BIS STANDARDS

A SEMINAR SUBMITTED TO ANDHRA UNIVERSITY IN THE PARTIAL FULFILMENT FOR THE

AWARD OF THE DEGREE OF MASTER OF PHARMACY
in
PHARMACEUTICAL REGULATORY AFFAIRS

Presented by
GOGU NIMISHA
(Reg.no 622275227004)

Under the guidance

of
Dr.D.Raghava , M.pharm, Ph. D
Associate Professor & Head of the
Department Dept. of Pharmaceutical
Regulatory Affairs

K.G.R.L COLLEGE OF PHARMACY

(Under the Management of The Bhimavaram Education Society)
Affiliated to Andhra Umiversity, Aproved by PCI (New Delhi) and APSCHE (Amaravathi)
 PRESENTATION OUTLINE

• Definition
• Purpose and scope
• Objective
• Statutory framework
• Activities
• References
 Bureau of Indian Standards
DEFINITION:
BIS Standards’ Bureau of Indian Standards (BIS) is the National Standard Body of
India established under the BIS Act 2016 for the harmonious development of the activities of
standardization, marking and quality certification of goods and for matters connected therewith or
incidental thereto.

PURPOSE :
Bureau of Indian Standards (BIS) is the National Standard Body of India. BIS is responsible
for the harmonious development of the activities of standardization, marking and quality
certification of goods and for matters connected therewith or incidental thereto.

SCOPE :
BIS has been providing traceability and tangibility benefits to the national economy in a
number of ways – providing safe, reliable quality goods; minimizing health hazards
to consumers; promoting exports and imports substitute; control over proliferation of
varieties etc.
 Bureau of Indian Standards
In recent years, BIS has worked towards specifically addressing various national priorities and other
government initiatives like Swacch Bharat Abhiyan, Digital India, Make in India and ease of doing
business through its activities of standardization and certification. In standards development, BIS
continues to address issues of technology changes and advancements, climate change, environment and
energy conservation, conditions of health and safety and facilitation of trade. In the area of conformity
assessment BIS is working towards making the processes simpler and faster.

OBJECTIVES OF BIS:
Harmonious development of the activities of standardization, marking and quality certification of
goods
To provide thrust to standardization and quality control for growth and development of industry on
one hand and to meet the needs of consumers on the other.
 Bureau of Indian Standards
STATUTORY FRAMEWORK:

The Bureau of Indian Standards Act, 2016, has been implemented since 12 October 2017. The
highlights of the new BIS Act are:

● Positions BIS as the National Standards Body.

● Allows multiple conformity assessment schemes in line with global practices.
● Enables the Government to authorize any agency apart from BIS to certify and enforce conformity
to a standard.
● Enables the Government to include products under mandatory certification on grounds of health,
safety, environment, national security and prevention of deceptive practices.
● Enables the Government to bring Hallmarking of precious metal articles under mandatory
certification.
● Provides consumer protection measures like recall of non-conforming standard marked products,
compensation to the consumer and more stringent penal provisions.
 Bureau of Indian Standards

ACTIVITIES :

The activities of BIS can be broadly grouped under the following heads:

1. Standards formulation
2. International activities
3. Product Certification
4. Hallmarking
5. Laboratory services
6. Training services - National Institute of Training for Standardisation
7. Consumer Affairs and Publicity
INTERNATIONAL ACTIVITIES

International Organization for Standardization (ISO)- ISO is an independent, non-governmental

membership organization and the world’s largest developer of voluntary International Standards. BIS is
a founder member of ISO and is actively involved in development of International Standards by acting
as Participating (P) member or Observer (O) member on various Technical Committees, Sub-
Committees, Working Groups, etc.

International Electro-technical Commission (IEC)- IEC was founded in 1906 and is the world’s
leading organization for the preparation and publication of International Standards for all electrical,
electronic and related technologies. India is represented in IEC through BIS.

Regional and Bilateral Cooperation- BIS is actively involved in the Regional and Bi-lateral Co-
operation Programmes pertaining to standardization, testing, certification, training etc. So far, BIS has
signed several MoUs with national standards bodies of various countries. BIS also plays an active role in
formulation and implementation of regional standards and on conformity assessment scheme for the
SAARC countries under the South Asian Regional Standards Organization (SARSO).
 Bureau of Indian Standards

STANDARDS FORMULATION

BIS formulates Indian Standards in line with the national priorities for various sectors that have been
grouped under 14 Departments like Chemicals, Food and Agriculture, Civil, Electro-technical,
Electronics & Information Technology, Mechanical Engineering, Management & Systems,
Metallurgical Engineering, Petroleum Coal & Related Products, Medical Equipment and Hospital
Planning, Textile, Transport Engineering, Production & General Engineering and Water Resources.
Corresponding to these Departments fourteen Division Councils exist. Each Division Council has a
number of Sectional committees working under it. The standards cover important segments of economy
and help the industry in upgrading the quality of their goods and services.
PRODUCT CERTIFICATION

BIS operates a Product Certification scheme for ensuring compliance to Indian Standards. Presence of
BIS standard mark (popularly known as ISI mark) on a product indicates conformity to the relevant
Indian Standard. Before granting licence to any manufacturer, BIS ascertains the availability of
required infrastructure and capability of the manufacturer to produce and test the product conforming
to the relevant Indian Standard on a continuous basis.

HALLMARKING:

Hallmarking of Gold Jewellery was started by BIS in April 2000 to provide third party assurance to
consumers on the purity of gold jewellery or its fineness. The scheme for Hallmarking of Silver
Jewellery / artefacts was launched in October 2005. Under the hallmarking scheme, the jewellers are
granted certificate of registration to sell hallmarked jewellery and Assaying & Hallmarking (A&H)
centres are recognized to assay the purity of the jewellery submitted by the registered jeweller along
with declaration of purity and apply hallmark on such jewellery which is found conforming to
relevant Indian Standard including declared fineness.

LABORATORY :

To cater to the needs of testing for certification activity, BIS has established eight laboratories in the
country namely Central Laboratory (CL), Sahibabad; Western Regional Office Laboratory (WROL),
Mumbai; Northern Regional Office Laboratory (NROL), Mohali; Eastern Regional Office Laboratory
(EROL), Kolkata; Southern Regional Office Laboratory (SROL), Chennai; Bangalore Branch Office
Laboratory (BNBOL), Bangalore; Patna Branch Office Laboratory (PBOL), Patna; Guwahati Branch
Office Laboratory (GBOL), Guwahati. In addition, BIS has also recognized NABL accredited
laboratories and government laboratories to discharge the work related to testing of products for
conformity assessment. In addition, BIS also has a Gold Referral Assaying Laboratory at Chennai for
testing of samples.
NATIONAL INSTITUTE OF TRAINING FOR STANDARDIZATION (NITS)

BIS imparts training through NITS to the technical and management personnel from industry,
consumer organizations, public sector undertakings, govt. bodies and developing countries. The
institute also conducs International Training Programmes (ITP) for developing countries under
different cooperation schemes of Government of India

CONSUMER AFFAIRS AND PUBLICITY:

BIS endeavours to create awareness and promote quality amongst all its consumers through various
awareness programmes:

1. Consumer Awareness Programmes: For promoting the concept of standardization,

certification and quality consciousness among consumers, awareness programmes are
organized on a regular basis through various Regional offices and Branch offices of BIS,
sometimes in association with Consumer Organizations.
2. Industry Awareness Programmes: To propagate the concept of standardization, product
certification, management systems certification and other BIS activities amongst Industries,
Industry Awareness Programmes are conducted by BIS.
3. Educational Utilization of Standards Programmes: BIS organizes Educational Utilization
of Standards Programmes (EUS) for students and faculties of schools, colleges etc., to
inculcate the young minds with the concepts and benefits of standardization.
4. World Standards Day: BIS celebrates the World Standards Day on 14th Oct to pay tribute to
the collaborative efforts of thousands of experts worldwide, which develop voluntary technical
agreements that are published as International or National Standards.
5. Public Grievances: Consumer complaints relating to BIS certified products are reviewed and
monitored regularly for redressal.
6. Public Relations: The publicity activity of BIS is aimed at creating awareness for various BIS
activities among its target audience including the Industry and common Consumer,
significantly relating to Standardization, Certification of Hallmarking of jewellery
 Bureau of Indian Standards

References:

https://consumeraffairs.nic.in/organisation-and-units/division/bureau-indian-standards#:~:text=Bureau%20of%20Indian%20Standards%20

https://www.bis.gov.in/the-bureau/about-bis/

THANK
YOU