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.^[