INTRODUCTION:

WHAT IS REGULATORY AFFAIRS?

Regulatory Affairs (RA) is a profession within the healthcare industry, specifically pharmaceuticals, medical devices, biologics, and dietary supplements. Management is a profession that has evolved beyond the wishes of governments to protect public health, by controlling the safety and effectiveness of products in areas such as pharmaceuticals, veterinary drugs., medical devices, pesticides, agrochemicals, cosmetics and supplements.

The RA profession is at the heart of the collection, analysis, and communication of the risks and benefits of healthcare products to regulators and the public worldwide. Regulated work (RA), also known as Government Affairs, is a profession in regulated industries, such as pharmaceuticals, medical devices, etc. This department is responsible for understanding regulatory requirements for approval of new/generic products.

They know what commitments the company has made to the regulatory authorities where the product will be approved. They also submit annual reports and supplements to agencies. The Drugs Administration is a function that regulates the science of pharmaceuticals aimed at facilitating trade/business in and out of the country of origin for the public good.Regulatory our bodies together with the food and pills management (FDA) within the usa are liable for approving whether a drug can continue to scientific trials and whether it have to be allowed to are available to the marketplace or no longer. Those frame has to evaluate the medical and clinical statistics to make sure that the drug can be produced with always high purity, better therapeutic effects and it does not have unaccepted facet effects. It ought to additionally approve the labeling of the drug and the instructions for its use or we can say regulatory frame has taken interested by all aspects of a drug designing and its formulation ¹

Various functions of the regulatory affairs department:

A pharmaceutical company’s Regulatory Affairs (RA) department is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wishes to keep the product on the market. Acts as an interface between the regulatory authority and the project team and is a channel of communication with the regulatory authority throughout the project to ensure that the project plan correctly anticipates what the regulatory authority will require prior to product approval. It is the RA’s responsibility to keep abreast of current legislation, guidelines and other regulatory information. Such rules and guidelines often allow some flexibility, and regulators expect companies to take responsibility for deciding how they should be interpreted. ¹

1. The RA department plays an important role in providing advice to the project team on how best to interpret the rules. As a member of the project team, the RA is also involved in designing the development program.

2. The RA department reviews all documentation from a regulatory perspective and ensures that it is clear, consistent and complete and that its conclusions are unambiguous. The department also drafts basic prescribing information that is the basis for global approval and later provides a platform for marketing.

3. Documentation includes applications for clinical trials as well as regulatory applications for new products and changes to approved products. This is the main task and makes up about half of the work of the RA department.

4. A regulatory affair plays a crucial role in the industry and is involved in all stages of drug development and also after drug approval and marketing.

5. The Regulatory Affairs professional’s job is to keep track of the ever-changing legislation all the regions in which the company wishes to distribute its products.

6. Coordinate, prepare and review all appropriate documents for example dossier and submit them to regulatory authorities within a specified time frame in conjugation with the organization.

7. Manage review audit reports and compliance, regulatory and customer inspections

8. Regulatory affairs professional also play an important role in Pharmacovigilance of drugs^2,3

Regulatory affairs in different branch:

Objectives of Regulatory Affairs:⁴

1. How and why the pharmaceutical industry and drug regulation developed in the US.

2. Rules for medicinal products in the European Union.

3. Major US regulations.

4. The EU framework and its regulation.

5. Pharmaceutical legislation of the EU.

6. Indian pharmaceutical industry and development of drug prescriptions in different periods.

7. Types of registration procedure on the EU market.

8. Main Rules and Law of India.

9. The role of an expert on regulatory matters in health authorities and also in the pharmaceutical industry.

10. Ensuring that their companies comply with all regulations and laws relating to their business.

11. Cooperate with federal, state and local regulatory authorities and staff on specific issues affecting their business.

12. Advising companies on regulatory aspects and climate that would affect their proposed activities ⁵

Regulatory Bodies in the World⁵

Different regulatory bodies in the world.

Country	Regulatory Authority
India	Central Drugs Standard Control Organization.Drug controller general of India (DCGI)
US	Food and Drug Administration (US FDA)
UK	Medicines and Health care products regulatory Agency (MHRA)
Australia	Therapeutic Goods Administration (TGA)
Japan	Japanese Ministry of Health, Labour and Welfare (MHLW)
Canada	Health Canada
Brazil	Agency Nacional degradation Vigilancia Sanitaria (ANVISA)
South Africa	Medicines Control Council (MCC)
Europe	European Directorate for Quality of Medicines (EDQM)

Drug Regulatory Agencies in India:

India has emerged as one of the main markets for pharmaceutical merchandise. growth inside the private healthcare infrastructure, widening rural markets, and inclusion of more modern technologies Have placed healthcare as an impartial region in India. With privatization of healthcare, the scientific gadgets quarter is growing too. with a view to regulate the import, manufacture, distribution and sale of drugs and cosmetics, the capsules and Cosmetics Act, 1940 (“D&C, Act”) become brought in India in 1940. but, no Separate regulation has been enacted for regulating the import, manufacture, distribution or Sale of scientific devices in India till date by the government of India. tablets and health is in concurrent list of Indian charter. it is ruled by means of each Centre And kingdom Governments below the medication & Cosmetics Act, 1940.⁶

Main Bodies:⁶

· Central Drug Standard Control Organization (CDSCO)

· Ministry of Health & Family Welfare (MHFW)

· Indian Council of Medical Research (ICMR)

· Indian Pharmaceutical Association (IPA)

· Drug Technical Advisory Board (DTAB)

· Central Drug Testing Laboratory (CDTL)

· Indian Pharmacopoeia Commission (IPC)

· National Pharmaceutical Pricing Authority (NPPA)

· Drug controller General India (DCGI)

The various duties of regulatory authorities are as follows:

1. Regulatory authorities are responsible to review clinical trials of both non-Registered medicinal substances and new indications of registered medicinal Substances.

2. Regulatory authorities has a statutory obligation to ensure that the drugs

Available in the country fulfils the necessary requirements for safety, quality and Efficacy.

3. Regulatory authorities has the responsibility to close down an on going trial in The case there are serious breaches of Good Clinical Practice.

4. Regulatory authorities are responsible to implement a regulatory system where In all clinical trials to be conducted in the country have to register with them.

5. Regulatory authorities will have the overall responsibility to promote, ensure and monitor compliance by approved ethics committees in a country with Relevant legislation, regulations and guidelines including guidelines for Good Practice in the Conduct of Clinical Trials in Human Participants in the count.

6. Have a duty to provide physicians and other healthcare Professionals with accurate and complete information about The quality, safety and effectiveness of the product.

7. Regulatory authorities are responsible for effectively reviewing All the documents (containing both clinical and non clinical Data) before giving permission for the marketing of a new drug In any country to ensure the efficacy and safety of the drug in human.^4,7

Present Regulatory Issues in Indian:

Pharmaceutical Industries:

· As reported in a survey by economic times, The Pharmaceutical sector is one of the most Dynamic sectors in the country, but its Compliance structure is more complex since The process for drug approval entails the Coordination of different departments

· Issues related to industrial policy includeThe regulation of patents, drug exports, and Government support to the industry. With The introduction of the Patents Act, Pharmaceutical companies were allowed to Patent their process of manufacturing drugs.

· Big Pharma companies are now setting up R&D labs to find new molecules. Licensing And quality control issuesduetorapidongoingc Hanges at global level related to GMP, GCP & GLP

· Issues related to market authorization, e.g., The Indian Patent Office granted US Pharma giant Pfizer patent authorization for Prevenar 13, (Pneumonia vaccine) in 2017, Which gives the company exclusive rights to Distribute the vaccine within India until 2026 and blocks Indian manufacturers from Making a generic version of the life-saving Vaccine for export ^8,9

Future Avenue or Prospective:

India has the World’s largest healthcare program for its half of a Billion citizens, as per the union budget 2018. The Brand-new scheme “Namocare” is covering nearly 40% of the health policy of Indian citizens.

Though, the government has promised to bring Some major changes in the DPCO area and Probably come out with a new pharma policy to Implement “Namocare” across the country and Successfully the mission PHARMA2020. The new Pharma policy will unify & synergize its various components such as DPCO, manufacturing, R&D, financing, quality control, drug control, price control & medical devices. Though, the pharmacists of India are committed to the cause of placing patients first & will continue to advocate the need for better regulations in the Indian pharmaceutical industry ¹⁰

CONCLUSION:

Drug Regulatory Affairs branch is constantly evolving and growing and is least impacted for the duration of the purchase and merger, and throughout recession. Regulatory Affairs departments are Developing within organizations. Regulatory Affairs agree with the new method to regulation will sooner or later be followed for all healthcare products as it represents the quality model for delivering New healthcare advances to marketplace in an inexpensive time with suitable safety. The right implementation of regulatory hints and legal guidelines will enhance the monetary Boom of the pharmaceutical industry and additionally improves the protection of the human beings. The major role of regulatory affairs in industrial development, industrial resources.

REFERENCE:

1. https://www.slideshare.net/DipakBhingardeve/regulatory-affairs-238230245

2. https://www.sciencedirect.com/topics/medicine-anddentistry/regulatoryaffairs#:~:text=The%20regulatory%20affairs%20(RA)%20department,the% 20product%20on%20the%20market.

3. https://www.internationaljournalssrg.org/IJPBE/2016/Volume3- Issue1/IJPBE-V3I1P101.pdf

4. https://www.linkedin.com/pulse/regulatory-affairs-its-rolepharmaceutical-industry-numra

5. https://www.worldwidejournals.com/global-journal-for-research-analysisGJRA/recent_issues_pdf/2018/January/January_2018_1515152068__76.p df

6. https://wjpr.s3.ap-south-1.amazonaws.com/article_issue/1522475057.pdf

7. https://www.researchgate.net/publication/301637817_Drug_Regulatory_Agencies_In_India_USA_Europe_And_Japan-A_Review/link/571f57d908aefa64889a7182/download

8. http://webstor.srmist.edu.in/web_assets/srm_mainsite/files/downloads/Responsibilities_of_Regulatory_authority.pdf

9. https://www.researchgate.net/publication/357649862_Current_Scenarios_On_Regulatory_Landscape_Of_Indian_Pharmaceutical_Industries/link/61d823d2e669ee0f5c8db757/download

10. http://shodhganga.inflibnet.ac.in/bitstream/10603/114212/6/chap

11. Avhad P: The Indian pharmaceutical industry: The “pharmacy of the world‟?. Available from: https://www. Farmavita.net/documents/Indian Pharmaceutical Industry.

Received on 15.11.2022 Modified on 07.12.2022

Asian J. Res. Pharm. Sci. 2023; 13(1):73-76.

DOI: 10.52711/2231-5659.2023.00014