But the opposition from the trade sector to the reforms is equally strong. Even as you ask for making degree basic qualification for pharmacy practice, trade associations in the drug sector are demanding that experienced non-qualified persons be allowed to run drug stores. How do you explain this ironic situation? Do you feel professionalism will have the last laugh?First of all let me say that their argument is totally wrong, totally baseless. In fact I have had discussions with AIOCD also in this matter. They have their own compulsions to talk about this. Today registered pharmacists are in a minority in AIOCD. I am sure when this minority converts into majority, the demand will be more that it should be only registered pharmacists. With regard to their argument that management of drug stores is much easier than the earlier days, and that they need just to read the label and dispense the medicine today, I would say that the Supreme Court has already clarified on this. They should not talk about it. It becomes contempt of court. The Supreme Court full bench judgement given in 1997 says that no dispensing should take place from a person other than a pharmacist. A presence of a registered pharmacist is compulsory in drug stores. What they are talking now is against the judgement of the Supreme Court.
Secondly, pharmacist is not just a drug dispenser. He is a drug counselor and a drug custodian. He has to play a very pivotal role in clinical pharmacy. He has to tell about the drug monitoring and advice the physicians. These are the roles of the pharmacist. It is not only the community drug store. In the community drug store, the pharmacist should know how to store the drug and its requirements. He has to give the advice, which is not happening with majority of our pharmacists in the drug stores. He has to keep a record; he should carry out studies into the drug interactions. He should have the courage to study the prescription and if something is wrong he should be in a position to tell the doctor that his prescription is wrong. That happens in developed countries.
In foreign countries unless the pharmacist is consulted, the doctor never gives complete prescription. That is bound to happen here also. If not today, tomorrow. If such things are to happen, a person working in the medical shop for six years, will he be able to do that? Why are we aiming at degree? We feel that degree with ER 2001 curriculum will give the future pharmacist the courage to face the challenges that lay ahead. Then clinical pharmacy, it is catching up in some private hospitals. When the doctor takes rounds, the pharmacist also has to accompany him. Doctor gives the prescription. But compliance of the drug is the responsibility of the pharmacist. It is he who has to see that the patient is taking the prescribed medicine in the proper way.
For all these things to happen, drug regime has to be properly monitored by the pharmacist. I feel the arguments made by the trade sector are very selfish. I have always told our friends in AIOCD that they belong to a very noble profession. Stop thinking this profession as a trade. Selling drugs is not selling vegetables. It is a professional act. Unless these people think of themselves as professionals, these things are going to be talked about. Such selfish attitude is ultimately harmful and comes in way of providing proper healthcare to our citizens.
So you feel there cannot be any compromise on the quality of future pharmacy education and on the requirement of degree as the basic qualification?
Consumerism is becoming very strong day by day. Even the services of the doctors are being questioned. The day is not far when the services of the pharmacists will also be challenged. It is to meet the challenges of the future in healthcare system we have to have degree as the minimum qualification for registration. It is with this objective PCI started working on ER-2001. The entire exercise that went into the making of ER-2001 was very transparent. We discussed each point with different segments, we had brainstorming sessions, and finally we came out with a hospital and patient oriented curriculum with the required component of industrial pharmacy. We thought this would be an ideal curriculum for a country like ours. This has gone through all statutory meetings and finally the government has also considered it. But government says it is a major change, which has to be approved at the highest level. So it may go to parliament for approval.This 10 + 2 + 4 programme ie, the one proposed by ER-2001, is more hospital and patient oriented, has much more focus on drugs store management, hospital and community pharmacy, clinical pharmacy. This is meant to make it an internationally acceptable profession.
You said the ministry has asked for the implementation of ER-2001 in a phased manner. How it would be like?
As phase 1 we have suggested to ministry that no more new diploma in pharmacy institutions should be permitted in the country. In the Phase 11, which may start by 2005 or so, we should be able to implement it uniformly. But these things have to be cleared by the government. So the ball is in the court of the Ministry of health and family welfare. We have started implementing Phase 1. We have done a survey with the information that we have and found that at least 2/3 of these existing colleges offering diploma in pharmacy can be very easily converted into degree. The additional infrastructure that is required in the form of laboratories or staff can be added. PCI will be giving enough time or the institutions to upgrade themselves. We are ready for initiating the change the moment the government gives us the green signal. Once the approval comes, then we will have to discuss the matter with the universities as only they can award degrees. Lot of work has to be done in order to make this transition smooth. We are prepared for it.
You have on many occasions emphasized the need for compulsory registration for all pharmacy professionals. Is there any progress in your effort?
The basic problem here is that it requires amendment to the Drugs and Cosmetics Act. The Act governs all the activities pertaining to import, manufacture, sale and distribution of drugs. For sale and distribution, registration is mandatory. For manufacture, as on today, registration is not mandatory. So there has to be an amendment to the rule or act. Pharmacy Act merely governs with pharmacy education and the registration of it. But whether the registration is required for manufacturing or not is under the purview of D&C Act. As member of Drugs Technical Advisory Board and in my capacity as the president of PCI, myself and my other colleagues in DTAB have been asking for making registration mandatory for all professional activities. But then again there has to be this amendment done. We are positive in that direction and we feel that a stage has come wherein this registration should be made mandatory for all segments of the profession of pharmacy.
Do you feel that it will bring down the instances of registration being misused or duplicated for sales licenses?
As such, the registration procedure is not faulty. What goes wrong is the implementation part.As per the section 42 of the Drugs and Cosmetics Act, there should be a registered pharmacist available in each pharmacy. At least one registered pharmacist should be there in each drug store. We have sufficient number of registered pharmacists, more than 5 lakh. And we have only 3.5 lakh retail outlets. So it is not true to say that there is a shortage of pharmacists. Pharmacists are available in sufficient number now. But their distribution is not uniform. Again the payment is not made properly, especially in the rural areas. So pharmacists are refusing to work there.
In this context, we have to look into the pharmacy practices that are carried out by other developed countries. In these countries it is the registered pharmacist who owns the medical shop. Such a restriction is not brought here. Only then pharmacy practice or community pharmacy will be very effectively strengthened. If the owner of the shop is registered pharmacist himself naturally he will take care of the community pharmacy.
What is happening today? Now anybody can open a medical shop. He has to only employ a registered pharmacist for namesake. And he takes his certificates and displays it. That''s how the malpractice is starting. I wish that our consumer activists and associations insisted upon this type of requirement. Lt them make government feel, realize that there is a need to make amendments. And it is only a registered pharmacist, diploma holder or degree holder who should be allowed to run a medical shop. Then there will be a radical change in our community pharmacy. PCI can only advise the government and is for the government to take action. The public at large, who are the sufferers because of lack of proper services that are made available to them, should raise the voice. In fact they should impress upon the government that whatever is the practice adopted in developed countries that should be practiced here also. PCI will definitely support such a noble cause for the interest of the profession.
How do you rate the functioning of state pharmacy councils? There are elections due in some of the councils. Any suggestions?
Elections are overdue in some of the state pharmacy councils. PCI does not have any direct control over the state pharmacy councils. The relation between us is like the relation between the Central-Stategovernments. If there is any delay in conducting elections or any other procedural delay, we cannot dictate terms with state pharmacy councils. We had been writing to state governments that elections are due in many of the state pharmacy councils. I would say that the pharmacy councils of Andhra Pradesh, Tamil Nadu, Karnataka, Kerala, Gujarat and Orissa are doing well. In other states there are lot of things to be done. And we have been writing to state pharmacy councils whenever there is a complaint. If there is no response, then we write to the government also. We try to intervene, but we can only play an advisory role. We do not have the teeth to directly monitor the activities of the state pharmacy councils.
Some of the state pharmacy councils have appointed Pharmacy Inspectors as per the Pharmacy Act. Do you think that their role is essential when the drug inspector is also doing the same job?
There are two types of inspectors under the Pharmacy Act. The first group of inspectors is meant to monitor the education regulations. They are usually selected from among teachers who go to the institutions and conduct inspections at the time of examinations or otherwise and report that to Pharmacy Council. That system is working very well. We have 220 such inspectors throughout the country. And we do not depute the inspectors from the same state to the institution. These reports, formats are all printed and done in a systematic manner. The inspection of education institutions is centralised. However, under the same Act the state pharmacy councils can also appoint inspectors. The job of these inspectors is to visit the drug stores and ensure that there is a registered pharmacist available. They will look into the qualification of the person who is looking into the drug store. That is where there is clash between the pharmacy inspector and the drug inspector. Drug inspector also has to ensure that there is a qualified person in the drug store. Then they have to go into the details of the medicines. The problem arises when both the reports are clashing against each other.If drug inspector says that there is a qualified person available and Pharmacy Inspector says NO, conflicts are possible. The solution is to have an understanding with the drugs control department.
Any suggestions for better cooperation between the drugs control department and the state pharmacy councils?
Both these agencies have a very effective role to play in the healthcare system. They have to be complementary and supplementary to each other. There has to be a good dialogue between the DCA and state pharmacy councils. State pharmacy council gives registration to the pharmacist and inspectors appointed by the state pharmacy councils have to look into this requirement of registrations. Drug inspectors have an entirely different job to do. There should not be any clashes. Normally there would be no problem between these two agencies. But if there is any rift, there are chances for problems also. I am of the opinion that there should be continuous dialogue between both the agencies. Each should honour and consider seriously the recommendations made by the other agency. Professional interest should be given the priority. So long as it is profession, everything is fine. Whenever personal interests get involved, there is a clash.
PCI was planning to introduce dress code for working pharmacists. Has there been any progress on this front?
DTAB in one of its meetings had decided that wearing of white apron should be made compulsory for the proper identification of the pharmacist. When it was approved and when the draft was circulated, All India Organisation of Chemists and Druggists (AIOCD) insisted that it should not be made mandatory. Because of their opposition, ministry preferred not to make it mandatory. I have my strong opposition to this. One year has passed now and with the exception of two states, there is no improvement in this front. Gujarat is doing a wonderful job. Without this provision also, the drug control administration there succeeded in influencing the chemists and druggists association and started a good tradition. Because of the recommendatory nature of this provision, it is difficult to implement it. We are to take up the same issue in the next DATB meeting also. Here again the consumer associations can play a major role in sensitising the governments of the need to insist on a proper dress code meant for the pharmacist. The public has every right to get proper medicines from the hands of the registered pharmacist.
There are talks about the possibility of a common pharmacopoeia among the SARC countries. IPA is known to be an association to have taken much interest in this. Any progress to this date?
IPA has taken an initiative and about six months back we had a meeting at Delhi at the instance of International Pharmaceutical Federation, World Health Organisation & IPA. Representatives from south east Asian countries like Malaysia, Thailand, Bhutan, Sri Lanka, Bangladesh, Nepal, Maldives and India had attended the meeting. The South East Asian Forum of Pharmacists was the positive outcome of the meet. IPA is the founder member of the forum. The Forum has signed an MoU by way of which 1/3rd of the expense for the professional activities of the forum in the region will come from WHO, 1/3rd by IFP, the body of pharmaceutical associations of 84 countries and the remaining 1/3rd will come from the participating countries. We have started some community pharmacy oriented programmes in these regions. We have a common agenda of action. Last week we had a meeting in Delhi wherein India has been given the responsibility of preparing a work paper on community pharmacy which is to be presented in a conference to be held in Europe about two months from now. IPA is working on it and Praful D Seth, our former president is the secretary of this forum in Delhi. There is a possibility that something concrete will come out from this grouping.
Under the present circumstances it may be difficult to work with Pakistan, but excluding Pakistan, the other countries of the region has something concrete to do. It would be premature to comment on the possible outcome of the grouping.
Have the AICTE - PCI problems been sorted out?
We are working with perfect harmony as on today. We had a very fruitful meeting in the ministry of HRD about four months back. We discussed all the issues and sorted out some of the problems. Though a decision to sign a MoU was taken, it was not signed because it needed the clearance of two ministries, the ministry of health and family welfare and ministry of HRD. Until then, whether there is an MoU or not, we thought of synchronizing the work. It has been agred in that meeting that president PCI, by designation will be the chairman of Pharmacy Board in AICTE all the times. This type of arrangement has been made. President will automatically be the chairman, vice-president will also be a member. Three members of the executive committee of PCI will also be among the members of the board. And then whatever proposals for new colleges are coming, it will reach the board after the preliminary screening at the regional level. Then the board will take the decisions. I have an excellent rapport with Prof. Natarajan, the new chairman of AICTE. We are working on several committees together. All these days the decisions were taken independently by AICTE. It will not be the same hereafter and PCI will also be consulted by way of it s active presence in the Pharmacy Board before any decisions.
Could you comment on the recent report of National Human Rights Commission on Hospital Pharmacy?
I have seen that report and it is a requirement, no doubt. But unfortunately it has affected the pharmaceutical profession in few states. For example in Karnataka, there were number of people who were involved in parental preparation in hospitals. Now these units have been totally closed down. The rigid rules and requirements are prompting the hospitals to close down such drug-manufacturing units associated with the hospitals. Some of the solutions, liquid oral preparations or say solid dosage forms, there are being manufactured in few well established hospitals, but parental have been totally stopped.
In Karnataka 16 pharmacists working in government hospitals and many more in private hospitals have been affected to a great extent because the government said that we are not in a position to implement the recommendations. Unfortunately there is a trend in hospitals to purchase readymade packs rather than storing their own medicines. Hospitals are also going back from the responsibilities of storing medicines and are in turn allowing private pharmacies to function within its premises. As the commission''s report points out there are many hospitals, which do not have registered pharmacist in the drug store. This trend has to be reversed. Drug store in the hospital has to be under the control of a qualified postgraduate in pharmacy.
Do you feel that your post as a vice chancellor will help improve industry-academia interaction in a better way?
I am a firm believer of this industry academia interaction. I was with Bombay College of Pharmacy from 1972 to 1980. The concept behind the establishment of this college was based on this principle of industry-academia interaction. That time we used to do lot of consultation work for the industries. Our department here in Kakatiya University is also actively involved in such type of interaction.
As the Vice Chancellor of the university, I had, in the last executive council meeting, decided to adopt AICTE guidelines for consultation. Any teacher in Kakatiya University can enter into a consultancy agreement with any industry and the profit will be shared between the teacher and the university. The industry has to play a pivotal role in the development of infrastructure of R&D in the institutions. We have already had many such interactions with pharmaceutical companies at Hyderabad. We have been enrolling students from the well-established pharmaceutical companies for PhD programme. Our students are going there and taking the training and now projects are also coming. As far as our university college is concerned it is catching up very well. Most of the equipment you find here came either as part of research projects or such interactions.
Do you feel that our universities are capable of carrying our genuine basic research as their foreign counterparts? If so, is it true that the posture of the animal activists that universities are more prone to misuse of animal experimentation is against the interests of such research initiatives?
We are overplaying the card of animal experimentation. There is too much of politics involved in it. Without animal experiments we cannot achieve anything. Our pharmaceutical drug research has certainly received a setback because of certain wrong policies. Animal sacrifice is required for genuine experimentation. My advice to the champions of this cause is that if they are very particular about animal welfare let them stop all over the country non-vegetarian food. Then let them talk about all these things. How many animals are slaughtered every day in India? We have an animal ethics committee here also. No experiment is conducted without the approval of the committee. But I feel that there has to be changes in the way things are been seen today.