Guest guest Posted November 3, 2008 Report Share Posted November 3, 2008 Dear Members: In my previous post I have stressed upon the need for creating Quality Control Laboratories that are duly approved by the Drug Control Dept in every major hospital pharmacy dept. Only when they are duly approved, can their test reports be honoured legally in the court of law. One has to apply on FORM 36 and pay some nominal fee to get their lab approved and it is not mandatory to have highly sophisticated instruments at the beginning itself. As I stated earlier, most of the drug estimations can be done using UV- Spectrophotometry and HPLC. I need not say that these instruments are also required/available in clinical pharmacology dept for pharmacokinetic and pharmacodynamic studies. Here is a link of FDA Maharashtra giving guidelines for setting up of such laboratories.It gives complete procedure, requirements to be fulfilled and fee details for such approval. The URL is http://www.fda-mah.com/guidelines/guidelineblood.html For smooth and effective functioning of these labs we can follow the GLP guidelines put forth by WHO in the form of a GLP Handbook that is available online at: http://www.who.int/tdr/publications/publications/glp-handbook.htm Once such QC laboratories are established in every major hospital, they can test their own medicines periodically and regularly and check their quality without depending on govt laboratories for analysis and test reports. With regards Dr Geer M. Ishaq Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 3, 2008 Report Share Posted November 3, 2008 Dear all !! FOR CONSITENTLY KEEPING WATCH ON GOOD QUALITY MEDICINES, 'WHO' can strengthen the national drug-regulatory authorities- The role of WHO may be Firstly,through the development of internationally recognized norms, standards and guidelines. Secondly by providing guidance, technical assistance, and training in order to enable countries to adapt global guidelines to meet their specific drug regulatory environment and needs. Dr.Kiran V.Barar. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 3, 2008 Report Share Posted November 3, 2008 Dear Dr.Ishaq, Thanks. I too feel the same. Your post was very useful to me. Gitanjali On Mon, Nov 3, 2008 at 3:12 PM, ishaqgeer <ishaqgeer@...> wrote: Dear Members:In my previous post I have stressed upon the need for creating Quality Control Laboratories that are duly approved by the Drug Control Dept in every major hospital pharmacy dept. Only when they are duly approved, can their test reports be honoured legally in the court of law. One has to apply on FORM 36 and pay some nominal fee to get their lab approved and it is not mandatory to have highly sophisticated instruments at the beginning itself. As I stated earlier, most of the drug estimations can be done using UV-Spectrophotometry and HPLC. I need not say that these instruments are also required/available in clinical pharmacology dept for pharmacokinetic and pharmacodynamic studies. Here is a link of FDA Maharashtra giving guidelines for setting up of such laboratories.It gives complete procedure, requirements to be fulfilled and fee details for such approval. The URL is http://www.fda-mah.com/guidelines/guidelineblood.html For smooth and effective functioning of these labs we can follow the GLP guidelines put forth by WHO in the form of a GLP Handbook that is available online at:http://www.who.int/tdr/publications/publications/glp-handbook.htm Once such QC laboratories are established in every major hospital, they can test their own medicines periodically and regularly and check their quality without depending on govt laboratories for analysis and test reports. With regardsDr Geer M. Ishaq -- Dr.Gitanjali Batmanabane MD PhD Professor of Pharmacology & Officer-in-charge,Dept. of PharmacyJawaharlal Institute of Postgraduate Medical Education & ResearchPondicherry 605 006India Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 3, 2008 Report Share Posted November 3, 2008 Dear Dr. Ishaq You have given good information on the establishment of quality control laboratories and their approval by drug regulatory authorities. Our organisation, Vaagdevi College of Pharmacy, Warangal, is running M. Pharm. (Pharmacy Practice) programme at MGM Hospital, a 1200 bed government hospital located in Warangal. We have the facilities like UV spectrophotometer, HPLC and many more equipment that we have established the facility with about 15 laks rupees. So far we are concentrating on therapeutic drug monitoring after obtaining blood and urine samples from the patients. Now with the discussion on the NETRUM, I felt it is also necessary to look into the quality aspects of the drugs that are being supplied in the hospital. But as you know one need support from the hospital authorities too. Appointment of analysts or pharmacists with postgraduation is also required to assess the quality of medicines. Apart from these two, necessary funding is required to meet the analysis expenses viz., chemicals and other consumables. The link that you have given for GLP guidlines of WHO is not working. It can be found at the following link http://www.who.int/tdr/publications/training-guideline-publications/good-laboratory-practice-handbook/pdf/glp-handbook.pdf Dr. Srisailam K Dear Members:In my previous post I have stressed upon the need for creating Quality Control Laboratories that are duly approved by the Drug Control Dept in every major hospital pharmacy dept. Only when they are duly approved, can their test reports be honoured legally in the court of law. One has to apply on FORM 36 and pay some nominal fee to get their lab approved and it is not mandatory to have highly sophisticated instruments at the beginning itself. As I stated earlier, most of the drug estimations can be done using UV-Spectrophotometry and HPLC. I need not say that these instruments are also required/available in clinical pharmacology dept for pharmacokinetic and pharmacodynamic studies. Here is a link of FDA Maharashtra giving guidelines for setting up of such laboratories. It gives complete procedure, requirements to be fulfilled and fee details for such approval. The URL is http://www.fda- mah.com/guidelin es/guidelinebloo d.htmlFor smooth and effective functioning of these labs we can follow the GLP guidelines put forth by WHO in the form of a GLP Handbook that is available online at:http://www.who. int/tdr/publicat ions/publication s/glp-handbook. htmOnce such QC laboratories are established in every major hospital, they can test their own medicines periodically and regularly and check their quality without depending on govt laboratories for analysis and test reports.With regardsDr Geer M. Ishaq-- Dr.Gitanjali Batmanabane MD PhDProfessor of Pharmacology & Officer-in-charge,Dept. of PharmacyJawaharlal Institute of Postgraduate Medical Education & ResearchPondicherry 605 006India New Email addresses available on Get the Email name you've always wanted on the new @ymail and @rocketmail. Hurry before someone else does! Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 3, 2008 Report Share Posted November 3, 2008 Dear Gitanjali and allLooking in to the discussions, it seems that all face this situation of helplessness. The tender and quotation system perhaps comes from the British era and we have not been able to shake it off. Often the prices quoted are so low that it seems impractical...so the first casualty of low prices seems quality. Another problem that is observed is that the sole supplier who gets the order does not keep up a regular supply or the quality deteriorates as months pass. The mechanisms of blacklisting such suppliers are tedious and easily circumvented by other means. The RTI is also " misused " often. A way out of this could be... Choose 2-3 suppliers(with lowest quotations) instead of just one. That would ensure a regular supply and could also instill some sense of competition. I do not know if this is acceptable/followed anywhere...maybe Drs Gitanjali or Vijay can tell us. An issue that also merits attention is how do we ensure that the consumers are getting good quality medicines from the retailers? The mechanisms to regulate these and checks and counterchecks are even more slack here. Consumers who are otherwise very conscious about the quality of food and clothes, usually do not doubt the quality of medicines they consume, unless a catastrophe happens! They rely on the judgment of the presciber in most cases. Chetna2008/11/4 Gitanjali Batmanabane <gitabatman@...> Dear Dr.Ishaq, Thanks. I too feel the same. Your post was very useful to me. Gitanjali On Mon, Nov 3, 2008 at 3:12 PM, ishaqgeer <ishaqgeer@...> wrote: Dear Members:In my previous post I have stressed upon the need for creating Quality Control Laboratories that are duly approved by the Drug Control Dept in every major hospital pharmacy dept. Only when they are duly approved, can their test reports be honoured legally in the court of law. One has to apply on FORM 36 and pay some nominal fee to get their lab approved and it is not mandatory to have highly sophisticated instruments at the beginning itself. As I stated earlier, most of the drug estimations can be done using UV-Spectrophotometry and HPLC. I need not say that these instruments are also required/available in clinical pharmacology dept for pharmacokinetic and pharmacodynamic studies. Here is a link of FDA Maharashtra giving guidelines for setting up of such laboratories.It gives complete procedure, requirements to be fulfilled and fee details for such approval. The URL is http://www.fda-mah.com/guidelines/guidelineblood.html For smooth and effective functioning of these labs we can follow the GLP guidelines put forth by WHO in the form of a GLP Handbook that is available online at:http://www.who.int/tdr/publications/publications/glp-handbook.htm Once such QC laboratories are established in every major hospital, they can test their own medicines periodically and regularly and check their quality without depending on govt laboratories for analysis and test reports. With regardsDr Geer M. Ishaq -- Dr.Gitanjali Batmanabane MD PhD Professor of Pharmacology & Officer-in-charge,Dept. of PharmacyJawaharlal Institute of Postgraduate Medical Education & ResearchPondicherry 605 006India -- Dr Chetna DesaiDepartment of PharmacologyB. J. Medical CollegeAhmedabad 380016Visit http://www.pharmacologybjmc.org http://pharmacbjmc.110mb.comwww.poliofoundation.org Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 3, 2008 Report Share Posted November 3, 2008 Dear all, I was stunned by what Gitanjali mam has revealed.These companies are playing with the quality of drugs consumed by common man.Why these parties not blacklisted and why do they continue to get orders further? Dr.santosh n netrum , " Chetna Desai " <chetna99@...> wrote: > > Dear Gitanjali and all > Looking in to the discussions, it seems that all face this situation of > helplessness. The tender and quotation system perhaps comes from the British > era and we have not been able to shake it off. Often the prices quoted are > so low that it seems impractical...so the first casualty of low prices seems > quality. Another problem that is observed is that the sole supplier who gets > the order does not keep up a regular supply or the quality deteriorates as > months pass. The mechanisms of blacklisting such suppliers are tedious and > easily circumvented by other means. The RTI is also " misused " often. A way > out of this could be... > > - Choose 2-3 suppliers(with lowest quotations) instead of just one. That > would ensure a regular supply and could also instill some sense of > competition. I do not know if this is acceptable/followed anywhere...maybe > Drs Gitanjali or Vijay can tell us. > > An issue that also merits attention is how do we ensure that the consumers > are getting good quality medicines from the retailers? The mechanisms to > regulate these and checks and counterchecks are even more slack here. > Consumers who are otherwise very conscious about the quality of food and > clothes, usually do not doubt the quality of medicines they consume, unless > a catastrophe happens! They rely on the judgment of the presciber in most > cases. > Chetna > > 2008/11/4 Gitanjali Batmanabane <gitabatman@...> > > > Dear Dr.Ishaq, > > Thanks. I too feel the same. Your post was very useful to me. > > Gitanjali > > > > On Mon, Nov 3, 2008 at 3:12 PM, ishaqgeer <ishaqgeer@...> wrote: > > > >> Dear Members: > >> In my previous post I have stressed upon the need for creating > >> Quality Control Laboratories that are duly approved by the Drug > >> Control Dept in every major hospital pharmacy dept. Only when they > >> are duly approved, can their test reports be honoured legally in the > >> court of law. One has to apply on FORM 36 and pay some nominal fee > >> to get their lab approved and it is not mandatory to have highly > >> sophisticated instruments at the beginning itself. As I stated > >> earlier, most of the drug estimations can be done using UV- > >> Spectrophotometry and HPLC. I need not say that these instruments > >> are also required/available in clinical pharmacology dept for > >> pharmacokinetic and pharmacodynamic studies. Here is a link of FDA > >> Maharashtra giving guidelines for setting up of such laboratories.It > >> gives complete procedure, requirements to be fulfilled and fee > >> details for such approval. The URL is > >> http://www.fda-mah.com/guidelines/guidelineblood.html > >> > >> For smooth and effective functioning of these labs we can follow the > >> GLP guidelines put forth by WHO in the form of a GLP Handbook that > >> is available online at: > >> http://www.who.int/tdr/publications/publications/glp- handbook.htm > >> > >> Once such QC laboratories are established in every major hospital, > >> they can test their own medicines periodically and regularly and > >> check their quality without depending on govt laboratories for > >> analysis and test reports. > >> With regards > >> Dr Geer M. Ishaq > >> > >> > > > > > > -- > > Dr.Gitanjali Batmanabane MD PhD > > Professor of Pharmacology & Officer-in-charge, > > Dept. of Pharmacy > > Jawaharlal Institute of Postgraduate Medical Education & Research > > Pondicherry 605 006 > > India > > > > > > > > -- > Dr Chetna Desai > Department of Pharmacology > B. J. Medical College > Ahmedabad 380016 > > > > Visit > http://www.pharmacologybjmc.org > http://pharmacbjmc.110mb.com > www.poliofoundation.org > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 4, 2008 Report Share Posted November 4, 2008 hello, What Chetna has suggested is followed by our state where, in RC there is more than one company for most of the medicines .However we still face the problem of non supply and at some point of time the medicine is not available from any source. All this talk of RC is only restricted to Govt. hospitals but what happens to the unsuspecting public who is exposed to low quality medicine?We believe that FDA officials do their duty by taking random samples from private pharmacies. Knowing fully well about our political system , we can imagine the truthfulness of the test reports of the quality control labs.As rightly exemplified by Geetanjali, the same medicine may be passing on in the trade for the gullible to consume. In one of the posts I read about having quality control labs in large institutes/hospitals.Do we have any such in the large corporate hospitals ? I am ignorant about it. About Govt. run institutes it is beyond my dream. since to manage day to day work of medical stores in our hospital, the government does not feel it necessary to have a pharmacist. where will it have finances to appoint a full fledged pharmacist for quality control lab? kunda Dear Members:In my previous post I have stressed upon the need for creating Quality Control Laboratories that are duly approved by the Drug Control Dept in every major hospital pharmacy dept. Only when they are duly approved, can their test reports be honoured legally in the court of law. One has to apply on FORM 36 and pay some nominal fee to get their lab approved and it is not mandatory to have highly sophisticated instruments at the beginning itself. As I stated earlier, most of the drug estimations can be done using UV-Spectrophotometry and HPLC. I need not say that these instruments are also required/available in clinical pharmacology dept for pharmacokinetic and pharmacodynamic studies.. Here is a link of FDA Maharashtra giving guidelines for setting up of such laboratories. It gives complete procedure, requirements to be fulfilled and fee details for such approval. The URL is http://www.fda- mah.com/guidelin es/guidelinebloo d.htmlFor smooth and effective functioning of these labs we can follow the GLP guidelines put forth by WHO in the form of a GLP Handbook that is available online at:http://www.who. int/tdr/publicat ions/publication s/glp-handbook. htmOnce such QC laboratories are established in every major hospital, they can test their own medicines periodically and regularly and check their quality without depending on govt laboratories for analysis and test reports.With regardsDr Geer M. Ishaq-- Dr.Gitanjali Batmanabane MD PhDProfessor of Pharmacology & Officer-in-charge,Dept. of PharmacyJawaharlal Institute of Postgraduate Medical Education & ResearchPondicherry 605 006India-- Dr Chetna DesaiDepartment of PharmacologyB. J. Medical CollegeAhmedabad 380016Visit http://www.pharmaco logybjmc. orghttp://pharmacbjmc. 110mb.comwww.poliofoundation .org Cricket on your mind? Visit the ultimate cricket website. Enter now! Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 4, 2008 Report Share Posted November 4, 2008 Dear Dr. K. Srisailam: Thanks a lot for rectifying error in the link on WHO-GLP Handbook, provided by me in my previous post. Way back in the year 1975, well- known Hathi Committee had recommended upgradation and strengthening of Hospital Pharmacies in our country. However unfortunately even after more than 30 years have passed since then, there is not much improvement visible on ground. An M.Pharm with Pharmaceutical Analysis specialization and some experience is the best person to manage approved QC units in our hospital pharmacies that can conduct analysis of most of the hospital supplies. For testing parenterals they may have to depend on central labs initially. National Human Rights Commission in its report on hospital pharmacy services submitted in January, 1999 has also recommended that, " every hospital should organize the pharmaceutical activities in regard to purchase, storage, testing, compounding, dispensing and distribution of drugs under the charge of a competent and experienced persons possessing at least degree in pharmacy " . In reputed hospitals like JIPMER that already have such competent and qualified staff, initiating such QC activities will be much easier. In October 2003, GOI had undertaken a five-year capacity building project under world bank assistance to the tune of Rs. 350 crores, whereunder 23 state and 06 central drug testing laboratories were to be strengthened and upgraded and a few more new labs were to be established. Can anybody provide information on the present status of the project because it had provided our countrymen a silver lining in the dark clouds then. Institutions like yours can also look out for such type of financial assistance from relevant bodies in establishing approved QC labs in their hospital pharmacies. With regards Dr. Geer M. Ishaq Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 4, 2008 Report Share Posted November 4, 2008 Dear Madam Kunda Gharpure: It was me who proposed establishment of Quality Control Units/Labs in Hospital Pharmacies. I wish to put forth an age old maxim, "where there is will there is a way", and where there is no will, there are a lot of hurdles, hiccups, obstacles, hinderances, excuses, problems and what not in the way (Please don't think I am aiming at you, I am talking in general). Pharmacies are ignored every where, they are understaffed, mostly manned by unqualified people, funds are meager, support is scarce, preference is least, but that should not deter one from moving in positive direction. That is not an excuse sufficient enough to make us submit and surrender meekly. We in a poor state like J & K had 14 drug inspectors managing 16 districts. We initiated a struggle and forced the govt to create 90 fresh posts of drug inspectors that didn't exist anywhere. It didn't come to us on a platter. They didn't know at first place what is pharmacy and why should we have so many DIs. But after a spine straining exercise of over five years we succeeded in our mission and today the posts already stand advertised. Can you imagine a small pharmacy graduates association getting 90 posts created afresh. I don't want to blabber on our achievements but is it really so impossible in your state for you and your institution to get one post of a pharmaceutical analyst sanctioned for your QC unit. We in Srinagar have SK Institute of Medical Sciences where one of our senior colleagues is successfuly analysing the quality of most of their medical supplies. It is not that big an Institute but the dedicated and relentless efforts of one committed person has made it possible. There is no point brooding over the falling standards in our society. As Prof Gitanjali has rightly put it, let us see, "what we are doing" and let us introspect, "what we can do". We all must take a cue from Prof Gitanjali who has so valiently and firmly stood against politically and economically powerful pharma companies. The way she has blacklisted them and charged them speaks volumes. She has made us believe that yes, "one person alone too can change the society and its redundant conventions". I agree there is dearth of people at the helm of affairs who appreciate the needs and requirements of hospital pharmacy departments throughout the country, but at the same time there is no dearth of funding agencies. We in our department are presently working towards establishing a Drug Testing Laboratory with UGC financial assistance. So many agencies like ICMR, DST etc are ready to help those who come up with innovative and productive ideas. Even international agencies open up their arms for such entrepreneurs. Only thing needed in my opinion is the courage of conviction and the will. If you are confident on your competence and capabilities, trust me nothing will ever come in your way. Please don't take any of my comments badly. I don't mean to question your commitment or credibility, it is just my reply to your comments, "...it is beyond my dreams". With regards Dr. Geer M. Ishaq Assistant Professor Dept. of Pharmaceutical Sciences University of Kashmir Srinagar-190006 (J & K) Ph: 9419970971, 9906673100 Website: http://ishaqgeer.googlepages.com From: kunda gharpure <gharpurekunda@...>netrum Sent: Tuesday, 4 November, 2008 3:58:01 PMSubject: Re: Re:Quality of Medicines hello, What Chetna has suggested is followed by our state where, in RC there is more than one company for most of the medicines .However we still face the problem of non supply and at some point of time the medicine is not available from any source. All this talk of RC is only restricted to Govt. hospitals but what happens to the unsuspecting public who is exposed to low quality medicine?We believe that FDA officials do their duty by taking random samples from private pharmacies. Knowing fully well about our political system , we can imagine the truthfulness of the test reports of the quality control labs.As rightly exemplified by Geetanjali, the same medicine may be passing on in the trade for the gullible to consume. In one of the posts I read about having quality control labs in large institutes/hospital s.Do we have any such in the large corporate hospitals ? I am ignorant about it. About Govt. run institutes it is beyond my dream. since to manage day to day work of medical stores in our hospital, the government does not feel it necessary to have a pharmacist. where will it have finances to appoint a full fledged pharmacist for quality control lab? kunda Dear Members:In my previous post I have stressed upon the need for creating Quality Control Laboratories that are duly approved by the Drug Control Dept in every major hospital pharmacy dept. Only when they are duly approved, can their test reports be honoured legally in the court of law. One has to apply on FORM 36 and pay some nominal fee to get their lab approved and it is not mandatory to have highly sophisticated instruments at the beginning itself. As I stated earlier, most of the drug estimations can be done using UV-Spectrophotometry and HPLC. I need not say that these instruments are also required/available in clinical pharmacology dept for pharmacokinetic and pharmacodynamic studies.. Here is a link of FDA Maharashtra giving guidelines for setting up of such laboratories. It gives complete procedure, requirements to be fulfilled and fee details for such approval. The URL is http://www.fda- mah.com/guidelin es/guidelinebloo d.htmlFor smooth and effective functioning of these labs we can follow the GLP guidelines put forth by WHO in the form of a GLP Handbook that is available online at:http://www.who. int/tdr/publicat ions/publication s/glp-handbook. htmOnce such QC laboratories are established in every major hospital, they can test their own medicines periodically and regularly and check their quality without depending on govt laboratories for analysis and test reports.With regardsDr Geer M. Ishaq-- Dr.Gitanjali Batmanabane MD PhDProfessor of Pharmacology & Officer-in-charge,Dept. of PharmacyJawaharlal Institute of Postgraduate Medical Education & ResearchPondicherry 605 006India-- Dr Chetna DesaiDepartment of PharmacologyB. J. Medical CollegeAhmedabad 380016Visit http://www.pharmaco logybjmc. orghttp://pharmacbjmc. 110mb.comwww.poliofoundation .org Cricket on your mind? Visit the ultimate cricket website. Enter now! Check out the all-new face of India. Click here. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 4, 2008 Report Share Posted November 4, 2008 Dear Dr.Srisailam, This is one area which will fund itself. There are so many hospitals which will want to test the drugs that you can easily stay afloat. Once you get accreditation it will be smooth sailing. I am seriously considering set up such a lab in JIPMER except that I fear it will tie me down too much since the workload will be high even with trained staff - the implications of labeling a product poor quality will come with a high price. Sincerely Gitanjali On Tue, Nov 4, 2008 at 10:38 AM, Dr. Keshetti Srisailam <ksrisailam@...> wrote: Dear Dr. Ishaq You have given good information on the establishment of quality control laboratories and their approval by drug regulatory authorities. Our organisation, Vaagdevi College of Pharmacy, Warangal, is running M. Pharm. (Pharmacy Practice) programme at MGM Hospital, a 1200 bed government hospital located in Warangal. We have the facilities like UV spectrophotometer, HPLC and many more equipment that we have established the facility with about 15 laks rupees. So far we are concentrating on therapeutic drug monitoring after obtaining blood and urine samples from the patients. Now with the discussion on the NETRUM, I felt it is also necessary to look into the quality aspects of the drugs that are being supplied in the hospital. But as you know one need support from the hospital authorities too. Appointment of analysts or pharmacists with postgraduation is also required to assess the quality of medicines. Apart from these two, necessary funding is required to meet the analysis expenses viz., chemicals and other consumables. The link that you have given for GLP guidlines of WHO is not working. It can be found at the following link http://www.who.int/tdr/publications/training-guideline-publications/good-laboratory-practice-handbook/pdf/glp-handbook.pdf Dr. Srisailam K Dear Members:In my previous post I have stressed upon the need for creating Quality Control Laboratories that are duly approved by the Drug Control Dept in every major hospital pharmacy dept. Only when they are duly approved, can their test reports be honoured legally in the court of law. One has to apply on FORM 36 and pay some nominal fee to get their lab approved and it is not mandatory to have highly sophisticated instruments at the beginning itself. As I stated earlier, most of the drug estimations can be done using UV-Spectrophotometry and HPLC. I need not say that these instruments are also required/available in clinical pharmacology dept for pharmacokinetic and pharmacodynamic studies. Here is a link of FDA Maharashtra giving guidelines for setting up of such laboratories. It gives complete procedure, requirements to be fulfilled and fee details for such approval. The URL is http://www.fda- mah.com/guidelin es/guidelinebloo d.html For smooth and effective functioning of these labs we can follow the GLP guidelines put forth by WHO in the form of a GLP Handbook that is available online at:http://www.who. int/tdr/publicat ions/publication s/glp-handbook. htm Once such QC laboratories are established in every major hospital, they can test their own medicines periodically and regularly and check their quality without depending on govt laboratories for analysis and test reports.With regardsDr Geer M. Ishaq -- Dr.Gitanjali Batmanabane MD PhDProfessor of Pharmacology & Officer-in-charge,Dept. of PharmacyJawaharlal Institute of Postgraduate Medical Education & ResearchPondicherry 605 006 India New Email addresses available on Get the Email name you've always wanted on the new @ymail and @rocketmail. Hurry before someone else does! -- Dr.Gitanjali Batmanabane MD PhD Professor of Pharmacology & Officer-in-charge,Dept. of PharmacyJawaharlal Institute of Postgraduate Medical Education & ResearchPondicherry 605 006India Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 4, 2008 Report Share Posted November 4, 2008 Dear Chetna, I am sorry I did not reply to your mail earlier. You are right in that some places they select 2-3 of the lowest and come to an agreement giving percentage of the total order to all the three. In my institute we only select the lowest. It was an eye opener for me that some firms will buy the raw material, hire the premises and machinary to manufacture the medicines only AFTER they get the order! These medicines are not on sale for the public. After they manufacture these medicines they disappear from the face of the earth! Let me give you another story. A company was constantly sending substandard medicines to our hospital and the drug committee blacklisted it for three years. This year, I found another company with a different name but with the same address. When I checked the technical bid I found that the directors were the son & wife of the owner of the previous (blacklisted) company. I asked one of my friends living near the company to check it out. He said that both companies were registered from the same address and were bonafide. All papers were submitted. They had all the required approvals. There was no way we could do anything about this though everyone knew what was happening. Don't you feel sorry for me Chetna? Gitanjali On Tue, Nov 4, 2008 at 11:32 AM, Chetna Desai <chetna99@...> wrote: Dear Gitanjali and allLooking in to the discussions, it seems that all face this situation of helplessness. The tender and quotation system perhaps comes from the British era and we have not been able to shake it off. Often the prices quoted are so low that it seems impractical...so the first casualty of low prices seems quality. Another problem that is observed is that the sole supplier who gets the order does not keep up a regular supply or the quality deteriorates as months pass. The mechanisms of blacklisting such suppliers are tedious and easily circumvented by other means. The RTI is also " misused " often. A way out of this could be... Choose 2-3 suppliers(with lowest quotations) instead of just one. That would ensure a regular supply and could also instill some sense of competition. I do not know if this is acceptable/followed anywhere...maybe Drs Gitanjali or Vijay can tell us. An issue that also merits attention is how do we ensure that the consumers are getting good quality medicines from the retailers? The mechanisms to regulate these and checks and counterchecks are even more slack here. Consumers who are otherwise very conscious about the quality of food and clothes, usually do not doubt the quality of medicines they consume, unless a catastrophe happens! They rely on the judgment of the presciber in most cases. Chetna 2008/11/4 Gitanjali Batmanabane <gitabatman@...> Dear Dr.Ishaq, Thanks. I too feel the same. Your post was very useful to me. Gitanjali On Mon, Nov 3, 2008 at 3:12 PM, ishaqgeer <ishaqgeer@...> wrote: Dear Members:In my previous post I have stressed upon the need for creating Quality Control Laboratories that are duly approved by the Drug Control Dept in every major hospital pharmacy dept. Only when they are duly approved, can their test reports be honoured legally in the court of law. One has to apply on FORM 36 and pay some nominal fee to get their lab approved and it is not mandatory to have highly sophisticated instruments at the beginning itself. As I stated earlier, most of the drug estimations can be done using UV-Spectrophotometry and HPLC. I need not say that these instruments are also required/available in clinical pharmacology dept for pharmacokinetic and pharmacodynamic studies. Here is a link of FDA Maharashtra giving guidelines for setting up of such laboratories.It gives complete procedure, requirements to be fulfilled and fee details for such approval. The URL is http://www.fda-mah.com/guidelines/guidelineblood.html For smooth and effective functioning of these labs we can follow the GLP guidelines put forth by WHO in the form of a GLP Handbook that is available online at:http://www.who.int/tdr/publications/publications/glp-handbook.htm Once such QC laboratories are established in every major hospital, they can test their own medicines periodically and regularly and check their quality without depending on govt laboratories for analysis and test reports. With regardsDr Geer M. Ishaq -- Dr.Gitanjali Batmanabane MD PhDProfessor of Pharmacology & Officer-in-charge,Dept. of PharmacyJawaharlal Institute of Postgraduate Medical Education & ResearchPondicherry 605 006 India-- Dr Chetna DesaiDepartment of PharmacologyB. J. Medical CollegeAhmedabad 380016 Visit http://www.pharmacologybjmc.orghttp://pharmacbjmc.110mb.comwww.poliofoundation.org -- Dr.Gitanjali Batmanabane MD PhD Professor of Pharmacology & Officer-in-charge,Dept. of PharmacyJawaharlal Institute of Postgraduate Medical Education & ResearchPondicherry 605 006India Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 4, 2008 Report Share Posted November 4, 2008 Yes Gitanjali, i do feel sorry for you and all others like minded persons who can only grin and bear it!! Not many would take the pains to go the extent that you did....it needs a lot of courage and conviction! It makes us think... " is ignorance bliss?? well no...what is needed is a public awareness and some activism...The instances you mentioned exist in most Govt hospitals...the bigger they are, the larger the stakes, the dirtier the game gets. At purchase committee meetings too one is always apprehensive of falling in to some " unseen " wiles of these suppliers... Responding to Madam Kunda's query about QC or similar labs in corporate hospitals, in Gujarat, there are none and i have a feeling that the scenario is the same elsewhere too. In corporates though, there is a problem of " Plenty " and the " cheaper " medicines hardly find a place, with most prescribers scrambling to write the " expensive " " Brands " !! Its a different world all together there! Chetnatanjali Batmanabane <gitabatman@...> Dear Chetna, I am sorry I did not reply to your mail earlier. You are right in that some places they select 2-3 of the lowest and come to an agreement giving percentage of the total order to all the three. In my institute we only select the lowest. It was an eye opener for me that some firms will buy the raw material, hire the premises and machinary to manufacture the medicines only AFTER they get the order! These medicines are not on sale for the public. After they manufacture these medicines they disappear from the face of the earth! Let me give you another story. A company was constantly sending substandard medicines to our hospital and the drug committee blacklisted it for three years. This year, I found another company with a different name but with the same address. When I checked the technical bid I found that the directors were the son & wife of the owner of the previous (blacklisted) company. I asked one of my friends living near the company to check it out. He said that both companies were registered from the same address and were bonafide. All papers were submitted. They had all the required approvals. There was no way we could do anything about this though everyone knew what was happening. Don't you feel sorry for me Chetna? Gitanjali On Tue, Nov 4, 2008 at 11:32 AM, Chetna Desai <chetna99@...> wrote: Dear Gitanjali and allLooking in to the discussions, it seems that all face this situation of helplessness. The tender and quotation system perhaps comes from the British era and we have not been able to shake it off. Often the prices quoted are so low that it seems impractical...so the first casualty of low prices seems quality. Another problem that is observed is that the sole supplier who gets the order does not keep up a regular supply or the quality deteriorates as months pass. The mechanisms of blacklisting such suppliers are tedious and easily circumvented by other means. The RTI is also " misused " often. A way out of this could be... Choose 2-3 suppliers(with lowest quotations) instead of just one. That would ensure a regular supply and could also instill some sense of competition. I do not know if this is acceptable/followed anywhere...maybe Drs Gitanjali or Vijay can tell us. An issue that also merits attention is how do we ensure that the consumers are getting good quality medicines from the retailers? The mechanisms to regulate these and checks and counterchecks are even more slack here. Consumers who are otherwise very conscious about the quality of food and clothes, usually do not doubt the quality of medicines they consume, unless a catastrophe happens! They rely on the judgment of the presciber in most cases. Chetna 2008/11/4 Gitanjali Batmanabane <gitabatman@...> Dear Dr.Ishaq, Thanks. I too feel the same. Your post was very useful to me. Gitanjali On Mon, Nov 3, 2008 at 3:12 PM, ishaqgeer <ishaqgeer@...> wrote: Dear Members:In my previous post I have stressed upon the need for creating Quality Control Laboratories that are duly approved by the Drug Control Dept in every major hospital pharmacy dept. Only when they are duly approved, can their test reports be honoured legally in the court of law. One has to apply on FORM 36 and pay some nominal fee to get their lab approved and it is not mandatory to have highly sophisticated instruments at the beginning itself. As I stated earlier, most of the drug estimations can be done using UV-Spectrophotometry and HPLC. I need not say that these instruments are also required/available in clinical pharmacology dept for pharmacokinetic and pharmacodynamic studies. Here is a link of FDA Maharashtra giving guidelines for setting up of such laboratories.It gives complete procedure, requirements to be fulfilled and fee details for such approval. The URL is http://www.fda-mah.com/guidelines/guidelineblood.html For smooth and effective functioning of these labs we can follow the GLP guidelines put forth by WHO in the form of a GLP Handbook that is available online at:http://www.who.int/tdr/publications/publications/glp-handbook.htm Once such QC laboratories are established in every major hospital, they can test their own medicines periodically and regularly and check their quality without depending on govt laboratories for analysis and test reports. With regardsDr Geer M. Ishaq -- Dr.Gitanjali Batmanabane MD PhDProfessor of Pharmacology & Officer-in-charge,Dept. of PharmacyJawaharlal Institute of Postgraduate Medical Education & ResearchPondicherry 605 006 India-- Dr Chetna DesaiDepartment of PharmacologyB. J. Medical College Ahmedabad 380016 Visit http://www.pharmacologybjmc.orghttp://pharmacbjmc.110mb.com www.poliofoundation.org -- Dr.Gitanjali Batmanabane MD PhD Professor of Pharmacology & Officer-in-charge,Dept. of PharmacyJawaharlal Institute of Postgraduate Medical Education & ResearchPondicherry 605 006India -- Dr Chetna DesaiDepartment of PharmacologyB. J. Medical CollegeAhmedabad 380016Visit http://www.pharmacologybjmc.org http://pharmacbjmc.110mb.comwww.poliofoundation.org Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 4, 2008 Report Share Posted November 4, 2008 Dear Geetanjali madam, Here in Gujarat drugs are commonly supplied to all government hospitals through "Central Drug Stores Department" Those drugs/ surgical items which are lacking, the poor patient is made to purchase them from his pocket. As Chetna mam has said, the private practitioners make merry prescribing expensive branded medicines (with usual freebies and sponsored trips), while the poor suffer for want of even cheaper generics. -Anupama Dear Members:In my previous post I have stressed upon the need for creating Quality Control Laboratories that are duly approved by the Drug Control Dept in every major hospital pharmacy dept. Only when they are duly approved, can their test reports be honoured legally in the court of law. One has to apply on FORM 36 and pay some nominal fee to get their lab approved and it is not mandatory to have highly sophisticated instruments at the beginning itself. As I stated earlier, most of the drug estimations can be done using UV-Spectrophotometry and HPLC. I need not say that these instruments are also required/available in clinical pharmacology dept for pharmacokinetic and pharmacodynamic studies. Here is a link of FDA Maharashtra giving guidelines for setting up of such laboratories. It gives complete procedure, requirements to be fulfilled and fee details for such approval. The URL is http://www.fda- mah.com/guidelin es/guidelinebloo d.html For smooth and effective functioning of these labs we can follow the GLP guidelines put forth by WHO in the form of a GLP Handbook that is available online at:http://www.who. int/tdr/publicat ions/publication s/glp-handbook. htm Once such QC laboratories are established in every major hospital, they can test their own medicines periodically and regularly and check their quality without depending on govt laboratories for analysis and test reports.With regardsDr Geer M. Ishaq -- Dr.Gitanjali Batmanabane MD PhDProfessor of Pharmacology & Officer-in-charge,Dept. of PharmacyJawaharlal Institute of Postgraduate Medical Education & ResearchPondicherry 605 006India -- Dr Chetna DesaiDepartment of PharmacologyB. J. Medical CollegeAhmedabad 380016Visit http://www.pharmaco logybjmc. org http://pharmacbjmc. 110mb.comwww.poliofoundation .org -- Dr.Gitanjali Batmanabane MD PhDProfessor of Pharmacology & Officer-in-charge,Dept. of PharmacyJawaharlal Institute of Postgraduate Medical Education & ResearchPondicherry 605 006India-- Dr Chetna DesaiDepartment of PharmacologyB. J. Medical CollegeAhmedabad 380016Visit http://www.pharmaco logybjmc. orghttp://pharmacbjmc. 110mb.comwww.poliofoundation .org Add more friends to your messenger and enjoy! Invite them now. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 4, 2008 Report Share Posted November 4, 2008 Hi, We usually say " No one can change anything in this country " . Think positive, remove no and see the difference in the phrase! Vijay > > Dear Members: > In my previous post I have stressed upon the need for creating > Quality Control Laboratories that are duly approved by the Drug > Control Dept in every major hospital pharmacy dept. Only when they > are duly approved, can their test reports be honoured legally in the > court of law. One has to apply on FORM 36 and pay some nominal fee > to get their lab approved and it is not mandatory to have highly > sophisticated instruments at the beginning itself. As I stated > earlier, most of the drug estimations can be done using UV- > Spectrophotometry and HPLC. I need not say that these instruments > are also required/available in clinical pharmacology dept for > pharmacokinetic and pharmacodynamic studies.. Here is a link of FDA > Maharashtra giving guidelines for setting up of such laboratories. It > gives complete procedure, requirements to be fulfilled and fee > details for such approval. The URL is > http://www.fda- mah.com/guidelin es/guidelinebloo d.html > > For smooth and effective functioning of these labs we can follow the > GLP guidelines put forth by WHO in the form of a GLP Handbook that > is available online at: > http://www.who. int/tdr/publicat ions/publication s/glp-handbook. htm > > Once such QC laboratories are established in every major hospital, > they can test their own medicines periodically and regularly and > check their quality without depending on govt laboratories for > analysis and test reports. > With regards > Dr Geer M. Ishaq > > > > > -- > Dr.Gitanjali Batmanabane MD PhD > Professor of Pharmacology & Officer-in-charge, > Dept. of Pharmacy > Jawaharlal Institute of Postgraduate Medical Education & Research > Pondicherry 605 006 > India > > > > -- > Dr Chetna Desai > Department of Pharmacology > B. J. Medical College > Ahmedabad 380016 > > > > Visit > http://www.pharmaco logybjmc. org > http://pharmacbjmc. 110mb.com > www.poliofoundation .org > > > ________________________________ > Cricket on your mind? Visit the ultimate cricket website. Enter now! > > > Add more friends to your messenger and enjoy! Go to http://messenger./invite/ > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 4, 2008 Report Share Posted November 4, 2008 Hi, And I am also aware of a case where the address of company on product label, stationery and web site was of national capital. We noticed that it was grossly misusing WHO name in promotion and reported to WHO SEARO. The WHO sent it a " standard letter " which returned back since the addressae was not found! It was only the initiative of Dr Kris Weerasuriya that his stff could pain stakingly trace the company and it was found to be operatingly from excise free zone of a northern State. Vijay > >> > >>> Dear Members: > >>> In my previous post I have stressed upon the need for creating > >>> Quality Control Laboratories that are duly approved by the Drug > >>> Control Dept in every major hospital pharmacy dept. Only when they > >>> are duly approved, can their test reports be honoured legally in the > >>> court of law. One has to apply on FORM 36 and pay some nominal fee > >>> to get their lab approved and it is not mandatory to have highly > >>> sophisticated instruments at the beginning itself. As I stated > >>> earlier, most of the drug estimations can be done using UV- > >>> Spectrophotometry and HPLC. I need not say that these instruments > >>> are also required/available in clinical pharmacology dept for > >>> pharmacokinetic and pharmacodynamic studies. Here is a link of FDA > >>> Maharashtra giving guidelines for setting up of such laboratories.It > >>> gives complete procedure, requirements to be fulfilled and fee > >>> details for such approval. The URL is > >>> http://www.fda-mah.com/guidelines/guidelineblood.html > >>> > >>> For smooth and effective functioning of these labs we can follow the > >>> GLP guidelines put forth by WHO in the form of a GLP Handbook that > >>> is available online at: > >>> http://www.who.int/tdr/publications/publications/glp- handbook.htm > >>> > >>> Once such QC laboratories are established in every major hospital, > >>> they can test their own medicines periodically and regularly and > >>> check their quality without depending on govt laboratories for > >>> analysis and test reports. > >>> With regards > >>> Dr Geer M. Ishaq > >>> > >>> > >> > >> > >> -- > >> Dr.Gitanjali Batmanabane MD PhD > >> Professor of Pharmacology & Officer-in-charge, > >> Dept. of Pharmacy > >> Jawaharlal Institute of Postgraduate Medical Education & Research > >> Pondicherry 605 006 > >> India > >> > > > > > > > > -- > > Dr Chetna Desai > > Department of Pharmacology > > B. J. Medical College > > Ahmedabad 380016 > > > > > > > > Visit > > http://www.pharmacologybjmc.org > > http://pharmacbjmc.110mb.com > > www.poliofoundation.org > > > > > > > > > > -- > Dr.Gitanjali Batmanabane MD PhD > Professor of Pharmacology & Officer-in-charge, > Dept. of Pharmacy > Jawaharlal Institute of Postgraduate Medical Education & Research > Pondicherry 605 006 > India > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 4, 2008 Report Share Posted November 4, 2008 Hi, Govt hospitals have to make RC purchase. To get on RC, grease is required. Those who grease, want assured business. So the intrests of industry are protected. So why Govt hospitals need QC labs? What analytical Pharmacist are we talking about?? Vijay > >>> > >>>> Dear Members: > >>>> In my previous post I have stressed upon the need for creating > >>>> Quality Control Laboratories that are duly approved by the Drug > >>>> Control Dept in every major hospital pharmacy dept. Only when they > >>>> are duly approved, can their test reports be honoured legally in the > >>>> court of law. One has to apply on FORM 36 and pay some nominal fee > >>>> to get their lab approved and it is not mandatory to have highly > >>>> sophisticated instruments at the beginning itself. As I stated > >>>> earlier, most of the drug estimations can be done using UV- > >>>> Spectrophotometry and HPLC. I need not say that these instruments > >>>> are also required/available in clinical pharmacology dept for > >>>> pharmacokinetic and pharmacodynamic studies. Here is a link of FDA > >>>> Maharashtra giving guidelines for setting up of such laboratories.It > >>>> gives complete procedure, requirements to be fulfilled and fee > >>>> details for such approval. The URL is > >>>> http://www.fda-mah.com/guidelines/guidelineblood.html > >>>> > >>>> For smooth and effective functioning of these labs we can follow the > >>>> GLP guidelines put forth by WHO in the form of a GLP Handbook that > >>>> is available online at: > >>>> http://www.who.int/tdr/publications/publications/glp- handbook.htm > >>>> > >>>> Once such QC laboratories are established in every major hospital, > >>>> they can test their own medicines periodically and regularly and > >>>> check their quality without depending on govt laboratories for > >>>> analysis and test reports. > >>>> With regards > >>>> Dr Geer M. Ishaq > >>>> > >>>> > >>> > >>> > >>> -- > >>> Dr.Gitanjali Batmanabane MD PhD > >>> Professor of Pharmacology & Officer-in-charge, > >>> Dept. of Pharmacy > >>> Jawaharlal Institute of Postgraduate Medical Education & Research > >>> Pondicherry 605 006 > >>> India > >>> > >> > >> > >> > >> -- > >> Dr Chetna Desai > >> Department of Pharmacology > >> B. J. Medical College > >> Ahmedabad 380016 > >> > >> > >> > >> Visit > >> http://www.pharmacologybjmc.org > >> http://pharmacbjmc.110mb.com > >> www.poliofoundation.org > >> > >> > > > > > > -- > > Dr.Gitanjali Batmanabane MD PhD > > Professor of Pharmacology & Officer-in-charge, > > Dept. of Pharmacy > > Jawaharlal Institute of Postgraduate Medical Education & Research > > Pondicherry 605 006 > > India > > > > > > > > -- > Dr Chetna Desai > Department of Pharmacology > B. J. Medical College > Ahmedabad 380016 > > > > Visit > http://www.pharmacologybjmc.org > http://pharmacbjmc.110mb.com > www.poliofoundation.org > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 5, 2008 Report Share Posted November 5, 2008 Dear Prof. Gitanjali: Present discussion on the quality of medicines, that has generated sufficient interest by way of a fruitful discourse among the members and has benefitted us a lot in respect of enriching our knowledge on ensuring quality medicines to our patients, is gradually inching towards its culmination stage. Thanks to you for the same. Before its final conclusion, I wish to draw kind attention of all members towards "Good Procurement Practices" (reproduced below) adopted by some states in their State Drug Policies. Kindly throw some light on these practices and suggest to what extent they can be implemented in actual practice. Ø Transparency and written procedures Ø Key procurement functions and responsibilities to be distributed among different offices, committees and experts, each with appropriate expertise and resources for the specific function. Ø Procurement planning and monitoring procurement performance. Ø Procurement limited to the EDL primarily. Ø For all drugs covered under the National Programmes made available by GoI / UNICEF / WHO / other agencies, the programme managers operating in the State should appropriately co-ordinate and integrate with the State level procurement system, not only in order to avoid duplication and consequent wastage of resources but also to facilitate rational use of such drugs. Ø Procurement by the generic name / International Non-proprietary Name (INN). Ø Order quantities to be based on reliable estimate of the actual need. Ø Mechanisms to assure reliable financing for procurement, and good financial management policies and procedures. Ø Bulk procurement to achieve economically viable procurement quantities. Ø To optimise a balanced mix of centralised – decentralised mechanisms in procurement. Ø Procurement from only cGMP (Schedule M) compliant manufacturing units through competitive bidding at national level but with some weightage for the State based manufacturing units. Ø Provision for emergency procurement with some exemption for special situations like natural calamities, disasters etc. Ø Sole-source commitment – the commitment by all the health facilities to purchase all contracted items from the supplier, which holds the contract - is mandatory for sustaining the procurement programme using competitive tenders. However in order to adapt to the local conditions the procurement authority may exercise discretionary power by selecting up to a maximum of five suppliers. Ø Provision for special procurement mechanism, centralised or local for drug items under EDL for which bidders are not available. Ø Formal vendor evaluation / supplier qualification and monitoring – prospective suppliers should be pre- and post-qualified through a process that considers product quality, service reliability including delivery time, and financial viability. Ø Product quality assurance programme - This should embrace not only procurement of optimum quality products but maintaining their quality up to the level of consumption by the patients. The existing facility for quality testing should be strengthened appropriately, if necessary by developing regional drug testing laboratories. With Kind regards Dr. Geer M Ishaq Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 5, 2008 Report Share Posted November 5, 2008 Dear Dr.Ishaq, Your post was very informative. I believe each of the points is doable. These are basic issues simple to put in place and monitor. Only thing is we need the will to start, sustain and continue to do it, even if things don't improve as we expect them to. Most times people start these initiatives and after the initial years give up. We also need adequate back - up from those running the pharmacy, the grass root workers - so to speak. The problem in India as I see it is that trained people are not given the tasks they ought to be doing. For e.g., I am in-charge of the hospital pharmacy in my institute. In this field, I am a quack. We need an M.Pharm trained in hospital pharmacy practice to do this job. People are putting up with quacks like me in Jipmer, since things are somehow getting done. But I often ask myself would this be better if a trained person runs this? There are plenty of people who could perhaps do what I am doing, much more efficiently and take it to heights I cannot imagine only because they will be knowing what they are doing. Unfortunately we don't have the mechanism to recruit people like that to do the job (in govt. setting). The second problem is the clinicians. This group usually acts like spoilt children when it comes to prescribing habits. If we have an EML it will be ignored more than referred. The moment a medical rep comes singing praises of a new molecule there will be frantic requests for only that drug to be procured by local purchase. Only a handful use generic names ( I usually pretend I don't know the name of the drug even if I do when someone mentions a brand). No one wants to use omeprazole instead of pantoprazole...the list is endless. These good procurement practices are very important and will go a long way in procuremnt of quality drugs. Thank you Gitanjali On Wed, Nov 5, 2008 at 3:38 PM, ishaqgeer <ishaqgeer@...> wrote: Dear Prof. Gitanjali: Present discussion on the quality of medicines, that has generated sufficient interest by way of a fruitful discourse among the members and has benefitted us a lot in respect of enriching our knowledge on ensuring quality medicines to our patients, is gradually inching towards its culmination stage. Thanks to you for the same. Before its final conclusion, I wish to draw kind attention of all members towards " Good Procurement Practices " (reproduced below) adopted by some states in their State Drug Policies. Kindly throw some light on these practices and suggest to what extent they can be implemented in actual practice. Ø Transparency and written procedures Ø Key procurement functions and responsibilities to be distributed among different offices, committees and experts, each with appropriate expertise and resources for the specific function. Ø Procurement planning and monitoring procurement performance. Ø Procurement limited to the EDL primarily. Ø For all drugs covered under the National Programmes made available by GoI / UNICEF / WHO / other agencies, the programme managers operating in the State should appropriately co-ordinate and integrate with the State level procurement system, not only in order to avoid duplication and consequent wastage of resources but also to facilitate rational use of such drugs. Ø Procurement by the generic name / International Non-proprietary Name (INN). Ø Order quantities to be based on reliable estimate of the actual need. Ø Mechanisms to assure reliable financing for procurement, and good financial management policies and procedures. Ø Bulk procurement to achieve economically viable procurement quantities. Ø To optimise a balanced mix of centralised – decentralised mechanisms in procurement. Ø Procurement from only cGMP (Schedule M) compliant manufacturing units through competitive bidding at national level but with some weightage for the State based manufacturing units. Ø Provision for emergency procurement with some exemption for special situations like natural calamities, disasters etc. Ø Sole-source commitment – the commitment by all the health facilities to purchase all contracted items from the supplier, which holds the contract - is mandatory for sustaining the procurement programme using competitive tenders. However in order to adapt to the local conditions the procurement authority may exercise discretionary power by selecting up to a maximum of five suppliers. Ø Provision for special procurement mechanism, centralised or local for drug items under EDL for which bidders are not available. Ø Formal vendor evaluation / supplier qualification and monitoring – prospective suppliers should be pre- and post-qualified through a process that considers product quality, service reliability including delivery time, and financial viability. Ø Product quality assurance programme - This should embrace not only procurement of optimum quality products but maintaining their quality up to the level of consumption by the patients. The existing facility for quality testing should be strengthened appropriately, if necessary by developing regional drug testing laboratories. With Kind regards Dr. Geer M Ishaq -- Dr.Gitanjali Batmanabane MD PhD Professor of Pharmacology & Officer-in-charge,Dept. of PharmacyJawaharlal Institute of Postgraduate Medical Education & ResearchPondicherry 605 006India Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 5, 2008 Report Share Posted November 5, 2008 Hi, I share the same concerns with our esteemed moderator. Currently I am managing two medical stores- GMC Nagpur and SSH Nagpur. So I am doing managerial work whole day for six months and I am out of teaching for the period of my medical stores posting! Vijay > > > Dear Prof. Gitanjali: > > > > Present discussion on the quality of medicines, that has generated > > sufficient interest by way of a fruitful discourse among the members and has > > benefitted us a lot in respect of enriching our knowledge on ensuring > > quality medicines to our patients, is gradually inching towards its > > culmination stage. Thanks to you for the same. Before its final conclusion, > > I wish to draw kind attention of all members towards " Good Procurement > > Practices " (reproduced below) adopted by some states in their State Drug > > Policies. Kindly throw some light on these practices and suggest to what > > extent they can be implemented in actual practice. > > > > Ø Transparency and written procedures > > > > Ø Key procurement functions and responsibilities to be distributed among > > different offices, committees and experts, each with appropriate expertise > > and resources for the specific function. > > > > Ø Procurement planning and monitoring procurement performance. > > > > Ø Procurement limited to the EDL primarily. > > > > Ø For all drugs covered under the National Programmes made available by > > GoI / UNICEF / WHO / other agencies, the programme managers operating in the > > State should appropriately co-ordinate and integrate with the State level > > procurement system, not only in order to avoid duplication and consequent > > wastage of resources but also to facilitate rational use of such drugs. > > > > Ø Procurement by the generic name / International Non- proprietary Name > > (INN). > > > > Ø Order quantities to be based on reliable estimate of the actual need. > > > > Ø Mechanisms to assure reliable financing for procurement, and good > > financial management policies and procedures. > > > > Ø Bulk procurement to achieve economically viable procurement quantities. > > > > > > Ø To optimise a balanced mix of centralised – decentralised mechanisms in > > procurement. > > > > Ø Procurement from only cGMP (Schedule M) compliant manufacturing units > > through competitive bidding at national level but with some weightage for > > the State based manufacturing units. > > > > Ø Provision for emergency procurement with some exemption for special > > situations like natural calamities, disasters etc. > > > > Ø Sole-source commitment – the commitment by all the health facilities to > > purchase all contracted items from the supplier, which holds the contract - > > is mandatory for sustaining the procurement programme using competitive > > tenders. However in order to adapt to the local conditions the procurement > > authority may exercise discretionary power by selecting up to a maximum of > > five suppliers. > > > > Ø Provision for special procurement mechanism, centralised or local for > > drug items under EDL for which bidders are not available. > > > > Ø Formal vendor evaluation / supplier qualification and monitoring – > > prospective suppliers should be pre- and post-qualified through a process > > that considers product quality, service reliability including delivery time, > > and financial viability. > > > > Ø Product quality assurance programme - This should embrace not only > > procurement of optimum quality products but maintaining their quality up to > > the level of consumption by the patients. The existing facility for quality > > testing should be strengthened appropriately, if necessary by developing > > regional drug testing laboratories. > > > > > > > > With Kind regards > > > > > > > > Dr. Geer M Ishaq > > > > > > > > > > > > > > -- > Dr.Gitanjali Batmanabane MD PhD > Professor of Pharmacology & Officer-in-charge, > Dept. of Pharmacy > Jawaharlal Institute of Postgraduate Medical Education & Research > Pondicherry 605 006 > India > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 5, 2008 Report Share Posted November 5, 2008 Dear Madam Gitanjali and Vijay Sir: When we look around us, we see greedy people all time ready to grab whatever morsels are thrown before them. How many people like you both have the courage to say, "I am not fit for this job". Given your present circumstances wherein you either do not have relevant personnel available with your institution or there is lack of initiative to appoint the same, in my opinion, selfless and forthright people like you are the best choice to man your pharmacies. In my University, I see a biochemist heading biotechnology dept., an education specialist heading psychology dept., a physicist heading computer sciences dept., a geographist heading geology dept, a commerce specialist heading management dept, an english professor heading MERC, for the past several years. They take every measure, fair or foul to protect their chairs and do not hesitate to go to any extent to crush any voice of dissent. It is said, "actions speak louder than words" and your actions say it all. I need not say anything else. We are proud of people like you. Please continue to lead us. With regards Dr. Geer M. Ishaq Assistant Professor Dept. of Pharmaceutical Sciences University of Kashmir Srinagar-190006 (J & K) Ph: 9419970971, 9906673100 Website: http://ishaqgeer.googlepages.com From: Gitanjali Batmanabane <gitabatman@...>netrum Sent: Wednesday, 5 November, 2008 9:09:26 PMSubject: Re: Re:Quality of Medicines Dear Dr.Ishaq, Your post was very informative. I believe each of the points is doable. These are basic issues simple to put in place and monitor. Only thing is we need the will to start, sustain and continue to do it, even if things don't improve as we expect them to. Most times people start these initiatives and after the initial years give up. We also need adequate back - up from those running the pharmacy, the grass root workers - so to speak. The problem in India as I see it is that trained people are not given the tasks they ought to be doing. For e.g., I am in-charge of the hospital pharmacy in my institute. In this field, I am a quack. We need an M.Pharm trained in hospital pharmacy practice to do this job. People are putting up with quacks like me in Jipmer, since things are somehow getting done. But I often ask myself would this be better if a trained person runs this? There are plenty of people who could perhaps do what I am doing, much more efficiently and take it to heights I cannot imagine only because they will be knowing what they are doing. Unfortunately we don't have the mechanism to recruit people like that to do the job (in govt. setting). The second problem is the clinicians. This group usually acts like spoilt children when it comes to prescribing habits. If we have an EML it will be ignored more than referred. The moment a medical rep comes singing praises of a new molecule there will be frantic requests for only that drug to be procured by local purchase. Only a handful use generic names ( I usually pretend I don't know the name of the drug even if I do when someone mentions a brand). No one wants to use omeprazole instead of pantoprazole. ..the list is endless. These good procurement practices are very important and will go a long way in procuremnt of quality drugs. Thank you Gitanjali On Wed, Nov 5, 2008 at 3:38 PM, ishaqgeer <ishaqgeer (DOT) co.in> wrote: Dear Prof. Gitanjali: Present discussion on the quality of medicines, that has generated sufficient interest by way of a fruitful discourse among the members and has benefitted us a lot in respect of enriching our knowledge on ensuring quality medicines to our patients, is gradually inching towards its culmination stage. Thanks to you for the same. Before its final conclusion, I wish to draw kind attention of all members towards "Good Procurement Practices" (reproduced below) adopted by some states in their State Drug Policies. Kindly throw some light on these practices and suggest to what extent they can be implemented in actual practice. Ø Transparency and written procedures Ø Key procurement functions and responsibilities to be distributed among different offices, committees and experts, each with appropriate expertise and resources for the specific function. Ø Procurement planning and monitoring procurement performance. Ø Procurement limited to the EDL primarily. Ø For all drugs covered under the National Programmes made available by GoI / UNICEF / WHO / other agencies, the programme managers operating in the State should appropriately co-ordinate and integrate with the State level procurement system, not only in order to avoid duplication and consequent wastage of resources but also to facilitate rational use of such drugs. Ø Procurement by the generic name / International Non-proprietary Name (INN). Ø Order quantities to be based on reliable estimate of the actual need. Ø Mechanisms to assure reliable financing for procurement, and good financial management policies and procedures. Ø Bulk procurement to achieve economically viable procurement quantities. Ø To optimise a balanced mix of centralised – decentralised mechanisms in procurement. Ø Procurement from only cGMP (Schedule M) compliant manufacturing units through competitive bidding at national level but with some weightage for the State based manufacturing units. Ø Provision for emergency procurement with some exemption for special situations like natural calamities, disasters etc. Ø Sole-source commitment – the commitment by all the health facilities to purchase all contracted items from the supplier, which holds the contract - is mandatory for sustaining the procurement programme using competitive tenders. However in order to adapt to the local conditions the procurement authority may exercise discretionary power by selecting up to a maximum of five suppliers. Ø Provision for special procurement mechanism, centralised or local for drug items under EDL for which bidders are not available. Ø Formal vendor evaluation / supplier qualification and monitoring – prospective suppliers should be pre- and post-qualified through a process that considers product quality, service reliability including delivery time, and financial viability. Ø Product quality assurance programme - This should embrace not only procurement of optimum quality products but maintaining their quality up to the level of consumption by the patients. The existing facility for quality testing should be strengthened appropriately, if necessary by developing regional drug testing laboratories. With Kind regards Dr. Geer M Ishaq -- Dr.Gitanjali Batmanabane MD PhDProfessor of Pharmacology & Officer-in-charge,Dept. of PharmacyJawaharlal Institute of Postgraduate Medical Education & ResearchPondicherry 605 006India Add more friends to your messenger and enjoy! Invite them now. Quote Link to comment Share on other sites More sharing options...
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