INTRODUCTION:

The term "regulation" includes various texts with different legal bases and jurisdictions, such as guidelines, recommendations, procedures, policies, etc. Most national guidelines on drug development and marketing authorization applications are based on globally and regionally harmonized guidelines. Global Cyber Governance is made up of representatives from every country in the world. New and existing products, domestic products and products imported from other countries need to be regulated. The main objective of regulatory bodies is to maintain the standard of medicines at every stage of the process to meet the needs of the patient population.

Medicines regulatory systems must provide patients with timely access to effective treatments, protect patient safety and facilitate research into new treatments. Regulators provide strategic, tactical and operational advice and support work within regulations to accelerate the development and delivery of safe and effective medicines or health products to the public. Today’s pharmaceutical industry is highly organized, systematic and compliant with international regulations. Multiple tragedies such as the sulpha elixir, the vaccine tragedy and the thalidomide tragedy have led to the need for a tightly controlled regulatory framework. This results in the efficient manufacturing and marketing of safe, effective and quality health products.^1,2,3

National regulatory agencies:^4,5

Sr. No.	Country	Authority
1	USA	USFDA
2	UK	MHRA
3	Australia	TGA
4	India	CDSCO
5	CANADA	HEALTH CANADA
6	South Africa	MCC
7	Brazil	ANVISA
8	European Union	EMEA
9	China	SFDA
10	Nigeria	NAFDAC
11	New Zealand	MEDSAFE
12	Japan	MHLW
13	Zimbabwe	MCAZ
14	Switzerland	SWISSMEDIC
15	Korea	KFDA
16	Sri Lanka	MoH

International regulatory agencies and organizations:

· World Health Organization (WHO)

· International Conference on Harmonization (ICH)

· Pan American health Organization (PAHO)

· World Trade Organization (WTO)

· World Intellectual Property Organization (WIPO)

They also play an important and research role in the application of pharmaceutical regulations in various aspects such as drug research and development, registration, production, distribution, marketing and price control.

World Health Organization (WHO)^5,6,7

They also provide and strengthen regulatory enforcement in unregulated regions of the world to ensure public safety regulation covers registration, manufacture, distribution, price control, marketing, research and development and the protection of intellectual property. Pharmaceutical regulation refers to the promotion of various activities aimed at ensuring the efficacy, safety and quality of medicines. Medicines are available from a number of sources. People and governments are willing to spend money on drugs for many reasons. Medicines must therefore be safe, effective, of good quality and used appropriately. Therefore, effective drug regulation is necessary to ensure the safety, efficacy and quality of drugs, as well as the accuracy and relevance of drug information provided to the public. Each country has its own regulatory agency responsible for enforcing rules and regulations and issuing guidelines for the development, licensing, registration, manufacture, marketing and labelling of medicines. The production, import, storage, circulation, sale and supply of drugs must be regulated.

Effective medicines regulation requires multiple functions:

· Ensuring the safety, efficacy and quality of medicines.

· Approval of sites, personnel and practices.

· Inspection of production facilities and distribution networks.

· Product evaluation and registration.

· Monitor drug side effects.

· Quality control.

· Controlling drug promotion and advertising.

· Most important is the drug regulation process.

Drug regulations include:

1. Drug Law

2. Drug Regulatory Authority

3. Drug Regulatory Commission

4. Quality Management

5. Medicines Information Centre.

Drug Regulatory Agency of India:

India has become one of the major pharmaceutical markets. Increase in private healthcare infrastructure, expansion of rural markets and adoption of new technologies have made healthcare an independent sector in India. With the privatization of health care, the medical device industry is also growing. The Drugs and Cosmetics Act, 1940 (“D&C, Act”) was enacted in India in 1940 to regulate the importation, manufacture, distribution and sale of drugs and cosmetics. However, to date, the Indian government has not issued any separate regulations to regulate the importation, manufacture, distribution or sale of medical devices in India. Medicines and health are listed side by side in the list of the Indian Constitution. It is jointly controlled by the central government and the state governments under the Drugs and Cosmetics Act 1940.

Central Drugs Standard Control Organization (CDSCO):

Indian Regulatory Agency (National CDSRA) Directorate General of Health Services (DGHS), Ministry of Health and Family Welfare; Indian government. The CDSCO is the central drug regulatory agency responsible for the functions assigned to the central government under the Drugs and Cosmetics Act.CDSCO is headquartered in New Delhi. CDSCO and state regulatory agencies are jointly responsible for the licensing of blood and blood products, IV fluids, vaccines, and sera. Within CDSCO, the Drug Controller General of India (DCGI) is responsible for the regulation of pharmaceuticals and medical devices.

The Drug Technical Advisory Board (DTAB) and the Drug Advisory Board (DKK) advise the DCGI. The licensing and classification of medical devices is the responsibility of the Central Licensing and Approval Authority (CLAA). It is also responsible for setting and enforce safety standards, performing post-market surveillance, issue of warnings and recall of pharmaceutical products for adverse events .^5,6

Functions of CDSCO:

Central licensing authorities are responsible for:

· New drugs approval

· Performing clinical trials

· Establishing standards for drugs

· Quality Control of imported drugs, import registration and licensing

· Coordination of the activities of state drug control authorities by giving expert opinion to uniformly enforce the D&C Act

State licensing authorities are responsible for:

· Regulation of production, sale and marketing of drugs

Other Functions:

· Grant of license for blood banks, Large Volume Parenteral (LVP), vaccines, recombinant DNA products and some medical devices

· Amendment of D & C Act rules

· Ban of old drugs and cosmetics

· Grant of test license, personal license, No Objection Certificate (NOC) for export

· Testing of new drugs and cosmetics

· Functions of Central Drug Testing Laboratories:

· Acts as an appellate authority in drug quality related disputes

· Procurement, preservation and distribution of international reference standard pharmaceutical substances

· Preparation of national reference standard pharmaceutical substances and microbial cultures useful in pharmaceutical analysis. And also distribution of standard drugs and cultures to state QC laboratories and pharmaceutical manufacturing establishments

· Training of analysts appointed by state drug control laboratories and other institutions

· Training of WHO personnel from abroad on advanced analytical methods

· Advises the central drug control authorities with respect to quality and toxicity of drug awaiting license

· To work out analytical specifications for monograph preparation for the Indian Pharmacopoeia and the Indian

· Homoeopathic Pharmacopoeia

· Additionally the CDL also associates with the WHO in preparing standards and specifications for International Pharmacopoeia

· Research and analysis of drug and cosmetics

· Registration samples analysis for site registration approval as per Good Manufacturing Practices (GMP)

· To take up analytical research on standardization of drugs

Drug approval process in India:

For manufacture or import of a new drug, the company should obtain permission from the licensing authority (DCGI) by filing in Form 44 and submitting the necessary data according to Schedule Y of D&C Act 1940. Fig. 1 shows the drug approval process in India. To demonstrate the efficacy and safety of imported drugs in the Indian population, clinical trials are conducted as per Schedule Y guidelines and reports are submitted in the specified format, and DCGI reviews the applications and approves them if they are acceptable.

New Drugs and Clinical Trials Rules 2019:^8,9

New rules reduce approval time to 1 month and 90 days for drugs made in India Those developed abroad. These rules also eliminate the need to conduct local clinical trials (CTs) if the drug is approved for marketing in a country designated by DCGI. DCGI has waived CT for drugs approved in the EU, UK, Australia, Canada, Japan and the US. The new rules aim to encourage clinical research in India by providing transparent and efficient regulations for CT and ensuring faster access to new medicines for the Indian population. Submit in the specified format. DCGI reviews applications and, if acceptable, approves the FDA's

IND

Investigational New Drug (IND) program, which is how drug companies get approval to begin human clinical trials and send drugs experimental across state lines because the drug is already approved, so before marketing application (usually clinical investigators).

· A company submits a commercial IND for marketing authorization of a new drug.

A study or investigator IND is a non-commercial IND submitted by an investigator to study an unapproved drug or to study an approved drug for a new indication or patient population.

· Emergency use INDs, also known as compassionate use INDs or single patient INDs, are submitted for emergency use of an unapproved drug. It is most often used for life-threatening conditions for which there is no standard treatment

· Submit a therapeutic IND to provide a drug for the treatment of a serious or life-threatening condition prior to FDA approval. Serious diseases or conditions include stroke, schizophrenia, rheumatoid arthritis, osteoarthritis, chronic depression, seizures, Alzheimer's dementia, amyotrophic lateral sclerosis (ALS), and narcolepsy.

· A screening IND is submitted for multiple closely related compounds to screen for a preferred compound or formulation. Preferred compounds can then be developed under separate INDs. It is used to screen different salts, esters and other drug derivatives with different chemical properties but similar pharmacodynamics.

US Drug Regulatory Agency:^10-17

US Food and Drug Administration: The United States Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services. It consists of 6 product centers, 1 research centre and 2 offices. The Centre for Drug Evaluation and Research (CDER) ensures the availability of safe and effective drugs to improve the health of populations. The FDA has 4 responsibilities under the Food and Drug Modernization Act:

Improving health by reviewing research and approval of new products

Ensuring food and drugs are safe and properly labelled

Working with other countries to reduce the regulatory burden

Work with scientific experts and consumers to properly meet these obligations.

The FDA is led by the President's appointed Food and Drug Commissioner. The US Congress has authorized the FDA to enforce federal FD&C law. The FDA is headquartered in White Oak, Maryland. The agency also has 223 field offices and 13 laboratories in 50 states.

Functions of the FDA:

· Protecting and improving public health through monitoring and surveillance:

· Foods (food supplements, food additives, etc.).

· Prescription and non-prescription drugs

· Biological products such as vaccines, blood and blood products

· Cell and gene therapy products

· Allergens, tissues and tissue products

· Medical devices and electromagnetic radiation emitting devices (ERED)

· Cosmetics, Animal Feed and Veterinary Drugs

· Tobacco Products

· Protect public health by ensuring food safety and hygiene

· Help accelerate product discovery or innovation.

Australian Medicines Regulatory Agency

TGA (Therapeutic Goods Administration)^18,19

The Therapeutic Goods Administration (TGA) is the regulatory body for medicines, medical supplies, technology medicine and medical technology. and blood products) in Australia. The Therapeutic Goods Administration (TGA) is Australia's government regulatory agency for medicines and therapies. It is part of the Department of Health and Aged Care. The TGA regulates the quality, supply and advertising of drugs, pathology equipment, medical devices, blood products and most therapeutic agents. Any item that claims to have a therapeutic effect, involves the management of drugs or is covered by the Therapeutic Goods Act 1989, The Therapeutic Goods Regulations 1990 or a Ministerial Order must be approved by the TGA and registered as a therapeutic product on the Australian Register. Register.

· Agency overview

· Established in 1989

· Jurisdiction of Australian Government

· Employees 750 (2016)

In Australia, medical products are regulated by the TGA and, for drug control, by the Office of Cannabis (ODC). The TGA and ODC together form the Health Products Regulatory Group within the Department of Health and Aged Care. The health products regulatory group is made up of 11 regulatory directorates and 1 statutory directorate, organized into three divisions. Regulatory Services and Medicines Control is the only department that is not part of the TGA.

Medicines Regulatory Agency in the UK:²⁰

MHRA (Medicines) The Agency and Healthcare Medicines and Health Products Regulatory Agency is an executive agency of the UK Department of Health and Social Care responsible for ensuring the efficacy and acceptable safety of medicines and medical devices.

Headquarters: London

Executive Agency Overview Established 1 April 2003, 19 years ago The MHRA is organized into three main centers:

· MHRA Regulatory Authority - the body Pharmaceutical Industry and Medical Devices Regulatory Board

· Clinique Practice Research Datalink - licensing of anonymous health data to pharmaceutical and other pharmaceutical companies for research purposes

· National Institute for Biological Standards and Control - Responsible for standardization and control of the biological advisory committee which provides information and advice to the UK government on the regulation of medicines and medical devices.

There are currently eight such committees:

1. Homeopathic Products Registration Advisory Committee

2. Herbal Medicine Advisory Board

3. Review Group

4. Independent Scientific Advisory Committee for MHRA Database Study

5. Pharmaceutical Industry Relations Group

6. Innovation Office

7. Blood Advisory Committee

8. Device Expert Advisory Board

CONCLUSION:

The role of the regulation body includes the imposition of requirements, conditions, restrictions and Standards for workplace activities as well as enforcing and promoting compliances to them.

Although regulator authority cover a wide variety of professionals not all professionals are under the purview of regulatory body. Certain professions remain self regulated. Regulatory bodies are staffed by specialists who are versed in the complexities of regulations and how to best enforce them. There responsibilities are also include:

· Drafting rules

· Protecting consumer

· Adjudicating disputes and controversies.

· Conducting hearings

ACKNOWLEDGEMENT:

I would like to thank you management of YSPM’s YTC Faculty of Pharmacy Satara for guidance.

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Received on 01.04.2023 Modified on 27.01.2024

Asian J. Res. Pharm. Sci. 2024; 14(3):243-248.

DOI: 10.52711/2231-5659.2024.00040