JIMS SCHOOL OF LAW

TOPIC - DRUGS AND COSMETICS ACT 1940

SUBMITTED TO:
DR. VIJETA VERMA
(Associate Professor)

SUBMITTED BY:
Pulkit Goyal
BBALLB IX SEMESTER
ENROLLMENT NO:
55621503517
 INTRODUCTION

INTRODUCTION OF DRUGS AND COSMETICS ACT

Drugs And Cosmetics Act - The Parliament of India formed an Act which
regulates the import, manufacture and distribution of drugs in India. The
primary objective of the Act is to ensure that the drugs and cosmetics sold in
India are safe, effective and conform to prescribed quality standards. The
Drugs Act was formulated in 1940 in pursuance of recommendations of
Chopra Committee constituted in 1930 by Government of India. The drugs
under the Drugs and Cosmetic Act cover wide varieties of therapeutic
substances, diagnostics and medical devices. Under the Act cosmetic means
any article intended to be rubbed, poured, sprinkled, or sprayed on, or
introduced in to, or otherwise applied to the human body or any part thereof
for cleansing, beautifying, promoting the attractiveness or altering the
appearance, and includes any article intended for use as a component of
cosmetic but does not include soap. The Act has been further amended as
Drugs (amendment) Act 1964 (13 of 1964) to include Ayurvedic and Unani
drugs.

The Drugs Act, as enacted in1940, has since been amended several times
and is now titled as “The Drugs and Cosmetics Act, 1940”.
Drugs and Cosmetics covered under the Act
The definition of the word “drug” in the Act is sufficiently detailed to
include not only medicines but also substances for which it is intended to be
used for the care of diseases of animals or human beings. This description
introduces a distinction between medicines and substances that are not
purely so-called drugs. Therefore, the term “substances” must be anything
other than medications that are used for treatment. For example, since these
items are used for or in care, bandages and gauze are the substances that fall
under the context of the said word. Consequently, the term was expanded to
include substances which are necessary aids for the treatment of surgery or
other situations. The drug description also includes substances that may be
used for the preparation of medicinal products. The word “cosmetic” refers
to any item intended to be rubbed, poured, sprinkled or sprayed on, or
inserted into, or otherwise added to, the item. For cleansing, beautifying,
encouraging beauty or improving the appearance of the human body or any
part of it and includes any article intended for or use as a cosmetic part.

On the other hand, the concept of manufacturing includes any procedure or

part of a process for the manufacture, alteration, ornamentation, finishing,
packaging, marking, break-up or otherwise Treatment or administration of
any drug or cosmetic in order to sell or administer it. However, the
compounding or dispensing of any medications or the dispensing of any
drugs does not require it. In the usual course of retail industry, the packing
of every drug or cosmetic. But, whether a medicine or substance is used
exclusively or prepared for use exclusively in accordance with the ayurvedic
or unani systems of medicine is a question of fact and its decision would
depend on expert evidence.

Regulation of Drugs and Cosmetics other than Ayurvedic, Siddha and

Unani Drugs

Section 5 of the Act empowers the central government to constitute the

Drugs Technical Advisory Board to advise it and the state governments on
technical matters arising out of the administration of the present Act and to
carry out the functions assigned to them thereunder.
  The Drugs Technical Advisory Board
Talking about the members and the organogram, the Board is to consist of
18 members, of whom 8 are ex-officio members, 5 nominated members and
5 elected members. The Director-General of Health Services is the ex-
officio chairman of the Board. The nominated and elected members hold
office for three years but they are eligible for re-nomination or re-election,
as the case may be. The central government appoints a secretary to the
Board and provides other necessary staff. The functions of the Board may be
carried out in spite of there being a vacancy on the Board.

 The Central Drugs Laboratory

The central government is also empowered to establish a Central Drugs
Laboratory under the control of a director to carry out the functions
entrusted to it by or under the Act. The central government may require the
functions of the Central Drugs Laboratory, in respect of any drugs or
cosmetics, be carried out by the Central Research Institute, Kasauli, or by
any other prescribed laboratory. In such a case the functions of the director
of the Central Drugs Laboratory in respect of such drug or class of drugs or
such cosmetic or class of cosmetics can be exercised by the director of that
institution or of that other laboratory. The central government is authorized,
after consultation with the Advisory Board, to make rules prescribing the
functions of the Central Drugs Laboratory and the procedure for the
submission to the said laboratory samples of drugs or cosmetics for analysis
or test.[9]

 Drugs Consultative Committee

 
The central government is authorised to constitute an advisory
committee, namely the Drugs Consultative Committee to advise it
and the state governments and the Drugs Technical Advisory Board
on matters tending to secure nationwide uniformity in the
administration of the Act. The committee comprises two
representative nominees of the central government and one
representative nominee of each state government.[10]
 
1. Regulations about import of drugs and cosmetics
 
1. Standards of Quality
 
For the purposes of imports, the term ‘standard quality’ in relation to
medicines and cosmetics means that they should comply with the
specifications of imports. Standards set out in the Act’s second
timetable and any other standards that may be recommended.
[11] After consultation with the Board, the central government will,
within three months,[12] amend the second timetable for that reason.
Sections 12 and 13 of the Act grant the central government the power
to create rules prescribing the testing or examination methods to be
used to assess the standard quality of any medication.[13]
 
For the purposes of import of drugs and cosmetics, some other terms
have also been explained in the Act. Section 9 provides that a drug
would be deemed to be a misbranded drug, a spurious
drug, misbranded cosmetic, spurious cosmetics. Further, section 10
enables the central government to ban the importation of any
medicines or cosmetics that are not of standard quality or
misbranded, adulterated or spurious. No drug or cosmetic product for
which a license is prescribed for importation may be imported without
such a license.
 
1. Rulemaking about import of drugs and cosmetics
 
Laws for the importation of medicinal products and cosmetics may be
drawn up by the central government after consultation with or
following a recommendation of the Board and in the official gazette
following prior notice.[14] Such regulations which define the drugs or
the classes of drugs or cosmetics or the classes of cosmetics for
which a license is issued for importation. The form and conditions for
the issuance, suspension or revocation of licenses, the authority
approved to do so, and the fees payable are demanded and
prescribed.[15]
 
1. Penalties for importing prohibited drugs or cosmetics
 
Section 13 of the aforementioned Act talks about the importation of
any adulterated or counterfeit drug or cosmetic is punishable by
imprisonment for a period of up to three years and fines of up to three
years. It could stretch to five thousand rupees. For importing any
medicine or cosmetic that includes dangerous ingredients, the same
penalty is prescribed. Further, the punishments so provided are in
addition to any penalty to which the offender may be liable under the
Sea Customs Act. In particular, section 14 of the act talks about the
consignment of any drug or cosmetic, in respect of which the offence
has been committed, is liable to confiscation. Supporting this, the
Calcutta High Court, in Sherwal Jain v. Collector of Central Excise,
[16] held that even if the person who has smuggled the goods is not
traceable, they can be confiscated without proceeding against any
person. These offences are not triable by any court inferior to that of
a metropolitan magistrate or of a judicial magistrate of the first class.

Restrictions about manufacture, sale and distribution of drugs and cosmetics

Section 18 of the Act restricts manufacture, sale and distribution of certain

drugs and cosmetics of a non-standard quality or misbranded, adulterated or
spurious type. The restriction refers to any patent or patented medicinal
product on which a true formula or list of its active ingredients, containing
the quantity thereof, has not been shown on the label or container. In
addition, the manufacture of any medical product or cosmetic for sale or
distribution or sale should take place only in compliance with the conditions
of licence given for that reason. Those limitations are not applicable to the
creation of small amounts of any medicinal product or cosmetic for the
purpose of study, research or review.

For the purposes of extension of prohibitions under section 18 of the Act, a

drug or cosmetic cannot be considered misbranded, adulterated, fraudulent
or to be of below standard quality only by reason of the fact that any
innocuous material or component has been added to it or because, for the
manufacture or preparation of a drug or cosmetic, the same is needed as an
item of commerce in a state fit for transport or consumption and does not
increase the length, weight or measurement of the drug or cosmetic or
conceal its inferior quality or defects. A medicine or cosmetic may also not
be considered to be misbranded or so, if any foreign material has eventually
been inter-mixed with it in the course of processing, preparation or
conveyance. This clause does not extend to any selling or delivery of the
 drug or cosmetic that happens after the seller or distributor has become
aware of the inter-mixture.

Inspection of drugs and cosmetics

The central and state governments are empowered to nominate inspectors for
the purposes of inspection of drugs and cosmetics, having the necessary
qualifications, in various areas with such powers and obligations as may be
prescribed. However, it is not possible to nominate any person who has any
financial interest in importing, producing or selling drugs or cosmetics as an
inspector.

2. Powers, Role of an Inspector and the procedure of Inspection

Here, every Inspector is deemed to be a public servant within the meaning of

section 21 IPC and is officially subordinate to the authority, specified by the
appointing government. According to section 22 of the act, which defines
the powers of inspectors, they have multifarious powers including power to
inspect, conduct search, examine samples, call records etc. They can,
therefore, inspect any premises wherein any drug or cosmetic is being
manufactured, sold, stocked or exhibited or offered for sale or distribution or
where any other related action is being taken with respect to them. Further,
an inspector can, on reasonable belief, search any person who may have
secreted any drug or cosmetic or enter and search any place on a similar
belief. Moreover, the provisions of Cr.P.C. apply to any such search or
seizure as they apply to any search or seizure made under the authority of a
warrant issued under section 94 of the Code.

The Procedure of Inspection has been defined under section 23 of the act, it
explains the different course of inspection for different scenarios. Such as,
the procedure on taking sample of a drug or cosmetic for the purpose of test
or analysis, where the sample is taken from manufacturing premises and
where an Inspector conducts search on person, place or a vehicle regarding
any secreted drugs or cosmetics. After all the aforementioned prerequisites
are covered under the procedure of Inspection, Section 25 requires for a
government analyst to whom a sample of any drug or cosmetic has to be
submitted. And, the same shall be received by any person or any recognized
consumer association.

Prohibition on manufacture of drugs in public interest and penalties for

contravention

The Central government has powers to prohibit the manufacture, sale or

distribution of any drug or cosmetic, the use of which is likely to involve
any risk to human beings or animals or it does not have the therapeutic value
as claimed or contains ingredients in a quantity without therapeutic
justification. Furthermore, satisfaction of the central government as to
whether a drug should be prohibited or not on the ground that the same is
injurious to public health is essentially a matter dealing with a policy
decision, and thus, compliance with the principles of natural justice must be
held to be excluded in such a situation.

Under section 27 of the Act, the sale, stocking, exhibition or distribution of

any adulterated, spurious and sub-standard drugs or any such drug, which if
used by any person is likely to cause his death or harm his body amounting
to grievous hurt, is punishable with imprisonment for a term of five years to
a term of life and with fine of not less than ten thousand rupees. Penalties for
contraventions regarding manufacture, sale etc. of cosmetics have been
separately prescribed under section 27A. According to that, any
manufacture, sale, stocking, or distribution of any spurious cosmetic is
punishable with imprisonment for a term which may extend to three years
and with fine. The burden of proof for contraventions under the Act lies on
the prosecution.

Confiscation and cognizance of offences

Section 31 of the Act permits confiscation of stock of drugs or cosmetics in

respect of which any contravention has taken place under the provisions of
the Act. Also, where the court is satisfied on the application of an inspector
or otherwise and after it has been established through any enquiry that the
drug or cosmetic is not of a standard quality or is a misbranded, adulterated
or spurious drug or cosmetic, such a drug or cosmetic is liable to
confiscation.

The prosecution can be instituted only by an inspector or by the person

aggrieved or by a recognized consumer association whether such person is a
member of that association or not. No court inferior to that of a metropolitan
magistrate or of a judicial magistrate of first class can try the offence made
punishable herein. Prosecution of any act punishable under any other law
would not be affected by these provisions.

Note: The above provisions do not apply to ayurvedic and siddha. These are
governed by a separate set of provisions under the Act.

Regulations about Ayurvedic, Siddha and Unani Drugs

A separate regulatory mechanism has been provided under the Act for
controlling the manufacture and sale of ayurvedic, siddha and unani drugs. It
provides for establishment of a separate board and committees for this
purpose.

The Regulating bodies that cover Ayurvedic, Siddha and Unani Drugs

Ayurvedic, Siddha and Unani Drugs Technical Advisory Board

Section 33C of the Act authorizes the central government to constitute a

board to be called the Ayurvedic, Siddha and Unani Drugs Technical
Advisory Board to advise the central and the state governments on technical
matters relating to regulation oi ayurvedic, siddha and unani drugs, and to
carry out any other functions required for this purpose.
The Ayurvedic, Siddha and Unani Drugs Consultative Committee

Section 33D of the Act empowers the central government to constitute an

advisory committee, to be called the Ayurvedic, Siddha and Unani Drugs
Consultative Committee, to advise the central government, the state
governments and the Ayurvedic, Siddha and Unani Drugs Technical
Advisory Board on any matter related to ayurvedic, siddha or unani drugs

The Control mechanism for Ayurvedic, Siddha and Unani Drugs

The central or a state government may appoint analysts and inspectors,

having the prescribed qualifications, to act as government analyst for various
areas under the Act, as per need. Any person who has any financial interest
in the manufacture or sale of any drug is not to be appointed as a
government analyst.

Looking back, there is no doubt that whole journey of this particular act has
been exciting for the pharmaceutical and life sciences industry in particular.
Moreover, It is important to realize that these legal, regulatory and policy
measures when implemented will bring unique legal and regulatory
challenges. Therefore, it is important to be aware of these developments and
be prepared for the challenges in advance. Lastly, with the growing
technology, the implementation and the execution of law as per schedules
given in the Drug & Cosmetics Act shall be strictly adhered. These days,
one shall also understand about the few significant sub-categories like,
various storage conditions of the drugs, their shelf life (e.g. expiry dates) and
other various factors affecting the potency of drug during storage and in last
section about labelling and packaging of medicines.