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Welcome to GPC India - Regulation

ICMSR (India REACH)

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).  

 

BIS Certification

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: 

  • Product Certification Schemes: Scheme 1 - Indian Standards Institution (ISI)
  • 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.  

For non-Indian manufacturers to comply with BIS certification, Authorized Indian Representative (AIR) can be appointed to assist the application process, including:  

  1. Documentation and application submission  
  2. Factory inspection by Indian auditor 
  3. Provision of test samples by the AIR and execution of the tests 
  4. Marking and labelling of products with the standard or ISI marks for BIS certification 

 

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”.

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

All manufacturers or importers (or authorised pepresentatives acting on behalf of foreign entities) shall notify National Chemical Authority of all existing Substances that they have Placed in Indian Territory in quantities greater than 1 tonne per year. The notification is scheduled to start one year from the date of the enforcement of the rules, and end 180 days after their commencement. After this period, any substance not notified will be considered a new substance.

  • Registration

All manufacturers, importers and authorised representatives (in the case of Foreign Manufacturers) that have placed or are intending to place in Indian Territory a substance listed in Schedule II in quantities greater than 1 tonne per annum must register such substance within one and half years from the date of inclusion of the substance in Schedule II.

  • 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).

  • 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.

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The Indian Aspect

The Food and Drug Administration in India is an autonomous body established under the Ministry of Health & Family Welfare, Government of India. There are two individual bodies in India that regulate the markets for Food safety and Drug Regulation. Those bodies are:

  1. FSSAI(Food Safety and Standard Authorities of India) and
  2. CDSCO(Central Drugs Standard Control Organization)

These regulatory bodies control the manufacture, storage, distribution, sale and import of food and drugs to ensure availability and safety of the same for human consumption.

  • Removal of multiple
  • Harmonization with the international
  • Framing of regulatory requirements based on science and risk
  • Facilitating trade without compromising consumer safety and bringing in safe innovation in

The Food Safety and Standards Authority of India (FSSAI) has been established under Food Safety and Standards, 2006 which consolidates various acts & orders that have hitherto handled food related issues in various Ministries and Departments. FSSAI has been created for laying down science-based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import to ensure availability of safe and wholesome food for human consumption.

  • Everyfood business operator involved in the manufacturing, processing, storage distribution and sale of food products must compulsorily obtain FSSAI Registration or License. FSSAI Registration is different from FSSAI License in the sense that depending on the size and nature of the business, FBO (Food Business Operator) should obtain the necessary registration or license. It is a 14-digit registration or a license number which is printed on all the food 
  • Thisregistration procedure is aimed to create more accountability on the FBO to maintain the quality of the food 

FSSAI registration or license is based on the business volume and premises. Depending upon the installed capacity or turnover or location, applicant premises are eligible for the license such as central license, state license, registration, railway etc.

FSSAI Registration is a basic license and it is required for all the FBOs involved in the small-scale food business. This category covers the following business:

  • Pettyretailer dealing in food 
  • Anyperson who manufactures or sells any food article by 
  • Foodsale done by the temporary stall 

Any individual who distributes food in any religious or social gathering except a caterer.

Sr.No. Business Capacity
1 Food production capacity(other than milk and meat) Up to 100Kg/ltr per day
2 Procurement, handling and collection of milk Up to 500 ltr per day
3 Slaughtering Capacity 2 large animals or 10 small animals or 50 poultry birds per day

Common documents required for obtaining FSSAI registration:

  • FormA – completed and signed
  • PhotoIdentity of FBO
  • Proofof possession of premises (e.g. Rental Agreement)
  • PartnershipDeed / Certificate of Incorporation / Articles of Association 
  • Listof food products to be dealt with
  • Foodsafety management system plan

  • For all other FBO apart from small-scale business, FSSAI license must be obtained. FSSAI License canbe classified into two categories e. State FSSAI License & Central FSSAI License based on the size of the business whether it is a medium scale or large-scale business.
  • Generally, FBOs who are large manufacturers, importers, exporters dealing in large-scale food businessneed to obtain FSSAI license from central government and FBOs with small to medium sized manufacturing units, transporters, marketers, traders, , need to take FSSAI registration from the state government.

  • FormB duly completed and
  • Planof the processing unit showing the dimensions and operation-wise area
  • Listof Directors/ Partners/ Proprietor with address, contact details, and photo
  • Nameand list of equipment and machinery used with the number and installed
  • Listof food category to be
  • Authorityletter from manufacturer with name & address of the nominated responsible person .
  • Analysisreport of water to be used in the process to confirm the
  • Sourceof raw material for milk, meat
  • Recallplan wherever
  • Ministryof Commerce Certificate for 100% EOU (Export Oriented Unit).
  • NOCdocument issued by
  • IEcode document issued by
  • FormIX (nomination of persons by a company).
  • Certificatefrom Ministry of
  • Proofof possession of
  • Partnership deed/ affidavit of
  • NOC and copy of License from the
    • Food safety management system plan or certificate.
    • NOC from the municipality or local body.
  • Supporting document for proof of turnover and transportation.
  • Declaration Form.
Fee Structure for FSSAI Registration/ Central Licensing:

  • For Renewal of License: Depends upon the number of years
  • Modification of License: Fees of 1 year per licensemodification.
  • Duplicate of License: 10% of the applicable license

Food safety officer generally conducts the inspection of the food business operator’s facility and identifies the level of compliance with the regulation using a checklist. Based on the compliance level, the food safety officer marks it as:
  • Compliance(C)
  • Non-compliance(NC)
  • Partial compliance(PC)
  • Not applicable/Not observed(NA)
Based on the above, the food safety officer might issue an improvement notice where ever required per32 of the FSS Act, 2006

  • The FSSAI regulatory body is independent of appointment of OR as registration and licensing procedurefor the target country and non-target country is
  • Although,assistance on registration can be provided by uploading information for the registration as a Food Business Operator/ Petty Good
Pre-registration or extended deadline for registration :
  • Thereis no pre-registration or registration deadline for obtaining the central and state licensing and registration.

Although the license/registration certificate can be registered up to maximum 5 years, aGer which renewal of license/registration certificate is required.

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  • 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.

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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

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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.  

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

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

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

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

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

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

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

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

  1. 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. 

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.

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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.  

 

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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.

Graphical user interface, application

Description automatically generated

  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. 

  1. 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. 

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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.

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. 

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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

  • Food Safety Standards Authority of India – FSSAI is responsible for designing science-based standards for articles of food and their regulation.
  • India is one of the countries with non-specific/few regulations for Food Contact Materials.
  • The regulations of Food Contact Materials are very diverse with only one common similarity of general safety requirement.

  • 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. 

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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.

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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 30th 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.

 

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