Introduction to ASU Drug regulations in India :

In India, the regulation of Ayurvedic, Siddha, and Unani (ASU) medicines,

also known as traditional or indigenous medicines, is a complex and
evolving landscape. These ancient systems of healthcare have been
practiced in the Indian subcontinent for centuries, and continue to play a
significant role in the country's healthcare ecosystem. However, the
regulatory framework governing the manufacture, distribution, and sale of
ASU drugs has faced various challenges over the years, requiring ongoing
efforts to ensure quality, safety, and efficacy.
India has a long and complex history when it comes to the Regulation of
Ayurvedic, Siddha, and Unani (ASU) medicines. These traditional systems
of healthcare have been practiced In the country for centuries, but their
integration into the Modern pharmaceutical landscape has faced numerous
Challenges. As India continues to navigate the balance Between preserving
its rich heritage and ensuring safe and Effective medical practices,
understanding the evolving Regulatory framework for ASU drugs is crucial.
The regulatory landscape for ASU medicines in India is Governed by the
Drugs and Cosmetics Act of 1940 and its Subsequent amendments. This
legislation establishes the
Central Council for Indian Medicine (CCIM) and the Central Council for
Homoeopathy (CCH) as the primary authorities Responsible for overseeing
the registration, manufacture, And quality control of ASU drugs. However,
the Implementation of these regulations has been fraught with
Complexities, leading to ongoing debates and reforms within The industry.
Welcome to an in-depth exploration of the issues surrounding ASU drug
regulations in India. In this Document, we will delve into the background
of drug regulations in the country and shed light on the Challenges faced
in regulating ASU drugs.
Explore the challenges and impact of inadequate regulations on the public
health of India in relation to ASU

Issues in ASU drug regulation in India 1

Drugs. Discover potential solutions and recommendations to ensure
effective regulation and protection for the Indian population.

Background of Drug Regulations in India:

India has a long history of drug regulations dating back to the establishment
of the Indian Pharmacopoeia Commission in 1940. Over the years, various
acts and regulatory bodies have been put In place to ensure the safety,
efficacy, and quality of drugs in the country.

Overview of the Indian Pharmaceutical Industry

A Thriving Powerhouse
India’s pharmaceutical industry is a thriving powerhouse, ranked third
largest in the world by volume and fourteenth largest by value. With over
10,000 licensed manufacturing units and a skilled workforce of over 3
million, the industry produces a vast array of medicines, from essential
generic drugs to complex biologics and vaccines. India is a global leader in
the production of affordable, high-quality generic medicines, supplying
nearly 20% of the global generic drug demand.

Diverse Product Portfolio

The Indian pharmaceutical industry is highly diverse, manufacturing a wide
range of products including bulk drugs, formulations, biologics, vaccines,
surgical equipment, and diagnostics. While the generics segment accounts
for the largest share, the industry is also making strides in emerging areas
like biosimilar, complex generics, and specialty pharmaceuticals. This
diversification has enabled the industry to cater to both domestic and
international markets.

Export-Driven Growth
Exports play a vital role in the growth of the Indian pharmaceutical
industry, accounting for nearly 60% of the total production. The industry
exports to over 200 countries, with the United States, United Kingdom,

Issues in ASU drug regulation in India 2

Russia, Brazil, and South Africa being the key export destinations. India’s
ability to manufacture high-quality, cost-effective medicines has made it a
preferred supplier for both developed and developing countries, driving the
industry’s global expansion.

Overview of the Current Regulatory Framework:

Ayurvedic, Siddha, and Unani (ASU) Drugs Act :
The primary regulatory framework governing ASU drugs in India is the Drugs
and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. The
Ayurvedic, Siddha, and Unani Drugs Act was introduced in 1964 to provide
additional guidelines and regulations specific to these traditional Indian
medicinal systems. This act outlines the standards and requirements for
the manufacture, sale, and distribution of ASU drugs in the country.

Centralized Regulatory Bodies:

The Central Drugs Standard Control Organization (CDSCO) is the apex
regulatory body responsible for overseeing the implementation of the Drugs
and Cosmetics Act. At the state level, the respective State Drugs Control
Administrations (SDCAs) are tasked with enforcing the regulations. The
Pharmacopoeia Commission for Indian Medicine C Homoeopathy (PCIMCH)
is responsible for establishing quality standards and monographs for ASU
drugs. Registration and Licensing:
ASU drug manufacturers must obtain a valid license from the Respective
SDCA to operate and sell their products. The licensing process involves
submitting information about the manufacturing facility, equipment, and
processes, as well as providing samples for quality testing. Drugs must also
be registered with CDSCO before they can be marketed in India.

Traditional Medicine :

Issues in ASU drug regulation in India 3

ASU drugs, also known as Ayurvedic, Siddha, and Unani Medicines, have
been an Integral part of India’s Traditional healthcare system For thousands
of year.

Unique Characteristics:
ASU drugs are typically derived From natural sources and often Combine
herbs, minerals, and Metals to promote holistic Healing.

Popularity and Accessibility:

ASU drugs are widely used in India due to their cultural Significance and
the Affordability and accessibility of Traditional medicine.

Key Regulatory Bodies and Their Roles:

In India, the regulation of Ayurvedic, Siddha, and Unani (ASU) drugs is
primarily overseen by several key regulatory bodies. The Central Drugs
Standard Control Organization (CDSCO) is the national regulatory authority
responsible for approving and monitoring the quality, safety, and efficacy
of all drugs, including ASU medicines, in India. The CDSCO works in
collaboration with state-level drug regulatory authorities, known as the
State Drugs Control Departments, to enforce drug regulations across the
country.
The Drugs and Cosmetics Act, 1940 and its subsequent amendments provide
the legal framework for the regulation of ASU drugs in India. Under this
Act, the Ayurvedic, Siddha, and Unani Drugs Technical Advisory Board
(ASUDTAB) advises the central government on matters related to the
standardization of ASU drugs, including the development of
pharmacopoeial standards, testing methods, and quality control measures.
The Pharmacopoeia Commission for Indian Medicine C Homoeopathy
(PCIMCH) is responsible for publishing and updating the official
pharmacopoeias for Ayurvedic, Siddha, and Unani medicines.

Issues in ASU drug regulation in India 4

Additionally, the Ministry of AYUSH (Ayurveda, Yoga C Naturopathy, Unani,
Siddha, and Homoeopathy) is the primary government body responsible
for the regulation, promotion, and development of traditional and
complementary medicine systems in India, including ASU drugs. The
Ministry of AYUSH works closely with the C”SCO and other regulatory
agencies to ensure the quality, safety, and efficacy of ASU medicines.

Challenges in ASU Drug Registration and Approval

One of the primary challenges in the regulation of Ayurvedic, Siddha, and Unani
(ASU) drugs in India is the complex and often cumbersome process of drug
registration and approval. The current regulatory framework requires ASU drug
manufacturers to navigate a maze of bureaucratic hurdles, from obtaining licensing
and certifications to meeting stringent quality control standards. This process can be
time-consuming and costly, posing significant barriers to entry for many small and
medium-sized ASU drug companies.

Furthermore, the lack of clear and standardized guidelines for ASU drug registration
has led to inconsistencies in the approval process. Regulatory bodies often apply
different criteria and requirements, leading to confusion and uncertainty among
manufacturers. This lack of regulatory clarity and transparency has contributed to
delays, rejections, and even the withdrawal of ASU drug applications, frustrating
industry players and hindering the growth of this important sector.

Another challenge lies in the limited capacity and resources of the regulatory
agencies responsible for overseeing the ASU drug market. With a large and diverse
array of traditional medicines, the regulatory authorities often struggle to keep pace
with the volume of applications and ensure rigorous quality assessments. This has
resulted in backlogs, delays, and, in some cases, the approval of substandard or
unsafe products, undermining the overall integrity of the ASU drug regulatory
system.

Challenges in Implementing ASU Drug Regulations:

Regulating ASU drugs presents unique challenges due to their diverse
nature, varying formulations, and the Need to strike a balance between
traditional knowledge and modern scientific standards. Ensuring quality
Control, safety, and standardization remains a complex task.

Issues in ASU drug regulation in India 5

The implementation of Ayurvedic, Siddha, and Unani (ASU) drug regulations
in
India faces several Significant challenges. One of the primary hurdles is the
sheer diversity and complexity of the ASU systems, Each with its own unique
practices, formulations, and traditional knowledge. Effectively regulating
this Diverse landscape requires a nuanced understanding of these
traditional medicinal systems, which can be Difficult to capture within a
standardized regulatory framework. Another major challenge is the
fragmented nature of the ASU manufacturing industry, which is dominated
By small-scale, often unorganized players. Ensuring consistent quality,
safety, and efficacy across this Decentralized industry is an ongoing struggle
for regulators. Inadequate infrastructure, limited access to
Modern testing facilities, and a lack of skilled personnel further compound
these quality control issues. The limited availability of scientific evidence
and clinical data on the safety and efficacy of many ASU Formulations also
poses a significant challenge. Bridging the gap between traditional
knowledge and Modern scientific validation is crucial for building
confidence in these systems, but it requires substantial Investment and
research efforts. Additionally, the limited awareness and understanding of
ASU drug regulations among both consumers and Healthcare professionals
can hinder effective implementation. Educating and engaging stakeholders
at all Levels, from manufacturers to healthcare providers to the general
public, is essential for creating a Supportive ecosystem for ASU drug
regulation.

Current Issues in Drug Regulations of ASU Drugs in India:

1 Lack of Stringent Evaluation

Issues in ASU drug regulation in India 6

The current regulatory Framework often lacks Rigorous evaluation and
Clinical testing, leading to Concerns about the Efficacy and safety of ASU
drugs.

2 Inadequate Enforcement:
Insufficient enforcement of Regulations can result in The availability of
Unapproved ASU drugs in The market, putting public Health at risk.

3 Potential for Mislabeling:

Inconsistent labeling Practices can lead to Confusion and potential Harm to
consumers, Especially those with Allergies or pre-existing Medical
condition.

Lack of Standardization in ASU Drug Manufacturing:

One of the major challenges in the Indian traditional medicine industry is
the lack of standardization in the manufacturing of Ayurvedic, Siddha, and
Unani (ASU) drugs. ASU medicines are complex herbal formulations that
often contain multiple plant-based ingredients, each with its own unique
chemical composition and therapeutic properties. However, the absence of
consistent quality control measures and standardized manufacturing
protocols has led to significant variability in the final products.
Many ASU drug manufacturers rely on traditional, artisanal methods that
are passed down through generations, rather than adopting modern,
scientifically- validated production techniques. This results in
inconsistencies in factors such as ingredient sourcing, processing methods,
and final product composition.
The lack of standardization not only affects the efficacy and safety of the
drugs but also makes it difficult to conduct robust clinical trials and
regulatory oversight.

Issues in ASU drug regulation in India 7

Furthermore, the decentralized nature of the ASU industry, with numerous
small-scale producers and informal practitioners, has further exacerbated
the issue of standardization. The absence of a centralized regulatory
framework and limited enforcement of existing guidelines have allowed
substandard and adulterated products to proliferate in the market,
compromising the overall quality and reputation of traditional Indian
medicines.

Issues with Quality Control and Safety Monitoring:

A major challenge in the regulation of Ayurvedic, Siddha, And Unani (ASU)
drugs in India is the lack of robust quality Control and safety monitoring
mechanisms. Many ASU drug Manufacturers operate in the unorganized
sector, with Limited adherence to good manufacturing practices (GMP) And
quality standards. This has resulted in significant Variability in the quality,
purity, and potency of ASU drugs, Posing serious risks to consumer safety.
Ineffective post-marketing surveillance further exacerbates The problem,
with limited data on adverse drug reactions And long-term safety profiles
of ASU medications. The Regulatory authorities often lack the resources
and expertise To conduct comprehensive testing and inspections, leaving
Many substandard or unsafe products in the market.
This Has led to growing concerns over the reliability and Trustworthiness
of ASU drugs, undermining public Confidence in their use.
One of the major challenges in the regulation of Ayurvedic, Siddha, and
Unani (ASU) drugs in India is the lack of effective quality control and
standardization measures. Many ASU formulations are prepared using
traditional, artisanal methods, which can result in significant batch-to-
batch variations in the composition and potency of the final products. This
lack of consistent quality makes it difficult for regulatory authorities to
ensure the safety and efficacy of these medicines.

Issues in ASU drug regulation in India 8

Additionally, the complex nature of ASU formulations, which often contain
multiple herbal ingredients, makes it challenging to establish robust quality
control protocols. Identifying and quantifying the active compounds in
these mixtures can be a complex and time-consuming process, further
hindering the implementation of effective quality assurance measures. The
absence of standardized manufacturing practices and quality control
testing requirements for ASU drugs has led to a proliferation of substandard
and adulterated products in the market, posing serious risks to public
health.

Concerns over Adulteration and Mislabeling of ASU Drugs:

One of the major issues plaguing the regulation of Ayurvedic, Siddha, and
Unani (ASU) drugs in India is the Widespread problem of adulteration and
mislabeling. Many ASU products on the market have been found to Contain
undeclared synthetic chemicals, heavy metals, or other unapproved
ingredients, posing serious Health risks to consumers. This is often driven
by unscrupulous manufacturers looking to cut costs and Boost profits, with
little regard for consumer safety.
Adulteration can range from adding cheaper herbal extracts to diluting the
active ingredients in ASU Formulations. Mislabeling is also common, with
products falsely claiming to be natural or “organic” when They may contain
harmful synthetic additives. This lack of transparency and traceability in
the ASU drug Supply chain undermines consumer trust and makes it
challenging for regulatory authorities to enforce Quality standards.
The issue of adulteration and mislabeling is particularly concerning given
the widespread use of ASU Medicines in India, especially among rural and
underserved populations who may lack access to modern Allopathic
treatments. Consuming contaminated or mislabeled ASU drugs can lead to
severe side effects, Adverse reactions, and even life-threatening
complications, jeopardizing public health and safety.

Issues in ASU drug regulation in India 9

One of the major challenges in the regulation of Ayurvedic, Siddha, and
Unani (ASU) drugs in India is the widespread issue of adulteration and
mislabelling. Many unscrupulous manufacturers have been found to be
adulterating their products with undeclared and potentially harmful
synthetic ingredients, in order to boost efficacy or reduce production costs.
This not only compromises the safety and integrity of these traditional
medicines, but also erodes consumer trust and undermines the credibility
of the entire ASU system.
Mislabelling is another significant problem, with many ASU products falsely
claiming to contain certain herbs or minerals, or making exaggerated
health claims that are not scientifically validated. This deceptive practice
not only violates regulations, but also puts patients at risk of receiving
ineffective or even dangerous treatments. The lack of robust quality
control mechanisms and rigorous post-market surveillance has allowed
these unethical practices to thrive, posing a serious threat to public health.

• Adulteration with undeclared synthetic ingredients to boost efficacy

or reduce costs
• Mislabelling of ingredients or making unsubstantiated health claims
• Erosion of consumer trust and credibility of the ASU system
• Lack of effective quality control and post-market surveillance
• Potential health risks to patients due to unsafe or ineffective
products

Limitations in Post-Marketing Surveillance:

One of the major challenges in the regulation of Ayurvedic, Siddha, and
Unani (ASU) drugs in India is the lack of Effective post-marketing
surveillance. Once an ASU drug is Approved and reaches the market, there
are significant gaps In monitoring its long-term safety and efficacy. Unlike
Modern pharmaceuticals, ASU drugs often contain complex Herbal and

Issues in ASU drug regulation in India 10

mineral formulations, making it difficult to track Adverse reactions and
ensure quality control across the Supply chain.
The current post-marketing surveillance systems for ASU Drugs are often
inadequate and underfunded. Reporting of Adverse events is largely
voluntary, leading to significant Underreporting. Additionally, the
decentralized nature of the ASU industry, with numerous small
manufacturers, makes it Challenging to establish comprehensive
monitoring and Recall procedures. This lack of robust post-marketing
Surveillance heightens the risks of adulteration, Contamination, and the
use of substandard ingredients in ASU products, potentially compromising
patient safety.
Furthermore, the absence of a centralized database of ASU Drug
information and adverse event reports hampers the Ability of regulators to
identify emerging trends and take Proactive measures to protect public
health. This limited Post- marketing oversight also hinders the collection of
real-World evidence that could inform the improvement of ASU Drug
regulations and quality standards over time.

Limited Oversight:
One of the key challenges in the regulation of Ayurvedic, Siddha, and Unani
(ASU) drugs in India is the lack of robust post-market surveillance and
monitoring mechanisms. Once an ASU drug is approved and enters the
market, there is often insufficient oversight to ensure ongoing quality,
safety, and efficacy. This stands in contrast to the more stringent post-
market monitoring requirements for conventional pharmaceutical drugs.

Spotty Reporting:
The reporting of adverse events and product quality issues related to ASU
drugs is also sporadic and incomplete. Many such incidents often go
unreported, making it difficult for the regulatory authorities to identify and
address emerging problems in a timely manner. This lack of comprehensive

Issues in ASU drug regulation in India 11

data hinders the ability to make informed decisions and implement
corrective actions.

Inadequate Resources:
The regulatory bodies responsible for overseeing the ASU drug market, such
as the Drugs and Cosmetics Directorate and the Central Council for
Research in Ayurvedic Sciences, often lack the necessary resources,
staffing, and technical expertise to effectively monitor the post-market
performance of these products. This resource constraint limits their ability
to conduct regular inspections, sample testing, and follow-up
investigations.

Inadequate Infrastructure and Resources:

India’s regulatory landscape for Ayurvedic, Siddha, and Unani (ASU)

medicines is plagued by a severe lack of infrastructure and resources. The
regulatory bodies tasked with overseeing the registration, approval, and
quality control of these traditional medicines are often under-staffed,
under-funded, and ill- equipped to handle the sheer volume of products on
the market. Outdated testing facilities, inadequate laboratory equipment,
and limited access to specialized expertise pose significant challenges in
ensuring the safety and efficacy of ASU drugs.

Moreover, the decentralized nature of ASU drug regulation, with each state
having its own licensing and enforcement mechanisms, has led to a
patchwork of inconsistent standards and oversight. Many rural and remote
areas lack access to even the most basic regulatory infrastructure, leaving
them vulnerable to substandard or counterfeit products. This uneven
distribution of resources has created a vast disparity in the level of scrutiny

Issues in ASU drug regulation in India 12

and quality control applied to ASU medicines across different regions of the
country.

Addressing these infrastructure and resource deficiencies will require a

concerted effort by the government, regulatory bodies, and industry
stakeholders. Investing in modern testing laboratories, upgrading
equipment, and providing comprehensive training to regulatory personnel
are crucial steps towards strengthening the overall ASU drug regulatory
system. Only by bolstering the capacity and capabilities of these
institutions can India effectively protect the safety and integrity of its
traditional medicine market.

Impact of ASU Drug Regulations on Public Health:

1.Compromised Access to Traditional Medicines:
The complex and often opaque Regulatory framework for Ayurvedic,
Siddha, and Unani (ASU) drugs in India Has severely limited access to these
Traditional medicines for the general Public. Stringent licensing
Requirements, lengthy approval Processes, and inconsistent Enforcement
have made it increasingly Difficult for small-scale producers and Local
practitioners to legally Manufacture and distribute ASU Products. This has
effectively denied Many Indians, especially in rural and Underserved areas,
the ability to utilize Time-tested herbal remedies that are Culturally
integral to their healthcare .

2 Proliferation of Unsafe, Unregulated Products:

The challenges in implementing robust ASU drug regulations have led to the
proliferation of unsafe, substandard, and often adulterated herbal
products in the Indian market. Without proper quality control and post-

Issues in ASU drug regulation in India 13

marketing surveillance, consumers are exposed to significant health risks
from consuming contaminated or mislabelled ASU drugs.
This has eroded public trust in traditional medicine systems and
undermined their integration into the mainstream healthcare framework,
ultimately compromising the well-being of millions of Indians who rely on
these age-old practices.

3. Missed Opportunities for Innovation

The restrictive regulatory environment For ASU drugs has also stifled
innovation And research in the field of traditional Medicine. Rigid
requirements, high Costs, and uncertainty surrounding the Approval
process have discouraged Investment and collaboration in the Development
of new, evidence-based ASU formulations and products.
This Missed opportunity has not only limited The potential of traditional
medicine to Address emerging health challenges, but Also deprived the
public of access to Cutting-edge, scientifically validated Traditional
remedies that could enhance Overall public health outcomes.

4. Public Health Risks:

Inadequate regulations on ASU Drugs can compromise public Health and
undermine efforts to Ensure quality and safety in Healthcare practices.

5. Efficacy and Safety:

Concerns Substandard or mislabeled ASU Drugs may fail to provide the
Expected therapeutic benefits And can lead to adverse effects On patients.

6. Loss of Consumer Confidence:

Weak regulations erode public Trust in ASU drugs and hinder the Adoption
of traditional medicine As a valid healthcare option.

Issues in ASU drug regulation in India 14

Regulatory Gaps and the Need for Reform:

Gaps in Regulatory Framework

India’s regulatory framework for ASU (Ayurvedic, Siddha, and Unani) drugs
faces significant gaps and inconsistencies. The current laws and regulations
are often outdated, ambiguous, and fail to adequately address the unique
challenges posed by these traditional medicine systems. This has led to a
lack of clear guidelines for product registration, quality control, and post-
market surveillance.

Need for Harmonization:

There is a pressing need to harmonize the regulatory requirements for ASU
drugs with international standards and best practices. This would involve
aligning the registration and approval processes, strengthening quality
control measures, and implementing robust post-market monitoring
mechanisms. Harmonization would not only improve the overall quality and
safety of ASU products but also facilitate their acceptance and integration
into the global healthcare landscape.

Strengthening Institutional Capacity:

Effective regulation of the ASU sector requires a significant investment in
strengthening the institutional capacity of the regulatory bodies. This
includes providing adequate resources, training personnel, and upgrading
infrastructure to ensure efficient and transparent decision-making
processes. Additionally, there is a need to foster greater coordination and
collaboration between the various agencies involved in ASU regulation,
such as the Ministry of AYUSH, the Drugs Controller General of India, and
state-level regulatory authorities.

Fostering Innovation and Research:

Regulatory reform should also prioritize the promotion of innovation and
research in the ASU sector. This can involve incentivizing the development

Issues in ASU drug regulation in India 15

of new ASU drugs, supporting clinical trials, and facilitating the integration
of traditional knowledge with modern scientific principles. By creating an
enabling environment for research and innovation, the regulatory
framework can help unlock the full potential of ASU medicines and ensure
their continued relevance and effectiveness in the evolving healthcare
landscape.

Efforts to improve ASU drug regulations:

Recognizing the need for stronger regulation and oversight of the ASU
(Ayurvedic, Siddha, and Unani) drug industry in India, various stakeholders
have been working to implement reforms and improvements to the existing
regulatory framework. The Government of India, through agencies like the
Central Ayurveda Research Institute (CARI) and the National Medicinal
Plants Board, has initiated efforts to standardize manufacturing practices,
improve quality control, and enhance post-marketing surveillance of ASU
drugs.
One key initiative has been the development of Good Manufacturing
Practices (GMP) guidelines specifically for ASU drug manufacturers. These
guidelines aim to ensure the consistent production of high-quality, safe,
and efficacious ASU drugs by setting standards for raw material sourcing,
production processes, and quality testing. Regulatory bodies have also been
working to strengthen the licensing and registration requirements for ASU
drug manufacturers, distributors, and retailers to improve accountability
and traceability within the supply chain.
In parallel, there have been efforts to enhance the scientific research and
evidence base for the efficacy and safety of ASU drugs. Research institutes
and universities are collaborating to conduct clinical trials, phytochemical
analyses, and safety evaluations of traditional Ayurvedic, Siddha, and Unani
formulations. The goal is to build a more robust scientific foundation to
support the use of ASU drugs and facilitate their integration into the
mainstream healthcare system.

Issues in ASU drug regulation in India 16

Additionally, there have been calls for increased investment in the training
and capacity-building of ASU drug regulators, inspectors, and quality
control professionals. This is essential to ensure that the regulatory bodies
have the necessary expertise and resources to effectively monitor and
enforce compliance with the evolving regulations. Improved coordination
and information-sharing between central and state-level regulatory
authorities have also been identified as crucial steps to enhance the overall
effectiveness of ASU drug regulation in India.

Challenge s Solution:

1. Lack of Stringent Evaluation:

Strengthen clinical trials and research standards For ASU drugs to ensure
rigorous evaluation of Safety and efficacy.

2. Inadequate Enforcement :
Enhance regulatory agencies’ capabilities and Establish robust monitoring
and inspection
Mechanisms to enforce regulations effectively.

3. Potential for Mislabelling:

Implement strict labelling requirements and Enforce penalties for non-
compliance to ensure Accurate information for consumers.

Conclusion and Recommendations for Reform:

In conclusion, the regulation of Ayurvedic, Siddha, and Unani (ASU) drugs

in India faces significant challenges that require urgent attention and
reform. The lack of robust quality control measures, widespread
adulteration and mislabelling, and inadequate post-market surveillance
have compromised the safety and efficacy of these traditional medicines.

Issues in ASU drug regulation in India 17

The regulatory bodies tasked with overseeing the ASU industry often lack
the resources, infrastructure, and expertise necessary to effectively
monitor and enforce compliance with existing regulations.
To address these issues, a multi-pronged approach is necessary. First and
foremost, there must be a strengthening of the regulatory framework, with
clear and enforceable guidelines for the manufacturing, testing, and
labelling of ASU drugs. This should include the establishment of mandatory
Good Manufacturing Practices (GMP) standards, as well as the
implementation of stringent quality control measures throughout the
supply chain. Additionally, the capacity and capabilities of regulatory
agencies must be enhanced through increased funding, personnel, and
training to ensure more comprehensive oversight and enforcement.
Secondly, greater emphasis must be placed on research and standardization
of ASU formulations. Rigorous scientific studies to validate the safety and
efficacy of these traditional medicines should be conducted, with the
findings used to develop robust quality control parameters and
monographs. This will not only improve consumer confidence but also
facilitate the integration of ASU drugs into the broader healthcare system.
Finally, a robust post-market surveillance system should be established to
monitor the long-term effects of ASU drugs and promptly identify and
address any adverse events or quality issues. This should be complemented
by increased public awareness and education campaigns to empower
consumers and encourage responsible use of these traditional medicines.
By addressing these critical challenges, India can unlock the immense
potential of its traditional medicine systems, ensuring that Ayurvedic,
Siddha, and Unani drugs are safe, effective, and accessible to all. Through
a comprehensive regulatory reform and a renewed commitment to quality,
the ASU industry can become a shining example of the harmonious
integration of traditional and modern healthcare approaches.

1 .Strengthen Regulatory Framework:

Issues in ASU drug regulation in India 18

To address the key issues in ASU drug regulations in India, the government
must strengthen the overall regulatory framework. This includes
establishing clearer guidelines for manufacturing, quality control, and
post-marketing surveillance. Updating existing laws and empowering
regulatory agencies with sufficient resources and authority will be crucial
to ensuring consistent enforcement and compliance across the ASU drug
industry.

2 Promote Standardization and Harmonization:

The lack of standardization in ASU drug Manufacturing and quality control
is a major Challenge that must be tackled. Implementing robust good
manufacturing Practices (GMP) and harmonizing testing Protocols across
different ASU systems will Help improve product quality and safety.
Encouraging industry-wide adoption of These standards through incentives
and Mandatory requirements can drive progress In this area.

3 Enhance Post-Marketing Surveillance:

Robust post-marketing surveillance is Essential to identify and address any
issues With ASU drug safety and efficacy. This Should include strengthening
the adverse Drug reaction reporting system, conducting Regular market
sampling and testing, and Empowering regulatory agencies to quickly Recall
or ban problematic products. Improved data collection and analysis can
Also provide valuable insights to inform Future policy decisions.

4 Promote Evidence-Based Regulations:

As the ASU drug industry continues to Evolve, regulations must be updated
based On the latest scientific evidence and Research. This includes clinical
trials to Evaluate the safety and efficacy of ASU Drugs, as well as
comprehensive risk-benefit Analyses. By grounding regulatory decisions In
empirical data, the government can Ensure that ASU drug policies are
effective in Protecting public health while also Supporting the legitimate
use of these Traditional medicines.

Issues in ASU drug regulation in India 19

References:
• Textbook of Quality Control C Standardization of Herbals Dr. Navneet
Garud Santosh Bhadkariya Wasim Akram Ramakant Joshi
• Drug and cosmetic act 1945
• AYUSH GCP guidelines
• General Guidelines For Drug Development Of Ayurvedic Formulations,
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES Ministry
Of AYUSH, Government Of India New Delhi
• V.D.Rangari. Pharmacognosy C Phytochemistry.
• Pharmacopoeal standards for Ayurvedic Formulation (Council of
Research in Indian Medicine C Homeopathy)
• P Mukherjee, Quality Control of Herbal Drugs: An Approach to
Evaluation of Botanicals. Business Horizons Publishers, New Delhi,
India, 2002.
• S.S Agarwal and N Paridhabi. Herbal Drug Technology.
• Izhar Ahmad38/drugs-and-cosmetics-act-19-40-rule-1945
• Dr. Sufiyan Ahmad, “Regulatory Issues Regulations in India (ASUDTAB,
ASU DCC), Regulation of manufacture of ASU drugs-Schedule Z of
Drugs C Cosmetics Act for ASU drugs.”

Issues in ASU drug regulation in India 20