Regulatory issues regulations in india asu

Regulatory Issues - Regulations in
India (ASUDTAB, ASU DCC),
Regulation of manufacture of
ASU drugs-Schedule Z of Drugs
& Cosmetics Act for ASU drugs
Prepared By:
MOHAMMAD KHALID
(Assistant Professor)
Krishna Pharmacy College, Bijnor (UP)

Introduction
Regulatory Requirements
Key function of regulatory agencies
Regulation in India
DRUG TECHNICAL ADVISORY BOARD
Drugs Consultative committee-DCC
Schedule Z of Drugs & Cosmetics Act for
ASU drugs.
6 April 2020 Krishna Pharmacy College, Bijnor 2

Drugs play an important role in the health of both people and the
economy of a country.
Pharmaceutical drugs are available from a large number of
sources.
People and Governments willing to spend money on drugs for
many reasons so, it must be safe, effective and good quality and
used appropriately.
This means, in turn, that development, production, importation,
exportation and subsequent distribution of drugs must be
regulated to ensure that they meet prescribed standards.
Therefore, effective drug regulation is required to ensure the
safety, efficacy and quality of drugs as well as accuracy and
appropriateness of the drug information available to the public

In an ideal world, the need for analysis should be driven by the
desire to assure the quality of a drug product.
However, in the real world the need for pharmaceutical drug
analysis is driven largely by regulatory requirements.
A team consisting of R&D, QC, and QA unit members develops
these quality and compliance systems.
It should be one of the highest priorities of top management and QA
units to develop and monitor these systems to comply with the
cGMP and GLP expectations.
Compliance documents are needed, in addition to the regulatory and
research documents, to demonstrate the integrity of the data.
Compliance documents refer to those reports required by GMP
and/or utilized during the course of inspection by a health authority.

Product registration (drug evaluation and authorization, and
monitoring of drug efficacy and safety);
Regulation of drug manufacturing, importation, and distribution;
Regulation & Control of drug promotion and information.
Adverse drug reaction (ADR) monitoring.
Licensing of premises, persons and practices.
Main goal of drug regulation is to guarantee the safety, efficacy
and quality of drugs available to public.

Herbal drugs are regulated under the Drug and Cosmetic Act
(D&C) 1940 and Rules 1945 in India, where regulatory
provisions for Ayurveda, Unani, Sidha medicine are clealy laid
down.
Department of AYUSH is the regulatory authority and mandate
that any manufacture or marketing of herbal drugs have to be
done after obtaining manufacturing license, as applicable.
The D & C Act extends the control over licensing, formulation
composition, manufacture, labelling, packing, quality and
export.
Schedule “T” of the act lays down the good manufacturing
practice (GMP) requirements to be followed for the
manufacturing of herbal medicines.

The official Pharmacopoeias and formularies are available
for the quality standards of the medicines. First schedule
of the D & C Act has listed authorized texts, which have to
be followed for licensing any herbal product under the two
categories: ASU drugs & Patent or proprietary medicines.
In India, traditional medicines are governed by the Drugs
and Cosmetics Act of 1940 and the Drugs and Cosmetics
Rules of 1945.
They regulate the import, manufacture, distribution and
sale of drugs and cosmetics.

In 1959, the Government of India recognized the traditional Indian
system of medicine and amended the Drugs and Cosmetics Act to
include drugs which are derived from traditional Indian Medicine.
No products derived from traditional systems may be manufactured
without a licence from the State Drug Control Authorities.
Patent and proprietary medicines derived from the traditional
systems must contain ingredients which are mentioned in the
recognized books of the above systems, as specified in the Drugs
and Cosmetics Act.
The government in advised by a special committee and an advisory
board for Ayurvedic, Siddha and Unani drugs.
Pharmacopoeia committees have been constituted to prepare
Pharmacopieas for all these systems.

The Central Government constitute a Board
(to be called the Drugs Technical Advisory
Board) to advise the Central Government
and the State Governments on technical
matters arising out of the administration of
D&C, Act 1940
The Board shall consist of the following
members,

Director General of health
Drug Controller, India
Principle officer of ISM
Director of the Central drugs Laboratory
Government Analyst
Pharmacognocist
Phyto-chemist
4 person from ASU pharmacopeia committee
1 teacher in Dravaguna
1 teacher in Ilmul-advia
1 teacher in Gunapadam
3 person from ASU drugs industry
3 practitioner of ASU medicine

It advices matter related to Drugs.
The nominated and elected members of the
Board shall hold office for three years, but
shall be eligible for re-nomination and re-
election. The Board may, subject to the
previous approval of the Central
Government, regulating its own procedure.

It is also an Advisory Body consist of two representative
central government to be nominated by Government .
One representative of each state Government to be nominated
by the State Government.
Function
DCC to advise the Central Government, the State
Governments and the ASU-DTAB on any matter for the
purpose of securing uniformity throughout India in the
administration of this Act in so far as it relates to ASU drugs.
It shall meet when required.
It has power to regulate its own procedure.

Misbranded Drugs:-
• If it is so coloured , coated, powdered or polished that damage is
concealed or if it is made to appear of better or greater
therapeutic valve.
• If it is not labelled in the prescribed manner.
• If its label or container or anything accompanying the drug bears
any statement, design or device which makes any false claim for
the drug or which is false or misleading in any particular
Adulterated Drugs:-
• If it consists, in whole or in part, of any filthy, putrid or
decomposed substance.
• If it has been prepared, packed or stored under insanitary
conditions whereby it may have been contaminated with filth or
whereby it may have been rendered injurious to health

 Spurious Drugs:-
• If it is sold, or offered or exhibited for sale,
under a name which belongs to another drug.
• If it is an imitation of, or is an substitute for,
another drug or resembles another drug in a
manner likely to deceive, or bears upon it or
upon its label or container the name of another
drug, unless it is plainly and conspicuously
marked so as to reveal its true character and its
lack of identity with such other drug.

• Section33(EEC)Prohibition of manufacture and
sale of certain ASU drugs
• Section33(EED)Power of central government to
prohibit manufacture, etc., of ASU drugs in
public interest.
• Section33(F)Government analysts •
Section33(G)Inspectors •
Section33(H)Application of provision of
section 22,23,24,25.
• Section33(I)Penalty for manufacture, sale, et,.
Of ASU drugs in contravention of this chapter.

• Section33(J) Penalties for subsequent offences
• Section33(K) Confiscation
• Section33(I) Application of provisions to
government departments
• Section33(M) Cognizance of offences
• Section33(N) Power of central government to
make rules
• Section33(O) Power to amend first schedule
Continue…..

The Section 33(EEB) of the Drugs and Cosmetics
Act describes the regulations for the manufacture
and sale of ASU drugs.
The Act has set some standards related to the
hygienic conditions, factory premises, prohibition
of manufacture and sale of certain drugs and
penalties for contravention of this act.
The following requirements are taken into
account-

A. Requirements of Factory
premises and hygienic conditions
As per the Act, it is mandatory to maintain proper hygienic
conditions in the factory premises along with the following
requirements.
Factory or industry involved in the manufacture of ASU drugs
should not be situated adjacent to open sewage, drain, public
laboratory or any other factory which produces obnoxious
odour, large quantities of waste, dust or smoke.
The premises of manufacturing unit shall be clean, hygienic
and free from insects, rodents and other contamination.
NOTE: All the sections fall under the schedule-Z of the Drugs &
Cosmetics Act.

The walls and floor of manufacturing rooms should be
smooth, easily cleanable with water and should not
accumulate dust or waste products.
The water used in the manufacture shall be pure and
drinking quality. It should be free from pathogenic
organisms. Adequate facility should be provided to process
the containers and closures for washing, cleaning, drying,
etc. and it should be separated from the manufacturing unit.
Suitable arrangement shall be provided for disposing waste
water and other materials in a manner that it does not affect
the health of people in the surrounding area.
Personnel working in the factory should be free from
contagious diseases.
Continue…..

Appropriate dress should be provided to the
workers based on the nature of their work.
Adequate facilities for personal cleanliness such as
soap, towel and antiseptics should be provided.
Facilities for drinking water, separate wash rooms
and change rooms should be provided for men and
women.
Continue…..

B. Prohibition of manufacture
and sale of certain ASU drugs
The Act prescribes some criteria to prohibit the manufacture and
sale of certain ASU drugs which are not manufactured or sold in
accordance of the rules.
The following categories of ASU drugs can be prohibited from
manufacture and sale.
Any misbranded, adulterated or spurious ASU drugs.
Any proprietary or patented medicine which does not display the
list of all ingredients on the label of the container.

The selling, stocking and distribution of any ASU drug which
has not been manufactured in contravention of the provisions
of this Act.
The manufacture, sale and distribution of any ASU drugs for
which license has not been issued by the prescribed authority.
The above rules do not apply to vaidyas and hakims who
prepared ASU drugs for the use of their own patients.
The above rules do not apply to ASU drugs which are
manufactured in small quantities for the purpose of
examination, test or analysis.
Continue…..

C. Power of central government to prohibit
the manufacture, sale & distribution of
ASU drugs in Public interest
The section 33(EED) of the drugs and cosmetics Act prescribes
certain power of the central government based on which the
government can prohibit the manufacture, sale and distribution
of ASU drugs which involve any risk to humans or animals or
such drug does not have therapeutic value as claimed by the
manufacturer or any misbranded and spurious drugs.
Hence in such circumstance, the government may prohibit the
manufacture, sale & distribution of drugs in public interest.

D. Penalty for the manufacture, sale and
distribution of prohibited ASU drugs
As prescribed under the section 33-1 of the Drugs and cosmetics
Act, any person himself, on his behalf is engaged in the
manufacture, sale and distribution of prohibited ASU drugs, penalty
has been fixed as per the following guidelines.
Any ASU drug which is deemed to be adulterated or manufactured
without a valid licence shall be punishable up to one year
imprisonment and with fine up to 2 thousand rupees.
Any ASU drug which is deemed to be spurious shall be punishable
with Imprisonment up to 1 to 3 years and with fine up to 5 thousand
rupees.
Any ASU drug which contravenes any other provision of the Act
shall be punishable with imprisonment up to 3 months and with fine
up to 500 rupees

E. Manufacture on more than
one set of premises
If ASU drugs are manufactured on more
than one set of premises, a separate
application shall be made and a separate
license shall be obtained for each premises.

References
https://www.slideshare.net/sampathramaswamy1/regulatory-
aspects-17409779
https://www.slideshare.net/priyankagoswami/herbal-drug-
regulations?qid=d598a453-3403-4417-a636-0c0f373b58c2
&v=&b=&from_search=4
IzharAhmad38/drugs-and-cosmetics-act-1940-rule-1945
Dr. Sufiyan Ahmad, “Regulatory Issues - Regulations in
India (ASUDTAB, ASU DCC), Regulation of manufacture
of ASU drugs-Schedule Z of Drugs & Cosmetics Act for
ASU drugs.” https://www.youtube.com/watch?v=HtLZfdQyaS8

6 April 2020 Krishna Pharmacy College, Bijnor
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Regulatory issues regulations in india asu

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