Competencies for the Indian D.Pharm Holders

The Pharmacy Council of India, under the approval from Ministry of Health and Family Welfare, published revised syllabus for Diploma in Pharmacy (D.Pharm) course. 

‘Competencies for the Indian D.Pharm Holders’ based on the knowledge, skill, attitude and value that are essential for the successful practice of the profession have been derived. These competencies have  been mapped with the individual courses of the curriculum based on the expected outcomes of the individual course

Competency is defined as “A distinct composite of knowledge, skill, attitude and value that is essential to the practice of the profession in real life contexts”. 

The candidates who successfully complete the Diploma in Pharmacy (D. Pharm) program of Education Regulations 2020 (ER-2020), from the institutions approved by the Pharmacy Council of India are expected to attain the following professional competencies.

1. Review Prescriptions

2. Dispense Prescription / Non-Prescription Medicines

3. Provide Patient Counselling / Education

4. Hospital and Community Pharmacy Management

5. Expertise on Medications

6. Proficiency on drugs / pharmaceuticals

7. Entrepreneurship and Leadership

8. Deliver Primary and Preventive Healthcare

9. Professional, Ethical and Legal Practice

10. Continuing Professional Development

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Competencies for the Indian D.Pharm Holders explained

Centre asks States to follow TN model for procuring drugs for public health programmes

The Union Health Ministry has asked the States to follow the model of Tamil Nadu for purchase of drugs for public health programmes, with a view to ensure transparency, availability, and distribution as the model has proved to be very effective.

“There is also great merit in making bulk purchase of drugs through a specialised agency. This not only ensures better quality but also reduces the prices. States may like to examine the Tamil Nadu Medical Services Corporation model set up by the Government of Tamil Nadu for the purchase of drugs for public health programmes,” the Health Ministry told the States, at a recent meeting of Health Secretaries here.

The Centre also wanted the States to set up special courts to tackle the spurious drugs cases. “It is also important that once the drug samples fail quality and safety standards, prosecutions are launched and culprits are booked quickly. There is need to set up Special Courts to try prosecution cases under the Drugs & Cosmetics Act 1940. Many have already designated Special Courts for such trails while others also should act on a priority basis,” the meeting was told.

“While promoting the generic drugs, it is important that a rational Fixed Dose Combinations (FDC) are weeded out from the market. This not only enhances the price of the drug but also leads to several other health consequences including drug resistance. While granting licenses for manufacture of FDCs, State Drug Regulators must be very careful regarding efficacy of such drugs,” the written brief by the Centre said.

Tamil Nadu Medical Services Corporation Ltd was set up with the primary objective of ensuring ready availability of all essential drugs and medicines in the Govt Medical Institutions throughout the State by adopting a streamlined procedure for their procurement, storage and distribution. TNMSC aim is to make the drugs and materials available to the poorest of the poor and “Service to the Public.”

It handles procurement, testing, storage and distribution of medicines, surgicals, kits and reagents to the Government Medical Institutions of the State. It finalises rate contract every two years for various frequently used surgical appliances, Instruments for direct procurement by the medical institutions in the State.

Recently, the public interest organisations have also called for adopting the time-tested TN model across the country. The Jan Arogya Abhiyaan (JAA), a network of NGOs working on health issues in Maharashtra, urged the State Government to implement it. Kerala has adopted it and other states like Rajasthan and Bihar are also in the process.

Source: Pharmabiz

FGSCDA urges govt to amend D&C Act to disallow strip cutting

The chemists and the druggists in Gujarat have demanded to the government to make necessary amendments in Schedule P with regard to cut strips in the Drugs and Cosmetics (D&C) Act to ensure uniform strip size for all the drugs.

In a representation to the commissioner of Food and Drugs Control Administration (FDCA), the Federation of Gujarat State Chemist & Druggist Association (FGSCDA) urged the government to amend the Drugs and Cosmetics (D&C) Act and demanded that no strips size beyond ten, six, four or two should be permitted.

“There should not be more than 10 tablets or capsules per strip as the present strip size of 12 and above are either cumbersome to handle or they have to be cut to suite the budget of the patients,” reads the representation. Jashvant Patel, president, FGSCDA pointed out that this issue needs to be addressed urgently as cut strips is one of the causes for development of antimicrobial resistance as it leads to under dose of the antibiotics in patients.

Only about 1 per cent of the drugs in the market today are governed by mandatory pack size fixation. As of now D&C Act is silent on whether a strip can or should be cut or not which causes lot of confusion as different drug control authorities give different interpretations of this.

According to Patel, “We need more transparency in this matter as strip cutting is a serious problem which the lawmakers, FDA officials, pharma industry or the doctors cannot understand. It is finally the customers and the retail pharmacists who have to face the brunt of the losses and risk of consuming the wrong or expired medicines. Thus it is imperative that the government should take some steps to solve this problem so as to deal with the shortcomings of the present system of the pack sizes and problem of strip cuttings.”

For all the retail chemists, strip cutting is a huge problem that needs to be addressed urgently as it comes with heavy loss. Cut tablets are often difficult to be identified since the name of the drug may not appear on every part of the strip or foil and as embossing on the tablet is not always identifiable it is a potential loss to the chemist.

Patel further pointed out that adding to all these problems is the fact that cut strips which have expired are not settled by stockists and manufacturers thus putting the pharmacist at loss.

The association in its representation proposed certain suggestions to the government, which they expect to be amended in the Schedule P of the D&C Act. “Pro active steps should be initiated to ensure that strip cutting is disallowed completely as it will ensure that no physician samples or expired drugs with no batch number or expiry details are pushed forward to the patients,” he added.

26th IPGA conference pushes for change in pharmacy education

The 26th Annual conference of the Indian Pharmacy Graduate's Association (IPGA) was held on April 2, 2011 in New Delhi, with the theme of 'Pharma opportunities and challenges in the new decade'. Even though the event clashed with the finals ICC World Cup, with India as one of the teams, the event was very well attended, a sign that the topic was as great a pull as the game. Dr S S Ghonkrokta, Director-Enforcement, Food Safety and Standards Authority of India (FSSAI) was the guest of honour, while Dr S M Jharwal, Chairman, National Pharmaceutical Pricing Authority (NPPA) was the chief guest for the occasion.

In his keynote address, Professor S K Kulkarni, Bombay College of Pharmacy, touched on the aspect of 'building an innovation eco-system in pharmaceutical sciences', saying that the quality of education and research done in our country needs to be looked at with concern because the goals still needed to be met. There is a shortage of specialised talent in system biology, clinical research, healthcare delivery and so on, which are disappointingly not in the regular pharmacy curriculum and need to be introduced in pharmacy education in order to rightly equip students with the knowledge base to thrive professionally. "The current lack of research infrastructure and funding (private and public), lack of inter and cross disciplinary teaching and learning, unmindful expansion of professional education are all distressing factors that exist because the right priorities are not kept in mind," said Kulkarni. "To overcome this and to establish an innovation eco-system there is a great need to firstly shun the old and unproductive mindset in the industry and overhaul educational and research approaches with vigour and imagination in order to contribute to the global knowledge bank. Secondly, we need to adopt flexible and interdisciplinary learning modes, while rightly identifying ambitious young individuals and institutions; fund, network and establish credible environment of entrepreneurs and alumni," he added.

Among the speakers present at the event, Mukta Arora, India Head-Global External R&D and Global Sourcing India Market, Eli Lilly and Company traced the evolution of the Indian Pharma industry with respect to the various niches and identified opportunities for students in the fields of manufacturing of api, CT material, drug product; research, clinical research, formulation research, in sales and marketing jobs at Indian and MNCs, community pharmacist, market research, hospital pharmacy management, drug development--adme/tox/safety, medicinal chemistry, synthetic chemistry, natural products research, large molecules-biologics, regulatory--clinical, and pharmacovigilence.

While Dr Veena Kohli, Vice President, Diagnova, RFCL, talked about the opportunities for students in the field of medical diagnostics, Dr B R Jagashetty, Drugs Controller, Karnataka, gave an insight into the vast field of regulatory affairs pertaining to pharmaceuticals. Dr Jaspreet Kaur, Head Quality Assurance and Training, Fortis Clinical Research, Faridabad, enlightened pharmacy students about career in clinical research, and Dr Varun Katyal, Assistant Professor, Empower School of Health, spoke about the more sought after fields that pharmacy students would be interested in and the right educational pathway to follow to pursue them.

The conference saw delegates from all over the country, from regulatory departments, the pharma industry, R&D, hospital, community and clinical pharmacy, academia, marketing and pharmacy students. Later in the evening, Priolkar was felicitated as the President Elect for the 63rd Indian Pharmaceutical Congress, 2011.

Maharastra FDA to launch software for pharma units to enable access to all drug information soon

As part of its plan to introduce e-governance, the Maharashtra Food and Drug Administration (FDA) will soon introduce a new software which will be beneficial for thousands of drug manufacturers spread across the state as they can access all drug related information and status of pending works through online thereby saving a lot of time and energy.

The software will have several user-friendly features and the manufacturers do not have to visit the FDA office frequently as they can access everything online regarding drug manufacturing processes. The other features include process of additional products, certification of the products required for manufacturing purpose and any pending approvals of manufacturers, etc.

O S Sadhwani, joint commissioner, Maha FDA said “Gujarat Food & Drugs Control Administration (FDCA) is already using this software and if they are successful then we will use it across Maharashtra. We are at the primary stage of starting a software which will prove to be beneficial for the manufacturers. There are further talks regarding the meeting with National Informatics Centre (NIC) for the use of the software and for further developments we will follow the path of Gujarat FDCA as it has already implemented it in Gujarat.”

Sadhwani added that Maharashtra FDA had already approached NIC to develop software for online facility for granting licenses to the pharmacists across Maharashtra which was a successful initiative that helped the retailers to save time while applying for licenses and renewals. Likewise by introducing this software FDA is hopeful that it will help manufacturers to complete their pending work.

In the first stage, the Maharashtra FDA will be implementing this software in Konkan division which comprises Thane, Ratnagiri, Raigad and Sindhudurg. After launching this software in Konkan , then it will be used by manufacturers across Maharashtra for a specific period of time. This will help the manufacturer to analyse and complete their pending work or understand what are the need for manufacturing purpose.

As of now the FDA will focus on building the data, but in future they are hoping to continue and will be concentrating on developing the software for manufacturers and most importantly to get the right information about the pending products and approvals.

TNCDA opens Academy of Professional Excellence for grooming pharmacists

As part of its retail chain plan, the Tamil Nadu Chemists and Allied Distributors Alliance Ltd, a company formed by the Tamil Nadu Chemists and Druggists Association, will, from early next month, commence its plan of educating the member pharmacists to make them on par with international standards.TNCDA, an e affiliated body of AIOCD, has drawn up the plan with the help of the parent organization and subsequently launched an Academy for Professional Excellence which will conduct the training courses to enhance the professional competence of the drug dispensers.

The course is expected to enable the pharmacists to make them confident professionals at the counter as is the case with doctors in the healthcare system. A leading figure in the pharmacy profession and pharmaceutical trade, R Srinivasan of ‘EssenCorp’, has been made the director of the Academy.The courses, which will have five modules covering 12 days altogether, will be run based on a syllabus in which portions of other state syllabuses are also included besides a set of chapters framed by the Academy. Faculty members will be ranging from trade, manufacturing sector, regulatory bodies and doctors community. The course will enable to change the mindset of the pharmacists from a mere vendor to a true professional. The course will end with a written test and a viva-voce, and on its successful completion, the participant pharmacists will be given accreditation and a certificate, said R Srinivasan.

Sharing the details, M Arulkumar, managing director of the company, said “the chemists are now fragmented and they lack a common set of professional norms. We want them to bring into one chain and equip them professionally competent not only to become a successful trader but also to develop managerial skills of each person. Discussions are on now with the community pharmacy division of the IPA to co-ordinate the education programme.”

Vivek D Chaudhari, deputy registrar of Maharashtra state pharmacy council who has been identified by AIOCD as the master-trainer of the programme, while speaking to Pharmabiz said this is a continued education programme and in the beginning (Module A) there will have 5 days refresher classes which will help raise the confidence of the pharmacists and impart knowledge of storage conditions of medicines, general awareness about common diseases and how to handle the pharmacy with modern practices.The second Module (Patient counselling) will involve 3 days classes, but it may not be in close continuity with the first, covering five segments focusing on clinical aspects. Hypertension, angina, hyperlipidemia, asthma and diabetes are the core areas the second semester will concentrate on.

The third and the fourth modules, which will cover one day each, are dedicated to specialized areas such as dermatology and gynaecology for which competent doctors will be recruited as resource persons.The fifth module involves one day class on orthopaedics and the latest medical technologies involved in treating accidents and trauma.

A general awareness on various kinds of drugs used in ortho treatment will also be part of the training.Chaudhari said everybody knows the minimum requirement for starting a pharmacy, but nobody knows about the highest standards for maintaining a pharmacy, which will be imparted through this course.According to TNCDA Ltd, only the shareholders of the company or the members of TNCDA can become the participant for the educational program of professional excellence and a token fee for the course will be collected from the trainees. Business development, personality development, communication skill development, pharmacy development and changes in consumers’ behaviour are the areas based on which the courses are designed.Arul Kumar said all the registered owner-cum-pharmacists in the state will be encouraged to join the course. However, entry will be given to the non-registered pharmacists, if they are the owners of the pharmacy and having years of experience in the trade. He feels that the course will provide them some inputs for improving the professional standards. The members of TNCDA Ltd will retain the brand name ‘Allianz’ with their upgraded shop.In the first phase, classes will be conducted in Chennai, Madurai and Coimbatore starting with 50 participants each.

21 M Pharm students selected for this year’s ‘TNPSWT’ M Pharm Scholarship Awards

The Tamil Nadu Pharmaceutical Sciences Welfare Trust (TNPSWT) has selected 21 final year M Pharm students from various pharmacy colleges in Tamil Nadu for this year’s M Pharm Scholarship Awards. The awards were instituted by TNPSWT and are being given to selected M Pharm students for their on-going project work.

268 applications were received from seven different branches of pharmacy from 19 colleges. 262 synopses were sent to Dr Madhusudan Rao, Principal, University College of Pharmaceutical Sciences, Kakatiya University, Warangal, and his team for evaluation. Based on their best marks, students have been selected for award of scholarship.

Each branch of pharmaceutical sciences is given three scholarships with first, second and third ranks and there are seven branches. The first rank carries Rs. 8000, second rank, Rs. 7000 and Rs. 6000 for the third rank. Pharmaceutics, pharmaceutical chemistry, pharmaceutical analysis, pharmacology, pharmacognosy, pharmacy practice and biotechnology are the branches in which scholarships were awarded.

K R Vimal of PSG College of Pharmacy, Coimbatore has won the first rank of scholarship for the branch, pharmaceutics. Syam Potnuru of Adhiparasakthi College of Pharmacy, Melmaruvathur, won the second rank. The third rank holder is Anindita De of JSS College of Pharmacy, Ooty.

In pharmaceutical chemistry, the winner is S Jeevanantham from RVS College of Pharmacy, Coimbatore, the second rank goes to V Hemalatha of SRM College of Pharmacy, Kattankolathur and Sona Joseph from KMCH College of Pharmacy, Coimbatore bagged the third rank.

E Kumanan from Adhiparasakthi College of Pharmacy, Melmaruvathur is the first rank holder for pharmaceutical analysis and K Harsha Manjusha from JSS College of Pharmacy, Ooty ranked second. M Manu from RVS College of Pharmacy, Coimbatore bagged the third rank.

In pharmacology, the first rank goes to Kalpana Eluri of PSG College of Pharmacy, Coimbatore and R Ranjith Kumar from the same college has been selected for the second rank. R Anand from KM College of Pharmacy, Madurai is the third winner.

In pharmacognosy the first rank for scholarship was given to M Mubeen of Madurai Medical College, Madurai and V Jothi Rani of Arulmigu Kalasalingam College, Srivilliputhur has been chosen for the second. Aparna Sarepaka of JSS College is the third winner.

In the branch of pharmacy practice, the first rank was given to Raj Kucherlapati VSP of JSS College of Pharmacy, Ootty, and Merin Levy Philips from SRIPMS, Coimbatore got the second award. C Karthic Kumar from JSS College of Pharmacy, Ooty bagged the third rank.

In biotechnology, the first rank was given to N Karthikeyan of SRIPMS, Coimbatore and S Karthikeyan of the same college bagged the second rank. The third rank went to Mahesh Thondawada of JSS College of Pharmacy, Ooty.

Get emails on banned drugs.

How about getting emails on drugs that are banned in India? Yes, it is possible if you are registered Pharmacist in Karnataka.

The Karnataka State Pharmacy Council (KSPC) is collecting the email IDs of new as well existing members so that it can disseminate information about drugs as quickly as possible. KSPC registrar B S Bhagwan said, “The email service will work as an internal circular among registered pharmacists. For instance, if a drug is banned, or crucial information about a drug has to be passed on, this is the most effective way. We can also pass on research information.” Though providing email IDs is not mandatory, Bhagwan said that it could be a disadvantage since such information would not be sent through post. “They will have to depend on other sources of information, like circulars from the drug control department and newspapers,” he said.

This service is expected to start in a few months. The council plans to begin the service once it finishes collecting email IDs and that should take a few months. KSPC president D A Gundu Rao said though the service was optional, they were willing to help those without an email ID to create one. The state has 44002 as of 12th October 2010.

One day Seminar on Bioequivalence

Bioequivalence Studies are a commonly accepted method to demonstrate the therapeutic equivalence between two competing drugs, and form an essential part of the drug registration dossier. Using bioequivalence as a tool to introduce a new generic drug into the market can lead to significant reductions in both the time and costs involved, with the result that the design, performance and evaluation of the related bioequivalence studies have become critical in the drug development process in the pharmaceutical industry. The one day interactive Seminar on Bioequivalence being offered by AIPS will lead to an understanding of the planning, conducting, analyzing and reporting of BE Studies, and will be suitable for professionals in the drug development R&D, regulatory, clinical, medical etc functions.

e-mail : info@aips.ac.in

Total number of registered pharmacists in Karnataka

The total number of registered pharmacists in Karnataka as on 16th June 2010 is 43652.

Pharmacy Practice Regulation

The Government of India under the direction of Pharmacy Council of India (PCI) is in the process of finalizing the Pharmacy Practice Regulation which will mandate all hospitals to set up departments of clinical pharmacy manned by Pharm D graduates.

When Pharm.D was introduced in India in 2008 and there was a big question on the employment opportunities for those who complete this course. Hospital Pharmacy was (and is) a not so preferred job option by Pharmacy graduates due to the remuneration and the scenario was dreadful for those who will complete Pharm.D. Regulations made it mandatory that Pharmacy outlets should have a Pharmacist to dispense drugs but the real picture is that many Pharmacies, even in metros, are run by non-pharmacy people (sometimes a high school drop out dispenses drug).

Pharmacy graduates simply rent out their certificates to these shops and make a physical presence in case of an inspection. The blame is not on those who run the shops but the Pharmacists who make a hue and cry that there is unemployment and low salary.

With the introduction of the Pharmacy Practice Regulation, PCI may make an attempt to justify its stand in introducing Pharm.D course in India to take Pharmaceutical education in India to world standards. But what about the thousands of Pharmacists in the country with a Diploma or Degree in Pharmacy. A release stated "Pharm D will be the minimum qualification to seek postings at the departments of clinical pharmacy in hospitals"

Is this going to help the Pharmacist community or is it going to make things even worse? Most students in Pharmacy are aware of job options only in Marketing, Manufacturing, Teaching and Research. Clinical Research boom created a new career option but these days a fresher getting a job in a CRO is next to impossible. Also there is an influx from Medical doctors with M.B.B.S who are ready to work as CRAs or in Clinical Data Managment and Pharmacovigilance. So Pharmacists are still left with minimal job opportunities. Pharmacists hardly look for Government jobs (do not ask me the reason!)

PCI and the Government should consider improving the status of Hospital Pharmacy and also create more job opportunities for Pharmacists in both public and private sector.