MDU

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ABOUT AUTHORS
Bhupender Singh, Arun Nanda, Vikaas Budhwar, Rakesh K. Marwaha
Department of Pharmacy,
M. D. University, Rohatak
Haryana, India
* pharma.bsingh@gmail.com

ABSTRACT
Generic drugs are as effective as their branded counterparts in terms of safety and efficacy. Although their exists several myths about quality of generic medicines because of its less price as compared to branded counterparts. The present study aims to evaluate and compare the quality of generic medicine with their branded counterparts as per Indian Pharmacopoeial standards and other validated methods on a commonly used type 2 diabetes drug (Metformin). The qualitative as well as quantitative studies were performed as per IP 2010. The official test performed includes uniformity of weight, disintegration, dissolution, assay and friability. Non official test includes hardness test and assay by HPLC using validated methods. The study revealed that branded as well as generic metformin tablets comply with the standards provided in IP 2010 and generic metformin was found to be 111.52% lesser in cost per tablet as compared to costliest branded version of metformin.

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ABOUT AUTHORS
Annu*, Priyanka
Department of Pharmaceutical Sciences,
Maharshi Dayanand University, Rohtak, Haryana, India.
*annu.gvm@gmail.com

ABSTRACT
Adverse drug reaction (ADR) is the noxious and unintended response that occurs at the dose of drug normally used for prophylaxis, diagnosis or therapy of disease. ADRs cause a huge burden on the modern society because of the increase incidence of the morbidity and mortality. ADRs can occur with any class of drugs and the availability of the more and more number of therapeutics increases the risk of ADRs consequently. It has been found that the maximum numbers of ADRs occur more among infants and children and also they are generally more severe as compared to adults. ADRs are of particular interest in today’s practice because clinical trials are done in the limited number of the subjects and therefore the drug which is found safer in the clinical trial may produces serious ADRs. The most common reason for this is that the clinical studies generally have limited sample size and have low statistical power. Therefore the ADRs monitoring is an essential need for the better health care and therefore the health care centre should promotes the spontaneous monitoring, reporting, documentation and prevention of ADRs.

Maharshi Dayanand University, ab initio established as Rohtak University, Rohtak, came into existence by an Act No. 25 of 1975 of the Haryana Legislative Assembly in 1976  with the objective to promote inter-disciplinary higher education and research in the fields of environmental, ecological and life sciences. It was rechristened as Maharshi Dayanand University in 1977 after the name of a great visionary and social reformer, Maharshi Dayanand.

About Authors:
Apeksha Gupta
Maharshi Dayanand University,
Rohtak, India.
apekshagupta87@gmail.com

ABSTRACT
The word “Dossier” has its English meaning as - a collection or file of documents on the same subject, especially a file containing detailed information about a person or a topic. Any preparation for human use that is intended to modify or explore physiological systems or pathological states for the benefit of the recipient is called as “pharmaceutical product for human use”. Process of reviewing and assessing the dossier of a pharmaceutical product containing its detailed data (administrative, chemistry, pre-clinical and clinical)  and the permission granted by the Regulatory Agencies of a country with a view to support its marketing / approval in a country is called as the “Marketing Approval  or the “Registration” “Marketing Authorization” or the “Product Licensing”.
“Registration Dossier” of the pharmaceutical product is a document that contains all the technical data (administrative, quality, nonclinical and clinical) of a pharmaceutical product to be approved / registered / marketed in a country. It is more commonly called as the New Drug Application (NDA) in the USA or Marketing Authorization Application (MAA) in the European Union (EU) and other countries, or simply Registration Dossier. Basically, this consists of data proving that the drug has quality, efficacy and safety properties suitable for the intended use, additional administrative documents, samples of finished product or related substances and reagents necessary to perform analyzes of finished product. Therefore, they are the vehicle in a country through which drug sponsors formally propose that the Regulatory Agencies approve a new pharmaceutical for sale and marketing.