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Jitendra Kumar Badjatya

Jitendra Kumar Badjatya
IJDRA Publishing group · Drug regulatory affairs

M.Pharm, MIPL, Ph.D.

About

28
Publications
139,395
Reads
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76
Citations
Citations since 2016
17 Research Items
71 Citations
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2016201720182019202020212022051015
Introduction
Working as Editor in chief in IJDRA journal and in Pharma industry & Ensuring regulatory compliance and dossier life cycle management (US, EU, Australia, ROW), CMC specialist, DMF, cGMP, GDP regulation, Patent, and Product development. Products: Pharmaceuticals, OTC, Drug Substance, and Cosmetics. Dosage form: Tablets, Capsules, Injections, Liquids, Ointments, Nebulizers, PFS, and Granules. Submission format: CTD, ACTD, Regional, Electronic submissions (NeeS, eCTD and SDR). Submission Type: New, Variations, and Renewals.

Publications

Publications (28)
Article
Full-text available
Nutraceuticals are bioactive or natural chemical components that are been marketed all over the world. It claims to be disease preventing along with health promoting product with some of the medicinal properties. It is categorized as vitamin, mineral, animal product and health supplement. Nutraceuticals has the major advantage over the medicines as...
Article
Full-text available
This topic aims at reviewing the drug and drug product filing and obtaining USFDA EMEA and TGA approval and its effective role to improve the standards which are laid by them. The respective Regulatory Agency approves the new/generic drug products that govern respective market before introduction of particular product into the market. The Regulator...
Article
Full-text available
Registration of Pharmaceutical drug product in Emerging Market is most demanding task. Regulatory requirements are harmonized in regulated countries by Common technical document (CTD) filing, while there is diversity of requirements in emerging markets. International conference on Harmonization of Technical Requirements for Registration of Pharmace...
Article
Full-text available
This article states requirement of Marketing Authorization Application to get registration of Drug Product to EEA. The procedures for application of marketing authorization are: Centralised procedure, National procedure, Mutual recognition procedure, Decentralised procedure.
Article
Full-text available
A Drug Master File or DMF is a reference source that provides drug evaluator’s confidential information not available to drug product manufacturer about the specific process and components used in the manufacturing, processing and packaging of a drug meant for Human/Animal use. The submission of a DMF is not required by law or FDA regulation. A DMF...
Article
Full-text available
Timely Product registration is a challenge in today’s scenario. Regulatory agencies are keen in assessing CTD sections like redefining starting material of Drug substance manufacturing, Pharmaceutical development, impurities in Drug substance and Drug product, Container-closure. Common deficiencies are presented in this article.
Article
Full-text available
Most thoughtful way to sustain in this competitive highly regulated Pharma generic industry environment is depended on understanding the concept of the product life cycle management (PLCM). Fact is a very less number of Pharma professionals have been familiarized them with this fascinating strategic concept. So, it’s the time now to convey that wha...
Article
Provisions of Compulsory License balance this law between interest of Inventor & public as through these provisions License can be provided to others if the invention did not use sufficiently for Public. In case of medicine this law remains in debate from its beginning as Drugs are essential & Life saving commodities & monopoly on drugs products ca...
Article
Full-text available
The TRIPs Agreement has led to a reinforcement of the protection of intellectual property, particularly in many developing countries. From the point of view of transfer of technology, the imitation of technologies from industrialized countries and the marketing of the resulting products will now be more difficult. The MNCs are also expanding vigoro...
Article
The drug approval process is the vehicle through which drug sponsors formally approve a new pharmaceutical for sale and marketing. The goals of the approval process are to provide enough information about the drug safety and efficacy in human beings. Every country has its own regulatory authority, which is responsible to enforce the rules and regul...
Article
The urgent requirement to rationalize and harmonize regulation was impelled by instance of rising cost of Healthcare, Research and Development and need to meet the public requirement to approach for the safe and efficacioustreatments to patient in need. ICH committee has given priority to harmonize the format of reporting data for quality,safety an...
Article
Full-text available
There found a diversity of regulatory requirement in Semi regulated market. This region consists of mainly thecountries from Asia pacific, Latin America, Eastern Europe, Africa and Gulf countries. Countries from Asia pacificand Gulf have somewhat harmonized their regulatory environment through The Association of Southeast AsianNations (ASEAN) and G...
Article
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This aims to compare the generic drug approval and registration process in the regulatory market of Europe, USA andBrazil. Based on the information collected from various sources such as regulatory sites, Government websites,discussion with regulatory agent, interviewing pharma professionals and literature survey from various journals, aclear pictu...
Article
Russia is poised to be among the top five Global pharmaceutical markets in terms of value in the next five years. The registration is a state procedure of drug quality, efficacy and safety evaluation to obtain an approval for medical use of a drug in the Russian Federation. The designated federal executive authority regulating drug registration iss...
Article
Full-text available
In today scenario, as per market demand there is definitely carry out an increment or decrease in production, this is called SUPAC. Different guidelines are provided for those different types of SUPAC in by different regulatory authority for manufacturing of product. Here SUPAC guidelines for USFDA are elaborated for production in this review artic...
Article
Full-text available
Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the p...
Article
Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the p...
Article
Full-text available
Present study was conducted to examine the association of self- medication and health locus of control. It was also intended to know the health problems for which people do self – medication and the medicines which are more often bought by those who do self-medication. Initially a sample of 200 persons was selected on non-random purposive sampling...
Article
Generic medicines are those whose patent protection has expired, and which may be produced by manufacturers otherthan the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost savingmeasure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. Theobject...
Article
Full-text available
Generic medicines are those whose patent protection has expired, and which may be produced by manufacturers other than the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost saving measure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. The obj...
Article
Full-text available
A generic drug is a product that is comparable to brand/reference listed drug product in dosage form, potency, route of administration, quality and intended use. Generic drugs are equal and within the acceptable bioequivalence range to the brand name drugs. Branded drugs are typically sold at elevated prices as a large substantial human interventio...
Article
Full-text available
Pharmaceutical drug regulatory affairs govern registration parameters of pharmaceutical products. It has a broad spectrumcovering all aspects of documentation and marketing in legalized form. The pharmaceutical industry is highly regulatedindustries in our country. Regulatory affairs professionals are need of present market scenario to cater to lin...
Article
Product registration in rest of world is a challenging task like regulated countries (US, EU & Japan) as they are not harmonized. It creates a difference in regulatory environment in Semi Regulated countries. Enormous diversity of regulatory requirements are found in this area. This region consists of mainly the countries from Asia pacific, Latin A...
Article
Full-text available
Pharmaceutical product registration is a demanding task in regulated, semi regulated and rest of world countries. Although the requirements are harmonized in regulated countries by CTD (Common technical document) filing, yet others have enormous diversity in requirements.ICH (International conference on Harmonization of Technical Requirements for R...

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