Karnataka State Pharmacy Council (KSPC) has been at the forefront of pharmacy trade profession. From the organizing several people-oriented programmes like educating public on various diseases and their management by conducting workshops and seminars, to introduction of online registration, renewal of licences for pharmacists and investing in LED (light emitting diode) display in Bengaluru city, the Council has been leading from the front. The latest is that the Pharmacy Council of India (PCI), through its Education Regulation Committee, has gone in for the revision of the D Pharm syllabus. The Committee has approved the KSPC's newsletters, which are seen as informative and educative reference books for the new syllabus of D Pharm. In an interaction with Nandita Vijay of Chronicle Pharmabiz, DA Gundu Rao, president of KSPC, elaborates about 65th IPC 2013 - 'Pharma Vision 2020: Empowering the Pharmacist': Excerpts:
How do you view the theme of 65th IPC - 'Pharma Vision 2020: Empowering the Pharmacist' ? Knowledge is biggest empowerment for the pharmacist. Therefore, he needs to remain updates in a fast changing world. If a pharmacist is armed with the technical know-how and the practical exposure, he could chip in with his expertise to society. Today, Indian pharmacists are lacking on only one front, and this is in the area of skill up-gradation. Pharmacist's role is not mere dispensation of medicines, but he needs to be a dependable source of guidance to the patient community. To begin with, the need of the hour was to update syllabus of D Pharm, in which there has been no change since 1992. The education system was in a bad state, until PCI, through its Education Regulation Committee, finalised the D Pharm syllabus. This will transform the education of the entry level diploma holders in pharmacy. The new syllabus is expected to be enforced from coming academic year, July 2014. A committee headed by Dr FV Manvi, dean and professor of Pharmaceutics, Dept of Pharmaceutics, KLE University’s College of Pharmacy, Belgaum, has gone in for a major revamp, curriculum update to ensure that the candidates are in sync with the latest developments, along with inclusion of Ayush systems of medicine. In addition, two new subjects - Social pharmacy and Phamaco-therapeutics have been included and are been seen as vital topics in terms of understanding the clinical applications of biochemistry and pathology. This would definitely empower the pharmacists. A relevant and field-oriented syllabus with a reasonable salary would transform the pharmacists' image. It would help lead them to quality growth path of professionalism. It would see the emergence of cross-functional career opportunities for a diploma pharmacy entrant who in a few years could manage a team of pharmacists in a large pharmacy outlet format. I would also like to add that compared to the western world, there is no importance given to a pharmacist in India. Could you throw some light on new syllabus of D Pharm course? Currently, the two-year D Pharm course covers in the first year: Pharmaceutics, pharma chemistry, pharmacognosy, biochemistry and clinical pathology, human anatomy and physiology and health education and community pharmacy. In the second year: Pharmaceutics II, pharmaceutical chemistry, pharmacology and toxicology, pharmaceutical jurisprudence, drug store and business management and hospital and clinical pharmacy are covered. Now, we have omitted subjects like biochemistry and clinical pathology and health education and community pharmacy from the first year syllabus and replaced with social pharmacy. For this subject, the student will be taught on various diseases including community acquired infections. So long the role of the pharmacist involvement in health camps or event government initiated disease - disorder detection camps was not there. Now, the new subjects are seen as a paradigm shift to boost the candidate’s career prospects. In the second year, pharmaceutics II, pharmaceutical chemistry, pharmacology and toxicology, pharmaceutical jurisprudence, drug store and business management have been replaced with community pharmacy and management, biochemistry and clinical pathology and pharmaco-therapeutics. Upon completion of the two years course, the candidate will be made aware on the preventive healthcare aspects. It will provide opportunities to them chip in their expertise in hospitals and pharmacy-paramedical training centres. Further, D Pharm holders will also provide services to public to maintain good health - for instance, advises on smoking cessation, immunization and narcotic-psychotropic drug abuse. The new syllabus will also provide the much needed impetus to skill development enabling enhanced responsiveness to minor ailments. This will create a platform for patient counselling about the disease and medication. Subjects such as phamaco-therapeutics and hospital and clinical pharmacy will ensure the qualified D Pharm to be confident in counselling patients and their relatives on the manifestation of the disease and the different drugs that needed to be administered to control the condition. It will also provide exposure to adverse drug monitoring and clinical pharmacy besides creating openings in departments of pharmacovigilance. Are you confident that with only these changes, the pharmacist will be empowered? The practical and theoretical exposure to blood pressure checks, carrying out simple pathology lab tests the pharmacy profession will gain significance and his role cannot be overlooked. It has been extremely disheartening to note that even in the government of India’s Health Policy 2002, there was no mention a pharmacist instead nurses were given more importance. This indicated that efforts needed to be made to ensure that diploma holder or a graduate in pharmacy needed to find a place in the Indian healthcare space. The empowerment of knowledge for the pharmacist was seen to be best way. Now with the revised syllabus and with the first batch of the Pharm D graduates passing out in 2014, we are confident the profession is on its way to gaining limelight. Coming to Pharm D, what is your view on this qualification? There is a concern on the employment opportunities for the Pharm D candidates. This is where the government need to mandate that all 50-bed nursing homes and hospitals will need to hire a Pharm D graduate. The move will help to drive several preventive healthcare initiatives. The Pharm D candidate will need to work along with the doctors where he could advice home on the medicines available, it contents, pharmacological contraindications, thwart multiple drug administration and adverse drug reactions. We could see a paradigm shift in the healthcare space if Pharm D candidates service are utilized across medical centres. This is a big benefit for the patient if qualified Pharm D personnel are a part of the healthcare facilities. Coming to pharma manufacturing front, what are the opportunities for pharmacy graduates? Here, there is need for an amendment of the D&C Act, because currently a sizeable number of science graduates and postgraduates are employed at drug production plants after extensive training is imparted. This indicates that at many of these facilities, B Pharm, M Pharm candidates do not find a job. Many small- and medium-sized companies recruit a BSc or an MSc so that their services are cheaper than those of a B Pharm, M Pharm. The difference in package is almost double. As the president of KSPC, what are the visible trends in pharmacy profession that you can highlight? Pharmacists play a vital role in healthcare. He is a critical component in the healthcare milieu. Once empowered, we would see a drastic change, and he would be playing an important role in the daily activities of doctors - coordinate and cooperate with medical professionals to create a healthy society. What are the challenges for pharmacy profession? The biggest challenges for the pharmacy profession are the emergence and establishment of chain shops, since the introduction of foreign direct investment, several multinational chains are on their way to set up shops in the country. This would see the end of existing chemist and druggist outlets. In Karnataka, we have forewarned 28,500 pharmacy trade outlets that they could soon be out of business. The lack of knowledge and the inability to empower the pharmacy diploma holders led us to revise and update the syllabus. These diploma holders need to be taught and kept attuned with the advances like the third generation of cephalosporins, and new drug delivery devices. Further, the Karnataka govt is working to set up generics stores in 176 taluks, and this could further see a dent in sales of the existing chemist and druggist outlets, more so in the districts. What needs to be done to protect the future of pharmacists? Knowledge empowerment is the only way to protect the future of pharmacists. This would enable them to tap more job avenues not just in outlets, but at hospitals, industries and centres of pharmacovigilannces. For example, in the case of KSPC, it introduced online registration, renewal of licences for pharmacists in the state. The move follows the Pharmacy Council of India’s validity of expiry date of registered pharmacists' certificate until December 31, 2012. In 2010, the Council also went on to invest Rs. 1.3 lakhs to install LED display in Bangalore city which flashes tips on healthcare, medication usage, and storage methods. The concept is a first-of-its-kind in the pharmacy space in Asia, Now, we are working to expand it. There is no doubt that the future of pharmacists is bright by the efforts. The new syllabus would ensure higher emoluments and recognition world wide. This would also see the Indian pharmacist marching ahead and achieve the Pharma Vision 2020. |
Knowledge empowerment of pharmacist would drive to achieve Pharma Vision 2020 Thursday, December 19, 2013, 08:00 Hrs [IST]
KSPC works out strategies with Kerala govt to enforce Section 42 of Pharmacy Act in State
The Kerala State Pharmacy Council (KSPC) is aggressively working out strategies for enforcing the Pharmacy Act in true spirit. The Council has become a role model for other state pharmacy councils in many ways. Excerpts from an interview with B Rajan, president of KSPC by Peethaambaran Kunnathoor.
Implementation of Section 42 of Pharmacy Act is always a subject of discussion among the pharmacist community and sometimes it evokes the wrath of a section of traders. It has been found that there is difficulty in implementing the Act in all the community pharmacies in our country. In this respect, what are the steps taken by KSPC to implement Section 42 in Kerala?
We have taken several steps for implementation of Section 42 in the state with the support of the government. We do not think that there are difficulties in implementing the Act. We are of opinion that the drugs should be handled by a registered pharmacist only. KSPC has now appointed pharmacy inspectors in all districts with the approval of the government. Kerala is the first state in the country with pharmacy inspectors appointed in all the districts. We will not allow any pharmacy in the state to operate without the presence of a registered pharmacist because managing pharmacy and handling of drugs are exclusively the job of pharmacists. We are initiating action against the violators also.
So far how many violations you have noted and what follow up steps have been taken?
Within the last two years our inspectors conducted 489 inspections across the state and found violation of Section 42 in 43 pharmacies. The respective pharmacy inspectors have been asked to initiate prosecutions in these drug stores. Memo was issued for 439 cases. The council has suspended the registration of two pharmacists for violation of Rule 149, 150 and 151. Infringement of Section 34 (Renewal of Licence) was also noted.
Following this, 25 registered pharmacists were censured, and in another case, imposed penalties of Rs. 500 each to other 25 pharmacists for violation of code of ethics.
What is KSPC’s programmes to create confidence in pharmacists and to strengthen their profession? How do you want to empower them for the sake of society?
In the case of strengthening the profession of pharmacy and to empower them Kerala Pharmacy Council has become a role model for other state pharmacy councils. We have now started health insurance scheme for the practicing pharmacists and their families. With a small amount, the pharmacists can avail the benefits of Rs one lakh for their healthcare needs.
On the advice of Pharmacy Council of India, KSPC has started a continuing pharmacy education (CPE) programme for the practicing pharmacists. Two programmes were already conducted and the participants represented 10 districts.
Unlike in other states, we are issuing certificates through a convocation called ‘white coat ceremony’. Simultaneously, we conduct a one day orientation course for the fresh pharmacists before they step into their profession. The course comprises scientific classes and training for managing a pharmacy. We have requested the government for a grant of Rs 30 lakh for the purpose.
Primarily what are the things the pharmacy inspectors concentrate on while visiting a pharmacy store?
The pharmacy inspectors mainly concentrate on ensuring whether a registered pharmacist is dispensing the drugs. He will inspect the storage conditions and other things mentioned in the pharmacy Act. Display of registration certificate of pharmacist is mandatory. The pharmacist must wear white over coat and ID card issued by the state pharmacy Council.
Section 26 A (2) of the pharmacy Act says that the pharmacy inspector can inspect any premises where drugs are compounded or dispensed. We are planning to inspect the clinics of doctors to check whether medicines are dispensed there by registered pharmacists.
The inspector will submit the inspection report to the council registrar and the council will take necessary action on it. We have our own inspectors to enforce the pharmacy act.
Strengthening of pharmacy profession is a duty and concern of the pharmacy Council. What are the new projects of KSPC in this regard?
We are undertaking some new projects to strengthen the pharmacy profession. Apart from other training courses, we are introducing a certificate course for which we started one training centre, State Institute for Pharmacists’ Advanced Training & Research (SIPATR). Dr KG Ravikumar is the director. Another project in the pipeline is the launching of district wise drug information centres with the involvement of pharmacists.
How does KSPC support the pharmacy education in Kerala?
The power to regulate the pharmacy education is vested with the PCI. KSPC’s role in controlling the educational institution is nil, but we are giving all support to pharmacy education. Likewise, KSPC is getting full support and cooperation from all the pharmacy colleges also.
But, my view is that the state Councils should be given the power to monitor and supervise the pharmacy education in the respective states. It is too difficult for the PCI to properly regulate the academic institutions sitting in Delhi, so the quality of education is declining. The state Councils should be assigned to inspect the colleges. This can be done through an amendment. PCI has given suggestion to the government for amendment of PCI Act.
What is your opinion about Pharm D course? Do you see any scope for the Pharm D graduates in Kerala?
In all sense it is a super professional course. In Kerala, 11 colleges are conducting the Pharm D programme. The first batch will come out in this year and 200 qualified persons are expected.
Job opportunities can be generated in Kerala for these graduates. All the pharmacy colleges should absorb Pharm D holders to teach pharmacy practice. Besides, government should start clinical pharmacy departments and ADR centres in all the hospitals.
The clinical trials are conducted now by doctors who are busy with their profession. So, Pharm D graduates can be utilized for carrying out clinical trials and other research activities.
How far the drugs control department‘s support towards enforcing pharmacy Act.
KSPC is not satisfactory with the attitude shown by the drugs control department. They think it is something like dual control. We are enforcing the pharmacy act and they are implementing the D&C Act. Cooperation from DC department is necessary to enforce the pharmacy act in its true spirit. Some drug inspectors have got some kind of misunderstandings, but some people are cooperating.
What are the projects taken by KSPC for updating the knowledge of pharmacists?
KSPC is continuing pharmacy education programme of 15 days long orientation course. Both the programmes include scientific lessons.
What is the basic qualification of a pharmacy inspector?
The basic qualification of a pharmacy inspector is diploma in pharmacy with degree in any discipline. Besides, ten years of experience in pharmacy practice is also required. The B. Pharm graduates can also become pharmacy inspectors.
Implementation of Section 42 of Pharmacy Act is always a subject of discussion among the pharmacist community and sometimes it evokes the wrath of a section of traders. It has been found that there is difficulty in implementing the Act in all the community pharmacies in our country. In this respect, what are the steps taken by KSPC to implement Section 42 in Kerala?
We have taken several steps for implementation of Section 42 in the state with the support of the government. We do not think that there are difficulties in implementing the Act. We are of opinion that the drugs should be handled by a registered pharmacist only. KSPC has now appointed pharmacy inspectors in all districts with the approval of the government. Kerala is the first state in the country with pharmacy inspectors appointed in all the districts. We will not allow any pharmacy in the state to operate without the presence of a registered pharmacist because managing pharmacy and handling of drugs are exclusively the job of pharmacists. We are initiating action against the violators also.
So far how many violations you have noted and what follow up steps have been taken?
Within the last two years our inspectors conducted 489 inspections across the state and found violation of Section 42 in 43 pharmacies. The respective pharmacy inspectors have been asked to initiate prosecutions in these drug stores. Memo was issued for 439 cases. The council has suspended the registration of two pharmacists for violation of Rule 149, 150 and 151. Infringement of Section 34 (Renewal of Licence) was also noted.
Following this, 25 registered pharmacists were censured, and in another case, imposed penalties of Rs. 500 each to other 25 pharmacists for violation of code of ethics.
What is KSPC’s programmes to create confidence in pharmacists and to strengthen their profession? How do you want to empower them for the sake of society?
In the case of strengthening the profession of pharmacy and to empower them Kerala Pharmacy Council has become a role model for other state pharmacy councils. We have now started health insurance scheme for the practicing pharmacists and their families. With a small amount, the pharmacists can avail the benefits of Rs one lakh for their healthcare needs.
On the advice of Pharmacy Council of India, KSPC has started a continuing pharmacy education (CPE) programme for the practicing pharmacists. Two programmes were already conducted and the participants represented 10 districts.
Unlike in other states, we are issuing certificates through a convocation called ‘white coat ceremony’. Simultaneously, we conduct a one day orientation course for the fresh pharmacists before they step into their profession. The course comprises scientific classes and training for managing a pharmacy. We have requested the government for a grant of Rs 30 lakh for the purpose.
Primarily what are the things the pharmacy inspectors concentrate on while visiting a pharmacy store?
The pharmacy inspectors mainly concentrate on ensuring whether a registered pharmacist is dispensing the drugs. He will inspect the storage conditions and other things mentioned in the pharmacy Act. Display of registration certificate of pharmacist is mandatory. The pharmacist must wear white over coat and ID card issued by the state pharmacy Council.
Section 26 A (2) of the pharmacy Act says that the pharmacy inspector can inspect any premises where drugs are compounded or dispensed. We are planning to inspect the clinics of doctors to check whether medicines are dispensed there by registered pharmacists.
The inspector will submit the inspection report to the council registrar and the council will take necessary action on it. We have our own inspectors to enforce the pharmacy act.
Strengthening of pharmacy profession is a duty and concern of the pharmacy Council. What are the new projects of KSPC in this regard?
We are undertaking some new projects to strengthen the pharmacy profession. Apart from other training courses, we are introducing a certificate course for which we started one training centre, State Institute for Pharmacists’ Advanced Training & Research (SIPATR). Dr KG Ravikumar is the director. Another project in the pipeline is the launching of district wise drug information centres with the involvement of pharmacists.
How does KSPC support the pharmacy education in Kerala?
The power to regulate the pharmacy education is vested with the PCI. KSPC’s role in controlling the educational institution is nil, but we are giving all support to pharmacy education. Likewise, KSPC is getting full support and cooperation from all the pharmacy colleges also.
But, my view is that the state Councils should be given the power to monitor and supervise the pharmacy education in the respective states. It is too difficult for the PCI to properly regulate the academic institutions sitting in Delhi, so the quality of education is declining. The state Councils should be assigned to inspect the colleges. This can be done through an amendment. PCI has given suggestion to the government for amendment of PCI Act.
What is your opinion about Pharm D course? Do you see any scope for the Pharm D graduates in Kerala?
In all sense it is a super professional course. In Kerala, 11 colleges are conducting the Pharm D programme. The first batch will come out in this year and 200 qualified persons are expected.
Job opportunities can be generated in Kerala for these graduates. All the pharmacy colleges should absorb Pharm D holders to teach pharmacy practice. Besides, government should start clinical pharmacy departments and ADR centres in all the hospitals.
The clinical trials are conducted now by doctors who are busy with their profession. So, Pharm D graduates can be utilized for carrying out clinical trials and other research activities.
How far the drugs control department‘s support towards enforcing pharmacy Act.
KSPC is not satisfactory with the attitude shown by the drugs control department. They think it is something like dual control. We are enforcing the pharmacy act and they are implementing the D&C Act. Cooperation from DC department is necessary to enforce the pharmacy act in its true spirit. Some drug inspectors have got some kind of misunderstandings, but some people are cooperating.
What are the projects taken by KSPC for updating the knowledge of pharmacists?
KSPC is continuing pharmacy education programme of 15 days long orientation course. Both the programmes include scientific lessons.
What is the basic qualification of a pharmacy inspector?
The basic qualification of a pharmacy inspector is diploma in pharmacy with degree in any discipline. Besides, ten years of experience in pharmacy practice is also required. The B. Pharm graduates can also become pharmacy inspectors.
Maha govt undecided over parity of scales between state & central govt pharmacists despite protests Our Bureau, Mumbai Saturday, August 02, 2014, 08:00 Hrs [IST]
Despite protest by state government pharmacists a couple of months back on discriminatory pay scales among state and central government employees, no decision was taken in this regard and pharmacists are still waiting for a favourable response.
The indefinite strike which started on June 1, 2014 and further postponed on humanitarian grounds relates to revision in government provisions for promotional avenues, appointment of around 3000 state government pharmacists and pharmacy officers for rural hospital in the state for effective enforcement of Pharmacy Act, 1948.
Explains Satish Dhotre, president, Maharashtra Rajya Zila Parishad Aushadh Nirmata Sanghthana, "Our demand is very much relevant considering the fact that there is a shortage of around 3000 state government pharmacists for dispensing of medicines at 34 district hospitals, 350 rural hospitals and around 1809 Primary Health Centres (PHCs). There is also a need for appointment of two Pharmacy Officers for each 30 bed rural hospital in the state for effective enforcement of Section 42 of the Pharmacy Act, 1948."
Maharashtra state health department had issued a notice in the first week of July 2014 to the agitating state government pharmacists for compliance to Essential Services Maintenance Act (ESMA) following which the pharmacists had called off the strike.
Pharmacists rue that the state government pharmacists put in long hours beyond the eight hour duty time at state run health institutions in district and rural areas but are yet not paid on par with what is being availed by the central government pharmacists. They want the current pay scale of Rs.5,200 (basic pay) Rs. 2,800 (grade pay) to be upgraded to the central government's pay scale of Rs. 9,300 (basic pay) Rs. 4,200 (grade pay).
Says Arun Thengre, president, Gatak Karmachari Aushadh Nirmata Sanghthana, "The government should also introduce a Bridge Course in Pharmacy for upgrading the knowledge of pharmacy officers and regularise those who have been recruited on contractual basis under the National Rural Health Mission (NRHM) besides revising their salary as per the demands submitted to the state government."
The indefinite strike which started on June 1, 2014 and further postponed on humanitarian grounds relates to revision in government provisions for promotional avenues, appointment of around 3000 state government pharmacists and pharmacy officers for rural hospital in the state for effective enforcement of Pharmacy Act, 1948.
Explains Satish Dhotre, president, Maharashtra Rajya Zila Parishad Aushadh Nirmata Sanghthana, "Our demand is very much relevant considering the fact that there is a shortage of around 3000 state government pharmacists for dispensing of medicines at 34 district hospitals, 350 rural hospitals and around 1809 Primary Health Centres (PHCs). There is also a need for appointment of two Pharmacy Officers for each 30 bed rural hospital in the state for effective enforcement of Section 42 of the Pharmacy Act, 1948."
Maharashtra state health department had issued a notice in the first week of July 2014 to the agitating state government pharmacists for compliance to Essential Services Maintenance Act (ESMA) following which the pharmacists had called off the strike.
Pharmacists rue that the state government pharmacists put in long hours beyond the eight hour duty time at state run health institutions in district and rural areas but are yet not paid on par with what is being availed by the central government pharmacists. They want the current pay scale of Rs.5,200 (basic pay) Rs. 2,800 (grade pay) to be upgraded to the central government's pay scale of Rs. 9,300 (basic pay) Rs. 4,200 (grade pay).
Says Arun Thengre, president, Gatak Karmachari Aushadh Nirmata Sanghthana, "The government should also introduce a Bridge Course in Pharmacy for upgrading the knowledge of pharmacy officers and regularise those who have been recruited on contractual basis under the National Rural Health Mission (NRHM) besides revising their salary as per the demands submitted to the state government."
Patent Controller to issue revised “draft guidelines for examination of patent applications in field of pharmaceuticals” soon Ramesh Shankar, Mumbai Tuesday, August 05, 2014, 08:00 Hrs [IST]
The Indian Patent Controller will soon release the revised “draft guidelines for examination of patent applications in the field of pharmaceuticals” which will help the examiners and the controllers of the patent office in achieving consistently uniform standards of patent examination and grant of patents.
According to sources, this revised guidelines will not also be the final document as this revised guidelines would again be open for comments and suggestions by the stakeholders. After receiving the comments, the patent office once again will revise and publish the final document somewhere next month.
Earlier, the Patent Controller had held a stakeholders' meet on July 31 in Delhi to discuss the 'draft guidelines for examination of patent applications in the field of pharmaceuticals' which was released by the patent office on February 28, 2014 and the stakeholders' comments were invited. The meet was chaired by India's Controller General of Patents, Designs and Trade Marks (CGPDTM) Chaitanya Prasad.
A presentation was made by the patent office highlighting the various important points to be discussed which were taken from the summarised comments received from the stakeholders. The meeting was attended by the patent agents, representatives of pharmaceutical companies from India as well as abroad.
After long deliberations it was decided that the patent office would release the revised guidelines soon, after which the revised guidelines would again be open for comments. A meeting would again be convened by the patent office to finalise the guidelines somewhere next month.
These guidelines are supplemental to the practices and procedures followed by the Patent Office as published in the ‘Manual of Patent Office Practice and Procedure’, “Guidelines For Examination of Biotechnology Applications” and the “Guidelines For Processing of Patent Applications Relating to Traditional Knowledge and Biological Material”.
The present guidelines are prepared with the objective that the Guidelines will help the Examiners and the Controllers of the Patent Office in achieving consistently uniform standards of patent examination and grant. In case of any conflict between these Guidelines and the Patents Act, 1970 and the Rules made there under, the provisions of the Act and Rules will prevail.
According to sources, this revised guidelines will not also be the final document as this revised guidelines would again be open for comments and suggestions by the stakeholders. After receiving the comments, the patent office once again will revise and publish the final document somewhere next month.
Earlier, the Patent Controller had held a stakeholders' meet on July 31 in Delhi to discuss the 'draft guidelines for examination of patent applications in the field of pharmaceuticals' which was released by the patent office on February 28, 2014 and the stakeholders' comments were invited. The meet was chaired by India's Controller General of Patents, Designs and Trade Marks (CGPDTM) Chaitanya Prasad.
A presentation was made by the patent office highlighting the various important points to be discussed which were taken from the summarised comments received from the stakeholders. The meeting was attended by the patent agents, representatives of pharmaceutical companies from India as well as abroad.
After long deliberations it was decided that the patent office would release the revised guidelines soon, after which the revised guidelines would again be open for comments. A meeting would again be convened by the patent office to finalise the guidelines somewhere next month.
These guidelines are supplemental to the practices and procedures followed by the Patent Office as published in the ‘Manual of Patent Office Practice and Procedure’, “Guidelines For Examination of Biotechnology Applications” and the “Guidelines For Processing of Patent Applications Relating to Traditional Knowledge and Biological Material”.
The present guidelines are prepared with the objective that the Guidelines will help the Examiners and the Controllers of the Patent Office in achieving consistently uniform standards of patent examination and grant. In case of any conflict between these Guidelines and the Patents Act, 1970 and the Rules made there under, the provisions of the Act and Rules will prevail.
MCI plan action against doctors for having nexus with diagnostic centres, pharmacies Our Bureau, Hyderabad Wednesday, August 06, 2014, 08:00 Hrs [IST]
http://www.pharmabiz.com/NewsDetails.aspx?aid=83339&sid=1
The Medical Council of India (MCI) has taken a serious note of doctors falsely projecting their professional speciality even when they are not specialised in any areas. The council is also viewing seriously the illegal nexus between doctors, diagnostic centres, pharmacy stores and super speciality hospitals to earn commissions against their professional ethics.
“Doctors should abide to their professional ethics and should not cross the limits of their ethical dignity for the sake of earning money through commissions or by falsely projecting themselves as specialists. If found guilty of violating the norms and regulations set by Medical Council of India, the Council will not hesitate to take serious action against the violators,” said a source at MCI.
With growing competition among clinics and super speciality hospitals in Hyderabad, every other day, the managements are publicising hospitals in Television, News papers and hoardings, which is against the medical profession.
According to MCI, the doctors should not indulge in promotional activities. Giving promotional advertisement in Television, hoardings, banners and news papers is against MCI guidelines. In the event of recent illegal nexus brought to light in Delhi, between doctors and diagnostic centres for commission, the MCI has decided to issue notice to all the doctors under complaint and take stringent action against those who have crossed their limits of professional dignity.
Because of the commercial promotion in TVs and newspapers, the healthcare costs have sky rocketed in the country. In addition to this, it is observed that many MBBS doctors of smaller clinics in cities, towns, and even in villages have been subjecting patients to undergo unnecessary medical tests, directing them to go to super speciality hospitals and prescribing costly medicines of a particular brand even for small medical problems. Moreover doctors in the major towns and cities have increased their consultancy fees to 4 to 5 folds adding to overall healthcare costs.
“Earlier the doctor of smaller clinics used to charge Rs. 50 to Rs. 100 as consultancy fees, but now they have increased it to Rs. 200 to Rs. 300. For just a viral fever, I have to shell out Rs. 1500 to Rs. 2000, which included the medicines, tests and consultancy fees. For a common man healthcare costs are too high and unaffordable,” said a patient at a private hospital in Hyderabad.
In view of growing complaints against doctors, the MCI has directed the respective state councils to keep a tap on the illegal nexus between doctors, diagnostic centres and pharmacy stores. In Andhra Pradesh and Telangana alone, it is said that doctors get 30 to 50 per cent commission on referrals of medical tests and commission from pharmacy stores. About 5000 doctors in both Telangana and Andhra Pradesh have been found to be projecting themselves as ‘diabetalogists’ even without undergoing any speciality courses for the same. In view of this, the Union health ministry has directed the MCI to take stringent action against violators of medical profession in the country.
The Medical Council of India (MCI) has taken a serious note of doctors falsely projecting their professional speciality even when they are not specialised in any areas. The council is also viewing seriously the illegal nexus between doctors, diagnostic centres, pharmacy stores and super speciality hospitals to earn commissions against their professional ethics.
“Doctors should abide to their professional ethics and should not cross the limits of their ethical dignity for the sake of earning money through commissions or by falsely projecting themselves as specialists. If found guilty of violating the norms and regulations set by Medical Council of India, the Council will not hesitate to take serious action against the violators,” said a source at MCI.
With growing competition among clinics and super speciality hospitals in Hyderabad, every other day, the managements are publicising hospitals in Television, News papers and hoardings, which is against the medical profession.
According to MCI, the doctors should not indulge in promotional activities. Giving promotional advertisement in Television, hoardings, banners and news papers is against MCI guidelines. In the event of recent illegal nexus brought to light in Delhi, between doctors and diagnostic centres for commission, the MCI has decided to issue notice to all the doctors under complaint and take stringent action against those who have crossed their limits of professional dignity.
Because of the commercial promotion in TVs and newspapers, the healthcare costs have sky rocketed in the country. In addition to this, it is observed that many MBBS doctors of smaller clinics in cities, towns, and even in villages have been subjecting patients to undergo unnecessary medical tests, directing them to go to super speciality hospitals and prescribing costly medicines of a particular brand even for small medical problems. Moreover doctors in the major towns and cities have increased their consultancy fees to 4 to 5 folds adding to overall healthcare costs.
“Earlier the doctor of smaller clinics used to charge Rs. 50 to Rs. 100 as consultancy fees, but now they have increased it to Rs. 200 to Rs. 300. For just a viral fever, I have to shell out Rs. 1500 to Rs. 2000, which included the medicines, tests and consultancy fees. For a common man healthcare costs are too high and unaffordable,” said a patient at a private hospital in Hyderabad.
In view of growing complaints against doctors, the MCI has directed the respective state councils to keep a tap on the illegal nexus between doctors, diagnostic centres and pharmacy stores. In Andhra Pradesh and Telangana alone, it is said that doctors get 30 to 50 per cent commission on referrals of medical tests and commission from pharmacy stores. About 5000 doctors in both Telangana and Andhra Pradesh have been found to be projecting themselves as ‘diabetalogists’ even without undergoing any speciality courses for the same. In view of this, the Union health ministry has directed the MCI to take stringent action against violators of medical profession in the country.
MSPC refers back cases of professional misconduct of pharmacists to FDA for lack of clarity Shardul Nautiyal, Mumbai Wednesday, August 06, 2014, 08:00 Hrs [IST]
In order to seek clarity on cases of professional misconduct by pharmacists for timely action, Maharashtra State Pharmacy Council (MSPC) has referred back over 20 such cases to Maharashtra Food and Drug Administration (FDA) due to lack of documents required as evidence to back council proceedings on matters of non-compliance.
MSPC is a quasi-judicial body which takes action against errant pharmacists who fail on non -compliance to Pharmacy Act, 1948 can face action ranging issuance of warning letters to canceling registrations. According to an MSPC official, referral of cases of professional misconduct from FDA has to be backed by circumstantial evidence which could prove that the absence in the retail drug store was due to a pharmacist doing dual employment, in an incident of he being found forging bills and in an event of prescription medicines or Schedule H drugs sold without a bill in his/her absence.
Maharashtra FDA has till date referred over 200 such cases of professional misconduct of pharmacists to MSPC for appropriate action. State FDA officials maintains that most of the cases referred for MSPC action relate to the absence of pharmacists at drug stores across the state.
Such kind of cases take almost a year to get resolved by the state council which calls the aggrieved party for hearing and written submission at the full council meeting held twice a year in February and September. MSPC has till date canceled the registrations of 10 such pharmacists referred by FDA for professional misconduct from across the state. While cancellations done in five of the cases relate to misrepresentation of facts by the pharmacists, three relate to dual registrations and one relates to a pharmacist who has shifted base overseas.
As per the latest MSPC records, 81 cases were referred between 2005 and 2010 by the state FDA. Official records of period ranging from January 2013 to May 2014 revealed that the state FDA has also been stringent on its enforcement related to professional misconduct and filed FIRs on the same across the state.
MSPC is a quasi-judicial body which takes action against errant pharmacists who fail on non -compliance to Pharmacy Act, 1948 can face action ranging issuance of warning letters to canceling registrations. According to an MSPC official, referral of cases of professional misconduct from FDA has to be backed by circumstantial evidence which could prove that the absence in the retail drug store was due to a pharmacist doing dual employment, in an incident of he being found forging bills and in an event of prescription medicines or Schedule H drugs sold without a bill in his/her absence.
Maharashtra FDA has till date referred over 200 such cases of professional misconduct of pharmacists to MSPC for appropriate action. State FDA officials maintains that most of the cases referred for MSPC action relate to the absence of pharmacists at drug stores across the state.
Such kind of cases take almost a year to get resolved by the state council which calls the aggrieved party for hearing and written submission at the full council meeting held twice a year in February and September. MSPC has till date canceled the registrations of 10 such pharmacists referred by FDA for professional misconduct from across the state. While cancellations done in five of the cases relate to misrepresentation of facts by the pharmacists, three relate to dual registrations and one relates to a pharmacist who has shifted base overseas.
As per the latest MSPC records, 81 cases were referred between 2005 and 2010 by the state FDA. Official records of period ranging from January 2013 to May 2014 revealed that the state FDA has also been stringent on its enforcement related to professional misconduct and filed FIRs on the same across the state.
PHARMACY INSPECTORS IN STATES P A Francis Wednesday, July 16, 2014, 08:00 Hrs [IST]
http://www.pharmabiz.com/ArticleDetails.aspx?aid=82953&sid=3
Dispensing medicine in a pharmacy store is increasingly becoming a tough job for the pharmacists in India with uncontrolled growth of drug products in the market. Lack of effective control on irrational combination drugs and dosage manipulation in products to evade price control by pharmaceutical companies have made this responsibility of the pharmacists more complex at the counter. In an environment like this, absence of a qualified pharmacist in a retail medical store could be dangerous to millions of patients who are mostly not well informed. And in very few of the 7 lakh pharmacy outlets in India qualified pharmacists are present to dispense medicines to the patients. Regulatory authorities in all the states and Union territories are aware of this fact but rarely they conduct regular inspections of the premises of these outlets and take action. Maharashtra FDA, a few weeks ago, carried out a number of raids in Mumbai and other regions of the state and took action against the chemists for violation of the Section 42 of the Pharmacy Act,1948. Some of the chemists have even shut their shops and surrendered licenses while some others started keeping qualified pharmacists at their shops. But many others in semi urban and rural areas are still running their medical stores with unqualified persons having some experience in dealing medicines.
Inspections to curb violation of Section 42 are usually carried out by the drug inspectors as dispensing medicines in retail shops by the qualified persons is also a condition of the trade license issued by respective state drug control departments. As the number of inspectors in most of the state drug departments is far from adequate, regular checks are not taking place and the practice of illegal dispensing persists nationwide. In fact, enforcement of the Pharmacy Act is the prime responsibility of the respective state pharmacy councils. But barring Kerala and Maharashtra none of the other 27 states and Union Territories have pharmacy inspectors despite having pharmacy councils in all the states. Kerala has pharmacy inspectors for all the 14 districts whereas Maharashtra has just three pharmacy inspectors for the entire state. Why the Pharmacy Council of India and state pharmacy councils failed to convince state health ministries to appoint pharmacy inspectors in their states for so many years is question to be answered. As per the Pharmacy Act, State Pharmacy Councils are empowered under Section 26 A to appoint inspectors with the sanction of the respective state governments and pharmacy inspectors are expected to report the offences to the state pharmacy council. The new government at the Centre should earnestly take up this matter with all the state governments and get pharmacy inspectors appointed without any further delay for uniform implementation of the Pharmacy Act in the country.
Dispensing medicine in a pharmacy store is increasingly becoming a tough job for the pharmacists in India with uncontrolled growth of drug products in the market. Lack of effective control on irrational combination drugs and dosage manipulation in products to evade price control by pharmaceutical companies have made this responsibility of the pharmacists more complex at the counter. In an environment like this, absence of a qualified pharmacist in a retail medical store could be dangerous to millions of patients who are mostly not well informed. And in very few of the 7 lakh pharmacy outlets in India qualified pharmacists are present to dispense medicines to the patients. Regulatory authorities in all the states and Union territories are aware of this fact but rarely they conduct regular inspections of the premises of these outlets and take action. Maharashtra FDA, a few weeks ago, carried out a number of raids in Mumbai and other regions of the state and took action against the chemists for violation of the Section 42 of the Pharmacy Act,1948. Some of the chemists have even shut their shops and surrendered licenses while some others started keeping qualified pharmacists at their shops. But many others in semi urban and rural areas are still running their medical stores with unqualified persons having some experience in dealing medicines.
Inspections to curb violation of Section 42 are usually carried out by the drug inspectors as dispensing medicines in retail shops by the qualified persons is also a condition of the trade license issued by respective state drug control departments. As the number of inspectors in most of the state drug departments is far from adequate, regular checks are not taking place and the practice of illegal dispensing persists nationwide. In fact, enforcement of the Pharmacy Act is the prime responsibility of the respective state pharmacy councils. But barring Kerala and Maharashtra none of the other 27 states and Union Territories have pharmacy inspectors despite having pharmacy councils in all the states. Kerala has pharmacy inspectors for all the 14 districts whereas Maharashtra has just three pharmacy inspectors for the entire state. Why the Pharmacy Council of India and state pharmacy councils failed to convince state health ministries to appoint pharmacy inspectors in their states for so many years is question to be answered. As per the Pharmacy Act, State Pharmacy Councils are empowered under Section 26 A to appoint inspectors with the sanction of the respective state governments and pharmacy inspectors are expected to report the offences to the state pharmacy council. The new government at the Centre should earnestly take up this matter with all the state governments and get pharmacy inspectors appointed without any further delay for uniform implementation of the Pharmacy Act in the country.
PRICE & QUALITY OF DEVICES P A Francis Wednesday, July 30, 2014, 08:00 Hrs [IST]
http://www.pharmabiz.com/ArticleDetails.aspx?aid=83223&sid=3
Medical devices are life saving products like medicines and have to be produced with quality materials and as per good manufacturing practices (GMP). But, most of the units engaged in the manufacture of medical devices in India are small and they do not follow GMP voluntarily. As of now there are no specified standards laid down for the raw materials used for making them. Quality, safety and fair pricing are three factors that determine the growth of any industry and that is not happening in the case of medical devices sector in India. Perhaps profiteering in this sector with the collusion of hospital managements, distributors and doctors is one serious issue that needs to be addressed by the government urgently. A recent report by Pharmabiz brought out the huge margins charged on medical devices when these products are sold to patients. A big part of these margins on devices are shared between the hospital managements and the other intermediaries. Take the case of drug eluting stents (DES) required for the heart patients. The DES manufactured by Medtronic Inc and imported by India Medtronic Pvt Ltd at Rs.30,848 has a MRP of Rs.1,62,000. The huge difference in imported price and MRP is shared by the distributor and the hospital. Another DES manufactured by Abbott Vascular Devices Holland of Netherlands and imported by Abbott Healthcare Pvt Ltd, at Rs.40,710 is sold to the patients at a MRP of Rs.1,50,000 in hospitals. Maharashtra Food and Drug Administration recently came across many such cases of profiteering in medical devices and approached the Drug Controller General of India and National Pharmaceutical Pricing Authority urging these life saving products under the DPCO 2013 to make it affordable to the patients.
The medical devices industry in India is still at a nascent stage with more than 70 per cent of the country’s requirements are being imported as the domestic production is restricted to low technology and disposable items. At the same time, the demand for these life saving products has been steadily growing with a sharp rise in the life style diseases in the country. Quality and prices of medical devices used in India have been a matter of serious concern for some time as this sector has been outside the purview of any regulatory control. Medical devices imported into India also needs to be strictly monitored considering the number of device recalls in the US in recent years. According to a recent Global Business Intelligence report, in 2010 alone, 54 device recalls were effected in the US for their high risks of serious health problems or death. An attempt was made last year to bring medical devices under regulatory control by substantially modifying the Drugs & Cosmetics Act 1940 with a draft bill 2013. The bill also sought to establish a Medical Devices Authority to enable all medical devices and equipments to be regulated under the amended D&C Act. Although the bill was cleared by the Cabinet, it is yet to be passed by the Parliament. It is extremely important that the new government at the Centre should take up this matter with extreme urgency and get it passed in the Parliament.
Medical devices are life saving products like medicines and have to be produced with quality materials and as per good manufacturing practices (GMP). But, most of the units engaged in the manufacture of medical devices in India are small and they do not follow GMP voluntarily. As of now there are no specified standards laid down for the raw materials used for making them. Quality, safety and fair pricing are three factors that determine the growth of any industry and that is not happening in the case of medical devices sector in India. Perhaps profiteering in this sector with the collusion of hospital managements, distributors and doctors is one serious issue that needs to be addressed by the government urgently. A recent report by Pharmabiz brought out the huge margins charged on medical devices when these products are sold to patients. A big part of these margins on devices are shared between the hospital managements and the other intermediaries. Take the case of drug eluting stents (DES) required for the heart patients. The DES manufactured by Medtronic Inc and imported by India Medtronic Pvt Ltd at Rs.30,848 has a MRP of Rs.1,62,000. The huge difference in imported price and MRP is shared by the distributor and the hospital. Another DES manufactured by Abbott Vascular Devices Holland of Netherlands and imported by Abbott Healthcare Pvt Ltd, at Rs.40,710 is sold to the patients at a MRP of Rs.1,50,000 in hospitals. Maharashtra Food and Drug Administration recently came across many such cases of profiteering in medical devices and approached the Drug Controller General of India and National Pharmaceutical Pricing Authority urging these life saving products under the DPCO 2013 to make it affordable to the patients.
The medical devices industry in India is still at a nascent stage with more than 70 per cent of the country’s requirements are being imported as the domestic production is restricted to low technology and disposable items. At the same time, the demand for these life saving products has been steadily growing with a sharp rise in the life style diseases in the country. Quality and prices of medical devices used in India have been a matter of serious concern for some time as this sector has been outside the purview of any regulatory control. Medical devices imported into India also needs to be strictly monitored considering the number of device recalls in the US in recent years. According to a recent Global Business Intelligence report, in 2010 alone, 54 device recalls were effected in the US for their high risks of serious health problems or death. An attempt was made last year to bring medical devices under regulatory control by substantially modifying the Drugs & Cosmetics Act 1940 with a draft bill 2013. The bill also sought to establish a Medical Devices Authority to enable all medical devices and equipments to be regulated under the amended D&C Act. Although the bill was cleared by the Cabinet, it is yet to be passed by the Parliament. It is extremely important that the new government at the Centre should take up this matter with extreme urgency and get it passed in the Parliament.
STRENGTHENING REGULATORY SYSTEM P A Francis Wednesday, August 06, 2014, 08:00 Hrs [IST]
http://www.pharmabiz.com/ArticleDetails.aspx?aid=83347&sid=3
Under the 12th five year Plan, a budgetary allocation of Rs.1750 crore is provided by the Union finance ministry for expanding the country’s entire drug control machinery. Out of this, a sum of Rs. 900 crore is earmarked for the strengthening the Central Drugs Standard Control Organisation, country’s apex drug regulatory body while the remaining Rs. 850 crore is expected to be spent for the development of the state regulatory bodies. The funds will be used to help the CDSCO and state drug control departments in their capacity building measures like construction of new drug testing laboratories, expansion of existing facilities and hiring of regulatory staff. Adequate regulatory infrastructure, qualified technical staff and proper coordination between the Centre and state governments are the key factors that determine the efficient functioning of a national drug control network. And that is what has been lacking in the country for several years despite India being a major producer and exporter of drugs and pharmaceuticals today. Testing laboratories in major drug producing states like Maharashtra, Gujarat, Andhra Pradesh, Karnataka and Himachal Pradesh are far from adequate. Primarily it is the responsibility of the respective state governments to allocate funds to set up sufficient number of drug testing laboratories to ensure only quality medicines are produced and sold in the territory of that state. By allocating Rs.850 crore in 12th Plan, the Centre is trying to help the state governments which are hesitant to set up testing labs and recruit necessary regulatory staff.
Perhaps the most critical factor in a drug regulatory framework is the adequacy of technically qualified staff for regular inspection of establishments and quality testing of drugs. To oversee the regulatory compliance of 10,000 pharmaceutical companies and 7 lakh retail chemists spread across the country, a large team of drug control staff is necessary. Currently, there are only 200 staff with CDSCO as against the sanctioned staff strength of 470. And there are just 1,200 drug inspectors for all the 29 states against the requirement of more than 3,200. Such inadequacy in staff numbers has been leading to huge work pressure on the existing staff both at the Centre and the states resulting in poor enforcement of drug laws in the country. The plan to recruit 5,500 new regulatory staff for both at the Centre and in states during the 12th Plan period, therefore, makes a lot of sense. CDSCO alone will have 2,500 drug control officials whereas states will get 3,000 additional staff for inspection and testing labs. Allocation of funds for advanced infrastructure and building up a strong regulatory machinery is indeed a first step in the right direction. What is more important is the timely and effective implementation of this reform process through better coordination between CDSCO and state regulatory departments. Absence of a uniform implementation of various central drug laws and directives by the state drug control departments is, perhaps, the biggest challenge Indian drug regulatory system is facing today and that needs to be addressed most urgently.
Under the 12th five year Plan, a budgetary allocation of Rs.1750 crore is provided by the Union finance ministry for expanding the country’s entire drug control machinery. Out of this, a sum of Rs. 900 crore is earmarked for the strengthening the Central Drugs Standard Control Organisation, country’s apex drug regulatory body while the remaining Rs. 850 crore is expected to be spent for the development of the state regulatory bodies. The funds will be used to help the CDSCO and state drug control departments in their capacity building measures like construction of new drug testing laboratories, expansion of existing facilities and hiring of regulatory staff. Adequate regulatory infrastructure, qualified technical staff and proper coordination between the Centre and state governments are the key factors that determine the efficient functioning of a national drug control network. And that is what has been lacking in the country for several years despite India being a major producer and exporter of drugs and pharmaceuticals today. Testing laboratories in major drug producing states like Maharashtra, Gujarat, Andhra Pradesh, Karnataka and Himachal Pradesh are far from adequate. Primarily it is the responsibility of the respective state governments to allocate funds to set up sufficient number of drug testing laboratories to ensure only quality medicines are produced and sold in the territory of that state. By allocating Rs.850 crore in 12th Plan, the Centre is trying to help the state governments which are hesitant to set up testing labs and recruit necessary regulatory staff.
Perhaps the most critical factor in a drug regulatory framework is the adequacy of technically qualified staff for regular inspection of establishments and quality testing of drugs. To oversee the regulatory compliance of 10,000 pharmaceutical companies and 7 lakh retail chemists spread across the country, a large team of drug control staff is necessary. Currently, there are only 200 staff with CDSCO as against the sanctioned staff strength of 470. And there are just 1,200 drug inspectors for all the 29 states against the requirement of more than 3,200. Such inadequacy in staff numbers has been leading to huge work pressure on the existing staff both at the Centre and the states resulting in poor enforcement of drug laws in the country. The plan to recruit 5,500 new regulatory staff for both at the Centre and in states during the 12th Plan period, therefore, makes a lot of sense. CDSCO alone will have 2,500 drug control officials whereas states will get 3,000 additional staff for inspection and testing labs. Allocation of funds for advanced infrastructure and building up a strong regulatory machinery is indeed a first step in the right direction. What is more important is the timely and effective implementation of this reform process through better coordination between CDSCO and state regulatory departments. Absence of a uniform implementation of various central drug laws and directives by the state drug control departments is, perhaps, the biggest challenge Indian drug regulatory system is facing today and that needs to be addressed most urgently.
IPA seeks health minister's attention towards plight of registered pharmacists Our Bureau, Mumbai Friday, August 01, 2014, 08:00 Hrs [IST]
The Indian Pharmaceutical Association (IPA), an association working for the upliftment of the pharmacy profession in the country, has sought the attention of union health minister Dr Harshvadhan towards the pathetic plight of the registered pharmacists working at various levels in India.
In a recent representation, IPA general secretary Bhupendra Kumar apprised the minister that the pharmacists are the lowest paid health professionals though they are well qualified having qualifications upto Doctorate in Pharmacy. Other health professionals and workers with same or less qualifications are getting more pay than the pharmacists. A Group-D employee can reach upto Group-A post by promotions, but in case of pharmacist no promotional avenues are provided. They join as pharmacist and retire on the same post. Due to this stagnation, the pharmacy profession is losing academic interest and seats in pharmacy colleges are lying vacant, the IPA in its letter said.
The pharmacists should get minimum pay equivalent to that of a primary teacher or less qualified junior engineer, the IPA demanded in its letter to the minister. The IPA asked for proper cadre formation with directorate of pharmacy as represented by Pharmacy Council of India (Statutory body regulating the Pharmacy profession) to health ministry previously.
The IPA also opposed the union health ministry's decision to start B.Sc Community Health programme from this academic year. The IPA, which has been raising its voice against the course from the first day, said that the course will further aggravate the condition of pharmacist as well as common man of rural areas.
Pointing out that the Parliamentary Standing Committee on health had also opposed the course, the IPA said that working and experienced pharmacist can serve the purpose with a short duration upgradation training as initiated by the UP Govt. Every professional whether a doctor, nurse or a paramedical have the opportunity of upgrading their education by means of part time upgradation courses. But, in the case of pharmacists no such upgradation course is available.
In this regard, the IPA demanded that a part time course from IGNOU as available for the nurses and doctors should be started for the pharmacists also.
In a recent representation, IPA general secretary Bhupendra Kumar apprised the minister that the pharmacists are the lowest paid health professionals though they are well qualified having qualifications upto Doctorate in Pharmacy. Other health professionals and workers with same or less qualifications are getting more pay than the pharmacists. A Group-D employee can reach upto Group-A post by promotions, but in case of pharmacist no promotional avenues are provided. They join as pharmacist and retire on the same post. Due to this stagnation, the pharmacy profession is losing academic interest and seats in pharmacy colleges are lying vacant, the IPA in its letter said.
The pharmacists should get minimum pay equivalent to that of a primary teacher or less qualified junior engineer, the IPA demanded in its letter to the minister. The IPA asked for proper cadre formation with directorate of pharmacy as represented by Pharmacy Council of India (Statutory body regulating the Pharmacy profession) to health ministry previously.
The IPA also opposed the union health ministry's decision to start B.Sc Community Health programme from this academic year. The IPA, which has been raising its voice against the course from the first day, said that the course will further aggravate the condition of pharmacist as well as common man of rural areas.
Pointing out that the Parliamentary Standing Committee on health had also opposed the course, the IPA said that working and experienced pharmacist can serve the purpose with a short duration upgradation training as initiated by the UP Govt. Every professional whether a doctor, nurse or a paramedical have the opportunity of upgrading their education by means of part time upgradation courses. But, in the case of pharmacists no such upgradation course is available.
In this regard, the IPA demanded that a part time course from IGNOU as available for the nurses and doctors should be started for the pharmacists also.
MSPC refers back cases of professional misconduct of pharmacists to FDA for lack of clarity
| Shardul Nautiyal, Mumbai Wednesday, August 06, 2014, 08:00 Hrs [IST] |
In order to seek clarity on cases of professional misconduct by pharmacists for timely action, Maharashtra State Pharmacy Council (MSPC) has referred back over 20 such cases to Maharashtra Food and Drug Administration (FDA) due to lack of documents required as evidence to back council proceedings on matters of non-compliance.
MSPC is a quasi-judicial body which takes action against errant pharmacists who fail on non -compliance to Pharmacy Act, 1948 can face action ranging issuance of warning letters to canceling registrations. According to an MSPC official, referral of cases of professional misconduct from FDA has to be backed by circumstantial evidence which could prove that the absence in the retail drug store was due to a pharmacist doing dual employment, in an incident of he being found forging bills and in an event of prescription medicines or Schedule H drugs sold without a bill in his/her absence. Maharashtra FDA has till date referred over 200 such cases of professional misconduct of pharmacists to MSPC for appropriate action. State FDA officials maintains that most of the cases referred for MSPC action relate to the absence of pharmacists at drug stores across the state. Such kind of cases take almost a year to get resolved by the state council which calls the aggrieved party for hearing and written submission at the full council meeting held twice a year in February and September. MSPC has till date canceled the registrations of 10 such pharmacists referred by FDA for professional misconduct from across the state. While cancellations done in five of the cases relate to misrepresentation of facts by the pharmacists, three relate to dual registrations and one relates to a pharmacist who has shifted base overseas. As per the latest MSPC records, 81 cases were referred between 2005 and 2010 by the state FDA. Official records of period ranging from January 2013 to May 2014 revealed that the state FDA has also been stringent on its enforcement related to professional misconduct and filed FIRs on the same across the state.
http://www.pharmabiz.com/NewsDetails.aspx?aid=83340&sid=1
|
Watch your waistline to avoid diabetes, says new report
Aug 1, 2014 09:07 IST
London: A British health report has warned that adults with a large waistline are five times more likely to develop type 2 diabetes. In its report, the Public Health England (PHE), an executive agency of Britain's Department of Health, said they encourage people to monitor their waistline and assess risk of developing type 2 diabetes.
According to the report, men having a large waist circumference of over 102cm (40 inches)are five times more likely to develop type 2 diabetes. Women with a large waist circumference of over 88cm (34.6 inches) are three times more likely to develop type 2 diabetes, Xinhua reported.
Representational image of a sugar test. Reuters
Currently 90 percent of the adults with type 2 diabetes are overweight or obese, and the prevalence of both obesity and diabetes are on the increase, said PHE experts. Being overweight or obese is the main avoidable risk factor for type 2 diabetes, they added.
According to Alison Tedstone, chief nutritionist at PHE, type 2 diabetes is a very serious public health issue which can have significant consequences, such as limb amputations or blindness. The key to reducing your chances of type 2 diabetes is losing weight which can be achieved through a healthy diet and being more active, she added.
The report also revealed that deprivation is closely linked to the risk of both -- obesity and diabetes in Britain, with type 2 diabetes being 40 percent more common among people in the poorest communities compared to the rich ones.
IANS
http://www.firstpost.com/living/watch-your-waistline-to-avoid-diabetes-says-new-report-1644413.html
Neuronal 'sweet spot' may help curb obesity, shows study
Aug 4, 2014 09:10 IST
Washington: The discovery of a simple switch in the brain may let you eat what you want and stay slim, according to a new study. Preventing weight gain, obesity, and diabetes could be as simple as keeping a nuclear receptor from being activated in a small part of the brain, researchers have found.
When the researchers at Yale School of Medicine blocked the effects of the nuclear receptor PPARgamma in a small number of brain cells in mice, the animals ate less and became resistant to a high-fat diet.
"These animals ate fat and sugar, and did not gain weight, while their control littermates did," said lead author Sabrina Diano, professor in the Department of Obstetrics, Gynecology & Reproductive Sciences at Yale School of Medicine.
"We showed that the PPARgamma receptor in neurons that produce POMC could control responses to a high-fat diet without resulting in obesity," Diano said.
Representational Image. AFP
POMC neurons are found in the hypothalamus and regulate food intake. They are the neurons that when activated make you feel full and curb appetite. PPARgamma regulates the activation of these neurons. Diano and her team studied transgenic mice that were genetically engineered to delete the PPARgamma receptor from POMC neurons. They wanted to see if they could prevent the obesity associated with a high-fat, high-sugar diet.
"When we blocked PPARgamma in these hypothalamic cells, we found an increased level of free radical formation in POMC neurons, and they were more active," said Diano.
The findings also have key implications in diabetes. PPARgamma is a target of thiazolidinedione (TZD), a class of drugs used to treat type 2 diabetes. They lower blood-glucose levels, however, patients gain weight on these medications.
"Our study suggests that the increased weight gain in diabetic patients treated with TZD could be due to the effect of this drug in the brain, therefore, targeting peripheral PPARgamma to treat type 2 diabetes should be done by developing TZD compounds that can't penetrate the brain," said Diano.
"We could keep the benefits of TZD without the side-effects of weight gain. Our next steps in this research are to test this theory in diabetes mouse models," said Diano.
The study was published in The Journal of Clinical Investigation (JCI).
PTI
http://www.firstpost.com/living/neuronal-sweet-spot-may-help-curb-obesity-shows-study-1647955.html
MCI still corrupt, lacks formal and ethical structure: member - The Hindu
MCI still corrupt, lacks formal and ethical structure: member - The Hindu
Dr. Desai was arrested by the Central Bureau of Investigation for accepting a hefty bribe from a medical college in Punjab for granting it recognition.
Although Dr. Desai’s medical licence was suspended, he was later appointed as a member of the Gujarat Medical Council and currently serves as the head of the urology department at B.J. Medical College in Ahmedabad.
How probiotics are good for your gut revealed
Last Updated: Monday, August 04, 2014, 09:41
http://zeenews.india.com/news/health/health-news/how-probiotics-are-good-for-your-gut-revealed_29070.html
Washington: Researchers have found that "normal" bacteria plays vital for keeping intestinal lining intact and eating probiotics, which contains the good kind of bacteria, helps in avoiding inflammatory disorders that occur when the intestinal lining has been compromised.
http://zeenews.india.com/news/health/health-news/how-probiotics-are-good-for-your-gut-revealed_29070.html
Washington: Researchers have found that "normal" bacteria plays vital for keeping intestinal lining intact and eating probiotics, which contains the good kind of bacteria, helps in avoiding inflammatory disorders that occur when the intestinal lining has been compromised.
Sridhar Mani, M.D., said that by adding probiotics in the form of IPA-producing bacteria to the intestine or by administering IPA directly, might be able to prevent or treat IBD and other inflammatory disorders that occur when the intestinal epithelium has been compromised.
He further added that such a strategy could also be tried for other health problems that may occur when the intestinal epithelium breaks down, including certain forms of liver disease, diabetes, asthma, allergies, obesity and heart disease.
The research involved the intestinal microbiome, which contains some 100 trillion bacteria. The role of these microorganisms in promoting or preventing disease has been a major emerging field of study. Einstein scientists found that absorption of a specific bacterial byproduct was crucial for maintaining the integrity of the intestinal epithelium, the single-cell layer responsible for keeping intestinal bacteria and their toxins inside the gut and away from the rest of the body. Breaching of the intact intestinal epithelium was associated with a number of diseases.
Scientists at Albert Einstein College of Medicine of Yeshiva University have found in a series of mouse studies that a metabolite called indole 3-propionic acid (IPA), produced exclusively by so-called commensal bacteria, which aid in digestion, both strengthens the intestinal epithelium's barrier function and prevents its inflammation by activating PXR.
More specifically, PXR activation suppresses production of an inflammatory protein called tumor necrosis factor alpha (TNF-a) while increasing levels of a protein that strengthens the junctions between adjacent intestinal epithelial cells.
The researchers are now developing novel probiotics aimed at restoring the intestinal epithelium's barrier function by encouraging IPA's interaction with PXR.
The study is published online in the journal Immunity.
ANI
First Published: Monday, August 04, 2014, 09:41
First Published: Monday, August 04, 2014, 09:41
Indian drug makers to pay higher facility fees to USFDA The US drug monitor announced new rates for annual facility fees, with rates for foreign facilities up by 12-15% Read more at: http://www.livemint.com/Industry/9PDXawVQqTbpOzTEXY7F9I/Indian-drug-makers-to-pay-higher-facility-fees-to-USFDA.html?utm_source=copy
SUN, AUG 03 2014. 03 59 PM IST
Read more at: http://www.livemint.com/Industry/9PDXawVQqTbpOzTEXY7F9I/Indian-drug-makers-to-pay-higher-facility-fees-to-USFDA.html?utm_source=copy
Washington: Drug makers from India, the biggest source of medicines to the US, may soon have to cough up 12-15% more in annual facility fees as the Food and Drug Administration (FDA) has announced new rates. US laws authorize the drug and health watchdog to assess and collect user fees for certain applications and supplements for human generic drug products. The new rates, applicable on companies from all nations, are effective from 1 October 2014 and will remain in force through 30 September 2015, as per a communication from the FDA. A foreign FDF (Finished Dosage Form) facility will pay $262,717 (around Rs 1.6 crore) now, compared to $235,152 a year ago—an increase of 12%. India is home to over 150 FDA-approved plants, including facilities run by multinational companies. Of the total facilities identified as FDF, there were 271 domestic facilities and 410 foreign facilities, including those in India. Similarly, a foreign API (Active Pharmaceutical Ingredient) facility would attract $56,926 as fees—15% higher than the current rate. Of the total facilities identified as API facilities, there were 103 domestic facilities and 692 foreign facilities. Facility fees are required to be paid by those owning a facility, which is identified or intended to be identified in at least one generic drug submission that is pending or is approved to produce one or more generic drug FDFs and/or APIs. If a facility manufactures both generic FDFs and APIs, it incurs both annual FDF and annual API facility fees. Foreign generic drug facility fees are about $15,000 higher than domestic plants as the FDA reasons that the differential reflects the additional costs of inspections funded. For the US facilities, the FDF facility fee this year is $247,717 and the API facility fee is $41,926. Interestingly, the total FDF and API fees collected from domestic as well as foreign facilities account for 70% of the $312 million target fee revenue amount for the fiscal year 2015. This is why, industry players say, the cut in filing fees this year provides little relief. The new fee for drug master files (DMFs) is $26,720, down 15% year-on-year. The rates for abbreviated new drug applications (ANDAs) has also been lowered about 8% to $58,730. The same for PAS (prior approval supplement), which is equal to half the ANDA fee, will be about 7% less at $29,730. The FDA estimates there will be 1,065 ANDAs and 449 PASs. In case fees are not paid, no new generic drug submission referencing the facility will be received until fees are paid. Further, all FDFs or APIs manufactured in the non-paying facility and all FDFs containing APIs manufactured in such a facility are deemed mis-branded. Indian companies usually supply about 20-25% of the medicines used in the US. America accounts for about 25% of India’s about $15 billion pharmaceuticals exports.
Read more at: http://www.livemint.com/Industry/9PDXawVQqTbpOzTEXY7F9I/Indian-drug-makers-to-pay-higher-facility-fees-to-USFDA.html?utm_source=copy
Read more at: http://www.livemint.com/Industry/9PDXawVQqTbpOzTEXY7F9I/Indian-drug-makers-to-pay-higher-facility-fees-to-USFDA.html?utm_source=copy
Washington: Drug makers from India, the biggest source of medicines to the US, may soon have to cough up 12-15% more in annual facility fees as the Food and Drug Administration (FDA) has announced new rates. US laws authorize the drug and health watchdog to assess and collect user fees for certain applications and supplements for human generic drug products. The new rates, applicable on companies from all nations, are effective from 1 October 2014 and will remain in force through 30 September 2015, as per a communication from the FDA. A foreign FDF (Finished Dosage Form) facility will pay $262,717 (around Rs 1.6 crore) now, compared to $235,152 a year ago—an increase of 12%. India is home to over 150 FDA-approved plants, including facilities run by multinational companies. Of the total facilities identified as FDF, there were 271 domestic facilities and 410 foreign facilities, including those in India. Similarly, a foreign API (Active Pharmaceutical Ingredient) facility would attract $56,926 as fees—15% higher than the current rate. Of the total facilities identified as API facilities, there were 103 domestic facilities and 692 foreign facilities. Facility fees are required to be paid by those owning a facility, which is identified or intended to be identified in at least one generic drug submission that is pending or is approved to produce one or more generic drug FDFs and/or APIs. If a facility manufactures both generic FDFs and APIs, it incurs both annual FDF and annual API facility fees. Foreign generic drug facility fees are about $15,000 higher than domestic plants as the FDA reasons that the differential reflects the additional costs of inspections funded. For the US facilities, the FDF facility fee this year is $247,717 and the API facility fee is $41,926. Interestingly, the total FDF and API fees collected from domestic as well as foreign facilities account for 70% of the $312 million target fee revenue amount for the fiscal year 2015. This is why, industry players say, the cut in filing fees this year provides little relief. The new fee for drug master files (DMFs) is $26,720, down 15% year-on-year. The rates for abbreviated new drug applications (ANDAs) has also been lowered about 8% to $58,730. The same for PAS (prior approval supplement), which is equal to half the ANDA fee, will be about 7% less at $29,730. The FDA estimates there will be 1,065 ANDAs and 449 PASs. In case fees are not paid, no new generic drug submission referencing the facility will be received until fees are paid. Further, all FDFs or APIs manufactured in the non-paying facility and all FDFs containing APIs manufactured in such a facility are deemed mis-branded. Indian companies usually supply about 20-25% of the medicines used in the US. America accounts for about 25% of India’s about $15 billion pharmaceuticals exports.
Read more at: http://www.livemint.com/Industry/9PDXawVQqTbpOzTEXY7F9I/Indian-drug-makers-to-pay-higher-facility-fees-to-USFDA.html?utm_source=copy
Delhi HC refuses a stay on NPPA order fixing drug prices
The High Court also sought response of NPPA on a plea by an organisation of drug manufacturers, challenging the drug regulator's 10th July notificationthat brought over 100 medicines under price control
The Delhi High Court on Friday refused to stay order from National Pharmaceutical Pricing Authority (NPPA) fixing prices of over 100 non-scheduled drugs.
The High Court also sought response of NPPA on a plea by an organisation of drug manufacturers, challenging the drug regulator's 10th July notification that brought over 100 medicines under price control.
A bench of Justice Vibhu Bakhru, however, refused to allow Organisation of Pharma Producers of India's (OPPI) interim plea seeking a stay or status quo order preventing the government from taking any further steps in pursuance of its notification.
"I am not inclined to stay it or pass any ad-interim order. Issue notice. Respondent (NPPA) to file counter (reply) in three weeks and rejoinder thereto in two weeks. List on 29th September," Justice Bakhru said.
"Show that the power exercised by you (NPPA) is not unbridled as contended by them (OPPI)," the Court said to the drug regulator which was represented by Additional Solicitor General (ASG) Sanjay Jain.
The Court also observed that paragraph 19 of the 2013 Drug Prices Control Order (DPCO) does not restrict price fixation to only essential drugs.
Paragraph 19 of DPCO, 2013, authorises the NPPA in extraordinary circumstances, if it considers necessary so to do in public interest, to fix the ceiling price or retail price of any drug for such period as it deems fit.
During the proceedings, senior advocate Kapil Sibal, appearing for OPPI, argued that NPPA has cited extraordinary circumstances to fix caps on the prices of over 100 drugs, which are non-scheduled formulations and lie outside the scope of National List of Essential Medicines (NLEM), but without saying what the extraordinary circumstances are.
Sibal also said that as per the government's drug policy regime, prices of non-scheduled drugs are to be monitored, not fixed.
"The government can interfere with the prices of non-scheduled drugs only if there is anincrease of 10% more in their cost in a particular year," Sibal said.
"They (government) can only decrease the price by 10% and that too for one year. That is the drug policy regime," he added.
He also said that the government can include these drugs in the NLEM.
ASG Jain, however, said the "paramount" reason behind the fixation of caps on the pricesof these drugs was public interest and added that OPPI has not challenged the notificationor paragraph 19 of DPCO.
He also questioned the locus of the organisation to file the present petition.
The NPPA on 10th July had brought prices of over 100 non-scheduled drugs under price control as per paragraph 19 of DPCO.
While bringing these drugs under price control, the NPPA has noted that it is of the considered view that there exists huge inter-brand price differences in branded-generics/ off patent drugs, which is indicative of a severe market failure.
http://www.moneylife.in/article/delhi-hc-refuses-a-stay-on-nppa-order-fixing-drug-prices/38286.html
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