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LEGISLATIVE ANALYSIS OF THE DRUGS AND COSMETICS ACT, 1940
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LEGISLATIVE ANALYSIS OF THE DRUGS AND COSMETICS ACT, 1940
AUTHORED BY - TANYA KUKADE 1 & DR. VIVEK NEMANE 2
1. LLM Candidate, Symbiosis Law School,
Pune,
Symbiosis International (Deemed) University,
Pune, India.
2. Assistant Professor, Symbiosis Law
School, Pune,
Symbiosis International (Deemed) University,
Pune, India.
Introduction
The healthcare
industry has seen tremendous change in the past decade especially with the dawn of the pandemic over the world. Not
only the healthcare industry but the society as a whole has also come to realize the importance of increasing the
efficiency and improving the effectiveness of drugs and medical devices in the healthcare sector.
With increased research
and innovation in the healthcare industry there is a greater
need felt to ensure
that the quality of the drugs being manufactured domestically as well as drugs
being imported into the country
meet certain basic requirements. This is ensured
through the legislations and guidelines introduced by the authorities in the country.
Although, with innovations seeping into the healthcare industry
there is a constant need for the updating of the existing
legislations.
In India
drugs and cosmetics are primarily regulated
under the Drugs and Cosmetics
Act, 1940 (“D&C
Act”)[1]
and the Drugs and Cosmetics Rules, 1945 (“D&C
Rules”) framed thereunder. The
D&C Act also applies to Ayurvedic, Siddha and Unani drugs (“AYUSH drugs”). The D&C Act is implemented by the Central
Drugs Standard Control Organization (“CDSCO”), headed by the Drug
Controller General of India
(“DCGI”). The D&C Act and the D&C Rules
govern the manufacture, import, labelling, distribution as well as the
sale of drugs in the country.
Summary of Legislation
The D&C
Act aims to regulate various
processes associated with the manufacturing and import and distribution of drugs and cosmetics in the country.
It is a positive step taken in the direction of ensuring health
and safety of consumers in the country.
The D&C Act has various
objectives including the maintenance of
the quality of drugs and to prevent the adulteration of drugs and cosmetics. It also provides for the
definitions of what constitutes drugs and cosmetics in order to provide the ambit of regulation of
various substances in addition to the licenses required to be taken by individuals in order to import, distribute or sell drugs and cosmetics in the country.
The D&C seeks to ensure that drugs and cosmetics of sub-par quality
are prevented from entering the market
to ensure the quality of drugs is
maintained.[2]
The definition of drug encompassed under the D&C Act is of a wide
import and primarily includes pharmaceutical
drugs, medical devices and biologics. The D&C Act has established various specialized wings to cater to the
needs of the pharmaceutical and healthcare industry including specialized courts for the trial of offences covered
by the act. Certain acts are made cognizable and non-bailable under
the D&C Act and
certain officers are given the authority to initiate
prosecution for the violation of the D&C
Act. The D&C
Act further provides
the powers of licensing authorities to inspect drug
selling and storage establishments prior to the grant of licenses and to ensure that the conditions of the license are
satisfied to continue the validity of the
license. The penalties for the violation of any provision under the D&C Act
have been prescribed and may include fines or imprisonment.
D&C Rules
are further made under the D&C Act to cater to the specific regulatory
needs of the categories. The D&C Rules require a person
to obtain the relevant licenses
under the D&C
Act to undertake various activities including manufacturing, import,
distribution, etc. prior to undertaking
such activities to be in compliance with the applicable law. The D&C Rules
also categorize drugs into schedules
based on various
factors and subsequently, additional compliances are placed on the persons
undertaking any of the mentioned
activities with respect
to such scheduled drugs in
the country.
Analysis
The D&C
Act is the central legislation regulating drugs and cosmetics in India at present along
with the D&C Rules drafted thereunder. It caters to the compliances
as well as conditions for undertaking
manufacturing, distribution and sale of drugs and cosmetics in the country and
is a comprehensive legislation for
ensuring their quality is maintained. The D&C Act caters to the importance of health and safety of consumers and prescribes penalties for violation of any of its provisions on any person
dealing with drugs or cosmetics in the country. Further, the D&C Act is the parent legislation
under which various legislations have been introduced including the D&C Rules, Medical Devices Rules, 2017[3] (“MDR”) and the Clinical Trial Rules,
2019[4] which seek to regulate
drugs, medical devices
and clinical trials, respectively.
The D&C Act ensures the enforcement of its provision and maintaining
the quality of drugs and cosmetics by
imposing liability on all stakeholders undertaking manufacturing, import, distribution and sale of drugs and
cosmetics. While the D&C Act imposed liability on the manufacturers, importers and distributors
of drugs and cosmetics, a recent notification by the Ministry of Health and Family Welfare (“MoHFW”) to amend the D&C Act have imposed liability on the marketers for ensuring
quality and compliances of the drug being marketed in the country.[5]
Thus, the D&C Act makes each stakeholder liable for the drugs being
circulated in the market
and ensure shared liability.
While the
D&C Act is a comprehensive legislation for the regulation of drugs and
cosmetics, medical devices
are regulated under the MDR introduced under the parent
legislation i.e. D&C
Act without a special definition for the same. The MDR provides
elaborate provisions on maintaining
the quality, licensing, classifications, labelling, etc. for medical devices.
Thus, under the D&C Act only
medical devices notified by the Central Government were regulated as ‘drugs’. Although, the amendment
brought about to the definition of drugs in 2020 has brought within its
ambit all medical devices.[6]
The D&C Act and the D&C Rules cater to provisions for licensing
of establishments and individuals for
the sale and distribution of drugs and cosmetics. The license for sale or distribution
of drugs under the D&C Act is issued to the brick and mortar establishment
and not to a brand or individual.
Thus, the pharmaceutical industry is clouded with the confusion surrounding the running of online
pharmacies. The online sale of drugs is facing various hurdles in terms of recognition of scans of prescriptions,
obligations of the pharmacists, licensing of online pharmacies, storage and delivery
of medicines over long distances, etc.
Courts in different states have taken differing views regarding the same[7]
and there is no provision under the
D&C Act which provides for licensing of online pharmacies in India. In 2018 the Madras
High Court[8] stayed its view on banning
online sale of drugs and allowed such sale
under licenses issued to regular brick and mortar pharmacies. Although, the
Delhi High Court in the case of Zaheer Ahmed[9]
banned all online sale of drugs in the state of Delhi until further
clarification is issued by the Central Government on such sale. The absence
of provisions pertaining to online pharmacies may hamper the sale and distribution of drugs as no accountability may be ensured
without specific regulations.
The D&C
Act recognized drugs, cosmetics and AYUSH drugs as specified above, although it fails to recognize AYUSH cosmetics and
medical devices as separate products but continues to apply the provisions to all AYUSH products as one class of
products. There is a need for separate
regulation of AYUSH cosmetics as well as medical devices given the difference
in use and application of the
products. There is a need for the introduction of specific rules or guidelines for regulation of AYUSH products to ensure quality and safety for the consumers.
Further,
technological developments in the pharmaceutical and healthcare sector have led
to the application of nanomaterials
to increase the effectiveness and efficiency of existing drugs. Engineers and scientists around the
world are focusing on research and manipulating particles ranging between
the size of 0-100 nanometers or nanoparticles for exploiting the characteristics that each particle inhibits. At the root
of innovation with nanotechnology is its application to medicine. The application of nanotechnology to medicine has
gathered much attention in the recent
years. Adam Keiper[10]
recognizes the revolution that nanotechnology is bound to bring about in our understanding of the medicine
and drug delivery mechanisms in the healthcare
sector.
Although, the regulation of nanomedicine under the current drug
regulatory regime is a cause for concern.
There is an absence of a universally agreed definition for nanomedicine, given
its dynamic nature, and
various attempts made by researchers around the world to define the technology, there may be inherent
gaps in the legal recognition and regulation of the technology around the world until specific
guidelines are provided
or recognition is taken of the technology under existing laws. Robert Freitas Jr. has also recognized
that there are certain foreseeable limitations
to the application of nanotechnology to medicine.[11]
Various authors have undertaken to analyze the consequences that the application of nanotechnology in
the Indian scenario would have and further analyze the preparedness of the regulatory bodies in addressing concerns
arising out of such applications.[12]
Nanomedicine applications may range from drugs to medical devices and may
also perform complementary functions
in which case they fall within the ambit of regulation as both a drug and a medical device. In such instances,
regulation and compliance becomes a cause for
concern. For instance, smart pills meant for ingesting which involve
imaging as well as drug delivery
followed by dissolution are said to be a hybrid of a medical device and a drug.
The D&C Act fails to recognize nanomedicines as a combination product under any schedule to the D&C
Rules or to the D&C
Act respectively. In the absence
of a categorization attached to such nanomedicine products in India under any regulation, such products which fulfil the criteria of performing
functions falling within the ambit of both – a drug and a medical device -
should be categorized as a ‘combination
product’.
The MoHFW
recognized the lacunae arising out implementation of the existing legislation
in light of the advancements and developments taking
place in the pharmaceutical and healthcare industry. Thus, a need is felt for
refurbishing the drug regulatory law for governing modern medicine, to keep a check on the quality
of the medicines being imported and distributed as well as bring within a common umbrella all legislation
regulating drugs, medical devices and clinical trials to ensure harmonious regulation of the
same.
Current Developments
Recently in
2022, the MoHFW introduced the Drugs, Medical Devices and Cosmetics Bill, 2022 (“Bill”)[13]
to supplement the D&C Act to cater to the dynamic developments in the healthcare and pharmaceutical sector
in India. A committee was constituted by the Central Government to consider the
potential amendments to the existing drug laws to cater to the changing demands of the sector and inflow
of technology. The primary objective of the Bill is to regulate drugs, cosmetics, medical devices, clinical trials
as well as online or e-pharmacies in
the country.[14]
The Bill proposes amended definitions of medical devices,
new drugs, clinical
trials, investigational new drugs,
clinical trials, bioavailable and bioequivalence studies, etc.
The Bill seeks to regulate medical devices independent from regulation of
drugs as is practice under the
current legislation and brings within its ambit the entire legislation on
medical devices. The Bill also
proposes to establish an independent authority for the regulation of medical
devices and to constitute the Medical Devices
Technical Advisory Board and appointment of medical devices
officers for the implementation of the provisions pertaining to the same
under the proposed Bill.
The Bill also
seeks to fill the gap in the current legislation regarding the regulation of
online pharmacies. The Bill proposes
to mandate online pharmacies to obtain relevant licenses as provided under the Bill for the sale of
drugs and medical devices through the online mode. Although, the Bill too lacks specific compliances for the online
pharmacies which may be introduced in the
future.
Regarding
AYUSH products in India, the Bill proposes to regulate traditional medicines in addition to the AYUSH drugs, medical
devices and cosmetics. The Bill also proposes the setting up of a separate body for the regulation of AYUSH
products and a separate scientific research board for AYUSH products.
The Bill contains provisions which have been overlooked in the past and
many provisions to fill the existing
gaps in the D&C Act, which is being looked at from a positive light by the industry players in India. Issues such as
regulation of all medical devices separate from the definition of drugs, registration of medical devices, regulation
of software as medical device, compensatory provisions, etc. require further
deliberation as the Bill is silent on such provisions.
While the Bill contains welcome provisions for the regulation of drugs,
medical devices, cosmetics, clinical
trials, etc. it remains to be in the draft form and is under the refurbishing process. It may be introduced in the Parliament and upon deliberation may see the light of day as a law, thereby suppressing the D&C
Act. Although, the timelines for the Bill to become a law are cloudy and
have not been discussed at present.
Conclusion
The pandemic
has led to a rise in the number of players entering the pharmaceutical and healthcare market with an aim of
generating profits while ensuring low cost to the company. This race to the top of the profit
generating chain has led to the degradation of the quality of drugs and cosmetics around the world. The
D&C Act in its present form ensures that such threats to the health of the consumers are kept at bay as it
monitors the drugs being circulated in
the market and imposes liability on each stakeholder involved in the process
from the manufacturer to the
marketer. The D&C Act through its implementing agencies ensures that the quality of drugs is maintained and
that licenses are obtained by the individuals prior to undertaking the manufacturing, distribution or sale of drugs or cosmetics in India.
While the D&C Act is comprehensive, there is a need for certain
changes to be brought about to ensure
that the legislation caters to the dynamic technology entering into the pharmaceutical and healthcare sector.
This may be ensured by consolidating the various legislations governing drugs,
cosmetics, medical devices as well as biologics into a single comprehensive
legislation to prevent confusion
and chaos in the industry and to cater to the dynamic needs being generated.
References
Statutes
·
Drugs and Cosmetics Act, 1940
·
Drugs and Cosmetics Rules, 1945
·
Medical Devices Rules,
2017
·
Clinical Trial Rules,
2019
·
Drugs and Cosmetics (Amendment) Rules, 2020
Notifications and Bills
·
Ministry of Health and Family Welfare,
(Apr. 1, 2020), https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_fil e_division.jsp?num_id=NTU0OA== ;
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_fil e_division.jsp?num_id=NTU0OQ==
·
Draft of the Drugs, Medical Devices and Cosmetics Bill, 2022, https://main.mohfw.gov.in/newshighlights-97
Case Laws
·
The Tamil Nadu Chemists and Druggists Association v.
Union of India and Ors., W.P. No. 28716
of 2018.
·
Zaheer Ahmed v. Union of India W.P.(C)
11711/2018
Internet
Sources
· Anindita Deb, Drugs and Cosmetics
Act, 1940, iPleaders (Sept. 07, 2022), https://blog.ipleaders.in/drugs-and-cosmetics-act-1940/.
· Soibam
Singh, Two High Courts, two different
views on online drugs sale, THE HINDU (Jan. 21, 2019), https://www.thehindu.com/news/cities/Delhi/two-high-courts-two-different-views- on-online-drugs-sale/article26045505.ece
·
A.P. Jayanthi, Koen Beumer, Madhulika Bhati, Sujit
Bhattacharya, Nanotechnology: ‘Risk Governance’ in India, Economic and
Political Weekly, 2012, Vol. 47, No. 4 (Jan. 28, 2012), pp. 34-40, https://www.jstor.org/stable/41419763.
· Varsha
Rajesh, Darren Punnen, Milind Antani, Draft
Drugs, Medical Devices and Cosmetics Bill, 2022: Dawn of a New Era, NDA (Aug. 18, 2022),
https://www.nishithdesai.com/SectionCategory/33/Pharma-Healthcare- Update/12/67/PharmaHealthcareUpdate/6264/1.html
[1] Drugs and Cosmetics Act,
1940, Section 3(b).
[2] Anindita Deb, Drugs and Cosmetics
Act, 1940, iPleaders (Sept. 07, 2022), https://blog.ipleaders.in/drugs-and- cosmetics-act-1940/.
[4] Clinical Trial
Rules, 2019
[6] Ministry of Health and Family Welfare published two notifications (Apr. 1, 2020), https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?nu m_id=NTU0OA== ;
[7] Soibam Singh, Two High Courts,
two different views
on online drugs sale, THE
HINDU (Jan. 21, 2019), https://www.thehindu.com/news/cities/Delhi/two-high-courts-two-different-views-on-online-drugs- sale/article26045505.ece
[8] The Tamil Nadu Chemists
and Druggists Association v. Union of India and Ors.,
W.P. No. 28716 of
2018.
[9] Zaheer Ahmed v.
Union of India W.P.(C) 11711/2018
[10] Supra at 2.
[12] A.P. Jayanthi, Koen Beumer,
Madhulika Bhati, Sujit Bhattacharya, Nanotechnology:
‘Risk Governance’ in India, Economic and Political Weekly,
2012, Vol. 47, No. 4 (Jan. 28, 2012), pp. 34-40, https://www.jstor.org/stable/41419763.
[13] Draft of the Drugs,
Medical Devices and Cosmetics Bill, 2022, https://main.mohfw.gov.in/newshighlights-97
[14] Varsha Rajesh,
Darren Punnen, Milind Antani,
Draft Drugs, Medical
Devices and Cosmetics Bill, 2022: Dawn of
a New Era, NDA (Aug. 18, 2022), https://www.nishithdesai.com/SectionCategory/33/Pharma-Healthcare- Update/12/67/PharmaHealthcareUpdate/6264/1.html
Article Information
LEGISLATIVE ANALYSIS OF THE DRUGS AND COSMETICS ACT, 1940
Authors: TANYA KUKADE, DR. VIVEK NEMANE
- Journal IJLRA
- ISSN 2582-6433
- Published 2023/07/11
- Issue 7
About Journal
International Journal for Legal Research and Analysis
- Abbreviation IJLRA
- ISSN 2582-6433
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