Presently different countries must follow different regulatory requirements for sanction of new drug. Marketing Authourization Application (MAA) is a single. Every country has its own regulatory authourity which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. USFDA is the regulatory agency which is responsible for safety regulations of the food and drug products in U.S. EMA is the regulatory agency/decentralized body which is responsible for safety regulation of the food and drug products in Europe.

KEY WORDS: MAA, EMA, USFDA.

By increasing the catecholamine release, insulin has the ability to improve the cardiovascular functioning with limited
evidences. Some studies also reported that myocardial function has improved followed by insulin administration without
any increase in catecholamine levels. In 1999 on a report of drug-induced cardiogenic shock, with various drugs like
amlodipine, atenolol and/or verapamil overdose, among 4 patient, no traditional therapy of antidote was proven to be
effective in comparison with insulin-euglycemia therapy. Thus, reporting insulin euglycemic therepy (IET) to be more
effective in improving cardiovascular functioning during drug-induced cardiogenic shock ,in similar way in septic
‘cardiomyopathy’ , heart failure with reduced ejection fraction (HFREF) which should be evaluated . Patients brought to the
hospital with symptoms of cardiogenic shock which includes breathlessness, rapid heartbeat, low blood pressures,
diaphoresis, low cardiac output, with adequate intravascular volume. The patients have cool and clammy extremities, poor
capillary refill, tachycardia, narrow pulse pressure, and low urine output and pale skin have been enrolled into the study .
The common symptoms observed in the study population included increased heart rate, low blood pressure for both systolic
and diastolic. Decreased myocardial contractility activity resulting in decreased oxygen supply to the heart which was
reflected as decreased central venous oxygen saturation (Scvo2) levels. It was clearly observed and concluded from the
study that serum Lactate (mmol/L) has been reported to be slightly increased in insulin euglycemic therapy whereas, more
elevated in other group. Ejection fraction is effectively maintained in IET group when compared with OTM group. Similarly
mean arterial blood pressure values were maintained effectively in Insulin-euglycemic therapy group in comparison with
other group. Thus, it can be concluded that insulin euglycemic therapy may be effective in management of non – ischemic
cardiogenic shock , by shifting energy substrate from free fatty acid to glucose metabolism in non-ischemic cardiogenic
shock. The preponderance of evidence demonstrates that the positive inotropic effects of insulin occur because of metabolic
support of the heart during hypodynamic shock.

In India, thousands of flower species have been used as food and medicine in folk and Indian system of Medicine. Flowers are an integral part of our lives and are associated with the most poignant moments of human experiences like celebrations or grieving. Flowers are playing an important role in our day to day life directly or indirectly which act most significant role in the pollination. They have been an integral part of human beings since ancient times for various purposes like ornamental, decorations, medicine, nutrients/foods, during religious rites, to pray gods, culinary preparations, essential oils, and in beauty care products etc. An ethno pharmacological survey was carried out among the ethnic groups (Kani) in the southern Western Ghats of Tamil Nadu and traditionaly used 33 plant species belonging to 21 families and 30 genera are described under this study. In This communication, the informations recieved from the tribal were compared with already existing literature on ethnopharmacology of India. The documented ethnomedicinal flowers are used for various ailments either singly or in combination with other drugs. The unani medicinal plants used by kanis are arranged alphabetically followed by the Botanical name, Family name, Voucher specimen no, Unani name, Local name, Mode of application are discussed. Moreover life form of medicinally used flowers is 14 herbs, 12 trees and 7 shrubs are recorded and status of flowers is 26 in commonly available 6 are rare and one is sporadic in the study area. The traditional use of flowers in treating various ailments is a common practice among the tribal communities, depending on the socio-economic conditions of the people. The multiple uses of these flowers suggest to further investigation regarding phytochemical analysis and pharmaceutical applications.