SWAMI RAMANAND TEERTH MARATHWADA

UNIVERSITY NANDED

Project Report

“ issues in ASU drug regulation in India "

Submitted by
Deshmukh Suraj Satish
(B .PHARM FINAL YEAR )
Guided by
MR.DHEMBRE.G.N.
Shri Dhaneshwari Manav Vikas Mandal’s S.V.P College Of
Pharmacy (B.Pharm)
At. Hatta, Zero phata, Tq. Basmat Dist. Hingoli (431705)
2023-24
 Shri Dhaneshwari Manav Vikas Mandal s
SVP College Of Pharmacy
At .hatta ,zero phata tq. Basmati dist .hingoli (431705)
2023-2024

CERTIFICATE
This is to certify that Deshmukh Suraj Satish has satisfactorily Carried out
the required Research Project work entitled ‘“ issues in ASU drug
regulation in India "Under the guidance of Mr. Dhembre G.N
partial fulfillment of the Requirement for the degree of bachelor’s of
pharmacy under the faculty Of pharmacy swami Ramanand Teerth
Marathwada University Nanded for the Final year B .Pharmacy semester VIII
during acadmic year 2023-2024.

Place : Hatta
Date : / / 2024

Principal Guided by.

Dr. U.T Jadhao. Prof. Dhembre G . N
 CERTIFICATE BY THE GUIDE

This is to certify that, DESHMUKH SURAJ SATISH of B. Pharmacy

VIIIth Semester have completed their Practice School project entitled
“Formulation of Herbal Hair Oil” for the academic year 2023-24 in SVP
College of Pharmacy Hatta for consideration in partial fulfillment for the
award of degree of Bachelor of Pharmacy (B. Pharm.) from Swami Ramanand
Tirth Marathwada University, Nanded under my supervision.
He took proper efforts and showed sincerity in completion of the project up to
my expectation

Name of the Student

DESHMUKH SURAJ SATISH

Name & Sign of the Guide

Mr.Dhembre G.N

Date
Place: Hatta
 CERTIFICATE BY THE PRINCIPAL

This is to certify that, DESHMUKH SURAJ SATISH f B. Pharmacy VIII

Semester have completed their Practice School project entitled “Formulation
and evaluation of herbal gel” for the academic year 2023-24 in SVP College of
Pharmacy Hatta for consideration in partial fulfilment for the award of degree
of Bachelor of Pharmacy (B. Pharm.) from Swami Ramanand Tirth
Marathwada University, Nanded under the supervision of Prof. Dhembre sir
The report was found worthy and ready for submission

Date. Principle
Place: Hatta Mr. Jadhao. U.T
face Scrub

DECLARATION

I hereby declare that the project work entitled “ issues in ASU

drug regulation in India " is an original work by me and has not
been previously submitted to this or to any other university .

DESHMUKH SURAJ SATISH

Svp college of pharmacy hatta

face Scrub

Index
Sr. Content Page
No No
1 Introduction 1
2 Background 2
3 Overview 4
4 Regulatory bodies 6
5 Challenges in Licencing 7
6 Current issues 9
7 Issues with QC 11
8 Concern over adulteration 13
9 Limitation in surveillance 14
10 Impact of regulation 15
11 Solution and recommendations 17
12 Refference 18

Svp college of pharmacy hatta 6

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

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.

1
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, 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.

2
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 & Homoeopathy
(PCIM&H) 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 :

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.

3
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 & Homoeopathy (PCIM&H) is responsible
for publishing and updating the official pharmacopoeias for Ayurvedic, Siddha, and Unani
medicines.

Additionally, the Ministry of AYUSH (Ayurveda, Yoga & 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

4
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.

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

5
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

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.

6
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.

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.

7
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.

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

8
ASU drugs can lead to severe side effects, Adverse reactions, and even life-threatening
complications, jeopardizing public health and safety.

One of the major challenges in the regulation of Ayurvedic, Siddha, and Unani (ASU) drugs in
India is the widespread issue of adulteration and mislabeling. 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.

Mislabeling 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

• Mislabeling 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 mineral
formulations, making it difficult to track Adverse reactions and ensure quality control across
the Supply chain.

9
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 data hinders the ability to make informed decisions and implement
corrective actions.

Inadequate Resources:

10
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 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:

11
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-marketing surveillance, consumers are exposed to
significant health risks from consuming contaminated or mislabeled 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.

12
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.

5.Loss of Consumer Confidence:

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

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

13
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 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

14
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.

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 & 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 Mislabeling:

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

15
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 mislabeling, and inadequate post-market
surveillance have compromised the safety and efficacy of these traditional medicines. 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 labeling 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.

16
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:

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.

17
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.

References:
• Textbook of Quality Control & 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 & Phytochemistry.
• Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in Indian
Medicine & 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 & Cosmetics Act for
ASU drugs.”

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