Thursday, 30 October 2025

Wednesday, 29 October 2025

"Prescription is decided by the doctor, but the brand of medicine should be chosen by the patient with the help of a pharmacist, based on the patient’s income."

"Prescription is decided by the doctor, but the brand of medicine should be chosen by the patient with the help of a pharmacist, based on the patient’s income."

🔍 1. Role of the Doctor:

Doctors are responsible for diagnosing the illness and prescribing the generic name of the medicine (e.g., Paracetamol, Amoxicillin).

This ensures that the treatment is medically appropriate and based on clinical judgment.

💊 2. Role of the Pharmacist:

A qualified pharmacist is trained in pharmacology, drug interactions, and therapeutic alternatives.

In #communitypharmacy practice, pharmacists help patients choose from available brands of the prescribed generic medicine.

They consider:

1. Patient’s income level

2.Availability of brands

3. Quality and reputation of manufacturers

Patient preferences (e.g., tablet size, packaging, ease of use)

👥 3. Role of the Patient:

The patient has the right to be informed and involved in the decision-making process.

With guidance from the pharmacist, the patient can select a brand that is affordable and effective, rather than being forced to buy a specific brand that may be expensive or unavailable.

⚖️ 4. Legal and Ethical Basis:

According to Pharmacy Practice Regulations and Pharmaceutical Jurisprudence in India:

Doctors are encouraged to prescribe generic names.

Pharmacists are legally allowed to dispense any brand of the prescribed generic, unless the prescription explicitly prohibits substitution.

This model promotes rational drug use, cost-effectiveness, and patient empowerment.

This model promotes rational drug use, cost-effectiveness, and patient empowerment.

It reduces healthcare costs and ensures access to essential medicines for all income groups.

This approach aligns with the principles of community pharmacy, where:

Doctors diagnose and prescribe generics.

Pharmacists guide brand selection.

Patients make informed choices based on affordability and need.

It promotes transparency, accessibility, and collaborative care—the foundation of a strong healthcare system.

Thanks

Rohit Gupta, Pharma Expert


The Power Shift : from Physicians to Pharmacists
Is it GAME OVER for Physicians ?

In India, big pharmaceutical companies are struggling to do business compared to small, room-based local companies. Everyone knows the reason money matters more than quality. That's why patients should choose their medicine brands with the help of registered pharmacists (RPh).

In which book: brand names of medicines given, and how do Drs decide their quality, Is there any specific subject available, If No, then please prescribe Gen-medicines



ऐसा कौन सा ब्रांड प्रिस्क्राइब किया जाता है जो सिर्फ़ अस्पताल या क्लिनिक में ही मिलता है? समझ नहीं आया। क्या इनोवेटर्स का कोई नया ब्रांड आ गया है? अगर हाँ, तो कृपया जानकारी दें।😃


Brands matter because of quality, agreed. But why so many doctors prescribing branded products from local companies instead of Indian MNCs or global MNCs, I really don’t understand the logic. Poor-quality medicines are harming innocent patients.

POV: Rohit Gupta

Tuesday, 28 October 2025

Indian FDA(The "Indian FDA" is not a single entity but refers to the Central Drugs Standard Control Organisation (CDSCO), the national regulatory body for drugs, medical devices, and cosmetics in India) Vs USFDA

#IndianFDAVsUSFDA.
source:ChatGPT
Quote'
1. In 2005, there were 3 infants aged under 6 months in the US where cough & cold medications were determined by medical examiners or coroners to be the underlying cause of death. 

2. More broadly, in that period (2004-2005), about 1,519 children under age 2 were treated in US emergency departments for adverse events including overdoses from cough and cold medications. 

3. In the 1930s, there were more than 100 deaths (mostly children) in the US from #DiethyleneGlycol (DEG) poisoning, including from Elixir Sulfanilamide, which was given for coughs/sore throats. That tragedy helped lead to major drug safety laws. 

4. There is no recent public record I found that gives a reliable count of how many deaths from FDA-approved or FDA-regulated cough syrups have occurred in, say, the last 10–20 years in the US specifically attributed to either contamination or misuse.

5. Many of the recent deaths globally from toxic cough syrups have been linked to products from outside the US. 

6. The most noteworthy fact is that
 the contaminated products which caused recent deaths abroad have not and cannot  entere the US drug supply chain.

Unquote'
Now the million dollar questions :
  i. Are we deficient in technology?
  ii. Are our Regulators deficient in 
       quality or in Character?
  iii  Are our FDA officers are as 
        accountable as their 
        counterparts in US - FDA
   iv. Are our Drug Laws are so weak 
         to let loose all lapse?
     v. Don't we have strong political 
          will to adopt Zero-Tolerance?

There are two institutions meant to safeguard the pharmacy profession and the integrity of medicines:

A. Department of Food and Drug Control
B. State Pharmacy Council

Both these institutions have their own inspectors.

Yet, despite that, medical shops continue to operate freely and openly even in the prolonged absence of pharmacists.

Due to the fear of pharmacy inspectors, the attendance of pharmacists in medical shops had slightly improved for some time.

However, after the government took over control of the State Pharmacy Council, inspectors have been left without an effective system to perform their duties, and once again, license conditions are being openly flouted, with unauthorized or fake persons running medical stores, posing a serious public health risk.

The Drugs Inspectors are unable to stop this menace.

It is also unfortunate that pharmacy-based NGOs in the state — such as the Indian Pharmaceutical Association and the Registered Pharmacists Association — have failed to rise issues affecting public health and patients safety..

POV: Bhagwan PS


The "Indian FDA" is not a single entity but refers to the Central Drugs Standard Control Organisation (CDSCO), the national regulatory body for drugs, medical devices, and cosmetics in India. It serves a similar function to the U.S. FDA, ensuring the safety, efficacy, and quality of medical products. In addition, individual states, like Maharashtra, have their own state-level "FDA" to handle state-specific food, drug, and cosmetic regulations.  

National regulatory authority Central Drugs Standard Control Organisation (CDSCO): 
  • The national regulatory authority responsible for ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices throughout India.
  • Role: 
    CDSCO regulates the quality of medical products through the implementation of the Drugs and Cosmetics Act, 1940.
  • Headquarters: 
    Located in New Delhi.
  • Drug Controller General of India (DCGI): 
    The executive head of the CDSCO, who is responsible for regulating pharmaceutical and medical devices. State-level authorities
  • State FDA: 
    Many states have their own Food and Drug Administration (FDA) to enforce regulations at the state level.
  • Example: 
    The Food and Drug Administration, Maharashtra is an example of a state-level body responsible for food and drug safety within Maharashtra. Other international relevance
  • U.S. FDA India Office: The U.S. FDA also has an office in New Delhi to ensure that food and medical products exported from India to the U.S. meet U.S. safety standards. 

Tuesday, 21 October 2025

Pharma Scandals and Loopholes

Pharmacy - Ajeeb daastaan hy ye...
- kahaa shuru kahaa khatam

👉🏼 Pharmacists lending degree  PhD certificates to colleges, while working elsewhere and appearing in person only on Inspection day.

👉🏼Postfacto signing of all registers and records of the college a day before inspection day.

👉🏼 PCI inspectors ignoring lapses and deficiencies and sending Ok report to PCI for approval or renewal of the College

👉🏼Pharmacists lending Regn certificate to retailers while working elsewhere.

👉🏼 Drugs inspectors suppressing the Pharmacist's absence and allowing dispensing without Pharmacists.

👉🏼PCI and State Regulatory Officers working on paper bundles (false reports) to justify salary of establishment 😄

👉🏼Acts, Rules, Regulations have become Arterial circulation to energise officers to make money

👉🏼Money Money  Money - Venous circulation - to clean and clear hurdles and catches to rejuvenate😄

👉 Honest stakeholders know everything but dont open the mouth being obligated.

😜🤪😝🤑

POV: Bhagwan PS

Sunday, 12 October 2025

The way Mohalla clinic started in Delhi, Government of India should open pharma clinics across the country on the same line and employ pharmacists to end the unemployment of pharmacists.


The way Mohalla clinic started in Delhi,
Government of India should open pharma clinics across the country on the same line and employ pharmacists to end the unemployment of pharmacists.

If you agree then share 🙏 

POV: Unknown



Sunday, 14 September 2025

An Open Letter to Pharmacy Teachers.- Bhagwan PS

An Open Letter to Pharmacy Teachers.

Dear Respected Pharmacy teachers, 
Greetings & Good Wishes.

As we welcome a fresh batch of first-year pharmacy students, we are reminded once again of the profound responsibility placed upon us—not merely to teach subjects, but to shape young minds into competent, ethical, and dependable professionals of tomorrow.

Students in their journey look to us for guidance, not only in academics but also in conduct, values, and professional discipline.
In this journey, our role is more than just delivering lectures; it is about moulding personalities, instilling confidence, and nurturing integrity.

At this stage, I would like to share a few of my thoughts, if you don't mind.

Let us look into needs:

1. Strong Foundations
2. Learning with relevance
3. Discipline and Professional Identity
4. Shaping Attitude Along with 
     Knowledge
5.  Guidance through Challenges
6.  Nurturing Curiosity and Integrity
7.  Be Mentors, Not Just Examiners
8.  Collaborating with community  

Let us avoid encouraging shortcut learning. Insist that students read standard reference books, prepare their own notes, and develop the habit of thinking critically. Quick-fix guides do not build professionals. Let us ensure the foundation we lay is strong and lasting with open end to explore further. 

Subjects in pharmacy often appear abstract to new learners. It is our duty to connect theory with practice—linking anatomy to patient care, pharmaceutics to formulations, pharmacology to rational therapy, and law to professional responsibility. Let us show them the bigger picture of PharmaCare and healthcare delivery.We should never miss any opportunity to orient the issue towards practical application.

We should remind students that pharmacy is a discipline of service and responsibility. Ours is a supportive service to the Healthcare. Healthcare is a team work where Clinician is the Team head or Team leader. Egoistic thoughts and attitude are poisons to the Profession and should be discouraged.

We should impress upon students that the dress code, punctuality, and respect for institutions should not be seen as restrictions but as badges of identity and dignity. We, as teachers, must model this discipline ourselves.

Let us impress upon students that the Marks though are necessary as a scale of achievement, It alone will not make them professionals. A professional should have responsible attitude, humility to learn, and respect for doctors, nurses, and healthcare staff.

Students will face confusion, pressure, and fear of failure. Instead of judging them harshly, we should guide them patiently, show them learning techniques, and encourage perseverance. 

Every doubt clarified and every fear addressed adds strength to their professional journey.

Communication is the working tool of Pharmacists. Verbal communication, Written short and long narrative communications have to be given as exercise to practice.  Let us encourage students to ask questions, debate ideas, and learn from mistakes. Honest inquiry should be welcomed, not discouraged. At the same time, let us stress the values of academic integrity—discouraging malpractice, plagiarism, and unethical shortcuts.

Students remember not the marks we gave, but they do remember our encouragement, advice and inspiration. Our mentorship will stay with them throughout their lives.

We should help students communicate their role as future pharmacists to their families and community. Positive attitude in explaining our role as a supportive Healthcare  team member enhances respect and status. 

Dear Colleagues,
Let us take pride in moulding these young learners into trustworthy professionals who will stand before society with competence and integrity. 
If we give our best with honesty and dedication, our students will carry forward our legacy in the noble profession of pharmacy.

Good luck and good wishes

With Kind regards

Saturday, 13 September 2025

Attn: #IPCA, #IPA, #APTI,#IPGA, #PCI,#REGULATORIES,.Dear leaders,Please read your vision, mission statements and objectives of the Associations you are heading and objective of the Act under which you are appointed.Quit the leadership if you have any personal agenda to achieve for enjoyment.- Bhagwan PS (Negative Extreme)

Attn: #IPCA, #IPA, #APTI,#IPGA, #PCI,#REGULATORIES,.

Dear leaders,

Please read your vision,  mission statements and objectives of the Associations you are heading and  objective of the Act under which you are appointed.

Quit the leadership if you have any personal agenda to achieve for enjoyment.

I am finding your discomfort very conspicuous to support and associate with struggling Pharmacists.

You are very well aware that the Pharmacy Act and Drugs&Cosmetics Act are hurdles to the growth of the Pharmacy profession restricts only to dispense across the counter.

Yet, it has never occurred to you propose for necessary Amendments to ensure fulfledged professional service to the public and HealthCare system or propose for a separate Legislation to bring out 'Pharmacy Practice Act & Rules' 

Even Doctors and advocates get down to streets when they find some injustice to them happening.

But you leaders in Ivory towers are so indifferent  and cleverly deaf&dumb to react even when a heavy hammer falls on common pharmacist.

Your ceremonial  presence is well registered in all celebrations and 5 star meetings and you never miss  photo opportunities.

At the same time your absence physically and even morally is conspicuous when pharmacists are struggling for survival, against onslaught of law, against support being given by PCI and DcDs to licensees to violate the law.

99.9% of the pharmacists in and out of India have neither trust nor faith on your Associations and our Councils

These (your)  registered bodies have become a lucrative domain for a few to enjoy the luxury by organizing Bakwas meets.

Pharmacy teachers have no trust on APTI as APTI has betrayed the teachers and majority of them are underpaid with no respect and service security,

Pharmacy Graduates are disgusted with quality of education as they are not getting job worthy professionals.

Well,  Please introspect and come out of your cool Comfort zones to chalk out a common good roadmap to save the pharmacy profession which you have made a sinking ship loaded with millions of labelled pharmacists, Lest, common pharmacists will make you tumble down from your #IvoryTower.

Dear Respectable and knowledgeable CDSCO,- Bhagwan PS (Sarcasm)

Dear Respectable and knowledgeable  CDSCO,

I appreciate the very novel professional exemplary decisions you have been taking.

I think you have missed the fact or your medical and administrators have failed to notice that Sch K amendment, Chemist to Pharmacy amendment, Brand and Generic Sale merging amendment without ensuring Pharmacists presence etc terminal switche at:WERE NOT AT ALL REQUIRED 😄.- An unnecessary exercise!

If you think and apply your wisdom you will notice one #MainSwitch that can be operated instead of terminal switches to achieve your noble goal.

With that switch you will be doing the great service to the public and perhaps would be appreciated personally by Sri Modiji too🎉.

That #MainSwitch is.....?
- A simple amendment to Drugs & Cosmetics Act to delete  #PharmacistRequirement for Retail & Wholesale Drug Trade License.

CDSCO should Recommend to delete the Requirement of the "PHARMACIST" for Pharmacy license both in Government and Private sectors.

Thus, with One stroke you will:

a. Delete Sch K. wrt Pharmacists.

b. Deletes Corruption factor at:

i.  licensing and Inspection level.

ii  Pharmacy college sanctioning and Seats approval level

iii. Pharmacy Colleges inspection and Renewal level.

c.  Removes the agony of Pharmacists at the hands of State Councils for Registration, Renewal etc..

Further, you will be helping millions of 10+ and 10+2 students to chose better course and career.

Thank you,
Regards.

Pov: Bhagwan PS

An Open letter to 1st yr Pharmacy students.Dear Students,

An Open letter to 1st yr Pharmacy students.
Dear Students,

I welcome you to this new chapter of your life. Stepping into a professional course is an important milestone, and it is natural to feel a mix of excitement and uncertainty.

At this stage, I want to share something simple but essential:

success in your journey here does not come from shortcuts, nor does it come from being overly anxious about the future. It comes from honest and dedicated study, day by day, step by step.

Strictly avoid shortcut books like Guides, Q&A booklets. They are like junk fast-foods giving immediat taste but fail to provide strong foundation for the future. Read reference books and prepare your own notes.

Every profession demands a foundation of discipline, and pharmacy is no exception. Good professional career cannot be built on poor quality foundation.

The subjects you will study may sometimes feel heavy or even distant from immediate application. But as you move forward, you will realize that each piece of knowledge—whether in anatomy, pharmaceutics, pharmacology, or law—connects to the bigger picture of patient care and responsible Pharmacare practice.

Challenges cannot be wished away, Accept them Exams may feel tough, concepts may sometimes appear confusing, and the workload may seem demanding. But remember—these are not barriers meant to block you; they are tests that shape you for a good professional career. If you face them with sincerity, you will emerge stronger and more capable professional.

A good, respectable professional life is built on the values of integrity, responsibility, and perseverance. Your learning here is not just about marks; it is about preparing yourself to stand confidently before patients, society, and the healthcare system as a Trustworthy professional.

Never forget your dress code. Its your companion through out your life. Its your identity and be proud to wear it at all workplace.

So, Attend to your studies with seriousness without fear, Seek clarity, ask questions, and never hesitate to learn from teachers, peers, or even from mistakes.

Balance your academics with healthy habits and positive friendships.

If you give your best with honesty and dedication, your future will take care of itself. Let your years here be a time of growth, curiosity, and preparation for a meaningful professional career.

Explain to your parents your profession and be a healthCare partner to your family.

Respect Healthcare institutions, Doctors, Nurses and all staff therein.
Avoid egoistic attitude.

Good luck & Good Wishes 👍

Pov: Bhagwan PS

Friday, 12 September 2025

#Pharmacist - Kaha ka? - Neither for Industry nor for Healthcare

#Pharmacist - Kaha ka?
    - Neither for Industry nor for Healthcare

Pharmacists in India face a stark reality: 

There is no exclusivity for them in pharmaceutical industry, R&D, or marketing. Except Diploma Pharmacists graduates and even Clinical Pharmacists with PharmD have no slots to serve in Healthcare

Then, what for these courses are conducted to ruin the life of young aspiring Pharmacists?

 With thousands of colleges producing an overwhelming number of graduates each year, industry is not a viable source of employment.

Shockingly, the IPC which is a conglomeration of IPA, IGPA, APTI, IHPA and PCI has never considered this issue to evolve a solution, inspite of repeatedly voicing the need. 

Irony is IPC wants huge number of Pharmacists from various streams to attend and participate in various activities! but seldom addresses their issues since 1968.

Adding to this crisis are restrictions in our very laws:

Drugs & Cosmetics Act, 1940 does not grant pharmacists exclusive rights in manufacturing, R&D, or marketing; wholesale drug licenses can go to non-pharmacists; even in retail, ownership lies with anyone, with pharmacists reduced to mere signatories. Clinical roles such as counseling or therapy monitoring are not mandated at all.

Pharmacy Act, 1948 is confined largely to registration. Unlike doctors or nurses, pharmacists have no statutory role in patient care. Dispensing is mandatory only on paper—weak enforcement allows rampant proxy practice. Education provisions remain outdated, failing to orient graduates to healthcare needs.

This legal framework leaves them in “Na ghar ka, na ghat ka”—neither industry-recognized nor healthcare-anchored. Yet authorities, academicians, and faculty remain indifferent, even as NAAC delists pharmacy from Health Sciences.

The way forward lies in restructuring. We need intellectually smart teachers to shape smart pharmacists. 

Healthcare is the only sector with infinite potential to absorb all category of Pharmacists —from dispensing to logistics to clinical pharmacy which all together is PharmaCare support to healthCare.

Every hospital unit requires at least one clinical pharmacist and one or two chief pharmacists, besides diploma pharmacists. To make this a reality, pharmacy must be firmly recognized as a Health Science, with education restructured to produce competent professionals.

Since PCI has taken up the task of Updating the B. Pharm Curriculum it should seriously consider to incorporate all activities required to support HealthCare under PharmaCare.

Further, the Profession needs a Supportive laws. Hence, a separate law "#PharmacyPracticeRegulationAct should be legislated that empowers  the Pharmacist with due Accountability. This will eradicate the menace of Certificate renting, Absentee Pharmacist, Corruption arising out of this violation. 

#PCI
#APTI
#IPA
#IPC2025
#Pharmacist 
#Industry 
#Healthcare
POV: Bhagwan PS

One Syllabus One Book For All Courses

#OneSyllabusOneBookForAllCourses
I came across some advertisement of Books on Anatomy, Physiology, Jurisprudence, Pharmaceutics, Pharmacology etc claiming that it is for D Pharm and B Pharm. As we go through the syllabus we find the same content.

Does this mean both study the same, Knowledge is same, depth is same?
                          ***
A “One Book for All” approach though is convenient to the Author and gets better sales is usually oversimplified marketing—helpful for surface-level basics, but insufficient for B Pharm-level depth.
It is high dose to D Pharm and sub-dose to B Pharm.

Ideally, separate standard textbooks (or at least editions with differentiated depth) are needed

Pov: Bhagwan PS

Friday, 5 September 2025

VisionOfTheIndianPPRAct- Bhagwan PS

#MyVisionOfTheIndianPPRAct

Given the persistent failure of institutions and systems to provide fair, deserved opportunities to qualified pharmacists, an exclusive legislation with clear empowerment and accountability has become essential.

The Pharmacy Practice Regulations (PPR) Act is envisioned as the legal and professional backbone for safe, effective, and ethical pharmaceutical care in India. It will authorize pharmacists as direct patient care providers, backed by professional accountability, standard operating procedures, and defined service delivery models—integrating them seamlessly into the healthcare continuum.

Under the PharmaCare Clinical Support System, the Act applies across all professional tiers—D Pharm, B Pharm, M Pharm, and PharmD—with structured, competency-based roles:

1. #DiplomaInPharmacy (D Pharm):
Frontline dispensers and community care providers. Trained in medication handling, prescription verification, OTC guidance, and basic counselling. Accountable for legal dispensing, adverse event reporting, and prescription record maintenance.

2. #BachelorOfPharmacy (B Pharm):
Advanced technical and operational support. Skilled in dosage form optimisation, supply chain integrity, pharmacovigilance, and rational drug use promotion. Authorized to conduct prescription audits, assist in therapeutic substitutions under protocol, and support primary care clinics in medication therapy management.

3. #MasterOfPharmacy (M Pharm – Pharmacy Practice / Clinical / Hospital Pharmacy):
Specialised medication experts in clinical decision support, formulary management, and interprofessional collaboration. Lead quality improvement programs, train juniors, develop evidence-based protocols, and support health technology assessment initiatives.

4. #DoctorOfPharmacy (PharmD):
Apex patient-care pharmacists integrated into clinical teams. Conduct medication histories, identify and resolve drug-related problems, perform therapeutic drug monitoring, and provide evidence-based therapy recommendations. Drive clinical governance, patient safety initiatives, and pharmacare research.

The #PPRAct’s PharmaCare model creates a continuous patient-care chain where each cadre complements the next—ensuring medication use is safe, effective, and cost-efficient. It mandates standardised documentation, ICT-enabled monitoring, and continuous professional development to maintain competence.

Ultimately, the Act positions pharmacists as indispensable members of healthcare teams—bridging the gap between prescription and patient outcomes, reducing medication errors, and improving public health metrics. It shifts pharmacy practice from a supply-driven role to a patient-centred, outcome-oriented healthcare service—securing the pharmacist’s place as a critical partner in India’s healthcare service system.

Pov: Bhagwan PS

Wednesday, 3 September 2025

#PharmacyPracticeRegulationAct is in the urgent need to support the collapsing #PharmacyProfession.

#PharmacyPracticeRegulationAct is in the urgent need to support the collapsing #PharmacyProfession.

POV: Bhagwan PS

Drugs Law &Pharmacy Law are the main bottleneck preventing Pharmacists from delivering professional service..#DrugsRegulatory, #PCI, #APTI

Drugs Law &Pharmacy Law are the main bottleneck preventing Pharmacists from delivering  professional service..
#DrugsRegulatory, #PCI, #APTI

POV: Bhagwan PS

the right value is given only in the right place. If you are not valued, it doesn’t mean you are worthless — it only means you are standing in the wrong place.

Dear PharmDs, 

Let me tell you a short story.

An aged father once told his daughter: “I have nothing to give you except the old car standing outside. Before selling it, take it to different places and see how much people value it.”

The daughter took the car first to a dealer — he said it was too old, worth very little. Then to a shopkeeper — he offered a little more, just out of kindness. Finally, she showed it to a museum. The curator exclaimed, “This is a rare classic, priceless! We will pay you a fortune.”

The father then said, “My child, the right value is given only in the right place. If you are not valued, it doesn’t mean you are worthless — it only means you are standing in the wrong place.”

Friends, this is exactly the condition of our young pharmacists today. Many feel undervalued and frustrated. In some hospitals, they are treated merely as dispensers. In others, a little better as support staff. 

But when the system understands your expertise in medicines, patient safety, and therapy optimization — will be recognized as an  indispensable member of the healthcare team.

Now, the good news is that 'The All India PharmDs Association® (AIPDA) is bringing on the cards the PharmaCare Clinical Support System — a platform to approach Government of India with a well planed presentation and a Memorandum and to request to start 'Pharmacare Clinical Clinical support' department' in selected hospitals as a Pilot Project where pharmacists where your skills in drug information, evidence-based support, and clinical care will be recognized as essential for better patient outcomes.

Friends, the message is clear:
👉 Our value does not diminish because someone fails to recognize it.
👉 It is our responsibility to give moral push to our students, our young professionals, to move towards the right platforms, to innovate, to prepare, and to be part of systems like PharmaCare where their true worth will shine.

Let us not lament. Let us stand united and strengthen the AIPDA to negotiate intellectually with the Government to make 'Pharmacare' concept a reality.

Join AIPDA today!

Thank you.

POV: Bhagwan PS

Sunday, 31 August 2025

Accutane(isotretinoin) coverage depends on your specific health insurance and often requires a prior authorization, where your dermatologist must prove you've tried other treatments first.

Accutane (isotretinoin) coverage depends on your specific health insurance plan and often requires a prior authorization, where your dermatologist must prove you've tried other treatments first. Your insurer may prefer or only cover the less expensive generic versions, and you will likely still be responsible for costs like co-pays and lab fees. To confirm coverage and costs, contact your insurance provider and doctor before starting treatment. 
Key considerations for insurance coverage: 
  • Prior Authorization:
    Most insurance plans require this process for isotretinoin, where the insurer and your doctor discuss your treatment and approve it.
  • Generic vs. Brand-Name:
    Insurers often prefer generic forms of isotretinoin (like Claravis or Myorisan) over the brand-name Accutane.
  • Additional Costs:
    Even with insurance, you may have to pay for lab tests, monthly doctor visits, and co-pays.
  • Check Before You Start:
    Always verify coverage and potential costs with your insurance company and doctor before beginning the prescription.
What to do if your insurance denies coverage:
  • Review the Denial:
    Carefully read the denial letter to understand the specific reason for the decision. 
  • Contact Your Insurance:
    Speak with your insurance provider to learn more about the requirements. 
  • Appeal the Decision:
    You can appeal the denial by providing additional information or working with your doctor to submit a strong case. 
  • Explore Alternatives:
    If Accutane is not covered, discuss alternative acne treatments with your dermatologist. 
  • Look for Savings Programs:
    For commercial plans, you might be able to use a manufacturer's savings card to reduce your out-of-pocket costs for Teva's isotretinoin. 

Saturday, 30 August 2025

Phamacy Council Election

#PhamacyCouncilElection

All ills of Pharmacy councils are due to syndicate grouping of Yes-Men who preplan #MatchFixMeetings and Resolutions.

Hence, Tips to Voters:

👉Do not vote for all in one group.

- They become Yes-Men to their leader to flout all Rules and Regulations and it may lead to loot funds.

👉 Pick Good People from each group and do not ignore independents.

👉 Keep the elected members answerable to the Regd Pharmacists.

Good wishes

POV: Bhagwan PS

Monday, 18 August 2025

'Profession Vs Job' - Professional standards do not compromise whereas Job standards can be compromised.!

'Profession Vs Job'

Professional standards do not compromise whereas Job standards can be compromised.!

Making M Pharm equally eligible as Pharm D for Clinical Pharmacist post has Compromised the Profession.

Hence #NotAWiseMove.

A post in a Wtsp group:

    "Dear Sir/Madam, In a major relief to MPharm degree holders, the Union government has decided to include MPharm (pharmacy practice) as a sufficient qualification for appointing clinical pharmacists to hospitals. The government clarified its stance in the High Court in response to a batch of writ petitions filed by various MPharm degree holders.

Justice Viju Abraham, who considered the petitions, directed the government to implement the decision within three months. Earlier, the government had excluded MPharm as the eligible qualification for serving as clinical pharmacists in hospitals through an amendment brought to the Pharmacy Practice Regulations Act in 2019. Through this amendment, the government made doctor of pharmacy (Pharm D) the qualification for the post."

PCI committed the same blunder while starting B Pharm keeping D Pharm alive.

Had the D Pharm been closed the Hospital Pharmacy would have been in a strong position by now in health
sector.

This is result of having professionally unqualified people in authority.

Pov: Bhagwan PS

Thursday, 14 August 2025

Vision Of The Indian PPR Act by Bhagwan PS

#MyVisionOfTheIndianPPRAct
Pov: Bhagwan PS
Given the persistent failure of institutions and systems to provide fair, deserved opportunities to qualified pharmacists, an exclusive legislation with clear empowerment and accountability has become essential.

The Pharmacy Practice Regulations (PPR) Act is envisioned as the legal and professional backbone for safe, effective, and ethical pharmaceutical care in India. It will authorize pharmacists as direct patient care providers, backed by professional accountability, standard operating procedures, and defined service delivery models—integrating them seamlessly into the healthcare continuum.

Under the PharmaCare Clinical Support System, the Act applies across all professional tiers—D Pharm, B Pharm, M Pharm, and PharmD—with structured, competency-based roles:

1. #DiplomaInPharmacy (D Pharm):
Frontline dispensers and community care providers. Trained in medication handling, prescription verification, OTC guidance, and basic counselling. Accountable for legal dispensing, adverse event reporting, and prescription record maintenance.

2. #BachelorOfPharmacy (B Pharm):
Advanced technical and operational support. Skilled in dosage form optimisation, supply chain integrity, pharmacovigilance, and rational drug use promotion. Authorized to conduct prescription audits, assist in therapeutic substitutions under protocol, and support primary care clinics in medication therapy management.

3. #MasterOfPharmacy (M Pharm – Pharmacy Practice / Clinical / Hospital Pharmacy):
Specialised medication experts in clinical decision support, formulary management, and interprofessional collaboration. Lead quality improvement programs, train juniors, develop evidence-based protocols, and support health technology assessment initiatives.

4. #DoctorOfPharmacy (PharmD):
Apex patient-care pharmacists integrated into clinical teams. Conduct medication histories, identify and resolve drug-related problems, perform therapeutic drug monitoring, and provide evidence-based therapy recommendations. Drive clinical governance, patient safety initiatives, and pharmacare research.

The #PPRAct’s PharmaCare model creates a continuous patient-care chain where each cadre complements the next—ensuring medication use is safe, effective, and cost-efficient. It mandates standardised documentation, ICT-enabled monitoring, and continuous professional development to maintain competence.

Ultimately, the Act positions pharmacists as indispensable members of healthcare teams—bridging the gap between prescription and patient outcomes, reducing medication errors, and improving public health metrics. It shifts pharmacy practice from a supply-driven role to a patient-centred, outcome-oriented healthcare service—securing the pharmacist’s place as a critical partner in India’s healthcare service system.

Monday, 11 August 2025

PCI to integrate pharmacists' database with Healthcare Professional Registry

PCI to integrate pharmacists' database with Healthcare Professional Registry

Gireesh Babu, New Delhi
Saturday, November 23, 2024, 08:00 Hrs  [IST]

The Pharmacy Council of India (PCI) has sought all the pharmacists who don't have the ABHA (Ayushman Bharat Health Account) number to attain a number and ensure registration with the DIGI-PHARMed profile with the ABHA number on immediate basis, as part of its efforts to integrate the pharmacists' list with the Healthcare Professional Registry (HPR).

The Council is in the process of verification of all registered pharmacists on the DIGI-PHARMed portal in order to integrate pharmacists with the HPR, and asked all the pharmacists to consider certain action points in order to equip the Council for a smooth integration.

"All registered pharmacists are requested to verify their DIGI-PHARMed profile with the ABHA Number on immediate basis. The said verification must be completed within the timeline of 45 days from the date of issuance of this circular," said the Council in a communication to all registered pharmacists.

"Failing to this, the pharmacist's profile will be disabled for any further usage on the DIGI-PHARMed portal," it added.

In case of new registration, pharmacists must ensure to verify their account with the ABHA number at the time of registration and without verification of the profile with this number will be considered as incomplete registration.

If the pharmacists don't have the ABHA number, it is directed to create the ABHA number using Aadhar before initiating the process or the registration of DIGI-Pharmed portal.

The Council also requested to all the pharmacy institutions as well to check that all the faculty in their institutions are having the ABHA verified profiles and notified that during the Standard Inspection Format (SIF) applications and for further reference, only ABHA verified profiled of faculty will be considered by the Council from 2025-26 academic session, it added.

It also directed all pharmacists that they must ensure that the documents uploaded to the portal while registering are authentic and validated.

"If the Council discovers at any stage that any documents submitted during the registration process are incorrect, the respective profile of those pharmacists will be blacklisted," said the Council.

In case of any inconvenience or technical issues, the pharmacists or the institutions can share the issues over email to the Council or reach out over telephone, it added.

Healthcare Professionals Registry is a comprehensive repository of registered and verified different system of medicines (modern medicine, dentistry, Ayurveda, Unani, Siddha, Sowa-Rigpa, Homoeopathy) and nurses practitioners delivering healthcare services across India. 

The ABHA number will be used for the purposes of uniquely identifying persons, authenticating them, and threading their health records (only with the informed consent of the patient) across multiple systems and stakeholders

The repository is part of the Ayushman Bharat Digital Mission (ABDM), which empowers healthcare professionals to be part of India’s digital health ecosystem through a unique healthcare professional ID. With last mile coverage, people will be able to interact with healthcare practitioners or vice versa.

Healthcare professional profile visible in the ABDM ecosystem is verified and authorised to practice medicine in the country. The HPR ensures that healthcare practitioners suitably trained and qualified to practice medicine with competence and ethical conformity are allowed to register with the HPR.



Pharmacists are HealthCare Professionals.

Lets be worth it.

Really!!!,  then why the term ' PharmaCare ' was coined.
Pharmacist A HealthCare professional? If so why pharmacy course is not?. Has the Pharmacy education been got included in National Health Education Manual?

ok

So many regulatory bodies and governing bodies in pharmacy education: whims of my mind

PCI(Pharmacy Council Of India) and AICTE(All India Council for technical education) are the governing bodies in the pharmacy education , keeping in mind the compounding and dispensing as well as the technical aspects involved in Pharmaceutical Engineering .

Now with the advent of Pharm D course in pharmacy, which is clinically oriented 6 years course in pharmacy and the syllabus is designed such as  first 3 years are same as B.Pharm ( compounding and dispensing oriented) and next 2 years are same as MD Pharmacology (medically and clinically oriented) and 1 year of internship in an attached (minimum- 300 beded) hospital , one may expect MCI (medical council of India) to get into the thick of the things/matters.

As it requires an affiliation with a  hospital( minimum 300 beded), to get approval for an pharmaceutical institute from PCI to conduct the course , one must expect MCI(medical council of India)(Now NMC) also to get involved as a regulatory and governing body.

PCI governs courses like : D.Pharm
                                         B.Pharm
                                        Pharm D and Pharm D(PB)

AICTE governs courses like : B.Pharm( jointly with PCI)
                                              M.Pharm

Now one must expect AICTE,PCI and MCI may jointly govern : Pharm D and Pharm D(PB)

But no, its not a rational thinking on my part. MCI (Now NMC ) will get involve only when the course is a medical one or may be when the professional doctor is dealing with a body part.
So, its fair enough that MCI(NMC) is not involved into these matters.(Really?!!!)

                                             

Pharm D course introduction and D Pharma course closure is Propaganda !!! Is Pharm D and Pharm D(PB) course is approved by UGC?

I don't understand why D. Pharma course is being removed as minimum qualification for registration to practice Pharmacy in India. 

They say due to corruption. (Propaganda)

But I have seen corruption and malpractices happening at higher education level as well. 

1)PhD and PharmD students/interns publishing their names in scientific journals for research articles in which they have not done anything and just paid asked amount to the principal researcher so that their name get added in the research article as co-authors or co-researchers for publishing in scientific journals.

2)illogical sequence of subjects taught at colleges with these newly started courses.

3)Renting of license will continue even on Pharm-D ( doctor of pharmacy) degree.

4)To make minimum qualification for a registered pharmacist to do pharmacy practice in India, Pharm-D degree rather than D.Pharm ie. to replace the state's diploma of pharmacist.

Instead of updating and upgrading the syllabus of D.Pharm, what the policy makers have done is that they have created a new course named Pharm.D/Pharmd(PB) and obvious plan is to make it the minimum qualification for a registered pharmacist to do pharmacy practice in India and produce so called Next Generation and New Age Pharmacist. It's like a RESTART button pressed on.

Why create so much confusion, why malign the integrity of Pharmacy field. They could have retained the D.Pharm course and should have made neccessary changes in the syllabus and duration of D.Pharm, so that the minimum qualification for a registered pharmacist to do pharmacy practice in India remain D.Pharm and no need to replace the state's diploma of pharmacist. 

Just imagine if M.B.B.S course is replaced by some other course which is made minimum qualification for a registered physician to do medical practice in India.

And then they call themselves Pharma Expert or Drug Expert (DRX). What a pity situation ?

Is Pharm D and Pharm D(PB) course is approved by UGC? 

Medical Science vs Pharmaceutical Science (Residential Program Year)


RPY: Residential Program Year

Pharmacy residency is education a pharmacist can pursue beyond the degree required for licensing as a pharmacist (in the United States of America: PharmD). A pharmacy residency program allows for the implementation of skill set and knowledge acquired in pharmacy school through interaction with the public either in a hospital setting or community practice.The program is done over a span of about two years after graduation from pharmacy school and licensure as a pharmacist. Pharmacy residency helps improve the resume of a pharmacist so as to increase chances of obtaining employment outside community practice. A 2022 review suggested that there is sufficient evidence that residency develops key competencies for junior pharmacists


In India, after completing a Pharm.D. (Doctor of Pharmacy) degree, students can pursue residency programs to specialize in clinical pharmacy or related fields, enhancing their expertise and career prospects. These programs, often lasting one to two years, provide advanced training in areas like clinical pharmacy practice, patient care, and drug information. 

Details about Pharm.D. and Residency in India:
  • Pharm.D. as a Professional Qualification:
    The Pharm.D. is a professional doctorate recognized by the Pharmacy Council of India (PCI). It signifies expertise in pharmacy practice and allows graduates to become licensed pharmacists. 
  • Residency Programs:
  • Following the Pharm.D., residency programs offer specialized training in various clinical settings, such as hospitals and clinics. 
  • Focus Areas:
  • Residency programs can focus on areas like:
    • Clinical Pharmacy: Providing patient-centered care, medication therapy management, and drug information services. 
    • Critical Care: Managing patients in intensive care units, focusing on advanced life support and critical care protocols. 
    • Other Specializations: Opportunities may also exist in areas like oncology, cardiology, and infectious disease, depending on the specific program and institution. 
    • Career Paths:
  • Residency training can lead to various career opportunities, including:
    • Clinical Pharmacist Roles: In hospitals and other healthcare settings, directly involved in patient care. 
    • Medical Affairs: Bridging the gap between pharmaceutical companies and healthcare professionals, providing scientific expertise and support. 
    • Research: Participating in clinical trials and research activities.   
    •  Duration:Residency programs typically last one to two years, depending on the specialization and institution. 
  • Benefits:Residency programs offer valuable practical experience, enhance clinical skills, and improve career prospects for Pharm.D. graduates. 




Residency Medicine

Residency or postgraduate training is a stage of graduate medical education. It refers to a qualified physician (one who holds the degree of MDDOMBBS/MBChB), veterinarian (DVM/VMDBVSc/BVMS), dentist (DDS or DMD), podiatrist (DPM), optometrist (OD), pharmacist (PharmD), or Medical Laboratory Scientist (Doctor of Medical Laboratory Science) who practices medicine or surgeryveterinary medicinedentistryoptometrypodiatryclinical pharmacy, or Clinical Laboratory Science, respectively, usually in a hospital or clinic, under the direct or indirect supervision of a senior medical clinician registered in that specialty such as an attending physician or consultant.


The term residency is named as such due to resident physicians (resident doctors) of the 19th century residing at the dormitories of the hospital in which they received training.[1]

In many jurisdictions, successful completion of such training is a requirement in order to obtain an unrestricted license to practice medicine, and in particular a license to practice a chosen specialty. In the meantime, they practice "on" the license of their supervising physician. An individual engaged in such training may be referred to as a resident physicianhouse officerregistrar or trainee depending on the jurisdiction. Residency training may be followed by fellowship or sub-specialty training.[2]

Whereas medical school teaches physicians a broad range of medical knowledge, basic clinical skills, and supervised experience practicing medicine in a variety of fields, medical residency gives in-depth training within a specific branch of medicine.



In India, medical residency, also known as postgraduate training, typically lasts for 3 years after completing the MBBS degree. It's a period of intensive clinical training in a chosen specialty, preparing doctors for independent practice. The residency program is structured with academic coursework, clinical rotations in various departments, and research components, culminating in an MD or MS degree (depending on the specialty). 

Key aspects of medical residency in India:
  • Duration: Generally 3 years for most specialties, but can vary. 

  • Eligibility: Requires completion of MBBS and passing the NEET-PG exam. 

  • Structure: Includes clinical rotations, academic learning (case discussions, seminars, etc.), and research. 

  • Focus: Hands-on clinical experience and development of practical skills under supervision. 

  • Outcome: Leads to an MD or MS degree in the chosen specialty and prepares doctors for independent practice. 

  • Supervision: Residents work under the guidance of attending physicians and consultants. 

  • Workload: Residents typically work long hours, including nights, weekends, and holidays. 

Saturday, 9 August 2025

Is Pharm D and Pharm D(PB) course is approved by UGC?

University Grants Commission (UGC) is a statutory body under Department of Higher EducationMinistry of EducationGovernment of India. It was set up in accordance to the UGC Act 1956 and is charged with coordination, determination and maintenance of standards of higher education in India. It provides recognition to universities in India, and disbursements of funds to such recognized universities and colleges. The UGC headquarters are in New Delhi, and it has six regional centres in PuneBhopalKolkataHyderabadGuwahati and Bengaluru. A proposal to replace it with another new regulatory body called HECI is under consideration by the Government of India. The UGC provides doctoral scholarships to all those who clear JRF in the National Eligibility Test. On an average, each year ₹725 crore (US$86 million) is spent on doctoral and post-doctoral fellowships by the commission.

Monday, 4 August 2025

Pharmacists are Healthcare Professionals or Pharmacare Professionals?

Pharmacists are HealthCare Professionals.

Lets be worth it.

Really!!!,  then why the term ' PharmaCare ' was coined.
Pharmacist A HealthCare professional? If so why pharmacy course is not?. Has the Pharmacy education been got included in National Health Education Manual?

Someone kindled me to define and explain who is Healthcare professional? Where does the Pharmacist fit in?

Healthcare Professional.

Someone kindled me to define and explain who is Healthcare professional? Where does the Pharmacist fit in?

Not an easy question in light of Second question.

Any professional who serves the humans to safeguard his / her health and serves to mitigate the suffering and assists and supports the patient to be as comfortable as possible and treats him directly and fecilitates treatment could be called healthcare professional or Health Worker. All put together could be called a Medical Team

[This is my own extempore definition, I am subject to correction]

Now coming to second question,
Where does the Pharmacist fit in to be called Healthcare professional?

Excluding Pharm D Pharmacists, considering prevailing scenario and practice in India  the Pharmacist looks like a supporter external to the Treatment team  only to dispense what is advised. 

Unless the Pharmacists update themselves  or Course content is updated to familiarise the students on healthcare practices in preventive and curative services Pharmacists of India may not gain the Healthcare Professional tag.

#PCI, #IPA, #APTI,

POV :Bhagwan PS


Pharmacists are HealthCare Professionals.

Lets be worth it.

Really!!!,  then why the term ' PharmaCare ' was coined.
Pharmacist A HealthCare professional? If so why pharmacy course is not?. Has the Pharmacy education been got included in National Health Education Manual?

A different POV : Pharmacists have failed to impress professionally and leave professional footprints in Healthcare Sector

A different POV : Pharmacists have failed to impress professionally and leave professional footprints in Healthcare Sector . Therefore requirement of a new course like Pharm D / Pharma D (PB), which will produce professionals called Pharmacist and Pharmacotherapist. 

Is it true ? Really!!! 


Pharmacists are HealthCare Professionals.

Lets be worth it.

Really!!!,  then why the term ' PharmaCare ' was coined.
Pharmacist A HealthCare professional? If so why pharmacy course is not?. Has the Pharmacy education been got included in National Health Education Manual?

Digital Prescriptions are the solution

Handwritten prescriptions in India often pose significant risks due to their potential for misinterpretation. The diverse linguistic landscape of India, with multiple languages and scripts, adds to the complexity of deciphering these prescriptions accurately. Common issues include illegible handwriting, which can lead to confusion between drugs with similar names or incorrect dosing instructions. This is particularly problematic given the wide range of medications available and the critical importance of precise dosages.

Moreover, handwritten prescriptions sometimes lack essential information such as patient history, allergies, or specific instructions for drug administration. In a healthcare environment where pharmacists play a key role in the safe dispensing of medications, these omissions can lead to serious health risks.

The situation calls for a more robust system, possibly incorporating digital prescriptions, which can ensure clarity, accuracy, and traceability. Standardizing prescription formats and embracing electronic health records could greatly mitigate the risks associated with handwritten prescriptions, leading to safer and more effective patient care in the Indian context.

Sunday, 3 August 2025

Q-commerce is here to stay, retailers must upgrade themselves’, says CEO of Retailers Association of India

Q-commerce is here to stay, retailers must upgrade themselves’, says CEO of Retailers Association of India
On September 26, Madras High Court lawyer K Narasimhan alleged in his complaint to the DPIIT that e-commerce platform Flipkart is offering discounts at product level for select sellers and creating a non-competitive environment.
By  IMRAN FAZAL| Sep 27, 2024 8:44 AM

‘Q-commerce is here to stay, retailers must upgrade themselves’, says CEO of Retailers Association of India
The Department for Promotion of Industry and Internal Trade (DPIIT) has referred a complaint against quick commerce companies to the CCI for further investigation.

Multiple retail trade associations and federations have written to the Indian government, expressing concerns that the growth of Q-commerce platforms is hurting their retail businesses. The Retailers Association of India (RAI) believes that instead of complaining about the rise of Q-commerce and e-commerce platforms, retailers should focus on upgrading themselves.

It's worth noting that several FMCG companies have reported strong double-digit growth in online sales through quick-commerce. According to a RedSeer report, the Q-commerce market is expected to reach $5.5 billion by 2025. The contribution of quick-commerce platforms to the online grocery market is projected to increase from 10% to 45% in the coming years. In 2023, the gross merchandise value (GMV) of quick commerce in India reached $2.3 billion, showing a growth of over 70% compared to the previous year.

RELATED STORIES
‘Q-commerce is here to stay, retailers must upgrade themselves’, says CEO of Retailers Association of India
On the sidelines of the Retail Technology Conclave, ReTechCon 2024, Kumar Rajagopalan, CEO of the Retailers Association of India (RAI), spoke to Storyboard18 about the ongoing Q-commerce vs. Retailers conflict, which has now reached the Competition Commission of India (CCI).

Addressing the allegations of unfair trade practices by Q-commerce and e-commerce platforms, Rajagopalan stated, “When it comes to unfair trade practices and allegations by retailers, we need to wait and see. The government has a mechanism to address such issues.”

Rajagopalan added, “As far as Q-commerce platforms are concerned, they are here to stay because customers are getting something they've always wanted. At RAI, we believe in creating a level playing field for all retailers, and the Indian government has already launched the Open Network for Digital Commerce (ONDC), which will likely incorporate hyper-local and fast-commerce capabilities.”

He went on to say, “We are waiting for ONDC to improve further, and RAI is actively working with them. I believe that when your trusted local retailer can provide the product you want, whether online or offline, at the desired speed, small retailers will naturally thrive.”

Rajagopalan emphasized, “Our goal is to help small retailers improve their operations. As the Retailers Association, we don’t believe in halting new or innovative businesses, but we aim to ensure everyone has a level playing field.”

Recently, All India Consumer Products Distributors Federation (AICPDF), which claims to represent about 800,000 entities, expressed concerns over the rapid expansion of quick commerce platforms. They allege that these platforms create an uneven playing field, negatively impacting small retailers.

The AICPDF submitted a complaint to the Ministry of Commerce and Industry, raising concerns about anti-competitive practices by quick commerce companies and calling for an investigation.

When asked about RAI's stance on this issue, Rajagopalan said, “The debate over whether retailers should be available both online and offline is now irrelevant. Customers are shopping both ways. Any retailer worth their salt must be available online and offline, which is why I support ONDC. You can’t do anything that goes against customer interests—it will backfire.”

He added, “The key is to enable everyone to do business for the customer. However, if someone is engaging in deep discounting or loss leadership practices that are anti-competitive, these should be addressed, and it’s the government’s responsibility to ensure such practices are stopped.”

“At RAI, we always emphasize a level playing field. No one should take undue advantage of the situation with unfair trade practices. At the same time, businesses should not expect things to be the same as they were a decade ago—COVID has changed all of us as consumers. Retailers must adopt new methods to upgrade themselves.”

The Department for Promotion of Industry and Internal Trade (DPIIT) has referred a complaint against quick commerce companies to the CCI for further investigation.

Moreover, Confederation of All India Traders (CAIT) has urged the government to suspend the 'festival sales' events of Amazon and Flipkart, as they will further harm domestic traders through the continued use of anti-competitive practices.

On September 26, Madras High Court lawyer K Narasimhan alleged in his complaint to the DPIIT that e-commerce platform Flipkart is offering discounts at product level for select sellers and creating a non-competitive environment. The letter was sent to the Department for Promotion of Industry and Internal Trade Secretary Amardeep Singh Bhalla.




CBI raids PCI President Montu Patel in bribery probe


🔎 On July 3, 2025, the CBI raided the Ahmedabad and Gandhinagar homes of PCI President Montu Kumar Patel over alleged bribery and college approval irregularities . 

💸 An FIR alleges Dr. Patel accepted bribes to approve underqualified pharmacy colleges and bypass proper inspections . 

📺 Physical inspections were scrapped in favor of quick 8‑minute online audits in 2023–24, paving the way for potential corruption .

 🏫 Investigators found “phantom colleges” in UP, MP, Gujarat & Rajasthan approved despite dilapidated infrastructure .

 🕴️ A senior CBI officer noted that “college recognitions were being sold for money under Patel’s tenure” . 

🤐 The probe uncovered fake records, back‑dated approvals, GPSC portal manipulation, and electoral sway tactics . 🧠 The investigation follows a Supreme Court critique in May over PCI’s “arbitrary” decisions—spotlighting deep governance issues . 

🧾 The CBI will likely expand the probe to cover key states like Maharashtra, targeting systemic faults . 

⚠️ Dr. Patel, elected in April 2022, hasn’t been arrested yet; however, the evidence seized is described as “substantial” . 🏛️ With accreditation credibility at stake, experts now call for a full overhaul of PCI’s college recognition and inspection system . 

What’s your thoughts on this?

Sources : Harsh Y

#PharmacyEducation #PharmaRegulation #PharmacyCouncilOfIndia #PharmaGovernance #PharmaLeadership #PharmacyColleges #PharmaIndia #EducationStandards




Wednesday, 30 July 2025

Protect your Pharmacist. Save your Pharmacist.

Physicians are well protected by their own folks.

They are 'No Wrong Doers'!

Who should protect the Pharmacists in the service and in the Regulatory?

#RegulatoryOfficersAssociation
#IPA
#IHPA
#APTI
#AIOCD
#PharmacistsAssociation

Modern times require Modern Solutions


For modern times an ideal prescription should be a computerized printed form prescription so that it is legible opposite to oftenly an illegible physician's handwritten prescription. So that automization of dispensing of prescription medicines is possible by using modern technology like a computer scanner attached to pharmacy vending machines eg Script Pro Unit Dispenser.

Saturday, 19 July 2025

How can we determine quality of medicine in the ocean of generic medicines? Authorised Generics, Branded Generics, Unbranded (Ordinary) Generics

How can we determine quality of medicine in the ocean of generic medicines?

Check-List for Quality of Medicine

1 Look for the make and check their website.
A. Look for the Co. Profile.
B. Look for the Co. License.
C. Look for the approved products.

2. Look for the Standards like IP mentioned, Batch No and Exp date.

3. Never forget to collect Official Cash bill.

I think thats enough at consumer level

POV : Bhagwan PS


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

References

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