Global Summit on Generic Drugs and Quality Control September 07-08, 2020 Prague, Czech Republic

Bioequivalence (BE)/ bioavailability(BA) studies play a major role in drug development both for new drug and their generic equivalents, these studies are also done before the approval of drug (post approval period) and are expressed in systemic exposure measures, such as Area under plasma Concentration-Time curve(AUC) and maximum concentration C-max these measures are assumed to relate with safety and efficacy out comes that may expressed by biomarkers. This (BA), (BE) studies provide important information in overall set of data that ensures the safety and effectiveness to the practitioners and patients.

Preformulation studies mainly focus on the concepts of physicochemical properties of drug. These properties not only affect their therapeutic efficacy but also the growth process of their specific dosage form. The Preformulation studies investigations confirm that there are no significant barriers to the compound’s development as a Marketed Drug or Generic drug. Preformulation Studies specifies the physical, chemical and mechanical properties of a new drug substance, in order to develop stable, safe and effective dosage form.

Some chronic disorders require long term supervision and expensive medical care,Though repeated drug administration can help managing such conditions relapses and require re-hospitalization, this condition remains a challenging situation for both practitioners and patients, for this type of conditions long acting injectables which provide sustained release of drug are suggested.

Mostly the concept of generics in confined to oral drugs and biologics mostly injectables, the reason for this is molecular complexity and manufacturing process.

In the veterinary pharmaceutical market, the rise in the generic drugs for animal health care is the latest trend, the economic benefit of generic drugs is enabling the pet lovers to take care of their pets more efficiently.in the recent years FDA is approving the many number of generic drugs for the cats and dogs which has led to the adoption of generic drugs by the veterinarians, it is estimated that about 80% of the veterinarians are prescribing the generic drugs to save the pet owners money. However, the lower margin of profit given by the generic drugs compared to the branded drugs needs to be looked in by the veterinary practitioners.

The purpose of QA is to assure that medicine reaching every consumer or patient is safe, effective, and meets quality standards. A comprehensive quality assurance program includes both technical and managerial activities, many areas within a health care system are involved with quality assurance, including procurement, pharmacy, medical, nursing departments, as well as drug therapeutics committee by obtaining quality products which are safe and effective through structured selection and procurement methods, maintaining quality of products through the appropriate storage, monitoring and distribution and prescribing methods.

It’s clear that generic drugs manufacturers of have great chances of succeeding, but their journey comes with several challenges such as bringing product into the market as fast as possible, providing cost effective drugs while being profitable, marketing the product.

Once the branded drug goes off patient, the generic manufacturers go for a race to claim their share of the market, those first out in the market will get the highest attention.so this market players are looking for new versions of generic drugs by adding the value to the existing product rather than investing huge money for research and development of new drug.

Global health care expenditure is growing steadily and use of generic medicine is encouraged as cost cutting measure by many countries and their governments, as generic medicines are generally low expensive than their proprietary counterparts due to many reasons which include skipping necessity to research and development cost, less market competition.

But there are increased discussions in people with perceived doubts regarding the quality and equivalence of generic drugs, while there have been many reviews that have reported the views individually from professionals but not even a single review critically evaluating and appraising.

Although the faster approvals of generic product is encouraging, there are still many challenges to bring new economic and affordable product into the market that enables manufactures to make some profits and stay afloat as the cost of making generic drugs is same as branded drugs, yet branded drugs enjoy the greater profits because of patent protection.

It is also a challenge for health care personnel as there will be existence of several generic alternatives to a branded drug. To switch from a renowned branded drug to generic drug will be a challenging task for a chronic patient and polypharmacy users and elderly people who can easily be confused, especially due to the difference in morphology.

A biosimilar is a biologic medical product that is an identical copy of an original product. Biosimilars are practically identical to licensed original reference product with minor differences in clinically inactive components; also, there are no clinically meaningful differences between the biological and the reference product in terms of safety, purity, and potency. Although both generic drugs and biosimilars have related commercial basis, they are two completely different products when it comes to their structure, development and authorization. Biosimilars are becoming an increasingly significant in the field of pharmaceuticals industry worldwide, the challenges to develop and demonstrate biosimilars should overcome the inherent differences in the bioprocess manufacturing and biological, physiochemical characterization of a biosimilar compared with several different reference products. The technological difficulties to make copy of products while concentrating on regulatory and market demands is required to help innovation in the direction of attaining productive manufacturing process.

Good Manufacturing Practice is the role in quality management that ensures the products are reliably produced and controlled according to the quality standards and appropriate to their intended use as mandated by the marketing authorization, product specification or clinical trial authorization. GMP aims at both Quality Control and production. (cGMP) Current Good Manufacturing Practices is aimed predominantly at managing and minimizing the risks in pharmaceutical manufacturing to ensure the quality, efficacy of products and safety. FDA, TGA, ANVISA, CDSCO, CFDA, MHRA, MFDS, MCC, NAFDAC, EMCDDA are the Regulatory body’s that control the quality of pharmaceuticals very carefully.

It is a systemic approach for ensuring quality of pharmaceuticals with predefined objectives. The focus of this concept is that quality should be built into product with understanding of the product and the process by which its manufactured along with knowledge of risk involved in manufacturing it and how severe those risks can be, while quality by design (Qbd) have been used to advance product and process quality in industry, this has been adapted by the Us Food And Drug Administration.

The global pharma marketplace is experiencing essential auxiliary modifications with essential ramifications for India and Indian groups. North America continues on being the most important Pharma Market promotes it on earth including to about 33% of the $1 trillion in every year worldwide pharma deals in esteem phrases. Be that as it may, with the quick pace of improvement in Pharma Industry offers in Asia within the direction of the maximum latest five years and the European Biosimilars Market everyday development in the medium-term destiny, the focus of gravity for the pharma market is step by step shifting towards biosimilar manufacturers Europe is probably going to soon surpass North America as some distance as fashionable pharma offers. This is a pattern that might be going to proceed for year’s Biosimilars interchangeability to return because of expansive macroeconomic drivers, as an example, population and profits development biosimilar drugs. Beyond any doubt Japan and China accepted biosimilars will maintain on dominating pharma offers in Asia. For instance, with yearly pharma gives of over $eighty billion, China is as of now more than 5 times the extent of the Indian local pharma show off concerning esteem. Be that as it could, short every year marketplace profits development quotes of extra than 10-12 for each penny in countries, for example, India are likely going to peer an extending enthusiasm by global Pharma Industy corporations in different European Pharma markets such as from all global Pharmaceutical Industry.

The global generic drugs market reached value of US$340 Billion in 2018, registering a CAGR of 6.6% during 2011-2018. A generic drug is a medicine that contains the similar active ingredient and has an bioequivalent therapeutic effects like original drug. It is also identical in case of safety, quality, dosage, strength, route of intake, usage, effects, form, quality and side effects. These drugs can be produced only after the patent expiration of the brand-name drug. As compared to branded drugs, the production of generics cheaper as it does not require the repeated clinical (human) and animal studies to understand the effectiveness and safety of the medicine. The Global market for generic drugs should reach the target value $533 billion by 2021 from $352 billion in 2016 at a compound annual growth rate (CAGR) of 8.7%, from 2016 to 2021. Global drug markets for generic drugs, includes such as antibacterial, antidepressants, anticancer agents, anti-arthritics, cardiovascular drugs, Drugs for respiratory conditions, including asthma and COPD.

Intellectual property has different forms in case of access to medicine, patent is an public policy, where government  aims to provide  monopoly to a company in the market  as an compensation for Research and development and also providing benefits to public in from of technological advancements, extensive patent protection delays and controls the competition in generic drug market ,patent expiry dates are critical for the timing of generic entry into the market.

According to the FDA 2016 generic drug user fee amendment, a complex generic drug is a product that that has, complex active ingredients e.g. (peptides polymeric compounds, complex mixtures of active pharmaceutical ingredient, naturally sourced ingredients) or a complex formulation such as (liposomes, colloids). drugs with the complex route of administration tropical drugs such as dermatological drugs, pomological drugs which are basically formulate as suspensions or emulsions, and complex dosage form (e.g. long acting injectables, metered-dose inhalers, transdermal) drug device combinations and drugs whose complexity concerning approval pathway.

 A generic drug is a pharmaceutical product, usually intended to be interchangeable with an innovator product that is manufactured without a license from the innovator company and marketed after the expiry date of the patent or other exclusive rights. Already prevalent in the U.S., Europe and much of the developing world, generic drugs are now finding their way into previously untapped markets such as Japan, largely driven by regulatory efforts to reduce healthcare costs. Generic drugs will account for nearly $350 Billion in revenue by the end of 2015. The market is further expected to grow at a CAGR of 12% over the next 5 years. As the market consolidates; larger players continue to grow their market share on the heels of acquisitions and mergers. Well established players are particularly keen to capitalize on joint ventures in untapped markets such as Japan.