Pharmacovigilance committee to draw roadmap for PVPI programme shortly

The first meeting of the National Coordinating Centre (NCC) for Pharmacovigilance Programme of India (PvPI) will be held on February 15 at Indian Council of Medial Research (ICMR) in Delhi. The meeting assumes significance as it will discuss some of the pressing matters that needs that have to be focused to make the PvPI more effective in future.

Dr G N Singh, secretary and scientific director of Indian Pharmacopoeia Commission (IPC), nodal agency for the PvPI, informed that this meeting will be of high importance as the meeting is aimed at discussing future course of the PvPI programme of the country, so that it will enable safe and judicious use of medicines by effectively monitoring adverse drug reactions (ADR's) of the same on the Indian population.

The meeting will be chaired by Dr V M Katoch who is the secretary of the Department of Health Research and also the director general of ICMR and will be attended by 14 members of the NCC committee, which was set up by the union health ministry last year. 

“Our main agenda would be to discuss drafting of new roadmap for the PvPI programme, so that we can also generate independent data on the safety of medicines that will be at par with global drug safety monitoring standards. Apart from that, we will also be discussing other important aspects focusing on the current issues with respect to PvPI so that we can adopt more progressive approach towards strengthening it,” said Dr Singh.

Another important issue that will be discussed during this meet is how to distribute the funds for the PvPI programme in the coming financial year. According to reports, the government has demanded the Planning Commission (PC) to allot Rs.2 crore specifically for the programme in the 12th Five Year Plan from 2012 to 2017. 

However Dr Singh informed that major chunk of the funds if allotted will be invested to hire qualified manpower specifically dedicated to help in improving the delivery of services of the PvPI and also at upgrading the infrastructure accordingly. 

With respect to increasing the number of ADR centres across the country, Dr Singh informed that for the time being, IPC will not be adding new ADR centres to take part in the PvPI, as the government has limited the number to 75 for the current financial year. Recently the government had announced that they do not intent to increase the number of ADR centres in this financial year beyond 75 centres, due to lack of capacity and manpower.

At present, there are 62 ADR centres established across the country, in phased manner, to monitor ADRs in the Indian population and create awareness amongst healthcare professionals about the importance of ADR reporting in India. Initiatives are being taken by the IPC to add 13 new ADR monitoring centres across the country by March 2012, which will make the total count to 75.

Source: PB

The Pharmacovigilance Programme of India (PvPI) is an Indian government organization which identifies and responds to drug safety problems.^[1] Its activities include receiving reports of adverse drug events and taking necessary action to remedy problems.^[1] The Central Drugs Standard Control Organisation established the program in July 2010 ^[1][2] with All India Institute of Medical Sciences, New Delhi as the National Coordination Centre, which later shifted to Indian Pharmacopoeia Commission in Ghaziabad on 15 April 2011.

History

Many developed countries set up their pharmacovigilance programs following the Thalidomide scandal in the 1960s.^[2] India set up its program in the 1980s.^[2] This general concept of drug safety monitoring went through different forms, but the Central Drugs Standard Control Organisation established the present Pharmacovigilance Program of India in 2010.^[2] Now the program is well integrated with government legislation, a regulator as leader, and a research center as part of the Indian Pharmacopoeia Commission.

Activities

As of 2018 there were 250 centers around India capable of responding to reports of serious adverse reactions.^[2] One of the challenges of the organization is training doctors and hospitals to report adverse drug reactions when patients have them.^[3] The Pharmacovigilance Program makes these reports itself, but ideally, such reports could originate from any clinic.^[3] The Pharmacovigilance Programme seeks to encourage a culture and social expectation of reporting drug problems.^[3]

One of the successes of the program was detecting adverse effects of people in India using carbamazepine.^[3][4] While this drug is safer among people native to the Europe, people of South Asia have different genetics and are more likely to experience problems when using it.^[3][4] Other countries could not have been able to detect this problem, and the Pharmacovigilance Programme's detection of it was a success story

Collaboration

The establishment of the Pharmacovigilance Program made India a more attractive international destination for foreign companies to bring clinical trials research.^[5] Understanding the quality of India's pharmacovigilance programme is key to international researchers conducting trials in India.^[6]

The program collaborates both in India and internationally with the World Health Organization on projects for safe medication.^[7][2] As a collaborating center, the Pharmacovigilance Programme assists the WHO in developing international policy for other countries to manage their own drug safety programs.^[7]

While the United States and Europe have pharmacovigilance systems which are developed well in some ways, the Indian programme has more and specialized expertise to apply for the unique circumstances of India.^[8] The Pharmaceutical industry in India produces more drugs than any other national industry.^[8] Because of the large amount of drugs and the many countries which import them, the Indian program monitors in some ways more than anywhere else.

Note : PVPI must create employment for Pharma D/(PB)  and M.Pharm Pharmacy Practice graduates as well . (Not only for M.D Pharmacologist )

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.

-Bhagwan P S

Pharmacists cannot open clinics to diagnose disease & prescribe medicine; clarifies PCI

Clearing the doubts on pharmacists can open pharma clinics to treat common disease and prescribe medicine, Pharmacy Council of India (PCI) has recently notified that the pharmacists cannot open clinics to diagnose the disease and prescribe the medicines.

PCI has clarified that there is no provision in the Pharmacy Practice Regulations (PPR), 2015 which allows the pharmacists to practice medicine. Under the said Regulations, the registered pharmacist is required to dispense medicines on the prescription of a registered medical practitioner and can counsel the patient or care giver on medicine to enhance or optimise drug therapy.

The elements of patient counselling includes, name and description of the drugs;the dosage form, dose, route of administration, and duration of drug therapy; intended use of the drug and expected action; special directions and precautions for the drug; common severe side effects or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur; techniques for self monitoring drug therapy; proper storage of the drugs; prescription refill information; action to be taken in the event of a missed dose and to ensure rational use of drugs.

Dr. B Suresh, president of PCI informed that there are few groups of pharmacists who are claiming that they are doctors and there are various messages being circulated on social media, e-mails, WhatsApp etc. that pharmacists are empowered under PPR, 2015 to open pharma clinics to diagnose the disease and prescribe medicines.

We would like to clarify that there are no such provision under PPR, 2015 which allows pharmacists to diagnose and prescribe medicine. PPR, 2015 only allows the pharmacists to practice pharmacy and not medicine, they can counsel the patient or care giver and dispense medicines on the prescription of a registered medical practitioner but cannot prescribe medicines to the patients

He further adds, “Under no circumstances, the registered pharmacist is empowered under the Pharmacy Act, 1948 and PPR, 2015 to practice medicines or open clinics to provide medical care.

BUT, My query is : Can a registered pharmacist(PHARM D) approved with Clinical Pharmacy Council give PHARMA CARE in his PHARMACY? Services like prior authorization and refill authorization for prescription drugs is permitted?

Government allowed consultancy charges/fees by pharmacists

PCI overtook regulations under own for M.Pharm course.

PCI  course will be applied  all over India instead of VV course Central University of Rajasthan  .

PCI to follow MCI way, so that there will be similar course and rules.

Uptill now regulation for Pharmacy is done by VV university, Rajasthan and AICTE, and its difficult to coordinate between them.

Application of new PCI regulated course will change the pattern of exam conducted in Pharmacy education field, ie semester system will be applicable instead of annual exam.

Health is Celebrity: CHINA IS WEEPING

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Health is Celebrity: SHANGHAI – Thirty-five individuals had died in Ne...

Health is Celebrity: SHANGHAI –  Thirty-five individuals had died in Ne...: SHANGHAI –  Thirty-five individuals had died in New Year's festivals in Shanghai's memorable waterfront range. City authorities said...

Pharma Clinic- Now PHARMACISTS can also Practice like Physicians within their own Clinical Setups........ but Pharmacists cannot open clinics to diagnose disease & prescribe medicine; clarifies PCI

फार्मासिस्ट जो प्रैक्टिस कर रहे हैँ या करना चाहते हैँ जाने कुछ रुल जो ppr 2015 का गजट फार्मेसी कौंसिल ऑफ इंडिया से जारी होने के बाद प्रभावी हो गए ह

Pharma clinic means Pharmacists can treatment only as a primary health care / schedule k OTC medicine priscribe/treatment of uncomplicated disease .jiske liye koi registration Ki jarurat nahi hoti. Local district ke CMHO ko jab clinic estblisment aa jaye to registered karva skate hai.any pharacists can open pharma clinic.but can not stock medicine without drug licence.

If pharmacists can do as such type of work in pharmacy .separate cell must estblised in pharmacy as a primary care with drug councilling chamber.
Drug can dispence by pharmacists supervision/ presence so there no problems create for pharmacists . But all medicine bill should be signed & inspected by pharmacists.

Now PHARMACISTS can also Practice like Physicians . . . . .within their own Clinical Setups

GOOD PHARMACY NEWS

Advanced Pharmacy Practice Model came to India , introduced by CLINICAL PHARMACY COUNCIL.

- PHARMA CLINIC - A Center of Pharmaceutical Health Care. . . .

Pharma Clinic practice model framed by CLINICAL PHARMACY COUNCIL within certain provisions of PPR-2015 of Pharmacy Act 1948 framed by PHARMACY COUNCIL OF INDIA.

Its a clinical setup outside the hospitals , where qualified registered Pharmacists provides their professional services on individual consultation of patients. within /along with Pharma Clinic Pharmacists also facilitate Drug Dispensing services by getting a Retail Drug license from local drugs regulatory authority.

Practice Pharmacy in your Own Clinical setup on individual patients consultations , collect fees fro professional services. Use sign board with your names and qualifications on the board.

These are all lawful as per Pharmacy Practice Regulations -2015 (PPR-2015) of Pharmacy Act 1948 framed by Pharmacy Council of India.

Now, Pharmacists also can practice as like doctors within their own clinical setups on patients consultations.

As per Sec 2 (I) (II) (III) of Chapter 2 of PPR-2015 A registered pharmacist is eligible to practice pharmacy, pharmacy practice means not only Compound, Labelling and Dispensing of Drugs. Pharmacists also provide the following professional services

- Participation in Drug & Device selection - Administration of Drugs through different routes of administration i.e IM , IV, IVF, SC , PO etc. . . - Drug Regimen VV Reviews - Drug Research - Patient Counselling - Pharmaceutical Care in all specialties like cardiology, Dermatology , Oncology, etc. . . including Primary Care

Pharmaceutical Care is a bunch of 1000's professional services of Pharmacy Practices , for detailed services prescribed by PHARMACY COUNCIL OF INDIA refer Appendix III of PPR-2015 of Pharmacy Act 1948. F As per Sec 2 (g) of PPR-2015 Pharmaceutical Care means - along with patients care a pharmacist can prevent disease or and eliminate disease or and reduction of symptoms ( symptomatic treatment to all uncomplicated diseases ) arresting or slowing of disease process.

As per Sec 2 (h) (iv) of PPR-2015 Clinical Pharmacists may provide care in all health care settings ( Community Pharmacy /Hospitals / Clinics / Nursing Homes / Own Health care or Clinical setups like PHARMA CLINICS .

As per sec 3.3 (b) of Chapter 1 of PPR-2015 A registered pharmacist may display his/her name on sign board along with educational qualifications and PCI registration number.

As per Sec 3.3 (c) of Chapter 2 of PPR -2015 A Registered Pharmacist may use /display suffix any professional degrees , certifications , memberships and honors

CPC registered pharmacists may prefix RCPH and etc. . . specialty certification to their names on sign boards of practice areas or setups.

As per Sec 6.5 of Chapter 2 of PPR-2015 A registered pharmacist may charge / collect fees for their professional services on individual consultations.

As per Sec 11.2 of Chapter 6 of PPR-2015 A registered pharmacist may participate him/herself in public health programs , responsible for prevention and care of epedimic & communicable diseases

As per Sec 13 (s) of PPR-2015 of Pharmacy Act 1948 A registered pharmacist should not claim himself/herself as a specialist. means may claimed on certification of any professional organization in certain specialty .

CPC certified specialist registered pharmacists may prefix these specialty certifications to their names on sign board of any professional practice premises ( including PHARMA CLINIC setup)

Not need to get any approval / permission / NOC from any CMO or DM& HO to establish any setup of Pharmacy Practice ( including PHARMA CLINIC ), But Only for retail sale of drugs you required to get license from local drugs regulatory authority.

If the act ( CLINICAL ESTABLISHMENTS Act 2010 ( Regulations & Registrations ) applicable to pharmacy establishments in any state - the state belonging regd pharmacists may required to register the pharmacy establishment (pharma clinic) under this act with concer

"Public Pharmacist medicine " es AWARENESS campain ko suru karna chahiye pure desh me pharmacist ka naam sabhi ko yaad ho jaye aur naam yaad aate hi pharmacist ka role and importance mind me aaye aur dil me respect.....इसकी जरूरत ज्यादा है की pharmacists इन नियमो खुद ऐसे pharmacy store खोल धरातल पर लागु करे वरना नियम के नाम पर हम खुद को ज्यादा दिन तक नही ढो सकते और लोगो को ये नियम भी फालतू का लगने लगेगा मतलव हम फार्मासिस्ट फालतू के लगने लगेगे

फार्मासिस्ट स्वास्थ्य सेवाओं की महत्वपूर्ण कड़ी है इसलिए वह स्वास्थ्य सेवाओं की सभी सेवाओं का उपयोग कर सकता है
Pharmacists can diagnose disease, treatment ,priscriber medicine ,drug councilling of patient ,stock & dispense medicine ,
सच्चाई यही है
फार्मासिस्ट रोगी की सेवा के लिए कुछ भी कर सकता है परिस्थिति अनुसार यूज करेँ अपने अधिकार फार्मासिस्ट

pharmacist practice regulation 2015 - Google Search -https://www.google.co.in/search…

ELIGIBILITY to Practice PHARMA CLINIC

Pharmacists, who are willing to practice Clinical Pharmacy outside the Hospital setups and within their own Clinical setup PHARMA CLINIC, they should meet the following eligibility criteria:

1. Applicant Pharmacist should be a Licensed/Registered Pharmacist by any state Pharmacy Council of India.

2. Applicant Pharmacist should be a Registered Clinical Pharmacist (RCPh) in Clinical Pharmacy Council (CPC).

3. a. Applicant Pharmacist should be have minimum 3 months experience as a Hospital /or/ Clinical Pharmacist under supervision of MCI Registered Physician of any Hospital.

[OR]

b. Applicant Pharmacist should complete 2 months SAT-CP Training Program in CPC.

राजस्थान के फार्मासिस्ट के लिए CPC ट्रेनिंग जरुरी है क्योंकि उनकी ट्रेनिंग फार्मेसी स्टोर मेँ होती है हॉस्पिटल मेँ नही

HOW TO APPLY

Step 1: If you are not a RCPh in CPC, Register your name as Clinical Pharmacist in CPC with Application FORM-1.

One time Registration Fee: Rs 2600/- only.

Step 2: After Confirmation of Registration in CPC, Apply for Clinical Pharmacy Specialty Certification to BCPS in CPC. For General Practice apply for Consultant Clinical Pharmacist (CCP) certification by submitting your previous or current Experience Certificate [or] SAT-CP Training certificate.

Who are not having Previous Experience Apply for SAT-CP Training Program with Application FORM-2B

For CCP certification apply with Application FORM-2

(NOTE: For any other Specialty Clinical Pharmacy Practice apply for Specialty Certification to BCPS) For Specialty certification apply with Application FORM-3

Step 3: After confirmation of successful Certification, Apply for PHARMA CLINIC approval with Application FORM-4

Step 4: ENJOY YOUR PRACTICE BY SERVING THE MANKIND.

PHARMA CLINICS are Community Health Care setups outside the hospitals and medical homes, where qualified and registered / licensed Pharmacists provide Clinical Pharmacy services to the patients on their individual consultations.

PHARMA CLINICS are Community Health Care setups outside the hospitals and medical homes, where qualified and registered / licensed Pharmacists providesClinical Pharmacy services to the patients on their individual consultations.

A newest pharmacy practice model in India.

To become Clinical Pharmacy Practitioner Member (CPPM) of Clinical Pharmacy Council, register your name by applying in an on-line application. Transform from Tradtional Pharmacy Practice into Advanced Clinical Pharmacy Practice to provide better healthcare to the nation. 

Clinical Pharmacy Council (CPC) with the objective to Promote, Support, Strengthen, and Develop the Clinical Pharmacists through Membership Registration and Decolonising throughout India.

Pharmacy profession comprising the Hospital and Clinical pharmacy sectors is under going rapid change in India. Clinical Pharmacy Practice sector need skilled Pharmacy professionals, who can face global challenges and compete with multinationals. The Pharmacist is no longer a mere dispenser of drugs. But has assumed a more Clinical role in Therapeutic Drug, Disease Monitoring and Management and as overall Health Care Provider.

We realized that to Strengthen and Upgrade the Clinical Pharmacy Education and Practice in India, need to competent Clinical Pharmacists Force, which is able to meet the growing demands of the Health Care in India.

Today, a need has been felt on the Imperative for transparency, accountability and accessibility in order to establish Public and Physicians trust in Clinical Pharmacists and their Services in India. This would be feasible only if all Clinical Pharmacists are associated on a single stage.

CPC Membership Registration of Clinical Pharmacists will ensure Transparency, Accountability, and Accessibility in Clinical Pharmacy Services. By disclosing all Results or / and Interventions of Clinical Pharmacy Practice, Public confidence in Clinical Pharmacists in likely to be enhanced.

 As a step towards the directions, Clinical Pharmacy Council (CPC)  to Recognize Indian Clinical Pharmacists by the Process of Membership Registration and so as to strengthen & upgrade the Clinical Pharmacy Practice in India.

SAT-CCP course is a 6 months duration home based ( DISTANCE ) ContinuousPharmacy Education & Professional Development credential (value added) program. 

SAT-CCP course was aimed to educate, train, and advance Traditional PharmacyPractitioners ( Dispensing Pharmacists ) in providing advanced Clinical Pharmacyservices so as to deliver better health care to the nation.

SAT-CCP course improves professional expertise in the field of Clinical Pharmacy and prepares most competent Clinical Pharmacists force to the nation with world class standards.

SAT-CCP course was structured as three different sessions of self Study, Assessment, and Training in the field of Clinical Pharmacy. After successful completion of all sessions of the course the candidates has to appear a qualifying examination.

SAT - CCP (Self Assessment, Training & Certificate program in Clinical Pharmacy) is a Continuous Professional Developement Program in Clinical Pharmacy.  It's a 6 months duration home based distance learning program.

SAT-CCP course is a 6 months duration home based ( DISTANCE ) ContinuousPharmacy Education & Professional Development credential (value added) program. 

SAT-CCP course was aimed to educate, train, and advance Traditional PharmacyPractitioners ( Dispensing Pharmacists ) in providing advanced Clinical Pharmacyservices so as to deliver better health care to the nation.

SAT-CCP course improves professional expertise in the field of Clinical Pharmacy and prepares most competent Clinical Pharmacists force to the nation with world class standards.

SAT-CCP course was structured as three different sessions of self Study, Assessment, and Training in the field of Clinical Pharmacy. After successful completion of all sessions of the course the candidates has to appear a qualifying examination. 

There are two modes qualifying examination:

SAT-CCP course is a 6 months duration home based ( DISTANCE ) ContinuousPharmacy Education & Professional Development credential (value added) program. 

SAT-CCP course was aimed to educate, train, and advance Traditional PharmacyPractitioners ( Dispensing Pharmacists ) in providing advanced Clinical Pharmacyservices so as to deliver better health care to the nation.

SAT-CCP course improves professional expertise in the field of Clinical Pharmacy and prepares most competent Clinical Pharmacists force to the nation with world class standards.

SAT-CCP course was structured as three different sessions of self Study, Assessment, and Training in the field of Clinical Pharmacy. After successful completion of all sessions of the course the candidates has to appear a qualifying examination. There are two modes qualifying examination:

1. Online (Computer Based Online Examination)
2. Offline  (Pen & Paper Based Examination)

The mode of selection of the qualifying examination is the choice of the candidate; they have to select any one mode of examination at the time of the enrollment and may change at any time during the course period and just before 7 days of the examination.  

COURSE DURATION: 6 Months

FREQUENCY OF COURSE:  Admissions are open throughout a year. Applicants are requested to submit application before 25th of the Month, so that program will be starts from 1st of the next Month.

Clinical Pharmacy Council (CPC) is an autonomous Professional Organization that promotes, supports, implements and advances education, practice and research in clinical pharmacy. CPC represents clinical pharmacists and others who are interested in clinical pharmacy and in the development of clinical pharmacy throughout India.

Clinical Pharmacy Council works in non profit motive for the prime objective of - The development, promotion and advancement of Clinical Pharmacy Education and Practice in India.

The CPC actively develops and promotes Clinical Pharmacy Education and Practice as well as develops individual Clinical Pharmacy Practitioners through Professional Curricula, Professional Recognition, Credentialization, Professional tools, frameworks, support and contributes by promoting Advanced Practice of CLINICAL PHARMACY in India.

The CPC is able to access a wide range of Knowledge and Expertise in Clinical Pharmacy to enable high quality patient care in India.

CLINICAL PHARMACY COUNCIL provides certain fellowships (FCPC and FRCPC) annually to the eligible candidates.

CLINICAL PHARMACY COUNCIL provides certain awards annually to the eligible candidates through the nomination process

 In India hundreds of pharmacists providing their professional services in certain health care specialties as clinical pharmacy specialists, across the world there is huge demand for Clinical Pharmacy Specialists, Some professional organization providing them professional recognition through certain Specialty Certification Programs.

For MBBS  - ALLOPATHY CLINICS,

For BAMS - AYURVEDIC CLINICS,

For BHMS - HOMEO CLINICS,

For BNYS - YOGA CLINICS,

For BUMS - UNANI CLINICS,

For BVSc - VET CLINICS,

For BDS - DENTAL CLINICS,

Even for BPT - PHYSIO CLINICS are there in India.

www.clinicalpharmacy.in/pharma-clini

Pharmacists cannot open clinics to diagnose disease & prescribe medicine; clarifies PCI

Swati Rana, Mumbai Wednesday, October 21, 2015, 08:00 Hrs  [IST]

Clearing the doubts on pharmacists can open pharma clinics to treat common disease and prescribe medicine, Pharmacy Council of India (PCI) has recently notified that the pharmacists cannot open clinics to diagnose the disease and prescribe the medicines. PCI has clarified that there is no provision in the Pharmacy Practice Regulations (PPR), 2015 which allows the pharmacists to practice medicine. Under the said Regulations, the registered pharmacist is required to dispense medicines on the prescription of a registered medical practitioner and can counsel the patient or care giver on medicine to enhance or optimise drug therapy. The elements of patient counselling includes, name and description of the drugs;the dosage form, dose, route of administration, and duration of drug therapy; intended use of the drug and expected action; special directions and precautions for the drug; common severe side effects or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur; techniques for self monitoring drug therapy; proper storage of the drugs; prescription refill information; action to be taken in the event of a missed dose and to ensure rational use of drugs. Dr. B Suresh, president of PCI informed that there are few groups of pharmacists who are claiming that they are doctors and there are various messages being circulated on social media, e-mails, WhatsApp etc. that pharmacists are empowered under PPR, 2015 to open pharma clinics to diagnose the disease and prescribe medicines. We would like to clarify that there are no such provision under PPR, 2015 which allows pharmacists to diagnose and prescribe medicine. PPR, 2015 only allows the pharmacists to practice pharmacy and not medicine, they can counsel the patient or care giver and dispense medicines on the prescription of a registered medical practitioner but cannot prescribe medicines to the patients He further adds, “Under no circumstances, the registered pharmacist is empowered under the Pharmacy Act, 1948 and PPR, 2015 to practice medicines or open clinics to provide medical care.” BUT, My query is : Can a registered pharmacist and pharmacotherapist (PHARM D) approved with Clinical Pharmacy Council give PHARMA CARE in his PHARMACY? Services like prior authorization and refill authorization for prescription drugs is permitted?

The 5th ISCR Annual Conference receives overwhelming response from industry

The fifth annual conference of Indian Society for Clinical Research (ISCR) was recently held at Taj Krishna in Hyderabad. The theme for this year's conference was ‘Beyond Efficiency to Excellence’ and was attended by over 400 delegates from India and abroad.

Dr Prem Kumar Reddy, a leading authority on cancer research, inaugurated the conference and delivered the keynote address. This was followed by a welcome address by Dr Krathish Bopanna, President, ISCR. Bindhya Cariappa, Chairperson, Scientific Committee presented an overview of the conference, which was followed by a vote of thanks by Dr Radhika Bobba, Chairperson, Local Organising Committee. 

A panel discussion in progress

In synchrony to ISCR's objective of ensuring that the conference serves as a platform for the best minds in clinical research to share innovative views and best practices in clinical research, this year’s sessions focussed on excellence in line with the conference theme. The two-day conference had two clinical research tracks that touched upon each aspect of clinical development and covered early development, regulatory affairs, medical writing, clinical research technology, ethics, investigator site perspectives, project management, data management, quality assurance, pharmacovigilance, biostatistics and a discussion on the perception of clinical trials in India.  

Delegates attended Akshaya, Mandar Kelkar,
 Dr.Parthasarathi, Anand Harugery

The conference was preceded by four workshops on study management, medical writing, statistics and pharmacovigilance. Unique to this conference was also the young clinical research debate conducted at the end of day one of the conference. The conference was concluded by a valedictory speech by Dr PM Bhargava, scientist and recipient of Padma Bhushan and a vote of thanks to delegates, speakers, sponsors, organisers and volunteers. 

Participants at the conference

Speakers who attended the conference were Dr Rajesh Karan, Novartis; Dr Julius Vaz, Dr Reddy's Laboratories; Dr Shreemanta K Parida, Dept of Biotechnology; Dr Deven Parmar, Wockhardt; Dr Sudhakar Mairpadi, Phillips; Shenaz Vakharia, Theraverity; Dr Shashidhar Rao, Novartis; Dr Sanjay A Pai, Columbia Asia; Dr Roopa, Basrur, Parexel; Dr Graham Bunn, Medidata Solutions; Gunjan Jain, Oracle; Dr SD Rajendran, Sristek; Dr Ajay Parker, SIRO Clinpharm; Carol Isaacson Barash, Genetics, Ethics and Policy Consulting; Dr Gauri Gholap, Optra Systems; Sudip Sinha, CliniRx; Dr Mubarak Naqvi, Sanofi Aventis; Dr Aamir Shaikh, Assansa; Dr Ajoy Roy, Parexel; Dhiren Joshi, Voisin Life Sciences; Vivek Ahuja, Baxter; Dr Manish Kumar Shah, Pfizer; Narasimha Kumar, Parexel; Dr Sneha Limaye, CRF; Dr Milind Antani, Nishith Desai Associates; Gourav Kumar, Apollo Hospitals; Dr Vishwanath Iyer, Novartis; Dr Chitra Lele, Sciformix; Tommy Pedersen, Quintiles; Bindhya Cariappa, ClinTec international; Dr Rupam, KIMS; PV Rao, eminent media person; Dr Suresh Menon, Novartis; Professor Sarma, NALSAR; Dr Nimita Limaye, Siro Clinpharm; Dr Hema Bajaj, Sanofi Aventis; Mark Aubrey, Daiichi Sankyo; Dr Raghunatha Rao, NIMS; Dr Purvish Parikh, Americares and Dr Senthil Rajappa, Indo-American Cancer Hospital. The resounding success of the conference has raised the bar for the sixth annual conference to be held in Mumbai next year.

Source:ExpressPharma

Pharmaceutical legislation changes in Europe

 
Preparations are underway at the European Medicines Agency together with European Member States and the European Commission, for the introduction of the new pharmacovigilance legislation in July this year. The new legislation will represent the biggest change to the legal framework since The Agency was founded in 1995. The Agency is finalizing their preparations for the inaugural meeting of the new Pharmacovigilance Risk Assessment Committee (PRAC), which is scheduled for 19 July 2012. 

Stakeholders are kept up-to-date on the ongoing implementation process through The Agency's website and stakeholder meetings, including information on transitional arrangements for the pharmaceutical industry, consultations and guidance on new or revised processes, and information on ways in which patients and healthcare professionals can get involved in identifying and managing safety issues in European Member States. This information will be supplementary to the finalization of the implementing measures by the European Commission. 

Adjunct to the establishment of PRAC, the mandate of the existing Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) has also been revised to reinforce its role in pharmacovigilance, with meetings commencing as of September 2012 that will focus on its newly assigned responsibilities. 

According to The Agency, the new urgent Union procedure for safety issues with regard to nationally and centrally authorized medicines in 2012 will be starting to operate, and it will implement the procedure for protocol approval of post-marketing safety studies and results management, however, at first these will apply only for centrally authorized medicines. Furthermore, The Agency will develop a revised process for the coordination of pharmacovigilance inspections during the year starting from July 2012 with the revised process for signal detection for centrally authorized medicines with support from The European Member States for nationally authorized products providing additional data. 

Any patient in European Member States will be able to report suspected adverse drug reactions to his or her national medicines authority under the new legislation, a right that already exists in some Member States. Both, The Agency and Member States will cooperate to provide patients with information on direct reporting during 2012. 

The Agency's and European Member States' transparency of all their pharmacovigilance activities will be raised substantially under the new pharmacovivgilance legislation, with the Agency increasing transparency of its processes and procedures through the publication of its agendas, recommendations, opinions and minutes from its scientific committees, which include the PRAC, the CMDh and the Committee for Medicinal Products for Human Use (CHMP). The Agency will also organize public hearings on request of the PRAC that will enable the public to openly discuss safety issues with the Agency. This will reinforce the Agency's current responsibility in ensuring the exchange of coherent and consistent messages on safety issues across Europe. 

The Agency had a consultation with European industry associates in a workshop held on the 30 January 2012, and will subsequently publish details on the revised implementation of the electronic submission of information on all medicines for human use authorized or registered in the European Union (also known as Article 57 requirements) in February 2012. 

The Agency will also publish its concept paper on the structure of good pharmacovigilance practice (GVP) in February, releasing the first wave of GVP modules for public consultation, and has just published a new implementation plan that provides detailed activities of the new pharmacovigilance legislation scheduled to be implemented in 2012 together with those activities that will be a key issue beyond 2012. 

The highest priority will be assigned to activities that contribute to public health, followed by activities that increase transparency and improve communication, after which come those that simplify processes. 

Starting in February, the Agency and its stakeholders will be communicating closely on development issues regarding the implementation of the new legislation.