Drug Regulatory Affairs Certificate Institutes in India

Historical Overview of Pharmaceutical Industries and Regulatory Affairs:During 1950s, multiple tragedies i.e., sulfanilamide elixir, vaccine tragedy and thalidomide tragedy have resulted in substantial increase of legislations for drug products quality, safety and efficacy. This has also resulted into stricter norms for Marketing Authorization (MA) and Good Manufacturing Practices (GMPs). To understand the chronological development of the modern era of pharmaceutical industry and regulatory framework, we will glance through the historical evolution of regulations in USA, Europe and India. Let us see what happened in USA, Europe and India.

Basics of DRA (Drug Regulatory Affairs) : Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines, and by the companies responsible for the discovery, testing, manufacture and marketing of these products wanting to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare.A new class of professionals emerged to handle these regulatory matters for companies.

Importance of DRA : Indian pharmaceutical sector is rising very rapidly and there is a need of regulatory affairs professionals to provide the current needs of industries for the global competition. A regulatory affair is a somewhat new profession which has developed from the desire of governments to defend public health. The pharmaceutical companies responsible for the discovery, testing, clinical trials, production, manufacture and marketing of these products also want to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare. Regulatory affairs professionals are the  link between pharmaceutical industries and worldwide regulatory agencies. They are required to be well versed in the laws, regulations, and guidance of the regulatory agencies. There is a growing need to incorporate the current requirements of pharmaceutical industries. The present article discusses the regulatory education and its need, learning resources, courses available, syllabus contents, and job opportunities in regulatory affairs.

Working profile of DRA : Regulatory affairs professionals obtain essential paperwork and documentation for regulatory filings. All documents that are a part of the regulatory submissions should be of high quality  and up-to-date. The pharmaceutical sector is a good example of the complexity engaged in regulatory processing. Prior to a drug being officially marketed by a pharmaceutical organization, it must be accepted by the regulatory authorities such as US FDA, MHRA, HSA, CDSCO etc. A regulatory affairs professional who works for a pharmaceutical company generally consults with company researchers and other staff to obtain sufficient data to develop a strong application for regulatory agencies. This data might consist of information on how the drug was developed in a laboratory, how it was analyzed, information about its efficacy and safety profile etc. In some cases, particularly in the case of a new drug, the process takes several years to complete.

The regulatory affairs professionals are responsible to complete all applicable regulatory submission forms issued by the agency, file the forms together with the essential associated documentation and compile a dossier. The particular information requested on submission forms differs significantly based on the type of approval applying for. For instance, the FDA’s Investigational New Drug (IND) application must be presented to the authority by a drug producer prior to the company can perform clinical trials. IND form requests for information concerning the drug protocol, which is basically an explanation of how the drug is designed; data related to the animal studies performed on the drug etc. On the other hand, the FDA’s New Drug Application (NDA) form, which must be submitted before marketing the drug for human use, needs the drug maker to submit additional documentation relevant to the drug’s efficacy and safety in humans, package labeling, manufacturing and other information.

Once submissions have been made the regulatory affairs professionals must monitor the progress of regulatory submissions. It’s important to not only file submissions in a timely manner to start with, but also to follow-up on a periodic basis. Monitoring the progress of submissions is not usually easy. For instance, for a drug company that has a target time frame for getting a new drug on the market, it might be complicated to calculate how much time it will take the regulatory authority to approve NDA application. Sufficient time must be allowed for the regulators to evaluate and approve the application. Usually regulatory agencies will have well published timelines that they take for approvals, so regulatory professionals must anticipate timelines accordingly.

Institute : Jamia Hamdard
Duration : 1 year (2 semester) for both the programs
Location : Delhi
Fees : ADDRA(Rs24,500)
PGDDRA(Rs24,500)
Mode : Distance learning
Ranking : 1st
Course content:
(1) Advance Diploma in Drug Regulatory Affairs(ADDRA 1 year):
The main objective of this Programme is to provide good knowledge of pharmacy and regulatory affairs laws and system as applicable in the field of pharmaceutical regulation at both national and international levels. This course prepares the students to pursue career in pharmaceutical industry, drug licensing and control authorities, and export&import agencies dealing with the pharmaceuticals and medical devices.

An Introduction to Pharmaceutical Drug Regulatory Affairs
General Pharmaceutical Laws and Guidelines
Drug Regulatory Affairs in India
Information and Quality Management
Chemical, Pharmaceutical and Biological aspects of Regulatory Documentation
Clinical Trials and Health Care Policies
International Licensing
Regulatory Considerations in Controlled Drug Delivery and Future Aspects of Biopharmaceuticals

(2) Post Graduate Diploma in DRUG Regulatory Affairs(PGDDRA):
1st Semester: An Introduction to Pharmaceutical Drug Regulatory Affairs
- General Pharmaceutical Laws and Guidelines
- Drug regulatory Affairs in India
- Information and Quality Management
2nd Semester: Chemical ,Pharmaceutical and biological aspects of Regulatory documentation. -Clinical Trials and Health care policies
- International licensing
- Regulatory considerations in controlled Drug delivery and future aspects of Biopharmaceuticals.
Institute : James Lind Institute
Duration : 18 months(Maximum duration)
Location : Bengaluru
Fees : Rs 36000
Mode : Online
Ranking : 2nd

About course:The regulations related to the development, sale and marketing of healthcare products have seen stricter reforms over the last few decades. Regulatory authorities are being set up in an increasing number of nations throughout the globe. Those which are already set up are restructuring their regulations and trying to match with the regulatory authorities of other nations. The regulatory standards related to healthcare products has seen rapid advancement due to changes in product safety, regulatory compliance, technological transformation, enhanced understanding of disease characteristics and customer requirements.
Course content:
Professional Diploma in Regulatory Affairs and Quality Operation
• MODULE 01: GENERAL INTRODUCTION
• MODULE 02: INTRODUCTION TO JUDICIAL SYSTEM IN INDIA, D&C ACT
• MODULE 03: SCHEDULE Y
• MODULE 04: INDIAN REGULATIONS GOVERNING CLINICAL TRIALS
• MODULE 05: REGULATORY REGIME – FDA, EMA & JAPAN
• MODULE 06: SAFETY TOPICS RELATED TO PRE-CLINICAL & CLINICAL STUDIES
• MODULE 07: COMMON TECHNICAL DOCUMENT, IND & NDA REQUIREMENTS
• MODULE 08: CMC INFORMATION & GHTF OVERVIEW
• MODULE 09: MEDICAL DEVICES, VETERINARY PRODUCTS & BIOSIMILARS
• MODULE 10: BIOPHARMACEUTICAL INDIAN REGULATIONS AND REGULATORY STRATEGIC PLANNING

Institute: Indian Biological Sciences And Research Institutes (IBRI):
Duration: 3 months,6months & 12 months Location: Noida
Fees structure:
3 months: Rs 7500
6 months: Rs 10500
12 months:  Rs 16500
Mode:Classroom
Ranking: 3rd
Course content:
3 months course:
Certificate Program in Regulatory Compliances and Affair
Paper-I: Introduction to Regulatory Affairs
Paper-II: International Licensing and Drug Regulatory Affairs
Paper-III: Regulatory Documentation for Biologics /Medical Diagnostics and Pharmaceutics (Submission of DMF, Dossiers etc.)
Paper-IV: Global Regulatory Compliance Systems
6monthscourse :
• Certificate Program in Regulations for Biologics and Pharmaceutical Product
• Paper-I: Introduction to Regulatory Affairs
• Paper-II: International Licensing and Drug Regulatory Affairs
• Paper-III: Regulatory Documentation for Biologics /Medical Diagnostics and Pharmaceutics (Submission of DMF, Dossiers etc.)
• Paper-IV: Global Regulatory Compliance Systems
12monthscourse :
Comprehensive Program in Regulatory Affairs for Pharmaceutics:
Paper-|: Introduction to Regulatory Affairs
Paper-II: International Licensing and Drug Regulatory Affairs
Paper-III: Regulatory Documentation for Biologics /Medical Diagnostics and Pharmaceutics (Submission of DMF, Dossiers etc.) Paper-IV: Global Regulatory Compliance Systems
Paper-V: Regulations for Clinical Trials, GMP, GLP and ICH Guidelines
Paper-VI: Regulatory Strategy and Quality Assurance Systems
Paper-VII: Future of Biopharmaceuticals
Paper-VIII: Research Study

Institute: GITAM Institute of Pharmacy, Visakhapatnam campus :
GITAM Institute of Pharmacy, GITAM Deemed to be University is offering a certificate course in Drug Regulatory Affairs. The course is designed to contain global regulatory requirements and practices of drugs, pharmaceuticals and medical devices. After completion of the course, the participants are expected to have in-depth knowledge and understanding of concept of global regulatory agencies and regulations on drugs and pharmaceuticals, Drug discovery and development process, Innovator and generic drug regulatory filing and approval process. The participants will be trained in GMP, GLP, GCP and quality management systems.
Duration:3 months
Location: Visakhapatnam
Fees: Rs 15000/-
Mode: Offline
Ranking: 4th
Eligibility for admission: Pass in B.Pharm,M.Pharm, M.Sc. and B.Pharm final year students.
Course content:
• The course is designed to contain global regulatory requirements and practices of drugs, pharmaceuticals and medical devices.
• After completion of the course, the participants are expected to have in-depth knowledge and understanding of concept of global regulatory agencies and regulations on drugs and pharmaceuticals, Drug discovery and development process, Innovator and generic drug regulatory filing and approval process.
• The participants will be trained in GMP, GLP, GCP and quality management systems.
Institute: Institute of Good Manufacturing Practices India(IGMPI):
Duration: 1 year & 6 months
Location: New Delhi
Fees:1,50,000-Post graduate Diploma in Pharmaceutical Regulatory Affairs.
1,20,000- Course-Executive Diploma in Regulatory Affairs (Medical Device as  major)
Mode:Regular/Online /Part time
Ranking: 5th
Course content(1 year):
• Post graduate Diploma in Pharmaceutical Regulatory Affairs:
• Module 1 : Introduction to Global Regulatory Authorities for pharma and healthcare industries Module 2 : Drug Development Process, Clinical Trials and related norms and regulations.
Module 3 : GMP and other good practices (International perspective of USA, WHO, ICH & Europe
/ Australia & New Zealand / Gulf Countries (GCC) / Canada / Africa/India etc)
Module 4 : Documentation of drug trials and regulatory filings in US,Europe, UK, India, Japan, Canada, Australia, South Africa, etc.
Module 5 : Quality Assurance and Drug Regulations, ICH and WHO guidelines
Module 6 : Dossier preparation in CTD format, eCTD submissions
Module 7 : Pharma and Healthcare industries IPR, Patents, Copyrights and Trademarks
Module 8 : Pharma and Healthcare products- Marketing, Import and Export regulations
Module 9 : Compliance guidelines, Govt. Audits (FDA, MHRA, PMDA, TGA, DCG, etc) and    
Breach reports
Module 10 : Indian GMP Regulations.
• Module 11 : Drug Registration in African Countries.
• Module 12 : Drug Registration in Gulf (GCC) Countries.
• Module 13 : AYUSH Regulatory Affairs(Ayurveda, Unani, Siddha, Homeopathy, Yoga and Naturopathy)
• Module 14 : Industry specific case studies

Course - Executive Diploma in Regulatory Affairs (Medical Device as Major) 6-12months
• Module 1: Introduction to Global Regulatory Authorities for Medical Device Industry
• Module 2: Medical Devices, In –vitro devices, Biologics & Combination Products: Introductory Module
• Module 3: FDA Regulations and Guidelines on Medical Devices
• Module 4: European Union Regulatory Guidelines on Medical Devices
• Module 5: Medical Device Regulations from Indian perspective
• Module 6: Management of the risks associated with Medical devices
• Module 7: Bio-compatibility Studies and Medical Devices
• Module 8: Clinical Trials: Medical Devices
• Module 9: Overview of In – Vitro Device Regulation
• Module 10: Overview of Combination Products Regulation
• Module 11: Dossier preparation in CTD format, eCTD submissions

Institute : RoyedTraining (Distance learning Centre) :
Royed Training is online, onsite training provider catering to FMCG, Cosmetic, Food, Pharmaceutical, Biopharmaceutical and Medical Devices industry.
Duration: 1 year
Location: Kolkata, West Bengal
Fees:35,500/-
Mode: Online
Online Ranking : 6th
PG Certification in Drugs, Biologic and Medical Devices Regulatory Affairs.
Course content :
Section 1: Fundamental of Drug Discovery and Development Section 2: Innovation/Intellectual Property Management
Section 3: Regulatory Strategic Management and Planning
Section 4: Good Manufacturing Practice
Section 5: Submission Dosier: DTC|ACTD |DMF-SMF-ANDA|505 (B)(2)|NCE|PETITION|PRIOR   APPROVAL SUBMISSION
Section-6:Quality issue , Warning letter CAPA and Data Integrity
Section-7: Biopharmaceutical (Biologics and Biosimilar)
Section-8: Medical Devices Regulation

Institute : Universal School of Biosciences :
Duration: 6 months
Location: Delhi
Fees: 90,000
Mode: Online
Ranking: 7th

Course content: Module I: Introduction to Intellectual Property Rights
• Module II: Patent Law, Practice and Procedure
• Module III: Industrial IPR Design &Trademark
• Module IV: Indian Drug Regulations
• Module V: International Drug Regulations
• Module VI: WTO, GATT, IPR, TRIPS, Orange book guidelines, EMR, GMP, GLP, US-FDA & ICH Guidelines.
• Introduction to Drug Regulatory Affairs and functions of Drug Regulatory Authorities.
• Comparison of Indian Regulatory requirements with Global standards

Institute: Physis Learning Academy
This is a self-paced certificate course will provide you a comprehensive training on the concepts & processes in drug regulatory affairs in compliance with applicable guidelines.
Duration : 6 months
Location : Delhi
Fees : 7600/-
Mode : Online/Distance
Ranking : 8th
Certificate program in Drug Regulatory Affairs:
Course content :
• Module 1: Introduction to Drug Regulatory Affairs (Evolution, Scope and Role of DRA)
• Module 2: Regulatory Authorities (USFDA, Canadian, EU, CDSCO, ICH, WHO)
• Module 3: Regulatory Requirements in Pharmaceutical (Drug Product Lifecycle – Development, Regulatory Submission, Regulatory Compliance etc.)
• Module 4: Medical Device Regulation (Definition and Classification, Steps in Development, Product Lifecycle)
• Module 5: Applicable ICH Guidelines in DRA (Q1A, Q1B, Q1C, Q1D, Q1E, Q1F, Q2, Q3, Q6, Q7)
• Assessment and Evaluation through Exam.
• Section-9: European Drug Regulatory Affairs.
• Section-10: Asian Regulatory Affairs
• Section-11:African Regulatory Affairs
• Section-12:Lattam Regulatory Affairs
• Section-13:GCC Regulatory Affairs
• Section-14:China Regulatory Affairs
• Section-15: Russia Regulatory Affairs

Article by : Sohail Ahmad, B.Pharm, INDIA
Mentor: Mohit Khandelwal, Expert Regulatory Professional, INDIA