drugs. This standard of Phenol prescribes minimum assay of Phenol. The locally manufactured or imported Phenol shall conform to the Indian standard (IS 538: 2000) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) . The use of standard mark is governed by the provisions of Bureau of Indian Standards Act 1986 and the Rules and Regulations made there under. Bureau of Indian Standards shall be the certifying and enforcing authority.
Phosphorous Oxychloride	IS 11657: 1986	Specifications for Phosphorous Oxychloride Technical	2020-02-10	2020-04-10	other	Phosphorous Oxychloride finds wide use as catalyst and chlorinating agent in dyestuff industries, pesticides and pharmaceutical industries. The locally manufactured or imported Phosphorous Oxychloride shall conform to the Indian standard (IS 11657: 1986) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) . The use of standard mark is governed by the provisions of Bureau of Indian Standards Act 1986 and the Rules and Regulations made there under. Bureau of Indian Standards shall be the certifying and enforcing authority.
Phosphorous Pentachloride	IS 11744:1986, reaffirmed 2015	Specifications for Phosphorous Pentachloride Technical	2020-02-10	2020-04-10	other	Phosphorous Pentachloride is mainly used as chlorinating agent in the manufacture of pharmaceutical, dyestuffs and pesticides. The Indian standard prescribes minimum purity of Phosphorous Pentachloride. The locally manufactured or imported Phosphorous Pentachloride shall conform to the Indian standard (IS 11744:1986) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) . Bureau of Indian Standards of the State Governments shall be the enforcing authority.
Acetone	IS 170:2004, reaffirmed 2015	Acetone - Specification	2020-02-07	2020-04-07	other	Acetone is an important commercial solvent and raw material with a wide usage in the chemical, explosives and lacquer industry. • It is being increasing used in the synthesis of a number of chemicals such as diacetone alcohol, methyl isobutyl ketone, phorone, isophorone, methyl methocrylate and certain resins, and perfumes. • The pharmaceuticals sector consumes huge quantity of Acetone as solvent in various synthesis operations. • The Indian standard prescribes minimum purity of Acetone. The locally manufactured or imported Acetone shall conform to the Indian standard (IS 170:2004, reaffirmed 2015) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) . Bureau of Indian Standards of the State Governments shall be the enforcing authority.
Beta Picoline	IS 16112: 2013	Beta Picoline - Specification	2020-02-07	2020-04-07	other	Beta Picoline is used in the manufacture of agrochemicals, Vitanmin B3, Thermoplastics and polymers. • Since Beta Picoline finds application in the manufacturing of Pharmaceuticals, its quality need to conform to the BIS standards otherwise impurities of Beta Picoline may enter the animal & human change. • The standard prescribes minimum purity of Beta Picoline and stipulates maximum content of impurities. • The locally manufactured or imported Beta Picoline shall conform to the Indian standard (IS 16112: 2013) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) . • The use of standard mark is governed by the provisions of Bureau of Indian Standards Act 1986 and the Rules and Regulations made there under. • Bureau of Indian Standards shall be the certifying and enforcing authority.
Ethylene Glycol	IS 5295: 1985	Ethylene Glycol - Specification	2020-02-03	2020-04-03	other	This Order seeks to ensure conformity to Ethylene Glycol listed in the Schedule to the specified Indian Standard.
Melamine	IS 15623:2005	Specification for Melamine (2,4,6 Triamino 1,3,5 Triazine)	2020-02-03	2020-04-03	other	This Order seeks to ensure conformity to Melamine listed in the schedule to the Specified Indian Standard
n- Butyl Acrylate	IS 14709:1999	Specification for n- Butyl Acrylate	2020-02-03	2020-04-03	other	This order seeks to ensure conformity to n-Butyl Acrylate listed in the Schedule to the Specified Indian Standard
Terephthalic Acid	IS 15030:2001	Specification for Terephthalic Acid	2020-02-03	2020-04-03	other	This Order seeks to ensure conformity to Terephthalic Acid listed in the Schedule to the Specified Indian Standard.
Toluene	IS 537: 2011	Specification for Toluene	2020-02-03	2020-04-03	other	This Order seeks to ensure conformity to Toluene listed in the Schedule to the Specified Indian Standard.
Ether	IS 336: 1973	Specification for Ether	2020-02-03	2020-04-03	other	This order seeks to ensure conformity to Ether listed in the schedule to the specified Indian Standard
Phthalic Anhydride	IS 5158: 1987	Specification for Phthalic Anhydride, Technical	2019-11-25	2020-01-24	Prevention of Deceptive Practices & Cons. Protect.  Protection of Human Health or Safety  Protection of Environment	This order seeks to ensure conformity to Phthalic Anhydride listed in the schedule to the specified Indian Standard.
Poly Aluminium Chloride	IS 15573:2018	Poly Aluminium Chloride- specification	2019-04-08	2019-06-07	Protection of Human Health or Safety	Poly aluminium Chloride is used for the water treatment industry as a coagulant for quick removal of impurities such as microscopic suspended matter and algae from water. It is a cost effective and efficient chemical, used by all municipal and Public Health Department for treatment of water supply.
Caustic Soda	IS 252:2013	Caustic Soda- specification	2017-12-07	2018-02-05	Protection of Human Health or Safety  Protection of Environment	Caustic Soda is one of the important chemicals that finds application in products that touch the day to day life of all Indians such as Alumina, Textile, Paper & Pulp, Water Treatment, Soap & Detergents, Glass, Pharmaceuticals, Agro & Crop-care Chemicals, Pipes for Irrigation, Housing and Industrial use etc. In order to reduce the the consumption of inferior grade caustic soda having mercury impurity, quality standards IS-252:2013 is being mandated for caustic soda for both domestic makers as well as imports.

 

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 is manufacturing products under Compulsory Certification. Product certification includes two schemes, that is, Product Certification Schemes: Scheme 1 - Indian Standards Institution (ISI) and Scheme 2 - Compulsory registration scheme (CRS). 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.  

 

In India medical device are governed by CDSCO (Central Drugs Standard Control Organization) which is regulated by Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. Many committees have been set up and given their recommendation, like the Mahelkar Committee- CDSCO. All these are now being taken into to form the Indian Medical Device Regulatory Act (IMDRA). The Indian Medical Devices Regulatory Act had come into force on December 31, 2009 and the inputs of which are to be given to Dr B Hari Gopal, advisor Department of Science and Technology, New Delhi. 

India’s Central Drug Standard Control Organisation (CDSCO) has Central Licensing Authority (CLA) and State Licensing Authority (SLA) with responsibility for Licensing to Import, Manufacture for sale or for distribution and sale, stock, exhibit or offer for sale. CLA is responsible for all Import Devices Licensing and Class C & Class D Medical Devices Manufacturing, Loan and Wholesale Licenses. SLA is responsible for Class A & Class B Medical Devices Manufacturing, Loan and Wholesale Licenses.

1. Background 

Earlier manufacturers could sell medical devices in India without any jurisdictions. Since 2006, medical device regulations have been put forth by the Indian government through the CDSCO where all the devices entering the country must be in compliance with the set protocols. The CDSCO is responsible for medical device registration and regulation of any clinical trials of new drugs, laying down the standards for drugs, control over quality of imported drugs, coordination of the activities of the State Drug Control Organizations and providing expert advice with a view of bringing about uniformity in the regulation of medical devices. 

2. Notified medical devices 

For registration of medical devices in India, 21 devices categories have been listed as ‘Notified Medical Devices’ by the CDSCO. However, devices that need registration extends beyond the categories mentioned. 

• Determine if Product Requires Registration 

• Appoint an Authorized Indian Agent 

• Submit the Regulatory Dossier under Form 40 

• Obtain registration Certificate in Form 41 

• Obtain Import License in Form 10 

• Product Marketing 

How can GPC help you?

• Identification of compliance requirements under various guidelines including all data requirements.​ 

• Data gap analysis and pre-assessment support​ 

• Technical documentation support​ 

• Pre and post submission support and technical liaison with authorities. 

Indian policy-makers are paying close attention to the development of circular economic systems. At an overarching level, the 2019 Draft National Resource Efficiency Policy seeks to enhance resource efficiency and promote the use of secondary raw materials.  

 

Additionally, several industry-specific initiatives are underway. The National Institution for Transforming India (NITI Aayog) has formed 11 committees which will prepare comprehensive action plans for specific sectors to transition towards a circular economy. These key focus areas are: 

 

• Municipal Solid Waste and Liquid Waste 
• Scrap Metal  
• Electronic Waste 
• Lithium Ion Batteries 
• Solar Panels 
• Gypsum 
• Toxic and Hazardous Industrial Waste 
• Used Oil Waste 
• Agriculture Waste 
• Tyre and Rubber Recycling 
• End-of-life Vehicles (ELVs)

Plastic Waste Management (Amendment) Rules, 2022 

On 16 February 2022, the Ministry of Environment, Forest and Climate Change published the Plastic Waste Management (Amendment) Rules, 2022, amending the Plastic Waste Management Rules, 2016. 

 

The rules set a framework for further implementation of EPR and the prohibition of identified single-use plastic items with effect from July 01, 2022. 

 

The Rules brought in Extended Producer Responsibility (EPR) to ensure a collective system of plastic wastes by the producer and brand owners. Generators of plastic waste have to minimize plastic waste generation, not litter the environment with plastic waste and store them according to the rules.

 

Finally, they envisage recycling and reusing targets in the medium and long term, with targets of up to 80% reusing and recycling for some plastic categories. 

 

The full content of the Rules can be accessed here, as published in the Official Gazette. 

Circular Economic aims to Reduce Waste by keeping the products in use, which signifies each product's importance. The circular economy seeks to make the most of the material resources available by applying three basic principles: reuse, reduce, and recycle. In this way, the life cycle of the products is extended, waste is used, & a more efficient and sustainable production model is established over time. The idea arises from imitating nature, where everything is valued and used, and waste becomes a new resource. In this way, the balance between progress and sustainability is maintained. With the increasing amount of waste generated each year through various industries, the cosmetic industry is also not far behind. The cosmetic industry is one of the top contributors in the packaging space for plastic waste. It is far from pretty regarding its impact on the environment.

The cosmetic industry value chain broadly comprises of 6 levels:
• Stage 1: Inputs to Production – Consists of companies providing raw materials to manufacture cosmetics and their packaging.
• Stage 2: Manufacturing/Development – This step entails manufacturing cosmetic products as per the requirements. Product manufacturers of primary and supporting activities are involved in this stage.
• Stage 3: Packaging – This step involves the primary/secondary packaging of the product; hence this is of high relevance for our research. The product is capped and labelled for the stakeholders to understand the product.
• Stage 4: Distribution – This step is secondary/ tertiary packaging-intensive as it requires transporting the products to various geographic locations. The product reaches different distribution and wholesale centres from its warehouses.
• Stage 5: Retail & Wholesale – Product is distributed to various wholesalers and retailers from where the consumers can get access to the products.
• Stage 6: Consumers – They represent the final link in the value chain. Consumers are the ones who buy the product from retailers/ wholesalers in the previous steps. They are a crucial stakeholder in the entire value chain of the cosmetic industry.

The Cosmetic products in India are regulated under the Drugs and Cosmetics Act 1940 and Rules 1945 and Labelling Declarations by the Bureau of Indian Standards (BIS). BIS sets the standards for cosmetics for the products listed under Schedule 'S' of the Drugs and Cosmetics Rules 1945.

Voluntary Vehicle-Fleet Modernization Program

VVMP popularly known as India’s Scrappage Policy, 2021 is aimed at creating an eco-system for phasing out of unfit and polluting vehicles. The policy was introduced by Prime Minister Narendra Modi, at Investors’ Summit Gujarat. He said "We are promoting a circular economy. The aim is to develop a sustainable and environment-friendly economy," The policy aims at making the Indian scrappage industry organised, transparent and environment friendly. It targets voluntary scrapping of ~1 crore unfit vehicles strictly based on their fitness, irrespective of the vehicle age. The vehicles are to be declared as ELVs in case of failure in fitness test. The fitness certificate is mandatory for renewal of registration for commercial vehicles.

Battery Swapping Policy

India is in the process of creating a battery swapping policy in addition to formulating interoperability standards for EV batteries. It is aimed at making electric vehicles more viable and reducing range anxiety for potential buyers. Currently due to limited range of electric vehicles and limited charging stations, long distance travellers still prefer conventional vehicles. Hence this policy can encourage the long-distance travellers and reduce their hesitation for EV technology.

The Niti Aayog plans to roll it out by second half of 2022. Apart from standardisation of battery, the proposed policy would introduce disruptive business models such as battery as a service (BaaS), leasing, etc, so that the owners need not own the battery. It would also provide EV owners flexibility to swap batteries at swap stations within minutes and charge them at home. The focus in the initial phase would be to cater light electric vehicles where it is easy to plug and play batteries at the battery swapping stations.

FSS: The Food Safety and Standards Act of 2006. With the vision of developing a system to integrate and consolidate the already existing laws regarding food and food articles into a single science based system which would include the regulatory schemes and ensure the safety of materials FSSAI was formed.

FSSAI: The Food Safety and Standards Authority of India. This organisation is responsible for conducting all the checks including all the regulatory schemes, methodology for the evaluation of food and food contact materials, providing guidelines for new materials being introduced, also providing guidance with the risks involved and providing appropriate responses to ensure food safety. Moreover further development of this new regulatory scheme, draft regulations were published by the Ministry of Health and Family Welfare in the Gazette of India Extraordinary, part 3; in 2010 and were updated in August 2011.

Food Safety and Standards are divided into Six individual legislative titles: -

• Contaminants, Toxins and Residues
• Food Products Standards and Food Additives
• Laboratory and Sample Analysis
• Licensing and Registration of Food Businesses
• Packaging And Labelling
• Prohibition and Restriction on Sales

• Every packed food is supposed to have a label upon it, containing basic information about it.
• The label on the goods must not be misleading in any way, must not contain any false information which further may lead to people having erroneous impressions towards the product.
• The label must not be a temporary attachment to the article, but permanent so that proper stated use of the product is done.
•   The content provided on the article must be clear enough to read, permanent and readily legible by the consumer under normal conditions.
• Labels must be provided on the outermost surface of the whole article; in case of outer wrappings, labels must be present on the outermost surface.

• Overall Migration: The material shall also comply with the overall migration limits as detailed below when tested by the method prescribed in IS: 9845-19817.

• However, the value of the overall migration limit shall be equal to 10 mg/dm” of the surface of the material or article in the following cases:

  • Containers or articles which are similar to containers or which in any case may be filled to a capacity less than 250 ml provided it is possible to calculate the surface area of contact with the foodstuff.

  • Sheets, foils and other non-fillable articles for which ratio between the surface area of the material or article and the quantity of foodstuffs in contact may not be calculated.

Milk and Milk Products

• Automatic Sealing of the containers and the filling of the contains(bottles) must be done mechanically
• Reusable containers must not be used in case of milk and its products unless it has a container that can actually be used after washing/cleaning.
• Sealing must be done where the last heat treatment is carried out so as to prevent any kind of ill effects of the surroundings on the product; followed by storing it in the storage units.

Edible Oils/Fats

• Tin plates used for packaging edible oils and fats should adhere to the prime grade quality criteria as updated from time to time in BIS Standards No. 1993 or 13995 or 9025 or 13954 for Tin, and IS No. 10325 or 10339 for Fats.

Fruits and Vegetable Products

• For canned juices,fruits,vegetables
  • a tin plate conforming to standards stated above can be used.
• For bottled fruits,juices,vegetables;
  • the containers capable of providing an airtight environment for the products must be used.
• For Pickles
  • Tin containers, Glass bottles covered with a lining of 250 gauge or suitable lacquered cans shall be used
• For Preserves, Jams, Jellies
  • Clean jars, new canisters, aluminium containers shall be used and they must be sealed properly
• For Tomato Ketchup and Sauces
  • Clean Bottles shall be used. If acidity does not exceed 0.5%as acetic acid, open top sanitary cans may also be used.

Canned Meat Products

• Meat products in sealed containers must be treated to prevent spoiling under commercial storage and transportation conditions.

• Sanitary top cans made out of tin conforming to the standards shall be used; sealed airtight after being filled. The lacquer used must be insoluble in brine and fat.
• For Pork meat the inside of the cans must be coated with edible gelatin, lard or lined with vegetable parchment before being filled.

Drinking water (Mineral and Packaged)

• Clean, colourless, hygienic and tamper proof bottles must be used made out of:-
  • Polyethylene: conforming to IS 10146
  • Polyvinyl chloride: conforming to IS 10151
  • Polyalkylene terephthalate (PET or PBT): conforming to IS 12252
  • Polypropylene: conforming to IS 10910
• Food Grade polycarbonate glass bottles for preventing adulteration of water.

All packaging materials of plastic origin shall pass the prescribed Overall Migration and Colour Migration limits.

• Identification of compliance requirements under various guidelines including all data requirements.​ 

• Data gap analysis and pre-assessment support​ 

• Technical documentation support​ 

• Pre and post submission support and technical liaison with authorities. 

S. No.	Applications	Examples
1.	Energy storage, production, and conversion	Novel hydrogen storage systems based on carbon nanotubes and other lightweight nanomaterials Photovoltaic cells and organic lightemitting devices based on quantum dots Carbon nanotubes in composite film coatings for solar cells Nanocatalysts for hydrogen generation Hybrid protein-polymer biomimetic membranes
2.	Agricultural productivity enhancement	Nanoporous zeolites for slow-release and efficient dosage of water and fertilisers for plants, and of nutrients and drugs for livestock Nanocapsules for herbicide delivery Nanosensors for soil quality and for plant health monitoring Nanomagnets for removal of soil contaminants
3.	Water treatment and remediation	Nanomembranes for water purification, desalination, and detoxification Nanosensors for the detection of contaminants and pathogens Nanoporous zeolites, nanoporous polymers, and attapulgite clays for water purification Magnetic nanoparticles for water treatment and remediation TiO2 nanoparticles for the catalytic degradation of water pollutants
4.	Disease diagnosis and screening	Nanoliter systems (Lab-on-a-chip) Nanosensor arrays based on carbon nanotubes Quantum dots for disease diagnosis Magnetic nanoparticles as nanosensors Antibody-dendrimer conjugates for diagnosis of HIV-1 and cancer Nanowire and nanobelt nanosensors for disease diagnosis Nanoparticles as medical image enhancers
5.	Drug delivery systems	Nanocapsules, liposomes, dendrimers, buckyballs, nanobiomagnets, and attapulgite clays for slow and sustained drug release systems
6.	Food processing and storage	Nanocomposites for plastic film coatings used in food packaging Antimicrobial nanoemulsions for applications in decontamination of food equipment, packaging, or food Nanotechnology-based antigen detecting biosensors for identification of pathogen contamination
7.	Air pollution and remediation	Nanocomposites for plastic film coatings used in food packaging Antimicrobial nanoemulsions for applications in decontamination of food equipment, packaging, or food Nanotechnology-based antigen detecting biosensors for identification of pathogen contamination
8.	Construction	Nanomolecular structures to make asphalt and concrete more robust to water seepage Heat-resistant nanomaterials to block ultraviolet and infrared radiation Nanomaterials for cheaper and durable housing, surfaces, coatings, glues, concrete, and heat and light exclusion Self-cleaning surfaces (e.g., windows, mirrors, toilets) with bioactive coatings
9.	Health monitoring	Nanotubes and nanoparticles for glucose, CO2, and cholesterol sensors and for in-situ monitoring of homeostasis
10.	Vector and pest detection and control	Nanosensors for pest detection l Nanoparticles for new pesticides, insecticides, and insect repellents

The Department of Science & Technology

• In the year 2000, the five government departments, namely the Defence Research and Development Organisation (DRDO), the Council of Scientific and Industrial Research (CSIR), the Department of Space 15 DOS, DST, and the Ministry of Information Technology (MIT), jointly launched the National Programme on Smart Materials (NPSM), a five-year programme.

The Department of Biotechnology

• Since 2007, the Program has fostered fundamental research and development in the following areas (DBT 2008) like weed control, crop protection nanosensors, pesticide delivery vehicles, nanocides, smart packaging, disease and chemical detection sensors in food and crops, and other applications of nanotechnology in food and agriculture. ​​​​​​​

A nano pharmaceutical is a pharmaceutical preparation that contains nanomaterials for internal or external use on the body for treatments, diagnostics, or any other health benefit, and that contains materials with a size scale of 1 to 100nm in at least one dimension.  Also, if the particle size is between 100 and 1000 nm, it will be included in the definition if it has altered or different pharmacological qualities than API due to the use of nanotechnology. Nano-pharmaceuticals are subject to the same general regulations and guidelines that apply to any new medicine being manufactured or imported. Nano-pharmaceuticals are also subject to the criteria for conducting clinical trials outlined in Schedule Y of the Drugs and Cosmetics Rules, 1945, as well as other applicable legislation. Because of the complexities of nanotechnology, the system requires a "case-by-case approach" with the cooperation of experts in order to develop nano-pharmaceuticals successfully.

The Regulatory Body would be established within Petroleum and Explosives Safety Organisation (PESO) as a separate Division - Chemical Regulatory Division  - and is referred in the rules as "Division"

Three Key Committees:

• Steering Committee, oversee functioning of the Division, meet at least one each 90 days
• Scientific Committee, to evaluate and approve “Substances to be Registered”
• Risk Assessment Committee, to evaluate the “Priority Substances” and propose restriction of substances and related conditions.

The implementation of rules would be supported by 8 units of the division:

1. Chemistry Unit;
2. Toxicology Unit;
3. Chemical Accidents Unit;
4. Packaging and Labelling Unit;
5. Techno-legal Unit;
6. Priority Substance Unit;
7. Information Technology Unit; and
8. Socio-Economic Unit.

Indian Chemicals (Management & Safety) (ICMS) Rules covers the following critical compliance criteria: 

• ICMS Rules applies to all substances, substances in mixtures and Intermediates that are manufactured, imported, placed, or intended to be placed in the Indian territory.
• All existing substances shall be notified if they are placed in the Indian territory in quantities greater than one tonne per annum.
• Indian manufacturers, importers and Authorised Representative (AR) acting on behalf of a foreign manufacturer shall notify the Division any new substance that they intend to place into the Indian teritorry, after the expiry of initial notification period.
• All New substances have to be notified at least 90 days prior to the date on which they are placed on the Indian territory.
• The initial Notification period shall commence on the date that is one year from the date of coming into force of these Rules. The initial notification Period shall terminate on the date which is 180 days from the date of commencement of the Initial Notification Period.

Further, based upon the classification of notified substance registration requirements are decided:

• 750 substances are included in Schedule II, designated as “Priority Substances “and another 37 substances in the Schedule VI, designated as “Substances to be Registered”.
• Schedule VI would be updated from time to time based upon the evaluation of notified substances.
• Registration requirements are applicable for all tonnage bands within 18 months after the substance is included in Schedule VI.

India proposes that classification, labeling, and SDS align with the United Nations Eighth Revised Edition (Rev 8) of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

A Foreign manufacturer who wishes to place a Substance, Mixture or Article in Indian Territory may appoint an Authorized Representative to ensure compliance with these Rules and this Authorized Representative shall be liable for the discharge of all obligations under these Rules on behalf of Foreign manufacturer.

This Authorized Representative shall be an Indian national or an entity registered in India.

• Downstream users shall ensure that substances and mixtures are notified and registered “in accordance with these Rules.”
• In addition, downstream users are obligated to review uses that are part of the notified and/or registered substances. If their use is not included, then downstream user shall notify the use to the Division and shall submit a Safety Data Sheet in relation to such Use.

Notifier or Registrant may request that trade secrets, proprietary business information and other intellectual property related data and information shared by the Notifier or the Registrant be kept confidential and not be disseminated publicly. A request of confidnetiality may not be submitted for the Classification of Substances and endpoint summaries submitted during Notification or Registration. 

A request of confidentiality shall be accompanied by fees and a statement of reason identifying what information is to be kept confidential and the reason why such information should be kept confidential. 

Confidentiality request shall be submitted to the Division and which shall make the final determination of whether such request of confidentiality may be granted.

 

India proposes that classification, labeling, and SDS align with the United Nations Eighth Revised Edition (Rev 8) of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

Following information shall be submitted to the Division for Notification of Substances. This information must be based on test reports from NABL accredited labs or GLP labs or any other Published Authentic study reports.

• Name of Notifier
• Chemical Identifiers including IN number and composition details
• Chemical Structural details
• Spectral data
• Hazard classification of substance
• Chemical Uses
• Name of known Downstream Users
• Tonnage band within which the chemical is placed in Indian territory
• Annual quantity per annum
• Maximum storage capacity/Maximum quantity stored

• Transport vehicle carrying the hazardous chemical shall be properly labelling and enabled with Tracking & Communication system
• On site safety Report – Chemical accident hazards should be identified, and adequate steps should be taken to prevent or limit chemical accidents. Site information, training equipment and antidotes shall be provided to the employees
• Safety Report Audits - Safety audit shall be carried out at least every 2 years and safety audit report shall be submitted within within 6 months from the date of implementation of ICMR
• On site/off site emergency plan - Emergency plan shall be prepared and submitted within 90 days from the date of implementation of ICMR. Mock drill of emergency plan shall be carried out at least once in every 6 months and its report shall be submitted within 7 days of the drill.
• Notification of accidents – Chemical accidents shall be notified to the authority within 24 hrs of the accident and its report shall be submitted within 72 hrs.

Notification

Notification is required for all substances with a quantity above 1 Tonnes per Annum (TPA). Substances that are registered within the initial notification period will be considered as Existing Substances. Substances that are not notified will be considered as New Substances. New substances will need to be notified 60 days prior to their placement on the Indian market.  

For notification, applicants need to submit information on the notifier’s details, substance identifiers, impurities, tonnage, substance structural details and spectra, hazard classification, uses, downstream users, and maximum storage capacity. 

 

Registration

The draft ICMSR requires manufacturers/importers to register substances if the substances are classified as Priority Substances. Schedule II of the current draft of the ICMSR includes 750 substances that need to be registered. Schedule II is a list that will be updated regularly. Registrants also have the obligation of annual reporting after they register the substances. 

Schedule II substances placed on the Indian market in quantities greater than 1 TPA will need to submit a Technical Dossier and an Exposure Scenario. If the quantity is above 10 TPA, a Chemical Safety Report will have to be submitted instead of the Exposure Scenario. The obligations for handling transported intermediates are dependent on the tonnages. When transported in quantities of 1000 TPA or less, only the physical and chemical properties in the Technical Dossier have to be submitted. If transported in quantities over 1000 TPA, a full Technical Dossier and Chemical Safety Report must be submitted. A registration fee is charged according to the tonnage band and company size. 

Situation	Tonnage Bands and Obligations
Substances listed in Schedule II	Over 1 TPA: Technical Dossier and Exposure Scenario   Over 10 TPA: Technical Dossier and Chemical Safety Report
Articles containing Schedule II Substances
Intermediates that are Schedule II Substances

Under the current draft, the ICMSR does not regulate substances in articles except in two conditions. The first one deals with articles that contain substances listed in Schedule II that are intended to or likely to be released under normal or foreseeable conditions of use. In this case they will require registration. The threshold is 1 TPA. The second case concerns Schedule II Substances present in articles in concentrations of above 1% weight by weight. In that case, the manufacturers, or importers of the article must maintain an updated Safety Data Sheet (SDS) for the article, independently of the overall tonnage of the substance. 

Evaluation and Restriction

The Priority Substance Unit of the authority shall evaluate the available data to assess if a registered substance poses an unacceptable risk to human safety or the environment during various uses in India. If the risk is not acceptable, it may propose to restrict the use of such substance or prohibit such substance.

The list of restricted/prohibited substances is listed in Schedule VI. Currently only one substance, phosgene, is restricted.

Priority substance is defined as:

• Any Substance which falls under any of the following Hazard Classifications of the eighth revision of the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS Rev. 8): a. Carcinogenicity and/or Germ Cell Mutagenicity and/or Reproductive Toxicity and categorised as Category 1 or 2, or b. Specific Target Organ Toxicity (Repeated Exposure or Single Exposure) Category 1 or 2; or
• Any Substance which fulfils the criteria of Persistent, Bio-accumulative and Toxic or very Persistent or very Bio-accumulative, as set out in Schedule I of these Rules; or
• Any Substance listed in Schedule II.

• A Manufacturer, Importer or Downstream User shall ensure that all Priority Substances, Hazardous Chemicals and Mixtures containing more than 10% (w/w) of any Priority Substance or Hazardous Chemicals comply with labelling and packging requirements.
• A Manufacturer, Importer or Downstream User shall ensure that all product identifiers, hazard statements and pictograms, signal words, and precautionary statements used in the labels of Priority Substances that they Place in Indian Territory shall be in accordance with the eighth revision of the United Nations Global Harmonised System of Classification (UN GHS).

India’s Chemicals (Management and Safety) Rules (ICMSR) also referred to as ‘India REACH’ will come into force on the date of their publication in the Official Gazette, expected mid-2021, and will regulate all substances, substances in mixtures, and intermediates that are manufactured, imported or placed on the market in the Indian territory at quantities greater than 1 tonne per year. Indian Draft Chemicals (Management and Safety) Rules has gone through several amendments and the latest draft amendment was published in Aug 2020. These Rules provide for Notification, Registration and Restrictions, or Prohibitions, as well as labelling and packaging requirements related to the use of substances, substances in mixtures, substances in articles and intermediates placed or intended to be placed in Indian Territory and introduce REACH-like registration requirements to certain priority substances. The rules are also known as "India REACH”.

On April 5, 2022, India launched a Centralized Extended Producers Responsibility (EPR) Portal for Plastic Packaging. The initiative is a cooperation between the Indian Government, the Ministry of Environment, Forest and Climate Change, and the National Central Pollution Control Board (CPCB).

In the most recent amendment dated February 16, 2022, the Ministry of Environment, Forest and Climate Change included the Guidelines on EPR for Plastic Packaging into the Plastic Waste Management Rules, 2016, in order to streamline the EPR implementation process. Consequently, Producers, Importers, and Brand Owners (PIBOs) operating in more than two states are required to be registered in the Central Pollution Control Board's EPR portal. The same obligations are also valid for Plastic Waste Processors (PWP).

Accordingly, PIBOs and PWPs present in up to two states must register with the respective State Pollution Control Boards or Pollution Control Committee, which will be in charge of transferring the records to the Centralized EPR Portal. In addition, PIBOs are required to present half-yearly progress reports for each State in their EPR action plan, addressing their management of plastic waste. The report should indicate the quantity as well as the type of plastic waste, the evidence of state-wise collection of waste according to EPR target, and the details of the according to plastic waste collection, management, and processing. The submission should be done within 15 days from completing the preceding half-year term.

Moreover, a mandatory annual report is requested from PIBOs. The annual report must include information on the reused and/or recycled content for packaging purposes and the details of the registered recyclers from whom the recycled plastic has been procured. PIBOs have until June 30^th of the next fiscal year to submit the annual report.

The Portal will improve accountability, traceability, and transparency of EPR obligations. In short, the portal will be the main tool:

• Allowing PIBOs and PWPs registration
• Issuing certification & exchange of credits
• Monitoring the transactions between PIBOs and PWPs in real-time
• Collecting environmental compensation
• Providing system generated reports
• Filing of annual returns for stakeholders

The aforementioned guidelines and obligations will enter into effect from July 2022 onwards.

 

Before the specific legislation on E-waste management in India, The Hazardous Waste Management Rules were present for the management of hazardous waste, providing guidelines for managing E-waste in India. These rules are as follows:

1. The Hazardous Waste (Management and Handling) Rules, 2003.
2. The Hazardous Wastes (Management, Handling, and Transboundary Movement) Rules, 2008.
3. Guidelines for Environmentally Sound Management of E-waste, 2008.

For the management and disposal of e-waste, there were no environmental legislation in place until 2011. However, several the laws' prohibitions had been applied to different areas of electronic waste. 1989 saw the adoption of the Hazardous Waste (Management and Handling) Rules. E-waste, including all components, sub-assemblies, and their fractions except for batteries, was categorised as Waste Electrical and Electronic Equipment (WEEE) under the 2003 revisions to the Hazardous Waste (Management and Handling) Rules 1989. The Hazardous Wastes (Management, Handling, and Transboundary Movement) Rules 2008 were also announced on September 24th. The Central Pollution Control Board requires registration from anybody who wants to recycle or reprocess hazardous waste, including electrical and electronic waste, in accordance with these rules. A recognised or approved recycler, repressor, or reuse with environmentally sound facilities to recover metals, plastics, etc. must receive the trash produced or it must be sold to them. Additionally, it has divided the import of hazardous waste products into three categories: those that require prior authorization, those that can be brought in freely under an Open General License, and those that are strictly forbidden from entering the country. The 2008 Guidelines for Environmentally Sound Management of E-waste were created to give general guidance for recognising different sources of E-waste as well as the approach and methodology for processing and disposing of E-waste in an environmentally responsible manner. The trash produced must be sold or transported to a licenced or registered recycler, re-processor, or re-user with environmentally sound facilities to recover metals, plastics, etc. Additionally, it has divided the import of hazardous waste into three groups: compounds that require prior authorization, free imports under an Open General Licence, and substances that are forbidden from entering the country. The 2008 Guidelines for Environmentally Sound Management of E-waste were created to provide general guidance for recognising different sources of E-waste as well as the approach and methodology for processing and disposing of E-waste in an environmentally responsible manner.

E-waste (Management & Handling) Guidelines under the Environment Protection Act 2011 were originally announced as separate rules for managing e-waste in 2012. All producers, consumers, or bulk consumers who make, sell, buy, or process electrical and electronic equipment or components, as well as collecting facilities, dismantlers, and recyclers of E-waste, were subject to these regulations. To guarantee that E-waste is managed scientifically, these regulations outline the duties of producers, bulk consumers, dismantlers, recyclers, State Pollution Control Boards (SPCB), and Central Pollution Control Boards (CPCB). The following obligations of various stakeholders were outlined by these rules:

1. Responsibilities of Producers: Producer means any person who offers to sell:

1. Electrical & Electronic Equipment (E&EE) under his own brand.
2. Assembled E&EE produced by other manufacturers or suppliers.
3. Imported E&EE.

The producers are responsible for collecting E-waste generated under the ‘Extended     Producer Responsibility’ principle and ensuring that the collection is done by agencies authorized by Central Pollution Control Board (CPCB). The producers are also expected to create awareness about the hazards of improper disposal of WEEE through publications, advertisements, and posters. Records of E-waste handled should also be maintained by the producers.

2. Responsibilities of bulk consumers: Bulk consumer means bulk users of E&EE such as Central government or State government departments, public sector undertakings, banks, educational institutes, multinational organizations, international agencies & private companies that are registered under the Factories Act, 1948 and Companies Act, 1956.

Bulk consumers should ensure that the E-waste generated is channelized to authorized collection centre, registered dismantler, or recycler or is returned to the pick-up or take-back services provided by the producers. They should also maintain a record of E-waste generation and disposal.

3. Responsibilities of dismantler: Dismantler means any person or registered society or a designated agency or a company or an association engaged in dismantling of used E&EE into their components.

The dismantler should not process any E-waste unless he is registered with State Pollution Control Board (SPCB) as a recycler. Dismantlers should ensure that no damage is caused to the environment during storage and transportation of E-waste. The processes followed by them should not adversely affect health and the environment.

4. Responsibilities of recycler: Recycler means any person who is engaged in recycling or reprocessing of used E&EE or assemblies or their components.

The recyclers should obtain authorization and registration from SPCB or Pollution Control Committee (P.C.C.) and ensure that the facility and recycling processes are in accordance with the guidelines.

5. Responsibilities of State Pollution Control Board/Pollution Control Committee (SPCB/PCC): The SPCB/PCC should prepare inventories of E-waste, grant authorization and registration, monitor compliance of authorization and registration conditions, maintain information on the conditions imposed for authorization, act against violations of the standards and guidelines and ensure that collection centre does not store E-waste for a period exceeding one hundred and eighty days.
6. Responsibilities of Central Pollution Control Board (CPCB): The CPCB should coordinate with SPCB and P.C.C., prepare guidelines for environmentally sound management of E-waste, conduct assessment of E-waste generation and processing, recommend standards and specifications for processing and recycling E-waste, conduct training and awareness programs, and submit annual reports to the Ministry of Environment, Forest & Climate Change (MoEFCC).

In 2016, under the “E-waste (Management & Handling) Rules of 2016”, refurbishes (who repair used electrical and electronic equipment), dealers, and Producer Responsibility Organizations (P.R.O.s) are some of the inclusions made. According to these rules, the refurbishes should now channel the E-waste to a collection centre, dismantling, or recycling facility. P.R.O.s can take the responsibility of a group of producers for collecting and channelling E-waste generated from the ‘end of life’ of their products. Another new feature that the rules have incorporated is the Deposit Refund Scheme. Under this, the producers will retain a portion of the sale price and be refundable to consumers once the end-of-life products are channelized according to the prescribed methods.

Under these amendments, the following additions to the 2016 rules have been made:

1. The Extended Producer Responsibility (E.P.R.) targets have been revised. In case of transfer or sale of assets by the producers the liability under Extended Producer Responsibility shall also be transferred to the buyer.
2. The Central Pollution Control Board may conduct random sampling of electrical and electronic equipment placed in the market to monitor and verify the compliance with Reduction of Hazardous Substances (RoHS) provisions.

If the product does not comply with the Reduction of Hazardous Substances provisions, then the cost of the Reduction of Hazardous Substances test will be borne by the Producer. In addition, the Producer shall take corrective measures to bring the product into compliance and withdraw or recall the product from the market within a reasonable period as per the Central Pollution Control Board guidelines.

The target commodities now comprise large and small electrical equipment, electrical tools, and medical equipment in addition to information technology and telecommunications equipment and consumer electrical equipment. Additionally, the acquisition of EPR certificates will help offset the collection goal (recycling target), which is one of the manufacturers' obligations, and environmental penalties will be applied if the standards are not fulfilled. The Central Pollution Control Board's online portal is used to administer and monitor EPR certificate transactions and yearly report submissions, and the recycling target has been set at 80 percent for FY2024 and beyond (CPCB). The Producer Responsibility Organization (PRO) clauses have been eliminated, as you may have noticed. There is no definite timeline for implementation, and the plan is available for public discussion for 60 days.

Target products 

• Information technology and telecommunication equipment [Item code: ITEW 1 to 25]
• Consumer Electrical and Electronics and Photovoltaic Panels [Item code: CEEW1-18]: Screens, monitors, video cameras, video recorders, audio amplifiers, solar panels, etc.
• Large and Small Electrical and Electronic Equipment [Item code: LSEEW 1-29]: Large cooling appliances, freezers, clothes dryers, dishwashers, electric cookers, electric stoves, electric hot plates, electric fans, vacuum cleaners, irons, smoke detectors, thermostats, etc.
• Electrical and Electronic Tools (With the exception of large- Scale Stationary Industrial Tools) [Item code: EETW 1-8]: Drills, saws, sewing machines, tools for mowing or other gardening activities, tools for welding, soldering, or similar use, etc.
• Toys, Leisure and Sports Equipment [Item code: EETW 9-14]: Hand-held video games consoles, video games, sports equipment with electric or electronic components, Computers for biking, diving, running, rowing, etc.
• Medical Devices (except for all implanted and infected products) [Item code: MDW 1-10]: Radiotherapy equipment, cardiology equipment, dialysis equipment, pulmonary ventilators, laboratory equipment for in vitro diagnosis, analysers, MRI & ultrasound equipment, etc.

 

EPR certificate transactions (Article 20):

• A producer can buy EPR certificates up to the amount of their current year's EPR responsibility plus any residual liability from previous years plus 10% of the current year's liability.
• The webpage will provide information on the EPR certificate's availability, requirements, and other data.
• At the time of filing quarterly returns, all transactions must be recorded and filed on the internet portal by the producers/recyclers.

 

Environmental Compensation (Article 28):

If the rules are broken, environmental compensation must be given. Producers' EPR duties under these regulations are not released by the payment of environmental compensation. For a maximum of three years, the unpaid EPR obligation from one year will be carried over to the subsequent year and so on. 85 percent of the environmental compensation imposed will be reimbursed to the Producers if the EPR duty gap is closed within a year. If the gap in the EPR obligation is resolved after two years, 60% of the environment compensation assessed will be returned; after three years, 30% of the environment compensation assessed will be returned; and after four years, no EC will be paid back to the producer. The CPCB will draft standards for environmental compensation separately.

 

E-waste rules 2016	E-waste rules amendments 2022
A) Under “Information technology and telecommunication Equipment”, 16 items covered. B) Under “Consumer electrical and electronics Equipment”, 5 items covered.	A) Under “Information technology and telecommunication Equipment”, 25 items covered. B) Under “Consumer electrical and electronics Equipment”, 18 items are covered. C) 29 items covered under “Large and Small Electrical and Electronic Equipment”. D) Under Electrical and Electronic Tools, 7 items covered. E) Under Toys, Leisure and Sports Equipment, 6 items covered. F) Under Medical Devices, 10 items covered.
EPR was applicable only to Producer.	EPR certificates to be issued to recyclers registered with CPCB & refurbishes to get a refurbishing certificate.
E-waste collection targets were specified	E-waste recycling targets have been specified