International Journal of Drug Regulatory Affairs

32-36

Authors: 1Gupta Rajkumar

The sourcing of raw Gelatin for manufacturing hard Gelatin Capsules is a very critical function. It involves a thorough quality audit of the suppliers. The most critical audit points are: source of Gelatin used, quality control and quality assurance procedures, packaging system and storage conditions. In addition to these the facility shall be checked for domestic and international quality certifications and advance quality features.

29-31

Authors: 1Gupta Rajkumar

ANDA constitutes an important submission for marketing authorization of generic drugs. The FDA has recently mandated an electronic submission in the form of eCTD for the same. ANDA application is quite complex with respect to patent rights and BE evaluations. The incomplete applications are often refused to file and the accepted applications some time get disqualified due to technical deficiencies at the manufacturing site. Recently FDA has rejected many ANDA applications in ASEAN region on account of data integrity.

18-28

Authors: 1-3Amari A.S.G*, 1N’Guessan A, 2Sackou J.G, 3Amonkou A.C, 3Alloukou P.M, 3Duncan R.

With the blessing of WHO, the different regions of West Africa engaged in Pharmaceutical regulation harmonization processes on the continent. Indeed, In west Africa, WAEMU actions on the matter ended in the production of juridical rules opposable to member states who rationalize watching/control procedures and medicine marketing for both human medicine and veterinary products. What remains then to member states is to appropriate community regulation hoping that Pharmaceutical cooperation reinforcement with ECOWAS, that other sub regional economical organization, grows stronger in order to improve drug use and manufacturing in West African area.

12-17

Authors: 1 Mathur V*, 2Musyuni P.

Plant Variety Protection (PVP) legislation provide for the establishment of an effective system for protection of plant varieties, the rights of farmers and plant breeders to encourage the development of new varieties of plants. The TRIPS agreement has established the minimum standards for protection and enforcement of plant varieties by the each member country. TRIPS left to each country’s discretion whether to protect new plant varieties by means of patent or by effective sui generis system or by any combination thereof. In India and Africa protection to new plant varieties is provided through PVP Acts. This paper discusses the salient features of the PVP laws of these countries. The PVP law affects the agriculture based economy in countries such as India and Africa in a significant way, thus, economic implications of this law are discussed herein.

1-11

Authors: 1Prajapati Vishal*, 1Goswami Rahulgiri, 1Makvana Pratik, 2Badjatya Jitendra Kumar

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 public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on drug approval process in different countries like USA, Europe and India.