1 ^st Global Summit on Generic Drugs and Quality Control June 21-22, 2021 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 is 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 Quality Assurance 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 incouraging, 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.

In order to improve investment returns the pharmaceuticals have started focusing on re-innovating in the form of value-added generics (Super Generics) and value-added biologics (bio betters). The Re-innovated product offers advantages in terms of patient convenience by new route of delivery, dosage form, pharmacokinetic profile, stability, efficacy, safety, process of manufacturing.

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 free 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.