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International Journal of Drug Regulatory Affairs

Journal Papers (11) Details Call for Paper Manuscript submission Publication Ethics Contact Authors' Guide Line
1 CONCEPT OF 505 (b) (2) APPLICATION: BENEFITS AND CHALLENGES, Chaitanya Prasad K*, Prabodh M , Ashish S, Suthakaran R
A 505(b) (2) application is a new drug application (NDA) delineated in section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.505(b)(2) application is one that one or a lot of the investigations relied upon by the applicant for approval "were not conducted by or for the applicant and has not obtained a right of reference or use from the person by or for whom the investigations were conducted. Section 505(b) (2) was added to FFDC Act by the Drug price competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments). The applicant will depend on either revealed literature or agencys findings of an antecedent approved drug. This approval route was designed to encourage innovation and to eliminate expensive and long duplicative clinical studies. Keywords: ANDA; Clinical Trials; CFR; Exclusivity; FFDC Act; Hatch Waxman Act; 505 (b) (1); NDA; NME.
2 REGULATORY PERSPECTIVES OF PHARMACEUTICAL PRODUCTS IN GHANA, Raja Mohan Reddy. G, Venkatesh M. P., Pramod Kumar T.M.
Drug Registration is a procedure of expertise of pharmaceutical product quality, efficacy and safety by the Regulatory Authority. The emergence of various formats has enabled the manufacturers of the drug to easily gain access into various markets and thus was able to place their products into the market. The choice of Ghana as one of the destinations for the market of the Drug products ensures the manufacturer a good market value. Ghana is considered as one of the growing pharmaceutical market in east Africa. Of late, generic drugs are holding a major stake in the pharmaceutical market and are gaining more and more confidence in the usage. Majority of medicines in the Ghana are generic drugs which are considered as value for the money and affordable. With Ghana Regulatory Authority is the Food and Drugs Board, which takes decision to register the product and issues Registration Certificate. This study mainly focuses on the regulatory environment, registration process involved and the regulatory requirements that are applicable for the generic drug products in Ghana. Keywords: Ghana; FDB; Generic Drugs; NHIS.
3 COMMON DEFICIENCIES RAISED BY VARIOUS REGULATORY AGENCIES, 1Mohidekar S*, 1Maharao V, 2Badjatya J.K.
Timely Product registration is a challenge in todays 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. Keywords: Deficiencies; starting material; Impurities; ICH CTD.
4 A PARADIGM SHIFT IN DRUG REGULATIONS IN TAIWAN, Parasiya S.K.R*, Balamuralidhara V., Pramod Kumar T.M., Gujarati R, Shukla A, Kshatri V.
Across Asia, a convergence of economic trends, government policies and greater awareness among the general public of healthcare issues has created an environment that is poised for dramatic growth and change. Taiwan, for instance, can be taken as an example. Taiwan has one of Asia's most highly-praised healthcare systems with excellent provision of healthcare and key health outcomes. Nevertheless, the government is facing new pressures for public healthcare reforms as result of a rapidly ageing population and rising healthcare costs. This paper provides an introductory overview of Taiwans sudden changes in its Drug regulations due to TFDA (The Taiwan Food and Drug Administration) establishment in 2010, TFDA of the Department of Health (DOH) made an advance announcement about the amendment draft of the Provisions Governing the Registration and Market Approval of Drugs, which amends a total of 40 Articles. Without impeding the quality, safety and therapeutic effect of Drugs, most of the amended Articles are about simplification of application procedures and loosening of regulations for Drug registration and market approval. Regulations loosened are imposed on new Drugs, Radioactive Drugs, Allergenic Drugs and Drugs for export that is intended to accelerate the process to sell new Drugs on the market and promote the export of domestically manufactured Drugs. As a result of these changes in regulations many pharmaceutical MNCs and local manufacturers explored their business in Taiwan due to quick approval of their NDAs and gained more flexibility in the local market. To support Taiwan's generic Drug industry, DOH has also decided to take measures to simplify and reduce the ANDA application time. Keywords: Taiwan; TFDA; DOH; Drug Regulation
5 EXCLUSIVITY STRATEGIES OF INNOVATOR DRUG DEVELOPERS, Chaitanya Prasad K, Prabodh M , Ashish S, Suthakaran R,Naveen Reddy M, Ravindra Reddy M
Pharmaceutical drug development had become very costly and time consuming. There is an estimate that a drug from molecular development to marketing approvals cost $800 Millions. Drug approval process is time consuming process most companies loss their patent exclusivity before drug gets marketing approvals. To prevent innovators from monetary losses occurred in drug development and to encourage innovation US FDA and EMEA introduced exclusivities under various categories. Within the period of drug exclusivity no application is accepted either ANDA or 505 (b) (2). Keywords: FDCA; EU; Exclusivity; FDA; EMEA; CDER; NDA; ANDA; Hatch Waxman Act.
6 INDONESIAN PATENT SYSTEM: AN OVERVIEW, Prabodh M, Chaitanya Prasad K, Ashish S, Suthakaran R, Abhijit K.
Intellectual property protection is a one type of protection to the innovator from their creative efforts. On November 1, 1991, the Indonesian Parliament passed Law No. 6/1989 on Patents. The new law came into effect on August 1, 1991. The patenting system in Indonesia is discussed using some recent statistics and their fees, patent exclusivity, litigation, grace period. As of 1989, there have been over 13,000 applications for temporary patent registration, 96% of which were of foreign origins. None of the applications were denied, were ever granted because no patent Law existed. In this paper discussed brief introduction about Indonesia patent system. Keywords: Indonesia; Patent filing; New Patent law; Compulsory license; Residential and non-residential requirements.
7 A PRAGMATIC WAY TO SUSTAIN IN GENERIC PHARMA ENVIRONMENT: PLCM THROUGH REGULATORY STRATEGIES, Tripathy S, Murthy P. N., Patra B.P., Dureja H, Badjatya J.K.
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, its the time now to convey that what does this PLCM means and how to put it into work. The objective of this article is to convey the use of PLCM as a strategic concept for enhancing drugs sustainability in market for a long time, making better business decisions, enhancing profitability and finally delivering affordable, quality embedded generic drugs to customers. Also, in this manuscript an attempt has been made to compare corresponding regulatory agencies (US, EU, Canada and India) insights and view on preference of PLCM application. By careful analysis, its revealed that US provides most favourable environment to employ various PLCM strategies, wherein EU is equally good, nonetheless national polices could be a barrier, Canada is difficult to comprehend due to stringent laws and limited exclusivity and as of now India has least scope for PLCM application. Keywords: Product Life Cycle Management (PLCM); Regulatory strategies; Pharma generic industry.
8 ORAL FAST DISSOLVING DRUG DELIVERY SYSTEM: A MODERN APPROACH FOR PATIENT COMPLIANCE, Pallavi C. Patil, Shrivastava S.K., Vaidehi S, Ashwini P.
This review represents importance of mouth dissolving films as compared to other oral dosage forms. Fast dissolving oral drug delivery system are solid dosage form which disintegrate or dissolve within seconds when placed in the mouth without need of water or chewing. First developed fast dissolving dosage form in formulation and the rapid disintegrating properties were obtained through a special procedure or formulation modification, hence mouth dissolving film is proved to be better alternative in such cases. This fast dissolving drug delivery system is suited for the drugs which undergo high first pass metabolism and is used for improving bioavailability. Mouth dissolving film consists of thin oral strip; which release active ingredients immediately after uptake into oral cavity. In present investigation, an attempt has been made to develop oral fast dissolving film. Availability of larger surface area that leads to rapid disintegrating and dissolution in the oral cavity. Keywords: Fast Dissolving Oral Films; Oral Strip; Film Forming Polymer; Solvent Casting Method.
9 ORAL FAST DISSOLVING DRUG DELIVERY SYSTEM: A MODERN APPROACH FOR PATIENT COMPLIANCE, Pallavi C. Patil, Shrivastava S.K., Vaidehi S, Ashwini P.
This review represents importance of mouth dissolving films as compared to other oral dosage forms. Fast dissolving oral drug delivery system are solid dosage form which disintegrate or dissolve within seconds when placed in the mouth without need of water or chewing. First developed fast dissolving dosage form in formulation and the rapid disintegrating properties were obtained through a special procedure or formulation modification, hence mouth dissolving film is proved to be better alternative in such cases. This fast dissolving drug delivery system is suited for the drugs which undergo high first pass metabolism and is used for improving bioavailability. Mouth dissolving film consists of thin oral strip; which release active ingredients immediately after uptake into oral cavity. In present investigation, an attempt has been made to develop oral fast dissolving film. Availability of larger surface area that leads to rapid disintegrating and dissolution in the oral cavity. Keywords: Fast Dissolving Oral Films; Oral Strip; Film Forming Polymer; Solvent Casting Method.
10 ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF DILTIAZEM HYDROCHLORIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP- HPLC, Bhagyashree R. Patil, Bhusnure O.G., Paul B. N., Ghodke A. Y., Suraj S. Mulaje.
A simple, specific, precise and accurate Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the estimation of Diltiazem Hydrochloride in bulk and pharmaceutical dosage form. The chromatographic determination was performed on isocratic high performance liquid chromatography system of Agilent model no.1220. The separation was conducted by using column of Zorbax [C8 (5?, 4.6 mm250)] with mobile phase consisting of buffer and Acetonitrile in the ratio of (60:40). The mobile phase was delivered at the flow rate of 1.0ml/min. The eluent was monitored at wavelength 240 nm and found a sharp and symmetrical peak with retention time of 4.66min. The method was validated for linearity, accuracy, precision, specificity, robustness. Recovery of Diltiazem Hydrochloride was found to be in the range of 98%-102%. The method was found to be linear over the concentration range 50-150 ?g/ml with coefficient correlation r2 = 0.995. After developing method, validation parameters were carried out successfully and obtained results were complied with USP monograph. Keywords: Diltiazem Hydrochloride; Precision; Accuracy; Method Validation; Reverse phase chromatography.
11 SYNTHESIS AND CHARACTERIZATION OF A NOVEL BONE GRAFT MATERIAL CONTAINING BIPHASIC CALCIUM PHOSPHATE AND CHITOSAN FORTIFIED WITH ALOE VERA, Srividya S , Sastry T.P., Jeevitha D, Samiksha N
The bone grafts were prepared using nanohydroxyapatite (nanoHAP) with the extracts of AV and mixed with beta tricalcium phosphate (?TCP) in a ratio of 60:40. The formed BCP was then conjugated with CH to form the bone graft. The Phytochemicals of AV imparts an anti-inflammatory and wound healing property to the bonegraft in addition to its osteoconductivity. The bone graft was subjected to various conventional characterization techniques like FTIR, XRD, SEM, UV spectrophotometric analysis, compression and tensile strength to reveal its chemical composition, surface morphology and mechanical strength. The UV spectrophotometric analysis and SEM images revealed the mineral deposition on the bone graft after immersing in SBF, thereby increasing its ossification property. FTIR and XRD revealed the presence of BCP with nano HAP crystals and Chitosan in the graft. Compression and tensile strength of the graft showed that the graft can be used in nonload bearing areas. In this study, a bone graft was synthesized using a novel technique of introducing the extracts of AV in the graft along with BCP and CH. The results revealed that the bone graft can be used as an Osteoconductive material for various biomedical applications. Keywords: Aloe vera; Biphasic calcium phosphate; Chitosan; Nanohydroxyapatite; ?-tricalcium phosphate; Bone graft.