Regulatory

UNIT 2 REGULATORY AUTHORITIES Authorities

Structure

2.1 Introduction
Objectives
2.2 Regulatory Agencies/Regulators
2.3 Central Drugs control organization (CDSCO)
2.4 National Pharmaceutical Pricing Authorities (NPPA)
2.5 Indian Council of Medical Research (ICMR)
2.6 Department of Science & Technology (DST)
2.7 Department of Biotechnology
2.8 Summary
2.9 Terminal Questions
2.10 Answers

2.1 INTRODUCTION

The regulatory agencies ensure that rules and regulations lay down in order to
maintain quality, safety and efficacy of drug(s) and drug product(s) are
implemented properly by Indian Pharmaceutical Industries. The chapter gives
an overview of Central Drugs Standard Control Organization (CDSCO) and
how rules and regulations are implementation. The chapter also deals with the
objectives and functions of various other government agencies of India like
National Pharmaceutical Pricing Authority (NPPA), Indian Council of Medical
Research (ICMR), Department of Science & Technology (DST), and
Department of Biotechnology (DBT).
Objectives
After studying this unit, you should be able to:
• understand the term regulatory authorities;
• understand the Central Drugs Standard Control Organization (CDSCO);
• discuss about Indian Council of Medical Research (ICMR);
• elaborate National Pharmaceutical Pricing Authority (NPPA); and
• differentiate between Department of Science & Technology (DST) and
Department of Biotechnology (DBT).

2.2 REGULATORY AGENCIES/REGULATORS

Regulatory Authority or Regulator is a government agency that regulates an

area of human activity by codifying and enforcing rules and regulations,
supervision or oversight, for the benefit of the public at large. It is usually a
part of the executive arm of the government or has statutory authority to
perform its functions. Examples of regulatory agencies are the US Food and 23
Drugs Regulatory Drug Administration, the UK Ofcom and The Telecom Regulatory Authority
Affairs of India.

The Regulatory process has three basic elements namely ensuring the exercise
of regulatory power as per the rules, regulated agencies have an effective
means to defend themselves against unauthorized or arbitrary requirements or
liabilities, and the wider interest group have a means to have their views
considered and addressed in administrative decisions.

The regulatory authorities are commonly set up to in order to enforce standards

and safety, oversee use of public goods, and regulate commercial activities.

To ensure that it does fulfill its role, a regulatory body uses mechanisms such
as the following:

• transparency of information and decision making

• procedures of consultation and participation
• requirement that administrators give reasons explaining their actions
• requirement that administrators follow principles that promote non-
arbitrary and responsive decisions
• arrangements for review of administrative decisions by courts or other
bodies

SAQ 1

What do you understand by the Regulatory authorities?

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2.3 CENTRAL DURGS STANDARD CONTROL

ORGANIZATION (CDSCO)

Central Drugs Standard Control Organization (CDSCO) is involved in the laws

related to drugs and cosmetics, notification and adverse drugs reaction, license
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and certification, import of drugs, and information for patient.
Under the Drug and Cosmetics Act, the regulation of manufacture, sale and Regulatory
distribution of drugs is primarily the concern of the state authorities while the Authorities
central authorities are responsible for approval of new drugs, clinical trials in
The Schedule C of Drug
the country, laying down the standards for drugs, control over the quality of and cosmetics Act and
imported drugs, coordination of the activities of state drug control rules give the list of
organisations and providing expert advice with a view of bringing about the biologicals and special
uniformity in the enforcement of the drugs and cosmetics Act. Drug Controller products.
General of India (DCGI) is responsible for approval of licenses of specified The Schedule C1 of Drug
categories of drugs such as blood and blood products, intravenous (I. V.) fluids, and cosmetics Act and
vaccine and sera. rules give the list of
other special products
Head quarter of Central Drugs Standard Control Organization is located at (not for parenteral
FDA Bhawan, Kotla Road, New Delhi 110002 and functions under the administration)
Directorate General of Health Services. It comprises of the Drugs Controller
General of India, Joint Drugs Controller of India, Deputy Director General
(Drugs), Asst. Drugs Controllers of India, and Technical Officers.

2.3.1 Zonal Offices of Central Drugs Standard Control Organization

The central government has established four zonal offices of the Central Drug
Standard Control Organization at Mumbai, Kolkata, Chennai, and Ghaziabad.
The zonal offices work in close collaboration with the state drug control
administration and assist them in securing uniform enforcement of the drug act
and other connected legislations, on all India bases. There are officer in-
charges at the following zonal organizations:

EAST ZONE: Andaman and Nicobar Island, Arunachal Pradesh, Assam, Bihar,
Jharkhand, Manipur, Meghalaya, Mizoram, Nagaland, Orissa, Sikkim, Tripura
and West Bengal.

WEST ZONE: Chattisgarh, Goa, Daman and Diu, Gujarat, Madhya Pradesh and
Maharashtra.

NORTH ZONE: Haryana, Himachal Pradesh, Jammu & Kashmir, Punjab,

Rajasthan, Uttaranchal, Uttar Pradesh, N.C.T. of Delhi and Union Territory of
Chandigarh.

SOUTH ZONE: Andhra Pradesh, Karnataka, Kerala, Pondicherry and Tamil

Nadu.

In addition there are Additional drug controllers at the ports of Chennai,

Cochin, Delhi, Kolkata, and Mumbai.

SAQ 2

List the tasks performed by the Central Drug Standard Control Organization.

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Drugs Regulatory …………………………………………………………………………………...
Affairs
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2.4 NATIONAL PHARMACEUTICAL PRICING

AUTHORITY (NPPA)

The government of India in order to streamline and simplify the mechanism for
the fixation and revision of prices of bulk drugs and formulations and to bring
about a greater degree of transparency as well as objectivity, constituted an
expert body known as National Pharmaceutical Pricing Authority (NPPA),
under the Drugs Price Control Order, 1995. The organization is also entrusted
with the task of recovering amounts overcharged by manufacturers for the
controlled drugs from the consumers. It also monitors the prices of
decontrolled drugs in order to keep them at reasonable levels.

NPPA consists of a chairperson in the status of the secretary to the government

of India, members having expertise in the field of pharmaceuticals, economics
and cost accountancy and member secretary in the status of joint secretary /
additional secretary to the government of India, and the same is entrusted with
the task of price fixation, revision and other related matters such as updating
the list of drugs under price control by inclusion and exclusion on the basis of
the established criteria / guidelines. The National Pharmaceutical Pricing
Authority is empowered to take final decisions, which are subject to review by
the Central Government as and when considered necessary. In addition to the
above mentioned functions, the authority is entrusted with certain other
functions as detailed in the schedule annexed to the resolution. The authority
shall possess the power to regulate its own procedure for performing the
functions entrusted to it. It can call for notes, memorandum, results of studies,
data and other material relevant to its work, from official and non-official
bodies / organizations, and hold discussions with them. The authority is
empowered to maintain close touch with the ministries of the central
government, state governments, industry, consumers and other related
organizations. The expenditure of the authority is borne by the central
Government. The Head Quarters of the authority is at YMCA Cultural Centre
Building, Jai Singh Road, New Delhi-110 001.
Functions of National Pharmaceutical Pricing Authority are to:

a) implement and enforce the provisions of the drug price control order in
26 accordance with the powers delegated to it.
b) deal with all legal matters arising out of the decisions of the authority; Regulatory
Authorities
c) monitor the availability of drugs, identify shortages, if any, and to take
remedial steps;
d) collect/ maintain data on production, exports and imports, market share of
individual companies, profitability of companies etc., for bulk drugs and
formulations;
e) undertake and/ or sponsor relevant studies in respect of pricing of drugs/
pharmaceuticals;
f) recruit/ appoint the officers and other staff members of the authority
g) render advice to the Central government on changes/ revisions in the drug
policy;
h) render assistance to the central government in the parliamentary matters
relating to the drug pricing.

2.4.1 Methodology / Procedure for Price Fixation / Revision of Bulk

Drugs

As explained earlier prices of scheduled bulk drugs are fixed by the NPPA to
make them available at a fair price from different manufacturers. These prices
are fixed from time to time by notification in official gazette.

The following steps are involved in fixation/revision of bulk drug prices:

Step 1 Identification of bulk drugs

The bulk drugs are taken up for study on the basis whose validity
period is due to expire, the concerned manufacturer/company gives a
request to NPPA, and drug produced in the country for which no price
has been notified under DPCO, 1995.

Step 2 Data collection

Data is collected by issuing questionnaire/Form of DPCO, 1995/cost-

audit report etc. and verification by manufacturing plant visits, if
needed.

Step 3 Preparation of actual cost statement

Actual cost for the year for which data is submitted is prepared based
on data submitted / collected and verified during plant visit.

Step 4 Preparation of technical parameters

Technical parameters are prepared based on data submitted, collected

and verified during plant visits. Plant capacity is assessed considering
330 working days for normal operation of plant leaving 35 days for
scheduled maintenance of plant. The achievable production level is
considered at 90% utilization of assessed capacity allowing 10%
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Drugs Regulatory production loss on account of unforeseen break down and non-
Affairs scheduled maintenance.

Step 5 Preparation of estimated cost

The estimated cost for the pricing period are then prepared based on
actual cost and the technical parameters. While projecting the future
cost, an increment is recognized at 5% per annum in respect of
salaries and wages. In respect of other overheads of fixed/semi
variable nature, increase at 2.5% per annum is made to cover the
normal incremental effects. The customs duty and other taxes as per
the current budget are considered.

Step 6 Calculation of fair price of bulk drug

While fixing the maximum sale price of the bulk drug, a post tax
return of 14% on net worth or a return of 22% of capital employed or
in respect of a new plant an internal rate of return of 12% based on
long term marginal costing is considered depending upon the option
exercised by the manufacturer of the bulk drug. In case, the
production is from basic stage, additional 4% return is considered on
net worth/capital employed.

Step 7 Fixation of maximum sale price of the drug

When the number of manufacturers of the said drug is more than one,
the maximum sale price is fixed at 2/3rd cut off level or weighted
average price, depending upon the situation.

Step 8 Notification of bulk drug price in official Gazette

The fair price may be further revised, if asked for by the

manufacturers, based on escalation formula for change in major raw
materials and utilities rates.

2.4.2 Procedure for Pricing of Formulations

Prices of formulations based on scheduled bulk drugs are fixed based on

applications of the manufacturers and on suo-motu basis. A manufacturer using
scheduled bulk drug in his formulation is required to apply for fixation of price
of formulation within 30 days of fixation of price of such bulk drug(s).
Applications received in NPPA from manufacturers and importers are
considered for price fixation. The time frame for granting price approval on
formulation is two months from the date of receipt of the complete information
from the company. The procedure for price fixation involves examination, suo-
moto cases, notification of ceiling prices, pro-rata price and non-ceiling price
order. The individual components are explained hereunder.

I. Examination

The various aspects for price fixation are examined which are as follows:
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 a) Examination of Technical Parameters: As per label claim the Regulatory
quantity of bulk drug is checked. The overage claim is allowed as per Authorities
batch production record or norms fixed by government.

b) Examination of Prices of Bulk Drug: When notified price of bulk

drug exists, the notified price or actual price is considered. In the case
of imported bulk drug used in the formulation, weighted average import
price is considered vis-à-vis the price submitted by the applicant. For
non-scheduled bulk drug used, the available information on prices is
applied.

c) Examination of Excipient Claims: Excipient claims given in the

application are examined and allowed after referring to information
available in NPPA.

d) Examination of Process Loss, Conversion Cost, Packing Charges

and Packaging Material Cost: The Process Loss (PL), conversion
cost (CC) and packing charges (PC) are considered as per the norms
notified in the Gazette. The Packaging Material (PM) cost is allowed
as per the actual claim supported by invoices and after referring to
information available with NPPA.

e) Application of Maximum allowable Post Manufacturing Expenses

(MAPE): MAPE is given at 100% on the ex-factory cost for
indigenous formulation, while MAPE upto 50% of the landed cost is
allowed for imported formulation.

f) Working out the retail price: The retail prices of formulations are
worked out as per the formula given in under:

R.P. = [M.C. +C.C. + P.M.+P.C.] x [1+MAPE/100] +E.D.

where R.P., M.C. and E.D. are retail price, material cost, and excise
duty and the other symbols as given earlier.

g) Treatment of Taxes: For bulk drugs used in formulation, all the

statutory taxes are considered at the actuals. Allowance up to 8% on the
notified price of scheduled bulk drugs is considered on this account.
The excise duty element is worked out in NPPA based on companies
claim. Allowance is made for 16% margin on price to retailer (as per
DPCO, 1995) and 8% margin to wholesaler as per practice, both on the
ex-factory price, which is the assessable value.

The prevailing excise duty rate is applied to the said assessable value. For
ceiling packs, notified prices are exclusive of excise duty. Manufacturers
are required to work out the excise duty.

II. Suo-Motu Cases

If the manufacturers or companies do not apply for revision of formulation

prices within a period of 30 days of price reduction of bulk drug or fall in
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Drugs Regulatory other statutory levies, steps are taken for suo-motu revision. Broadly the
Affairs procedure given above is followed.

III. Notification of Ceiling Prices in the Gazette of India

Ceiling prices are fixed or revised for commonly marketed standard pack
sizes of price control formulations. It is obligatory for all, including small
scale units, to follow the ceiling prices which are notified in the Gazette of
India. The ceiling prices are usually notified as exclusive of excise duty,
local tax etc. but maximum retail price (MRP) printed includes excise duty.

IV. Pro-Rata Price

The manufactures of all the scheduled formulation pack sizes different

from the notified pack sizes, shall have to work out the price for such pack
sizes, in respect of tablets and capsules of the same strength or composition
packed in different strips or blisters, on pro-rata basis of the latest ceiling
price fixed for such formulations.

V. Non-Ceiling Price Order

Non-ceiling Prices are specific to particular pack size and dosage form of
scheduled formulation of a particular company. Hence they are pack
specific and company specific. The prices fixed for non-ceiling packs are
communicated to the respective firms by issuing office orders. In such
order, usually excise duty element is shown separately. However, local
taxes are not included in Non-ceiling price.

SAQ 3

Give the functions of National Pharmaceutical Pricing Authority.

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2.5 INDIAN COUNCIL OF MEDICAL RESEARCH

(ICMR)

The Indian Council of Medical Research (ICMR), New Delhi, the apex body in
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India for the formulation, coordination and promotion of biomedical research,
is one of the oldest medical research bodies in the world. It has been now Regulatory
upgraded to independent department in the Government of India and named as Authorities
Department of Health Research (DHR) under Ministry of Health and Family
Welfare, Government of India. As early as in 1911, the Indian Research Fund
Association (IRFA) was set with the specific objective of sponsoring and
coordinating medical research in the country. After independence, several
important changes were made in the organization and the activities of the
IRFA. It was redesignated in 1949 as the Indian Council of Medical Research
(ICMR) with considerably expanded scope of functions. The ICMR is funded
by the Ministry of Health & Family Welfare, government of India.

The national health priorities are the council’s research priorities such as
control and management of communicable diseases, fertility control, maternal
and child health, control of nutritional disorders, developing alternative
strategies for health care delivery, containment within safety limits of
environmental and occupational health problems; research on major non-
communicable diseases like cancer, cardiovascular diseases, blindness,
diabetes and other metabolic and haematological disorders; mental health
research and drug research (including traditional remedies). All these efforts
are undertaken with a view to reduce the total burden of disease and to promote
health and well-being of the population.

The governing body of the Council is presided over by the Union Health
Minister. It is assisted in scientific and technical matters by a Scientific
Advisory Board comprising of eminent experts in different biomedical
disciplines. The Board, in its turn, is assisted by a series of Scientific Advisory
Groups, Scientific Advisory Committees, Expert Groups, Task Forces, Steering
Committees etc. which evaluate and monitor different research activities of the
Council.

The Council promotes biomedical research in the country through intramural as

well as extramural research. Over the decades, the base of extramural research
and also its strategies have been expanded by the Council.

Intramural research is carried out currently through the Council's Permanent

Research Institutes/Centres which are mission-oriented national institutes
located in different parts of India and address themselves to research on
specific areas such as tuberculosis, leprosy, cholera and diarrhoeal diseases,
viral diseases including AIDS, malaria, kala-azar, vector control, nutrition,
food and drug toxicology, reproduction, immunohaematology, oncology,
medical statistics, etc. and 6 Regional Medical Research Centres which address
regional health problems, and also aim to strengthen or generate research
capabilities in different geographic areas of the country.

Extramural research is promoted by ICMR through setting up Centres for

advanced research in different research areas around existing expertise and
infrastructure in selected departments of medical colleges, universities and
other non-ICMR Research Institutes, Task force studies which emphasize a
time-bound, goal-oriented approach with clearly defined targets, specific time 31
Drugs Regulatory frames, standardized and uniform methodologies, and often a multicentric
Affairs structure, and open-ended research on the basis of applications for grants-in-
aid received from scientists in non-ICMR Research Institutes, Medical
colleges, Universities etc. located in different parts of the country.

In addition to research activities, the ICMR encourages human resource

development in biomedical research through research fellowships, short-term
visiting fellowships, short-term research studentships, and various training
programmes and workshops conducted by ICMR Institutes and Headquarters.

For retired medical scientists and teachers, the Council offers the position of
emeritus scientist to enable them to continue or take up research on specific
biomedical topics. The Council also awards prizes to Indian scientists, in
recognition of significant contributions to biomedical research.

The balancing of research efforts between different competing fields,

especially when resources are severely limited, is a typical problem
encountered in the management of medical research, in India. Infectious
diseases and excessive population growth have continued to constitute the
major priorities to be addressed in medical research throughout the past several
decades. In addition to tackling these issues, in recent years, research has been
intensified on emerging health problems such as cardiovascular diseases,
metabolic disorders (including diabetes mellitus), mental health problems,
neurological disorders, blindness, liver diseases, hearing impairment, cancer,
drug abuse, accidents, disabilities etc. Research on traditional medicine/herbal
remedies was revived with a disease-oriented approach. Attempts have been
made to strengthen and streamline medical informatics and communication to
meet the growing demands and needs of the biomedical community. The
Council is alert to new diseases and new dimensions of existing diseases, as
exemplified by the rapid organization of a network of Surveillance Centres for
AIDS in different states of India in 1986.
SAQ 4

Give an overview of the governing body of the Indian Council of Medical

Research (ICMR).

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2.6 DEPARTMENT OF SCIENCE AND TECHNOLOGY Regulatory
Authorities
(DST)

Department of Science and Technology (DST) was established in May 1971,

with the objectives of promoting new areas of science and technology and to
play the role of a nodal department for organizing, coordinating and promoting
science and technology activities in the country. The Department has major
responsibilities for specific projects and programmes as listed below:

a) Formulation of policies relating to Science and Technology.

b) Matters relating to the Scientific Advisory Committee of the Cabinet
(SACC).
c) Promotion of new areas of Science and Technology with special emphasis
on emerging areas.
d) Research and development through its research institutions or laboratories
for development of indigenous technologies concerning bio-fuel
production, processing, standardization and applications, in co-ordination
with the concerned ministry or department
e) Research and development activities to promote utilization of by-products
to development value added chemicals.
f) Financially sponsoring scientific and technological surveys, research design
and development, Support and grants-in-aid to Scientific Research
Institutions, Scientific Associations and bodies

All matters concerning

a) Science and Engineering Research Council (SERC)

b) Technology Development Board and related acts such as the Research and
Development Cess Act,1986
c) National Council for Science and Technology Communication;
National Science and Technology Entrepreneurship Development Board;
d) International Science and Technology Cooperation including appointment
of scientific attaches abroad
e) Autonomous Science and Technology Institutions relating to the subject
under the Department of Science and Technology including Institute of
Astro-physics, and Institute of Geo-magnetism;
f) Professional Science Academies promoted and funded by Department of
Science and Technology; The Survey of India, and National Atlas and
Thematic Mapping Organisation;
g) National Spatial Data Infrastructure and promotion of G.I.S;
The National Innovation Foundation, Ahmedabad.

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Drugs Regulatory SAQ 5
Affairs
Enlist the major responsibilities of Department of Science & Technology
(DST).

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2.7 DEPARTMENT OF BIOTECHNOLOGY (DBT)

The setting up of a separate Department of Biotechnology (DBT), under the

Ministry of Science and Technology in 1986 gave a new impetus to the
development of the field of modern biology and biotechnology in India. The
department has promoted and accelerated the pace of development of
biotechnology in the country in these 14 years. Through several R&D projects,
demonstrations and creation of infrastructural facilities. The department has
made significant achievements in the growth and application of biotechnology
in the broad areas of agriculture, health care, animal sciences, environment,
and industry.

The department has been the deep involvement of the scientific community of
the country through a number of technical task forces, advisory committees and
individual experts in identification, formulation, implementation and
monitoring of various programmes and activities.

The impact of the biotechnology related developments in agriculture, health

care, environment and industry, has already been visible and the efforts are
now culminating into products and processes. There has been close interaction
with the state governments particularly through State Science and Technology
Councils for developing biotechnology application projects, demonstration of
proven technologies, and training of human resource in States and Union
Territories. Programmes with the states have been evolved. Biotechnology
Application Centres in Madhya Pradesh and West Bengal have already been
started.

The proven technologies at the laboratory level have been scaled up and
demonstrated in field. Patenting of innovations, technology transfer to
industries and close interaction with them have given a new direction to
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biotechnology research. Initiatives have been taken to promote transgenic Regulatory
research in plants with emphasis on pest and disease resistance, nutritional Authorities
quality, silk-worm genome analysis, molecular biology of human genetic
disorders, brain research, plant genome research, development, validation and
commercialisation of diagnostic kits and vaccines for communicable diseases,
food biotechnology, biodiversity conservation and bioprospecting, setting up of
micropropagation parks and biotechnology based development for SC/ST, rural
areas, women and for different States.

The functions of the department of biotechnology include the following:

a) Promote large scale use of biotechnology
b) Support R&D and manufacturing in biotechnology based
c) Promote university and industry interaction
d) Identify and set up centres of excellence for R&D
e) Integrated programmes for Human Resource Development
f) Serve as nodal point for international collaborations
g) Establishment of infrastructure facilities to support R&D and production
h) Framing of biosafety guidelines, manufacture and application of cell based
vaccines
i) Serve as nodal point for the collection and dissemination of information
relating to biotechnology.

2.7.1 Organizational Set Up

The Department of Biotechnology is being advised by two apex level

committees viz. the Scientific Advisory Committee (SAC-DBT) and Standing
Advisory Committee (overseas) SAC-O. These committees review the ongoing
programmes and suggest new and emerging areas that could be supported. The
Biotechnology Research Promotion Committee (BRPC) considers,
recommends and reviews major inter-disciplinary project proposals with
budget of more than Rs. 1.00 cores. In addition, several expert task forces
comprising eminent scientists, provide useful advice to the department in the
pursuit of its goals to promote R&D activities in the country.

2.7.2 Task Forces of Department of Biotechnology

The DBT has set up task forces and expert committees with the involvement of
eminent and active scientists from all over the country to advise on the
identification of thrust areas in biotechnology for financial support. As a result,
biotechnology has received a significant fill-up in the country with adequate
support from the Government. of India.

Fifteen Task forces and various expert/steering committees of the department

met two or four times during the year to review and monitor the on going
projects and also consider new proposals in the priority areas. A special thrust
has been given during the year on formulation and funding of new projects – 35
Drugs Regulatory specially multi-institutional and interdisciplinary as per the priority of the tenth
Affairs plan.

The task forces of Department of Biotechnology are:

a) Agriculture Biotechnology
b) Animal Biotechnology
c) Aquaculture and Marine Biotechnology
d) Basic Research Modern Biology
e) Biodiversity Conservation and Environment
f) Biofertilizers
g) Bioinformatics
h) Biopesticides and Crop Management
i) Biotech Product and Process Development
j) Biotechnology Programmes for SC/ST & Rural population
k) Biotechnology Programme for Women
l) Food and Nutrition Security
m) Human Genetics and Genome Analysis
n) Human Resource Development
o) Infectious Disease Biology
p) Infrastructure & Centers of Excellence
q) Inter-disciplinary Research Committee (IDRC) in Biotechnology
r) Medicinal and Aromatic Plants
s) Medical Biotechnology, Immunology diagnostics and vaccines
t) Plant Biotechnology
u) Seri Biotechnology
v) Stem Cell Biology

SAQ 6

Enlist the various task forces of Department of Biotechnology

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2.8 SUMMARY Regulatory
Authorities
Regulatory Authorities are government agencies that regulate various areas of
human activities for the benefit of the public at large. They are usually a part of
the executive arm of the government or have statutory authority to perform
their functions. Various regulatory authorities like Central Drugs Control
Organisation, National Pharmaceutical Pricing Authority, Department of
Science and Technology, Indian Council of Medical Research and Department
of Biotechnology have been set up to enforce standards of drugs and ensure
their safety, and also to regulate commercial activities involving drugs.

2.9 TERMINAL QUESTIONS

1. Fill in the blanks:

a) Head quarter of Central Drugs Standard Control Organization is located

at __________

b) The expenditure of the National Pharmaceutical Pricing Authority is

borne by_______________

c) The Head Quarters of the National Pharmaceutical Pricing Authority is

at ____________

d) Prices of _________________ bulk drugs are fixed by National

Pharmaceutical Pricing Authority.

e) A manufacturer using scheduled bulk drug in his formulation is

required to apply for fixation of price of formulation within
_______________ of fixation of price of such bulk drug (s).

f) The Indian Council of Medical Research offers ______________ of

which ____________ are meant exclusively for young scientists (below
40 years).

2. True or false:

a) The time frame for granting price approval on formulation is two

months from the date of receipt of the complete information from the
company.

b) The Department of Biotechnology (DBT) comes under Ministry of

fertilizers and Chemicals.

c) The governing body of the Indian Council of Medical Research is

presided over by President of India

3. What does MAPE stands for? How the retail prices of formulations
calculated?

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Drugs Regulatory 4. Name the two apex level committees which advise the Department
Affairs Biotechnology (DBT).

2.10 ANSWERS

Self Assessment Questions

1. a) Regulatory Authority or Regulator is a government agency that

regulates an area of human activity by codifying and enforcing rules
and regulations, supervision or oversight, for the benefit of the public at
large. It is usually a part of the executive arm of the government or has
statutory authority to perform its functions.

2. a) Central Drugs control organization (CDSCO) is involved in the

following tasks:

i) laws related to drugs and cosmetics,

ii) notification and adverse drugs reaction,
iii) license and certification,
iv) import of drugs, and
v) information for patient.

3. a) Functions of National Pharmaceutical Pricing Authority to:

i) implement and enforce the provisions of the Drugs (Prices

Control) Order in accordance with the powers delegated to it.
ii) deal with all legal matters arising out of the decisions of the
Authority;
iii) monitor the availability of drugs, identify shortages, if any, and to
take remedial steps;
iv) collect/ maintain data on production, exports and imports, market
share of individual companies, profitability of companies etc, for
bulk drugs and formulations;
v) undertake and/ or sponsor relevant studies in respect of pricing of
drugs/ pharmaceuticals;
vi) recruit/ appoint the officers and other staff members of the
Authority, as per rules and procedures laid down by the
government;
vii) render advice to the Central government on changes/ revisions in
the drug policy;
viii) render assistance to the Central government in the parliamentary
matters relating to the drug pricing.

4. a) The governing body of the Council is presided over by the Union

Health Minister. It is assisted in scientific and technical matters by a
Scientific Advisory Board comprising eminent experts in different
38
 biomedical disciplines. The Board, in its turn, is assisted by a series of Regulatory
Scientific Advisory Groups, Scientific Advisory Committees, Expert Authorities
Groups, Task Forces, Steering Committees etc. which evaluate and
monitor different research activities of the Council.

5. a) The Department has major responsibilities for specific projects and

programmes as listed below:

i) Formulation of policies relating to Science and Technology.

ii) Matters relating to the Scientific Advisory Committee of the

Cabinet (SACC).

iii) Promotion of new areas of Science and Technology with special

emphasis on emerging areas.

iv) Research and development through its research institutions or

laboratories for development of indigenous technologies
concerning bio-fuel production, processing, standardization and
applications, in co-ordination with the concerned ministry or
department

v) Research and development activities to promote utilization of by-

products to development value added chemicals.

vi) Financially sponsoring scientific and technological surveys,

research design and development, support and grants-in-aid to
Scientific Research Institutions, Scientific Associations and bodies.

All matters concerning

i) Science and Engineering Research Council (SERC)

ii) Technology Development Board and related acts such as the Research
and Development Cess Act,1986

iii) National Council for Science and Technology Communication;

National Science and Technology Entrepreneurship Development
Board;

iv) International Science and Technology Cooperation including

appointment of scientific attaches abroad

v) Autonomous Science and Technology Institutions relating to the subject

under the Department of Science and Technology including Institute of
Astro-physics, and Institute of Geo-magnetism;

vi) Professional Science Academies promoted and funded by Department

of Science and Technology; The Survey of India, and National Atlas
and Thematic Mapping Organisation;

vii) National Spatial Data Infrastructure and promotion of G.I.S; The

National Innovation Foundation, Ahmedabad. 39
Drugs Regulatory 6. a) Fifteen Task forces are help in the proper functioning of Department of
Affairs biotechnology. For names please consult section 2.7.2

Terminal questions

1. a) FDA Bhawan, Kotla Road, New Delhi

b) Central Government
c) YMCA Cultural Centre Building, 1, Jai Singh Road, New Delhi,
d) Scheduled
e) 30 days

2. a) True
b) False
c) False

3. The MAPE stands for Maximum allowable post manufacturing expenses.

The retail price is calculated by the formula R.P. = [M.C. +C.C. +
P.M.+P.C.] x [1+MAPE/100] +E.D. The abbreviations have there usual
meanings as given in text.

4. The Scientific Advisory Committee (SAC-DBT), Standing Advisory

Committee (overseas) SAC-O are the two apex bodies.

SUGGESTED READING
1. http://cdsco.nic.in/

2. http://nppaindia.nic.in/index1eng.html

3. http://icmr.nic.in/

4. http://dst.gov.in/

5. http://dbtindia.nic.in/index.asp

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