Authorised Generics, Branded Generics, Unbranded (Ordinary) Generics

Abstract

Nowadays, there are many generic medications available in the market. Their sale is increasing day by day due to their lower cost and affordability by most of the customers. Generic medications are pharmaceuticals that are therapeutically equivalent to an original off patent drug. Both authorized generics and branded generics are the versions of generic medications. They offer lucrative business and increase competition for ordinary generics. They supply medications having quality of branded drugs at lower prices and this establishes their recognition among the masses who earlier has limited options to buy only brand-name drugs. They are cheaper than brand name drugs but costlier than ordinary generics. Authorized generics are sold only by Innovator Companies but the branded generics can be sold by both innovator companies and generic companies. They both are different from one another and have their own impact on the brand drug companies, generic companies and consumers.

Introduction

Generic drugs are the pharmaceuticals that are similar in active ingredients, dosage form, route of administration, strength, safety, quality to an already approved brand name drug. They can contain different inactive ingredients and look different than their branded counterparts. They can cost up to 95% less than the brand name drugs and can be afforded by almost all the sections of the society.¹ They are cheaper because after the expiry of the patent many manufacturers compete with each other for their generic version which results in decrease in prices.

Authorized generics

Authorised generic is a pharmaceutical product that is exactly identical to a brand name drug but marketed as a generic version without the label of brand on it. They are marketed mainly by the brand name company or other subsidiary companies with the permission of Brand Name Company.² They are sold with different labelling and packaging at lower prices than the brand name drugs. They contain the same active and inactive ingredients like their branded counterparts and are manufactured according to the specifications of innovator companies. They are recognised as therapeutic equivalents of the brand name product, so they are not included in the orange book. They can be marketed under the brand name product’s NDA by notifying the FDA. They are defined in 21CFR 314.3 as is a listed drug that has been approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act and is marketed, sold, or distributed directly or indirectly to the retail class of trade with labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trademark that differs from that of the listed drug. The applicant of NDA can market both the brand name product and the authorised generic at the same time. No separate NDA is required for Authorised generics. They are different from branded and unbranded generics for which ANDA is submitted. A list of authorised generic has been published by the FDA and is updated regularly.³ Authorized generics reviews are handled by FDA/CDER office of Pharmaceutical Quality. They first came to use in early 1990’s as a part of litigation settlement where the generic company got an opportunity to market authorized generics in exchange of not challenging their patent.

According to USFDA, there are almost 1200 authorised generics in the USA.⁴ Their market is growing very fast because consumers are getting these authorized generics which have the quality of branded drugs at generic prices. It is expected that the global authorized generics will observe strong growth. There are many factors which are likely to drive the authorized generics in the market: 1) patent expiration of branded drugs 2) rapid increase in the cost of branded drugs 3) health care plans by government.⁵

Classification of global authorized generics:

1.

On the basis of product type

•

Simple generics

•

Super generics

•

Others

2.

On the basis of application

•

On the basis of application

•

Cardiovascular

•

Anti-infective

•

Anti-arthritis

•

Central Nervous System

•

Respiratory

•

Others

3.

On the basis of region

•

North America

•

Asia Pacific

•

Europe

•

Latin America

•

Middle East and Africa

Hatch-Waxman Act

According to this act, 180 day market exclusivity is given to a first ANDA applicant who challenges the patent of a brand name drug (Paragraph 4 Certification). During this period no other generic company is allowed to launch their product and the applicant can use this period to get incentives to recover litigation expenses. But this act doesn’t apply to authorized generics. If an authorized generic is launched during this 180 day exclusivity period, then it may increase the competition for the independent generic firm and makes it difficult for them to recover litigation expenses.⁶ The authorized generics allow the big companies to compete with generic company’s drug during this period even without lowering the cost of their brand name-product. So, authorized generics have the potential to reduce the revenue generated by the independent generic firms during this period.

Example: In 2003, FDA had given 180 day market exclusivity to generic manufacturer Apotex for its generic version of anti-depressant drug Paxil. During this period, brand drug company Glaxo Smith Kline also launched its authorised generic for Paxil. Although sales upto $575 million were expected by Apotex during this 180 day exclusivity period but due to introduction of authorized generic, the sales were reported to be between $150 million and $200 million. So, the entry of authorized generics increased the competition for independent generic firm (Apotex) and reduced their right to claim about two-thirds to the tune of approximately $400 million.⁷

Pay for delay deals

Brand drug manufacturers adopt many life cycle management strategies to extend their market exclusivity and to delay the entry of generic drug. After the entry of generic drugs in the market, the sale of brand drug manufacturers decreases. So sometimes to tackle this problem and to alleviate the influence of generic launches on market share, many innovator companies use ‘pay for delay deals’ in which they make an agreement with generic firms to delay the entry of their generic version in the market. This pay for delay deals cost consumers as they are left with the option of buying branded drugs or authorized generics.⁸

Pros and cons of authorized generics

Pros

•

They are less costly than brand name drugs and have been produced by the same manufacturer of brand name drugs.

•

They increase competition by encouraging the sale of low price authorized generics during the 180 day exclusivity period in which generics are often sold at higher prices.

•

They also provide benefits to the brand name firms by providing them additional revenues or royalties made on sales done by their contacting partners. This additional revenue can be employed in support of pharmaceutical innovation.

•

Authorized generics also helps in smooth settlement of patent infringement suits between brand-name firms and independent genric firms. By settling patent litigation and by allowing an ANDA applicant to produce an authorized generic, the brand-name firms will not only be able to manage risk but can also provide a more stable revenue system. The generic company manufacturing an authorized generic will also be benefitted by acquiring manufacturing experience as well as 180 day exclusivity period. Now they don’t have to spend their capital on litigation with an unclear result.

•

Authorized generics launched before the expiry of patent can help the customers to gain access to lower cost versions of brand name drugs.

•

Help the innovator companies to better control sales when more generic versions come into the market.

•

Authorized generics can be launched into the market more quickly than the other generics.

•

There are many consumers who have serious allergic reactions to many drugs which limits their choice to certain branded drugs. In this case, authorized generics can be helpful to them since they have same quality of brand-name drugs but are cheaper than brand-name drugs.

Cons

•

During 180 day exclusivity period, the launch of Authorized generic can reduce the profits gained by generic manufacturers.

•

To prevent loss of revenue, many generic manufacturers make an agreement with the innovator companies that they will delay the launch of generic in return for the brand drug manufacturer’s agreement to not launch their authorized generics during exclusivity period. The consumers have to face the consequences of this agreement as they are only left with the option of buying costly drugs.

Branded generics

Mainly two types of pharmaceutical products are launched by Indian Pharmaceutical companies for the same molecule: 1.brand-name drug -Their main drug which is developed and patented by them. 2. branded generics - they are not under any patent and are sold by using a brand name instead of a chemical name. Branded generics can be developed either by a generic drug firm or by the original manufacturer and can be marketed after the patent expiry of the original drug. Abbreviated New Drug Application (ANDA) is submitted to the regulatory body for marketing them and they should be therapeutically equivalent to the original drug for which the patent is expired.⁹ Their launch in the market is very advantageous to the brand name companies because of the following reasons: the innovator companies have production experience which can help them in producing branded generics. ii) no FDA approval is required to enter generic business as long as they are produced on the same production line used for innovator drug and less time is required in filing ANDA iii) the generic can be launched even before the patent expiration without any legal obstacles because it is marketed by the patent holder.

They are also known as value added generics and these can be either novel dosage form of an off patent drug developed by a different manufacturer or a copied molecule of an off patent drug.¹⁰ Example: Benitek A (Olmesatran in combination with Amlodipine) sold by GSK, Nifedical (nifedipine), Digitek (digoxin), etc.

Their global market is growing slowly since a large number of pharmaceutical products will experience patent expiry in the near future.

Branded generics market:

On the basis of product type

•

Value added generics: Developed by using innovative pharmaceutical technology to make them patient friendly.

•

Trade name generics: Generics sold by more than one trade name.

On the basis of application

•

Cardiovascular drugs

•

Anticancer drugs

•

Central nervous system

•

Anti-infective drugs

•

Others

On the basis of distribution channel

•

Hospital pharmacy

•

Clinics

•

Pharmacy and drug stores

On the basis of region

•

North America (US, Canada)

•

Latin America (Mexico, Brazil)

•

Western Europe (Germany, Italy, England, Spain, France etc)

•

Eastern Europe (Russia)

•

Asia Pacific (China, India, ASEAN, Australia, New Zealand, Japan)

•

Middle East Africa (GCC, South Africa, North Africa)

Unbranded generics are known by their chemical names like Amoxicillin for brand drug Trimox whereas branded generics are given brand names to promote patient recognition. Example: Cryselle (contraceptive pill). Its generic name is Norgestrel and Ethinyl estradiol. Since, it is very difficult for patients to remember long chemical names of combination products and also to increase its sale, it is sold by brand name Cryselle. These branded generics cost less as compared to brand- name drugs but are expensive than unbranded generics.¹¹

Pros and cons of branded generics

Pros

•

They are less expensive than brand name drugs and are sold as alternatives to brand name drugs.

•

There are many medications which come in combinations and it becomes very difficult to remember their generic names, so they are given a brand name which can be easily remembered.

•

They are generic drugs with brand names which attracts many consumers who are dependent on branded drugs only.

•

They provide quality assurance from well-known companies like Sandoz by Novartis, torrent etc.

Cons

•

There are some branded generics which have to be obtained from alternative suppliers, since they may not be available from key sources.

•

If a drug is prescribed by a brand name then it becomes difficult to get that specific brand of the drug since many pharmacies don’t stock all the branded generics.¹²

Difference between authorized generic and branded generic

Conclusion

Pharmaceutical companies use many life cycle management strategies either to avoid competition or to increase competition for generic manufacturers because after the expiry of patents many drugs become generics and the sale of big pharmaceutical companies decreases. Marketing of both authorized generics and branded generics is a strategy to increase competition for generic firms and to remain in the market. Both of the authorized generics and branded generics are sold at a price lower than brand- name drugs but higher as compared to unbranded generics or ordinary generics. Their market is growing rapidly and is very valuable for innovator companies and destructive for generic firms.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iD

Bharti Latwal https://orcid.org/0000-0003-3850-6544

References

1. Beall RF, Darrow JJ, Kesselheim AS. A method for approximating future entry of generic drugs. Value Heal 2018; 21: 1382–1389.

Drug Report Submissions by Marketing Firms: DTAB directs to constitute sub-committee to amend NDCT Rules

medicaldialogues.in

Drug Report Submissions by Marketing Firms: DTAB directs to constitute sub-committee to amend NDCT Rules

Farhat Nasim

4 - 5 minutes

New Delhi: The Drugs Technical Advisory Board (DTAB) has recommended forming a sub-committee to look into the proposed amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, to mandate that marketing companies submit Periodic Safety Update Reports (PSURs) annually until the drug product is marketed. This would replace the current provision, which mandates the submission of PSURs only for the third and fourth years after drug approval.

PSURs are submitted by marketing companies to monitor the safety of drugs after they are approved for use.

Under the current NDCT Rules, post-marketing surveillance requires marketing companies to submit Periodic Safety Update Reports (PSURs) as part of the safety monitoring of new drugs. Initially, these reports must be filed every six months for the first two years after drug approval. Afterward, they are submitted annually for two more years. However, if necessary for public health, the Central Licensing Authority can extend this duration. Additionally, serious unexpected adverse reactions must be reported within 15 days, and if drug marketing is delayed, the PSUR submission begins once marketing starts.

During its meeting held in August, the DTAB was deliberating a proposal for certain amendments to the PSUR under the Fifth Schedule of NDCT Rules, 2019.

The periodic safety update reports (PSURs), which are currently required annually for the third and fourth years, was proposed to be mandated annually until the drug is marketed. The proposal read;

    "In the sub-clause (iii) of clause (c) of sub-rule (5) of rule 1 under Fifth Schedule of NDCT Rules, 2019 the words “For subsequent two years – the periodic safety update reports need to be submitted annually.” Shall be substituted by the words “For subsequent years – the periodic safety update reports need to be submitted annually till the drug product is marketed.”

The Board was also apprised that the NDCT Rules, 2019 under Fifth Schedule as well as Drugs Rules, 1945 under Schedule M prescribes that the applicant/ licensee shall have a `Pharmacovigilance system in place for collecting, processing and forwarding the report to the licensing authority for information on adverse drug reactions emerging from the use of the drug imported or manufactured or marketed by the applicant in the country.

The amendments proposed to the NDCT Rules, 2019 suggested the inclusion of the word 'Pharmacovigilance System Master File (PSMF)' in the Fifth Schedule's appendix. The proposed amendment read;

    "The words “Pharmacovigilance System Master File (PSMF)” shall be inserted under the appendix of Fifth Schedule of NDCT Rules, 2019 which is as under:

    Appendix: The appendix includes the copy of marketing authorisation in India, copy of prescribing information, line listings with narrative of Individual Case Safety Reports (ICSR), Pharmacovigilance System Master File (PSMF)."

PharmacyPractice-IndianContext

#PharmacyPractice-IndianContext

👉Pharmacy Practice has no definition.

👉Pharmacy Practice has not been recognised by the Law and the Government or Private administration.

👉 Health Sector has done away with Pharmacists with the Amendment of Sch K. (Thanks to PCI, IPA and Our Pharmacy Officers in DTAB)

👉 There is no specific License to Practice Pharmacy and No detailed protocol to Inspect, Verify, and to punish the violators.

👉 It is just a glorified name given by pharmacy people @PCI and @Academy to camouflage simple dispensing and selling of drugs.

POV: Bhagwan PS

Note : Then what about PPR 2015, and amendments ? 

M.Pharmacy course and syllabus

M.Pharmacy course and syllabus was framed by VV University, Rajasthan uptill now.
In India, universities had started M. Pharmacy on 25 to 30 subjects.
Now, PCI has made it only on 12 subjects.
Also for every subject, intake has been set as 15 students. So that importance of Pharmacy remains intact.

Some of the M. Pharm subjects are :
Pharmaceutics
Pharmaceutical Chemistry
Regulatory Affairs
Pharmaceutical QA
Pharmacognosy
Pharmacology
Pharmacy Practice

Scope of taking specialization in M.Pharm

By taking specialization in any specific area while doing M.Pharm, one can focus to make a career in field like Pharmacology, Pharmaceutical Technology, Drug Discovery and Development. Another benefit of taking specialization is that aspirants can look for teaching jobs in both government and private pharmacy colleges.

M.Pharm in Quality Assurance course can help students opt for job of Quality Assurance Health Manager or Quality Control Manager in reputed firms like Cipla, Ranbaxy, Lupin Pharmaceuticals Limited etc. After completing this course, one can find the job of Quality Assurance Manager or Quality Control Executive in public sector undertakings like Bengal Chemicals and Pharmaceuticals Limited (BCPL), Rajasthan Drugs and Pharmaceuticals Ltd (RDPL) and Indian Drugs and Pharmaceuticals Limited (IDPL) too.

Those who possess M.Pharm in Pharmaceutical Chemistry/Pharmacognosy/ Medicinal Chemistry can join as Project Assistant in National Botanical Research Institute of CSIR. Remuneration offered for this post is Rs. 12,000 per month. After M.Pharm in Pharmaceutical Chemistry, one can pursue Ph.D in Pharmaceutical Chemistry and join Defence Research and Development Organization (DRDO) as Research Associate.

After completing M.Pharm in Clinical Pharmacy, one can work as Clinical Research Associate or Clinical Pharmacist in clinical research laboratories like Accutest Research Laboratories Private Limited. M.Pharm graduates in Drug Regulatory Affairs can find the job of Drug Regulatory Affairs Manager in companies like Novartis India Limited.

On successful completion of M.Pharm course in Pharmaceutics, Pharmacology and Pharmaceutical Marketing and Management, one can pursue Ph.D in corresponding stream and find the job of Research Associate in research institutes like National Institute of Pharmaceutical Education and Research (NIPER). After getting into the post of Research Associate in NIPER, one can earn a salary of Rs. 16,000 per month.

Source: http://entrance-exam.net/mpharm-specialization-areas-and-career-potential/#ixzz4m9hQJTgL


Those who want to pursue M.Pharm course can take specialization in streams like Pharmacology, Clinical Pharmacy, Quality Assurance, Industrial Pharmacy and Medicinal Chemistry. The advantage of doing specialization is that aspirants can pursue Ph.D in Pharmaceutics, Pharmacology and  Pharmaceutical Marketing and Management after M.Pharm course. There are also job opportunities available in public and private sector firms like Bengal Chemicals and Pharmaceuticals Limited (BCPL), National Botanical Research Institute (NBRI) and Indian Drugs and Pharmaceuticals Ltd (IDPL) for M.Pharm graduates.

Source: http://entrance-exam.net/mpharm-specialization-areas-and-career-potential/#ixzz4m9mGuns9
Other Subjects :

Specialization areas in M.Pharm

• M.Pharm in Biopharmaceutics
• M.Pharm in Drug Regulatory Affairs
• M.Pharm in Biotechnology
• M.Pharm in Pharmaceutical Chemistry
• M.Pharm in Medicinal Natural Products
• M.Pharm in Pharmaceutical Technology
• M.Pharm in Bulk Drugs
• M.Pharm in Pharmaceutical Analysis and Quality Assurance
• M.Pharm in Industrial Pharmacy
• M.Pharm in Clinical Pharmacy
• M.Pharm in Pharmaceutical Administration
• M.Pharm in Medicinal Chemistry
• M.Pharm in Drug Discovery and Development
• M.Pharm in Pharmaceutical Technology and Biopharmaceutics
• M.Pharm in Pharmaceutical Analysis
• M.Pharm in Pharmacology
• M.Pharm in Pharmaceutical Marketing Management
• M.Pharm in Phytopharmaceuticals and Natural products
• M.Pharm in Pharmaceutical Biotechnology
• M.Pharm in Quality Assurance
• M.Pharm in Pharmacognosy and Phytochemistry
• M.Pharm in Pharmacy Practice
• M.Pharm in Pharmaceutics

Source: http://entrance-exam.net/mpharm-specialization-areas-and-career-potential/#ixzz4m9hlaabX

The Pharmacy Management System OR The Pharmacy Information System

 The pharmacy management system, also known as the pharmacy information system, is a system that stores data and enables functionality that organizes and maintains the medication use process within pharmacies.

These systems may be an independent technology for the pharmacy's use only, or in a hospital setting, pharmacies may be integrated within an inpatient hospital computer physician order entry (CPOE) system.

Necessary actions for a basic, functioning pharmacy management system include a user interface, data entry and retention, and security limits to protect patient health information. Pharmacy computer software is usually purchased ready-made or provided by a drug wholesaler as part of their service. Various pharmacy software operating systems are common place throughout the many practice settings.

Purpose

The pharmacy management system serves many purposes, including the safe and effective dispensing of pharmaceutical drugs. During the dispensing process, the system will prompt the pharmacist to verify the medication they have is for the correct patient and has the correct quantity, dosage, and information on the prescription label. Advanced pharmacy management systems offer clinical decision support and may be configured to alert the pharmacist to perform clinical interventions, such as an opportunity to offer verbal counseling if the patient's prescription requires additional education in the pharmacy.

Pharmacy management systems should also serve the pharmacist throughout the Pharmacists’ Patient Care Process, a cycle developed by the Joint Commission of Pharmacy Practitioners (JCPP). The process details the steps pharmacists take to practice tangible, proven care to their patients.  

Pharmacist patient care process

The JCPP's pharmacist patient care process consists of five steps: collect, assess, plan, implement, and follow-up. Ideally, the pharmacy management system assists with each of these practices. The pharmacy system should Collect data at intake and continue to store and organize information as the pharmacist learns more about the patient's medications, their history, goals, and other factors that may affect their health. The technology within the pharmacy information system should allow the pharmacists to Assess the collected information to form a Plan and Implement creative strategies that address the patient's issues. After implementing a plan, the pharmacist should routinely Follow-Up with the patient and make adjustments as needed to further progress.  

Vendors

Outpatient software vendors

Outpatient pharmacies typically are retail pharmacies that offer patient care services outside of hospitals and treatment facilities. Outpatient pharmacies, also known as community pharmacies or independent pharmacies, offer care in the form of medication therapy management (MTM), patient education, and clinical services.  

Rx30

Developed in Florida in 1980, Rx30 is a multi-platform software that offers automated pharmacy processes, vendor integrations, and compounding functionality. The Core Services include Accounts Receivable, Point of Sale, and Virtual Pharmacist, a feature that automates the refill process. On October 6, 2016, Rx30 announced its merger with Computer-Rx.

Inpatient software vendors

Inpatient pharmacies operate within hospitals and dispense medications to admitted patients receiving treatment. Inpatient pharmacists manage patient health alongside doctors and nurses, and the pharmacy management system must integrate with the various systems operating throughout the hospital to maintain accurate Electronic Medical or Health Records (EMR, EHR).

Epic Willow

Epic, named for the long-form poems chronicling hero's lives, began in 1979 by founder Judith R. Faulkner. Epic software currently manages over 200 million patient electronic records. The Willow Inpatient Pharmacy System, when combined with other Epic systems, allows pharmacies access to medical administration records (MAR) and links all aspects of the ordering and dispensing process to simplify collaboration amongst all parties involved in patient care management.

Cerner PharmNet: Medication Manager

Cerner Corporation has provided health information technology (HIT) to hospitals and healthcare systems since 1979. Cerner PharmNet enables pharmacists to automate their workflow processes and center care around the patient, not the encounter. This software allows pharmacists and doctors to manage prescriptions and verification from the same order in order to streamline medication management.

Datascan: Winpharm

Datascan was started back in 1981 by Alex Minassian focused on providing pharmacy management software to independently owned community pharmacies. Initially, Datascan modified the code it had purchased and began selling its DOS based version of the software. In the early 2000's Winpharm was written and released as an updated Windows version of the software, which continued the ability to quickly fill prescriptions using only the keyboard as part of the fill screen. Back in 2009, Kevin Minassian stepped in to purchase Datascan. Today, over 40 years later, Datascan continues to serve the needs of independent pharmacies nationwide with a focus on technology and support. 

Pharmacoinformatics

 Pharmacoinformatics combines bio- and chemoinformatics approaches as well as artificial intelligence to support drug design and development at various stages, starting from preclinical research support to clinical trial design and execution support (stages I, II and III), as well as pharmacovigilance, pharmacoeconomics and personalized medicine. The rational use of these methods, combined with the relevant experimental approaches, is crucial to face the new challenges in drug design and development.

In recent years, a growing number of pharmacoinformatics approaches have been developed and implemented to enhance the design and development of therapeutic alternatives for multiple pathologies. In fact, the training of professionals working in this field is getting increasingly complemented by this type of approaches.

As such, we consider it crucial to show the most relevant advances in the design, development, improvement, and implementation of approaches that face the main challenges when designing new drugs. They aim at improving pharmacokinetic and toxicological profiles, increasing selectivity and bioavailability, finding novel chemical groups with activity against key targets in complex pathologies, finding molecular descriptions of mechanisms of action, pharmaceutical monitoring and surveillance,clinical trials, personalized medicine, etc.

The scope of this research topic involves subtopics where pharmacoinformatics tools are used to enhance drug design processes such as:

- Accelerate drug discovery and development.
- Identify novel molecular targets.
- Increase the efficacy of clinical trials.
- Computer-driven polypharmacology.
- Personalize and create targeted drugs.
- Reduce cost and increase drug adherence.
- Gain improved insight into marketing and sales performance.
- Improve safety and risk management.

The main idea behind the field is to integrate different informatics branches (e.g. bioinformatics, chemoinformatics, immunoinformatics, etc.) into a single platform, resulting in a seamless process of drug discovery. The first reference of the term "Pharmacoinformatics" can be found in the year of 1993.^[1]

The first dedicated department for Pharmacoinformatics was established at the National Institute Of Pharmaceutical Education And Research, S.A.S. Nagar, India in 2003.^[2] This has been followed by different universities worldwide including a program by European universities named the European Pharmacoinformatics Initiative (Europin^[3]).

Pharmacoinformatics is also referred to as pharmacy informatics. According to the article "Pharmacy Informatics: What You Need to Know Now" by the University of Illinois at Chicago Pharmacoinformatics may be defined as: “the scientific field that focuses on medication-related data and knowledge within the continuum of healthcare systems.^[4]” It is the application of computers to the storage, retrieval and analysis of drug and prescription information. Pharmacy informaticists work with pharmacy information management systems that help the pharmacist safe decisions about patient drug therapies with respect to, medical insurance records, drug interactions, as well as prescription and patient information.

Pharmacy informatics can be thought of as a sub-domain of the larger professional discipline of health informatics. Health informatics is the study of interactions between people, their work processes and engineered systems within health care with a focus on pharmaceutical care and improved patient safety. For example, the Health Information Management Systems Society (HIMSS) defines pharmacy informatics as, "the scientific field that focuses on medication-related data and knowledge within the continuum of healthcare systems - including its acquisition, storage, analysis, use and dissemination - in the delivery of optimal medication-related patient care and health outcomes.

PCI to introduce medical device mfg in revised curriculum

PCI to introduce Medical Device Mfg in revised curriculum - News Ref. AIOCD.

Why this stupidity?

Is medical devices any formula product?

It is an Engineering subject with medical application.

Knowledge of metals, Rubbers, plasticizers, plastics , PE, PVC, Acrylics, other synthetic materials, absorbability and non-absorbability, their ductile and malleability properties, thermal and irradiation sustainability, besides other related properties like ease of sterilization and application, disposability, special devices for handling radioactive materials etc are a must.

Why burden the pharmacy students for no extra gain?

I remember my B Pharm year 1965 to 69 where we were struggling to work on drawing board to draw basic machine drawings, studying Chemical engineering calculations and formula, orifice meters, Venturi meters, BSc level Arithmetics, Calculus Trigonometry , Algebra etc for no extra gain.

Now, with an eye on to capture control on Mfg and Trading in Medical devices PCI should not run after the mad race in others domain.

Drug and Cosmetic act and Pharmacy Practice Regulations Act

Drug and Cosmetic act 1940 and Pharmacy act 1948 and Pharmacy Practice Regulations Act 2015 all are different and are mismatch. 

KNOW (Y)OUR PHARMACY ACT & ITS WEAKNESS:

1.. The Act was enacted in 1948 to which the States can frame Rules. Rules should be in compliance with and without prejudice to the Act 

Weakness: Not updated to current scenario and needs. States and state councils are working with total disregard to the Act as if it is their own registered association.

2. The Act provides for constitution of Central council and state councils. Since ER is in force there is no provision to form Tribunal for RRegistation.

3. Act provides for elected and nominated and ex-officio Govt official members in the council.

Weakness :

a. Both central and state councils are dominated by traders and academicians.

No reservation to have representation from Industry, Clinical trial, hospital and clinical pharmacists and women.

3. All members except those from Medical council, UGC etc should be Registered pharmacists as per the Act.

Weakness:

Since neither the Govt nor the PCI is supervising the council:

a Many councils including Central council are running with members who are not Reg Ph as per the Act. .

b.There are councils headed, presided over  and administered by non pharmacists.

- How can the resolutions be considrd valid under the Act.

4. There are clear guidelines to convene and conduct meetings.

Central council passes hundreds of resolutions in just 4 to 6 hours- Amazing that Limka and Guinies book of records has not noticed.

Weakness: 

All meetings and deliberations are under mutual understanding, obligation and for self-esteem aggrandizement. 

Real professional interest and professionalism are nowhere seen or felt. There is no one to verify and pull up the violation.

5. The term of office of members is only 5 years.

Weakness:

Elections are delayed due to vested interest on one side and due to deviation in awarding registration.

Most of the times, the voters (reg Ph) do not get information on election schedules.

Voter should send the marked ballot paper by Reg.post a/d only.

Weakness:

a. It was good in 1948. Now it is outdated and has made easy way for the interested contestant to collect personally and mail by reg post on behalf of the Ph. Returning officer sinceerly accepts all ballot papers rceived by rreg post and declardeclares rsult.

Obvious name/s get elected.

Remedy:

Besides the Amendments needed the following measures would help:

All councils should publish on their website all documents:

a. Names of members, Reg.No with State, Validity and Govt nomination Notifications.

2. Meeting calendar for the year.

3. Proceedings of the meetings. Since all decisions except the administrative issues are related to profession publishing the same cannot be refused.

All resolutions should quote the section, clause and Rule No. under which the the decision was taken like, In exercise of the powers conferred under section...., Clause ....., Rule No. ....

4. List of Reg Ph. and List of names removed due to non renewal and names restored.

5.  D&C Act and Pharmacy Act mismatch with each other.:

a. Pharmacy Act and PPR 2015 doesn't mention SALE of drugs. D&c act do not recognize pharmacy practice.

b  Regulatory does not work in support of the council and do not share their inspection report extract with the council

6. The drugs controller should publish the name and address  of the licensee, Name of the approved pharmacist and his registration no. on their website

.

PHARMACY IS CELIBRITY

India is increasingly becoming an attractive destination for clinical research for pharma groups looking for faster and more efficient ways to test drugs for western countries

India is increasingly becoming an attractive destination for clinical research for pharma groups looking for faster and more efficient ways to test drugs for western countries, United Nations Conference on Trade and Development said on Thursday.

It has been estimated that firms can reduce costs by 20-30 per cent by moving their R&D activities to India, UNCTAD's World Investment Report 2005, said.

However, the new patent regime in the country has eroded the power of domestic pharma companies to absorb knowledge spillover through reverse engineering, Nagesh Kumar director-general of Research and Information System for Developing Countries said while releasing the report.

So while the patent regime has reduced the power of domestic companies for absorption of knowledge dissemination on the other hand it has made India an attractive country for clinical trials, said Kumar.

The UNCTAD report said savings for firms going for clinical trials in India come from hiring researchers, nurses and IT staff at less than a third of wages in the West, in addition to differences in the costs associated with the patients.

However, there are some factors holding back the development of clinical research in India such as relatively slow approval process, the report said.

"Another one is India's reverence for animals, which makes it difficult to use certain animals (like monkeys)," the report added.

India, which is well-endowed with skilled R&D personnel, also has a substantial number of people with diseases that exist in developed countries, making it a favoured destination for clinical trials, according to the report.

India has up to 30 million people with heart disease, 25 million people with type-II diabetes and 10 million with psychiatric disorders, the report said.

The country also has a large pool of "treatment naive" patients who have not yet been exposed to other drugs in the market, UNCTAD said.

"In addition, Indian recruits are more likely to comply fully with the trial process, unlike in developed countries where a significant proportion of subjects drop out in order to seek second opinions," the report said.

It is estimated that the number of clinical research organisations based in India increased fourfold between 2001 and 2003, UNCTAD said adding Indian firms, too, are participating in this new industrial activity.

One factor apparently underpinning the shift has been India's newly adopted guidelines on good clinical practices, including the issue of consent by the patients in line with global norms, the report said.

However, other commentators have questioned what consent can mean in a drug trial when patients are illiterate and might not adequately understand the experiment's true risks.

"By definition, the drugs being tested have unknown beneficial effects on the patient's illness or disease, and negative side effects are also unknown," the report pointed out.

whims of my mind:Therapy way upon use of colour, size, shape , structure(engravements) and smell of medicines ,pharmacy & pharmaceutical products/medicines/pills/tablets/capsules etc in psychiatric patients

Do psychiatrists , psychotherapists, psychologists etc. use colour, size, shape , structure and smell of medicines as indicators for behaviour for patients in Home Politics or Therapy in Social Politics or Therapy etc in the world of Psychology?

Please reply to this question at following space...

Pharmceutical Errors

Pharmceutical Errors are different from Medic ok p6 y yal Errors.

.

Manufacturing Errors
Compounding Errors 

Dispensing Error

Storage Errors

Clerical errors
Inventory errors
computer entry

Data entry in sheet errors
Pharmceutical Calculation Errors

Pharmaceutical Formulation Errors (Research & Development Errors)

Pharmaceutical Analysis Errors

Method of administration Errors

Drug Dose Titration Errors

Adverse Drug Reaction Reporting Errors (Pharmacovigilance Errors)

Drug Drug Interaction Reporting Errors

Ward Round Errors

NUTRACEUTICALS

Chia is grown commercially for its seeds rich in α-linolenic acid.

A Nutraceutical is a pharmaceutical-grade and standardized nutrient.^[1] In the US, "nutraceuticals" do not exist as a regulatory category; they are regulated as dietary supplements and food additives by the FDA under the authority of the Federal Food, Drug, and Cosmetic Act.

Regulation[edit]

Nutraceuticals are treated differently in different jurisdictions.

Canada[edit]

Under Canadian law, a nutraceutical can either be marketed as a food or as a drug; the terms "nutraceutical" and "functional food" have no legal distinction,^[3] referring to "a product isolated or purified from foods that is generally sold in medicinal forms not usually associated with food [and] is demonstrated to have a physiological benefit or provide protection against chronic disease."

United States[edit]

The term "nutraceutical" is not defined by US law.^[4] Depending on its ingredients and the claims with which it is marketed, a product is regulated as a drug, dietary supplement, food ingredient, or food.^[5][6]

International sources[edit]

In the global market, there are significant product quality issues.^[7] Nutraceuticals from the international market may claim to use organic or exotic ingredients, yet the lack of regulation may compromise the safety and effectiveness of products. Companies looking to create a wide profit margin may create unregulated products overseas with low-quality or ineffective ingredients.

Market[edit]

A market research report produced in 2012 projected that the worldwide nutraceuticals market would reach US$250 billion by 2018,^[8] defining that market as "Dietary Supplements (Vitamins, Minerals, Herbals, Non-Herbals, & Others), and Functional Foods & Beverages"^[9]

Classification of nutraceuticals[edit]

Nutraceuticals are products derived from food sources that are purported to provide extra health benefits, in addition to the basic nutritional value found in foods. Depending on the jurisdiction, products may claim to prevent chronic diseases, improve health, delay the aging process, increase life expectancy, or support the structure or function of the body.^[10]

Dietary supplements[edit]

Dietary supplements, such as the vitamin B supplement shown above, are typically sold in pill form.

In the United States, the Dietary Supplement Health and Education Act (DSHEA) of 1994 defined the term: “A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders.”^[11]

Dietary supplements do not have to be approved by the U.S. Food and Drug Administration (FDA) before marketing, but companies must register their manufacturing facilities with the FDA and follow current good manufacturing practices (cGMPs). With a few well-defined exceptions, dietary supplements may only be marketed to support the structure or function of the body, and may not claim to treat a disease or condition, and must include a label that says: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” The exceptions are when the FDA has reviewed and approved a health claim. In those situations the FDA also stipulates the exact wording allowed.

Functional foods[edit]

Considered a father of Western medicine, Hippocrates advocated the healing effects of food.

Functional foods are fortified or enriched during processing and then marketed as providing some benefit to consumers. Sometimes, additional complementary nutrients are added, such as vitamin D to milk.

Health Canada defines functional foods as “ordinary food that has components or ingredients added to give it a specific medical or physiologicalbenefit, other than a purely nutritional effect.”^[12] In Japan, all functional foods must meet three established requirements: foods should be (1) present in their naturally occurring form, rather than a capsule, tablet, or powder; (2) consumed in the diet as often as daily; and (3) should regulate a biological process in hopes of preventing or controlling disease.^[13]

History[edit]

The word "nutraceutical" is a portmanteau of the words "nutrition" and "pharmaceutical", was coined in 1989 by Stephen L. DeFelice, founder and chairman of the Foundation of Innovation Medicine.^[14] Indians, Egyptians, Chinese, and Sumerians are just a few civilizations that have used food as medicine.^[15] “Let food be thy medicine.” is a common misquotation ^[16] attributed to Hippocrates, who is considered by some to be the father of Western medicine.

The modern nutraceutical market began to develop in Japan during the 1980s. In contrast to the natural herbs and spices used as folk medicine for centuries throughout Asia, the nutraceutical industry has grown alongside the expansion and exploration of modern technology.^[