scholarly journals Pharmacovigilance in generic Indian pharmaceutical industries - Need of the moment

2021 ◽  
Vol 2 (2) ◽  
pp. 7-12
Author(s):  
Porus Rajpurohit ◽  
Manoj Suva ◽  
Hardik Rajpurohit ◽  
Yogesh Singh
Keyword(s):  
Adverse Reactions ◽  
Product Information ◽  
Drug Approval ◽  
Guidance Document ◽  
Medicinal Products ◽  
Regulatory Guidance ◽  
Suspected Adverse Reactions ◽  
Pharmaceutical Industries ◽  
Human Use ◽  
Drug Approval Process

Introduction: The pharmacovigilance department is liable for monitoring the safety of medicines during clinical trials and normal clinical use. The necessity of the pharmacovigilance department is an utmost requirement for effective regulations of the drug approval process and conscious pre and post-approval vigilance of the undesired effects, especially in India. Methods: In the light of the regulatory notification GSR 287(E) dated on 8th march 2016 by CDCSO, it has become clear that it is necessary to take measures to set up and improve the operation of the pharmacovigilance of medicinal products for human use in pharmaceutical companies.  Results: The regulators have also developed and posted Guidance document for marketing authorization holders (MAH) for Indian marketers and made clear that the MAH should be responsible for continuously monitoring the safety of its medicinal products for human use, for updating the health authorities of any changes related to the drug, and for ensuring that the product information is kept up-to-date. MAH should record all suspected adverse reactions occurring in the country, and which are brought to their attention spontaneously by the patients or their health care, or occurring in the context of the post-authorization study. Conclusions: According to the Regulatory Guidance document, MAH is also responsible for the submission of the information on suspected adverse reactions of a newly approved drug or applicable product, in form of periodic safety update reports (PSURs), to the competent authorities.

scholarly journals Overview of suspected adverse reactions to veterinary medicinal products reported in South Africa (March 2003 - February 2004) : report

2005 ◽  
Vol 76 (1) ◽  
Author(s):  
V. Naidoo ◽  
R. Sykes
Keyword(s):  
South Africa ◽  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Medical Profession ◽  
Drug Reactions ◽  
Medicinal Products ◽  
Medicines Information ◽  
Suspected Adverse Reactions ◽  
Suspected Adverse Drug Reactions ◽  
Veterinary Medicinal Products

The Veterinary Pharmacovigilance and Medicines Information Centre is responsible for the monitoring of veterinary adverse drug reactions in South Africa. An overview of reports of suspected adverse drug reactions received by the centre during the period March 2003 to February 2004 is given. A total of 20 reports was received. This had declined from the previous year. The general apathy with regards to the reporting of adverse drug reaction has prompted the Medicines Control Council to make reporting a legal obligation on all members of the veterinary and medical profession as from August 2004. The majority of reports involved suspected adverse reactions that occurred in dogs and cats. Most of the products implicated were Stock Remedies. Veterinarians predominantly administered these products. Only two reports were received from a veterinary pharmaceutical company.

scholarly journals A comprehensive review on registration requirements for Drug Approval in India, South Africa and US

2021 ◽  
Vol 9 (1) ◽  
pp. 62-71
Author(s):  
Veer J. Patel ◽  
Dasharath M. Patel
Keyword(s):  
South Africa ◽  
Drug Product ◽  
Drug Approval ◽  
Drug Products ◽  
Technical Requirements ◽  
National Regulatory Authority ◽  
Regulatory Guidelines ◽  
Pharmaceutical Industries ◽  
Drug Approval Process ◽  
The Comparative Study

The drug approval process is country-specific. The regulatory framework of all the national regulatory agencies differ from one another in terms of administration and product specific guidelines for registration of drug and drug products in a particular country. Every national regulatory authority provides regulatory guidelines for drug or drug product registration and the pharmaceutical industries which rely upon these guidelines prepare drug applications along with all the required administrative, non-clinical and clinical data in the form of a technical dossier which is known as Common Technical Document. This Dossier is prepared either in an electronic format or in the paper submission format. This review focuses on the comparative study of the registration requirements for getting a drug approval in India, South Africa and United States of America. The significant differences between the technical requirements of these three markets have been discussed in detail.

scholarly journals Overview of suspected adverse reactions to veterinary medicinal products reported in South Africa (March 2004 - February 2006) : report

2006 ◽  
Vol 77 (3) ◽  
Author(s):  
V. Naidoo ◽  
R. Sykes
Keyword(s):  
South Africa ◽  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Drug Reactions ◽  
Medicinal Products ◽  
Medicines Information ◽  
Lower Figure ◽  
Suspected Adverse Reactions ◽  
Suspected Adverse Drug Reactions ◽  
Veterinary Medicinal Products

The Veterinary Pharmacovigilance and Medicines Information Centre is responsible for the monitoring of veterinary adverse drug reactions in South Africa. An overview of reports of suspected adverse drug reactions received by the centre during the period March 2004 to February 2006 is presented. A total of 21 reports was received in the 2-year period, continuing the decline in the number of reports to a lower figure than in any previous year. This is surprising considering the legal obligation of the veterinary professionals to report all adverse drug reactions. Once again the majority of reports involved suspected adverse reactions that occurred in dogs and cats. Most of the products implicated were stock remedies. Veterinarians predominantly administered these products.

scholarly journals Overview of suspected adverse reactions to veterinary medicinal products reported in South Africa (March 2002 – February 2003)

2003 ◽  
Vol 74 (4) ◽  
Author(s):  
V. Naidoo
Keyword(s):  
South Africa ◽  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Drug Reactions ◽  
Medicinal Products ◽  
Medicines Information ◽  
Veterinary Pharmaceutical ◽  
Suspected Adverse Reactions ◽  
Suspected Adverse Drug Reactions ◽  
Veterinary Medicinal Products

The Veterinary Pharmacovigilance and Medicines Information Centre is responsible for the monitoring of veterinary adverse drug reactions in South Africa. An overview of reports of suspected adverse drug reactions received by the centre during the period March 2002 to February 2003 is given. In total, 40 reports were received. This had declined from the previous year. Most reports involved suspected adverse reactions that occurred in dogs and cats. Most of the products implicated were Stock Remedies. The animal owner predominantly administered these products. Only 1 report was received from a veterinary pharmaceutical company. Increasing numbers of reports are being received from veterinarians.

scholarly journals Overview of suspected adverse reactions to veterinary medicinal products reported in South Africa (March 2001 - February 2002) : report

2002 ◽  
Vol 73 (4) ◽  
Author(s):  
V. Naidoo ◽  
R. Gehring
Keyword(s):  
Adverse Reactions ◽  
Pharmaceutical Companies ◽  
Drug Reactions ◽  
Medicinal Products ◽  
Information Centre ◽  
Medicines Information ◽  
Veterinary Pharmaceutical ◽  
Suspected Adverse Reactions ◽  
Suspected Adverse Drug Reactions ◽  
Veterinary Medicinal Products

An overview of reports of suspected adverse drug reactions received by the Veterinary Pharmacovigilance and Medicines Information Centre during the period March 2001 to February 2002 is given. A total of 77 reports were received. The majority of reports involved suspected adverse reactions that occurred in dogs and cats. Most products implicated in the reports were Stock Remedies. The products were predominantly administered either by veterinarians or trained paraveterinary professionals. Although the majority of reports were received from veterinary pharmaceutical companies, the proportion of reports received directly from veterinarians increased compared with previous years.

scholarly journals Regulatory advances and prospects of variation filing for the registered parenteral products in USA and Europe

2021 ◽  
Vol 9 (2) ◽  
pp. 52-65
Author(s):  
Rajdeep G. Makwana ◽  
Kuldeep V. Desai ◽  
Vaibhav Kikani ◽  
Maulikkumar D. Vaja
Keyword(s):  
Academic Research ◽  
Drug Approval ◽  
New Drugs ◽  
Regulatory Requirements ◽  
Complementary Medicines ◽  
International Agencies ◽  
Regulatory Affairs ◽  
Pharmaceutical Industries ◽  
Drug Approval Process ◽  
Parenteral Products

Drug Regulatory Affairs (DRA) is a vital unit in a pharmaceutical company. It is concern about the healthcare product lifecycle, it provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safety and efficacy in pharmaceuticals, veterinary medicines, medical devices, cosmetics and complementary medicines, healthcare products to individuals around the world. Regulatory affairs (RA) professionals are employed in pharmaceutical industry, government, academic research and clinical institutions. As India is growing very rapidly in pharmaceutical sector, there is a need of regulatory affairs professionals to cater the current needs of industries for the global competition. Regulatory affairs professionals are the link between pharmaceutical industries and worldwide regulatory agencies. A regulatory affair is a somewhat new profession which has developed from the desire of governments to defend public health. Substantial documentation and data are required in these types of submissions, resulting in large, complex applications. Today 35 member countries along with 11 candidate countries and 4 international agencies have joined together to create the Pharmaceutical Inspection Cooperation Scheme (PIC/S) to promote a globally accepted GMP. Current constrain of Regulatory Affairs reveals diverse countries need  to follow different regulatory requirements for  marketing authorization  Application (MAA) approval of new drugs. In this present exertion, study expresses the drug approval process and regulatory requirements according to US Food and Drug Administration (UDFDA), European Medical Agency (EMA) and Central Drug Standard Control Organization (CDSCO).

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