Pharmaceutical Regulatory Affairs: Open Access

Compliance with therapy implies an understanding of how the medication is to be used, as well as a positive behavior in which the patient is motivated sufficiently to use the prescribed treatment in the manner intended, because of a perceived self-benefit and a positive outcome i.e. enhanced daily functioning and well-being. Although this is often the case, in a number of situations, the physician and pharmacist have not provided the patient with adequate instructions or have not presented the instructions in such a manner that the patient understands them. Nothing should be taken for granted regarding the patient’s understanding of how to use medication, and appropriate steps must be taken to provide patients with the information and counseling necessary to use their medications as effectively and as safely as possible.

Purpose and findings of the study: Discussion and projection of drug use and monitoring status in patients of Bangladesh. The pharmacists have a vital role to play which is thoroughly discussed. Bangladesh is a highly populated country. Economic development and academic flourishment do not represent development in health sector. Both the providers and patients are responsible for irrational drug uses and patient non-compliance or non-adherence.

Materials and methods: Research conducted a comprehensive year-round literature search, which included books, technical newsletters, newspapers, journals, and many other sources. Medicine and technical experts, pharma company executives and representatives were interviewed. Projections were based on estimates such as drug end users, providers or prescribers, general theories of rational use, implication and types of different irrational uses.

Research limitation: Very few articles found in matters regarding along with a very less interest paid by general people to talk about medicine use, prescription, suggested therapy in various illness, ADRs and their management. It was very difficult to bring out facts of irrational use of drugs, non-compliance and vigilance because business mentality of the providers very little knowledge about drugs crippled the facts.

Practical and social implication: The soul of this article was to detail about patient compliance and therapeutic drug uses with appropriate guidelines. Along with students, researchers and professionals of different background and disciplines e.g. Pharmacists, marketers, doctors, nurses, hospital authorities, public representatives, policy makers and regulatory authorities have to acquire much from this article. Along with healthcare facilities, patient compliance the soul of healthcare system in a country like Bangladesh as there is a scarcity of resources, fewer access to general people for adequate and better treatment, superstition and misbeliefs about drug, treatment and treatment providers. The article should contribute an integrated guideline for patient compliance, demand pharmacovigilance and last but not the least a silvery lining to better treatment near future.

India is the largest provider of generic drugs globally with the Indian generics accounting for 20% of global exports in terms of volume. Comparative pharmacokinetic data under the regulatory framework of bioavailability and bioequivalence (BA/BE) study data is widely accepted by the developed countries regulatory agencies over last 4 decades to establish the efficacy of the generic products. Ministry of Health and Family Welfare, Government of India recently published the ‘New Drugs and Clinical Trials Rules-2018’ vide gazette notification (GSR-104E) dated 01/02/2018. An elaborate and streamlined regulations for conducting clinical research (CT and BA/BE studies) in India has been provided in the said draft rule. It was available in the public domain for the responses of different stakeholders which will be wrapped up in near future. In the present paper, significance of the new clinical trials rules-2018 particularly in the field of BA/BE studies have been tried to capture.

Bilayer tablet is one of the great advanced technologies which contain two different layered formulations with one layer of drug provides immediate release and the other as sustained. Sumatriptan succinate is a triptans class of drug used to treat migraine headaches, which acts selectively at 5-HT1B/1D receptors. The objective is to formulate and evaluate the bilayer tablets of sumatriptan succinate of dose 50 mg. In this case immediate release layer is formulated using sodium starch glycolate, crospovidone and croscarmellose sodium as Super-Disintegrants, Sustained release layer is formulated using hydroxypropyl methylcellulose K15M, ethyl cellulose, xanthan gum and guar gum in various ratios to delay the drug release. FT-IR studies for excipients are tested for compatibility with the drug. Evaluations such as Hardness, Thickness, Friability, Weight variation, Disintegration time and Assay were determined for bilayer tablets. In vitro drug release was performed with USP dissolution apparatus type-II (paddle type) using 0.1 N Hydrochloric acid for first hours and later hours with 6.8 pH phosphate buffer by temperature maintaining at 37˚C ± 0.5˚C. Based on results among all formulations F7 formulation containing Xanthan gum and Guar gum in ratio of 1.5:1.5 showed maximum drug release of 97.41%. Thus, drug formulation of F7 has enhanced drug release profile.

Current constrain of Regulatory Affairs reveals diverse countries need to follow different regulatory requirements for Marketing Authorization Application (MAA) approval of new drugs. 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. Once a lead drug molecule has been discovered, nonclinical studies of a drug should be conducted to ensure efficacy and safety. Then, clinical trials can be performed, after an application is submitted to competent authority of the concerned country. The three phases of clinical trials are conducted as per the protocol. The competent authority reviews an application submitted to get approval for marketing the drug and approves it if satisfied that the drug supports quality, safety and efficacy concerns. Even after the approval of new drug, government should monitor its safety by post marketing surveillance which is considered as Phase IV. Though certain aspects of drug approval process are similar among different countries, some differences do occur. 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). This review outlines advances in therapy and the main spotlight for the improvement and advance of cell therapies that are being confronted today.

Health is the prime component for every person and in the world, there are different traditions have their own approaches to treat and cure illness. The dosage form of the drug may appear different but medically, however a generic medicament has the same mechanism in the body as that of the costlier brand-name drugs. They acquire the equal active ingredient and must pass the same satisfactory standards with respect to manufacturing and packaging of medicaments. The Generic medicinal drug beneath the regulation of U.S. Food and Drug Administration must have the equal quality and performance as that of the of brand-name drugs. The FDA states: “Generics have the identical quality as brand identify drugs. When a generic drug product is approved, it has met rigorous standards established via the FDA with respect to identity, strength, quality, purity, and potency. India started Jan Aushadhi scheme to make quality medicines handy to the shoppers at affordable prices. Given the socio-economic conditions and the level of ignorance and illiteracy with vast disparities of income in the country, the advantage of the scheme can be taken by the consumers or should reach the consumers particularly the poor and the needy, only when a proper multimedia publicity programmed is mounted to educate the consumers of all strata of society. India is still a developing country where quality and inexpensive remedy are still major issues.

The period between the 1940s and 1960s is commonly referred to as “the golden era of antibiotic discovery” saving million’s life and good health. However, generation and spread of multi-drug resistant bacteria are highly claiming life. MDR, XDR and PDR infections are alarming as cautioned by CDC and WHO with ten million infections worldwide. ESBL and MBL beta-lactamases (blaOXA, blaNDM1), heterogeneous acetyl/phospho/adenyl-transferases (catB3, aacC1, strA/B, aphA4, ANT) and drug efflux proteins (MFS/RND/ABC) are very much abundant in plasmids and chromosomes of most Enterobacteriaceae infections. This has happened due to three main reasons: First, mdr genes are assembled into large conjugative plasmids allowing to transfer of mdr genes into household bacteria by conjugation and secondly, drug industries are reluctant to invest in new drug discovery due to drug void following astonishingly fast mdr gene creation like blaNDM-1 and Mcr-1, inactivating carbapenems and colistin drugs that used against superbug infections; lastly, a symbiotic relation has generated signals across the bio-film for quick generation of new mdr gene against the any new oral drug consumed repeatedly. We believe abuse of multi-doses antibiotic intake without vitamins and probiotics may cause many disorders like gastrointestinal disturbances, diabetes, neurological disorders and cancer, due to death of bio-film making gut bacteria that synthesize 20 vitamins and complex bio-molecules involved in >30,000 enzymatic reactions, known as human metabolosome. Symbiotic relation is so important that 16S rRNA and 70S ribosomal proteins of bacteria are mutated as also gyrA/B and porins to withstand adverse effects of antibiotics. Many drug binding proteins have also increase the drug MIC like TetM and PenA. Due to high cost of new antibiotics, gene medicines and cancer drugs, >100,000 household are plunged into poverty line each year due to inadequate medical insurance coverage in most Asian, African and Latin American countries. As population was reached 7000 million, we need social reforms and united research agenda to lower the cost of drug. Heterogeneous phyto-antibiotics will solve the problem based on ancient Hindu and Chinese civilization but land reform is must to get enough cultivation of medicinal plants.