Monday, 4 August 2025

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


๐Ÿ”Ž 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 . 

๐Ÿ’ธ An FIR alleges Dr. Patel accepted bribes to approve underqualified pharmacy colleges and bypass proper inspections . 

๐Ÿ“บ Physical inspections were scrapped in favor of quick 8‑minute online audits in 2023–24, paving the way for potential corruption .

 ๐Ÿซ Investigators found “phantom colleges” in UP, MP, Gujarat & Rajasthan approved despite dilapidated infrastructure .

 ๐Ÿ•ด️ A senior CBI officer noted that “college recognitions were being sold for money under Patel’s tenure” . 

๐Ÿค The probe uncovered fake records, back‑dated approvals, GPSC portal manipulation, and electoral sway tactics . ๐Ÿง  The investigation follows a Supreme Court critique in May over PCI’s “arbitrary” decisions—spotlighting deep governance issues . 

๐Ÿงพ 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” . ๐Ÿ›️ 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.


Thursday, 10 July 2025

Mohalla Clinic , Mohalla Pharmacy , Mohalla Mediclinics, Mohalla Pharmaclinics

A Mohalla Clinic is a primary health center in India that offers free essential health services to the community: (Mohalla Mediclinics)
  • Services: Free consultations, diagnostics, and medicines
  • Location: Located within a kilometer of the patient's home 
  • Purpose: To reduce the financial burden on low-income households by providing free healthcare and saving travel costs 
  • Name: The word mohalla in Hindi means "neighborhood" or "community"
How about a Mohalla Pharmacy? (Mohalla Pharmaclinics)