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

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

Farhat Nasim

4 - 5 minutes

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

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

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

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

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

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

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

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

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

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

PharmacyPractice-IndianContext

#PharmacyPractice-IndianContext

👉Pharmacy Practice has no definition.

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

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

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

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

POV: Bhagwan PS

Note : Then what about PPR 2015, and amendments ? 

M.Pharmacy course and syllabus

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

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

Scope of taking specialization in M.Pharm

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

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

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

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

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

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


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

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

Specialization areas in M.Pharm

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

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

The Pharmacy Management System OR The Pharmacy Information System

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

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

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

Purpose

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

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

Pharmacist patient care process

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

Vendors

Outpatient software vendors

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

Rx30

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

Inpatient software vendors

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

Epic Willow

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

Cerner PharmNet: Medication Manager

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

Datascan: Winpharm

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

Pharmacoinformatics

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

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

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

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

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

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

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

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

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

PCI to introduce medical device mfg in revised curriculum

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

Why this stupidity?

Is medical devices any formula product?

It is an Engineering subject with medical application.

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

Why burden the pharmacy students for no extra gain?

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

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

Drug and Cosmetic act and Pharmacy Practice Regulations Act

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

KNOW (Y)OUR PHARMACY ACT & ITS WEAKNESS:

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

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

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

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

Weakness :

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

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

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

Weakness:

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

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

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

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

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

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

Weakness: 

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

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

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

Weakness:

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

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

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

Weakness:

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

Obvious name/s get elected.

Remedy:

Besides the Amendments needed the following measures would help:

All councils should publish on their website all documents:

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

2. Meeting calendar for the year.

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

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

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

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

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

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

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

.