How do you perceive the current status of the drugs control departments all over the country? What are all the ground realities as being faced by the drug inspectors? The drugs control administrations in India are grossly understaffed. For any reasonable performance to be expected from them, the staff strength will have to be increased several folds. As per the statistics given by the government of India to the Supreme Court in 1992, we had 703 drugs inspectors in the country. And we needed at least 2,300 drug inspectors more for efficient functioning of the departments during that period. Nine years have passed since then, yet the strength has remained unchanged!
All committees and taskforces appointed to study the ways and means of strengthening drugs control departments have repeatedly recommended the need for one drug inspector each for 100 medical shops, whether wholesale or retail. Similarly for every 25 industrial units there has to be one drugs inspector. If you see the recommendations of the task force headed by joint secretary of medical and health care recommendations of 1982, or the Hathi Committee recommendations of 1975, you will find the same suggestions as essential for giving better services to the public and to stall the movement of all spurious drugs. With no proper infrastructure facilities, mobility and budgetary allocation, the drug regulatory agencies in the country are finding it difficult to function properly.
If you take the case of AP as an example, as per the statistics given by the government, the requirement is 300 drug inspectors. And we have 55. If you see the industry and trade, right now there are 25,000 medical shops and nearly 1400-1500 industries in the state. Each drugs inspector is burdened with the job of 6 drugs inspectors here. The situation is the same everywhere. Even in Maharashtra, which is one of the country''s biggest drugs control administrations, there are vacancies for drug inspectors.
AP is considered as first in bulk drug exports and second in formulations. When we have only 55 drug inspectors, a state like West Bengal, which hardly has any major pharmaceutical industry, (They have only 100 to 150 drugs units including the small scale units) has 90 inspectors.
Our confederation demands the appointment of sufficient drug inspectors in the departments. We are certain that presence of spurious drugs is only because of improper vigilance. Which is mainly due to inadequate staff. If you provide adequate staff and budget allocation and good laboratory facilities and vehicle, definitely we will be able to control the movement of spurious drugs to the maximum extent.
It is a known fact that drugs control departments are under-staffed. In order to reduce the workload of the officials as well as to speed up and network the functioning of various state drug control departments the government has come out with ambitious plans for computerisation. How do you see these efforts? Can it alleviate the problems of the drug inspectors and bring about better regulatory systems in the country?
No efforts in improving the efficiency of the drug regulatory sector can be practical unless the governments can meet the basic demands that we have made. We are not asking anything new. What we need is the implementation of whatever recommendations made by the committees appointed by the government of India from time to time. We would say that no government is serious in addressing the problems faced by the drug regulatory sector. You just compare the growth of pharma industry over the last decade. In 1992 it was worth Rs 1,200 crore, and now it is Rs 29,000 crore.
To give you the statistics, today, 103 crore Indian population consumes 29,000 crore worth of drugs controlled by 703 officers. We have submitted number of representations to the state government through our state associations. We have submitted recommendations to the parliamentary subcommittee on drugs, we had deliberations with them, recommendations have gone to the parliamentary party leaders of various political parties, and in spite of all these the government is not responding in a proper way.
What can computers do without trained personnel to operate it? We have about commonly used 70 formulations in the country. Each medical shop will have at least 10,000 to 15,000 categories of drugs. No computer can verify the stocks. For that an inspector has to go and verify whether it is a drug manufactured by somebody else, whether it is duplicate, what drug it contains, whether it is an irrational combination or banned combination? For all these things you need physical presence. No computerization or sophistication can replace it. The computerisation can only be an additional support to the personnel but can never substitute the enforcement officers. Unfortunately too much hype is there on computerisation.
Unfortunately the media as well as the consumer organisations and public think that the drugs control officers do not work properly and that is why the market is flooded with spurious, contraband and all these imitation drugs. We want to say that it is not correct. You provide (us) the basic facilities, If AP needs 300 inspectors, you give (us) at least 150 inspectors. You forget about the recommendations of the task force, give the half of that. We can do something. And there will be more vigilance.
So you are totally against compromising on the number of drug inspectors. Right?
Yeah! Reduction of workforce, using computers, is possible in other sectors. But not with law enforcing agencies. You cannot expect to reduce the number of doctors with added equipment or computerisation. Same is the case with drugs control department also. One should understand in particular fields'' personnel are more important than gadgets.
In AP, public-private participation is encouraged a lot with the department issuing self-appraisal forms and categorising the companies based on their own submission. Seeking the participation of major companies and asking them to share the intelligence are of late being highlighted as an effective strategy to counter the imitation drug menace. How effective is it from the drug inspectors'' point of view?
The first point is sharing the information with the manufacturers and drugs inspectors. I have been involved in the detection of some imitations of fast moving drugs of some top companies in AP. These companies were very much aware of this fact, much before us; but they never passed on the information to the drugs control administration. No manufacturer has ever passed any information of spurious drug movement to the drugs inspector for the reasons better known to them. What I feel is that they are under the impression that if news about the presence of spurious drug of a well moving brand in the market is spread, it will affect the sales of the entire product. So they don''t want to kill their product. Which means they are ready to allow the spurious drugs to move in.
Now let us take the public-private participation programme of AP. We have prepared a list of companies that are manufacturing not-of-standard drugs. But if you look at the list of spurious drugs, which made its presence recently, they are all manufactured in other states. What can the companies or authorities do in such situations? Proper Vigilance is always necessary. You see the police department, the facilities they have, and the number of fresh recruitment taking place there. On the other hand we don''t have anything. No recruitment, no facility. We are also law enforcers. We should have basic facilities first. The rest, the fax machine, the Internet, the interconnectivity or networking all will only enhance our working capacity. It can never replace the actual requirement. Computers are not going to be a solution to this.
Do you think amendments in existing laws are necessary to strengthen the regulatory powers of inspectors?
In the Court of Law, the role of drugs inspector is very minimal. They only have to produce evidence and the witnesses. Even then, state governments can think of going the West Bengal way by adding state provisions to the Drugs and Cosmetics Act that relieves the drug inspector from the burden of proof. In AP and in other states the burden of proof lies on the prosecution. Where as in Bengal the law is so stringent that they even have provisions for death sentence for manufacturing spurious drugs. Such stringent laws should be there. We are for it.
How can you ensure proper implementation of drugs control rules when spurious drugs are manufactured in other states?
That is why we are asking the central government for a uniform drugs control administration controlled by technically qualified person. In Bhopal, the drugs inspector is the licensing authority and an IAS officer is the commissioner. In Maharashtra, an IAS officer is the commissioner. In Orissa, District Medical officer is in charge of the drugs control administration and here, an IPS officer is heading drugs control administration. We are saying that Uniform Drugs Control Act should be a central act implemented by all states. The Act should be enforced uniformly. Further the government has to create conducive environment; proper training academies should be there. Till date no formal training is given to drugs inspectors. We are asking the government to take all necessary steps and try to coordinate with the activities of all state departments. All these problems are mainly due to the lack of interest on the part of the government. The government is not concentrating on the affairs of drugs control administration.
But already the uniform system is in place!
It exists on paper.
Then what difference does it make if it is amended?
The DCGI and the central government have to coordinate the activities of other states. Act is the same. But you have to implement it uniformly. For that the government has to create a conducive environment. I still feel the government is not giving priority to drugs control administration. For example, in AP, the health budget is 1,200 crore. But the amount allotted to AP DCA is less than 2.5 crore. Let them just consider the export earnings the state gets from the pharma sector. How much money they are getting as excise duty as how much they are spending for the DCA? How many officers are thorough with the systems? What interest the government is showing except collecting the taxes and duties? You boast AP is a big state for pharma but what efforts you are putting to develop this drugs control administration? What training you are imparting to your officers? You are saying that within another five years the industry has to compete with global giants. Is DCA prepared to face the post - GATT era? We are not trained properly. You are not concentrating on that. You are saying you are going to set up pharma parks, give tax concessions to special zones, subsidies… but you are not talking about strengthening the drugs control department. If the government provides say about 1,100 crore to the DCA. We will see miracles here.
But without uniform implementation what is the purpose of all these efforts?
Let us have a beginning. If three major states, AP, Maharashtra and Gujarat the DCAs are strengthened most of the problems will be over. The other two are giving more attention to the department than AP. If money is the only problem that is preventing the government from going in for fresh recruits let them think about the amount they are spending for other departments. It is not lack of money. The priorities of the government are different. What they do when a spurious case arises is to form a house committee in the assembly. Already the recommendations of such a House Committee, formed under the chairmanship of Mr. Rossiaah in 1992 is pending. It said that to check the spurious drugs control administration should be strengthened, decentralized, every district should have an assistant director, good testing laboratories, vehicles… but nothing was implemented. Government is not serious about public health. They are not considering DCA as part of health care system.
When the government is not implementing the House committee recommendations and the task force recommendations how can you expect them to implement the drug advisory committee recommendations?
Comment on the efforts of your confederation in bringing about the desirable changes you insist?
Our major objective is to give better service to the public. Every state has their own associations and these associations are affiliated to the confederation. The central drugs inspectors have an association, which is also affiliated with the confederation. We also stand for better coordination among various state drug control administrations. If the DCGI sends a circular it would take at least six months for all of us to see it. In order to avoid that we have our communication networks. We publish all new drugs, banned combinations in our newsletter so that our members get it without delay. It has been very effective. Our people are happy because they are doing better than what the government is doing when it comes to sharing of information. We are planning to start one training centre for the drug inspectors. In that direction we have conducted at least 25 to 30 seminars during the past four-five years. We are also in touch with the industry in this regard. The land required for setting up the academy has already been offered by a well-wisher. It will come up in suburban Mumbai. We intend to have a good library and conference hall. We will have a formal training for the officers and the industry continuously.
We are also planning to approach the DCGI and WHO to help us streamline the functioning of the academy. The training imparted to our members will be free while we have to charge a nominal fee from the industry representatives. It should take at least three years. DCGI has accepted this in principle.
We are associating with the industry to give better service to the public and uniform status to the drugs control activities throughout the country. In that process we have submitted number of representations, finally there were no response from the government.
In November first week we had our first international programme in Mumbai. We gave away best the drugs inspector award at the state level during the programme. The best drugs control officers award will be given away at IPC.
As a constituent association of IPCA what is your opinion about IPC?
IPC is a criminal wastage of money. We collect a good amount of money and spend it, but unable to do anything constructive for the pharmacy profession. You are not utilizing that money to improve the standards of pharmacy institutions, you are not trying to develop the pharmacy profession, so you are not gaining anything out of it other than the fact that you are coming with your family members and meeting your friends. Very few committed people are coming to give lectures to even less committed audience. It is not at all organised in a proper way. You have the Indian Medical Association, All India Dental Association, there are many such professional bodies at the national level but no one has this kind of national `tamasha''. I am against it. We are a constitutent body of IPCA and we are going with them. We are only seven years old and IPC is more than 60 years. What we have observed all these years is no serious deliberations are going on there.
But the November meeting which we organised was exclusively for members. Ours is a professional meeting. This convention should help my colleagues some way or other. That is the reason we disassociated from IPC and had our conference a month earlier. We will attend IPC to meet our friends and to be part of the mela.
Is it because you feel you are a junior partner in IPC?
No, not at all. No other recognized pharma organisation other than ours is working so hard for its members. Now BSc grads are being appointed as drugs inspectors. What is IPC saying or IPCA doing on the matter? What purpose does IPCA serve if it is only meant for organising an annual event called IPC ?
If IPCA is of no use then why should you continue to be part of it?
We will continue to be part of IPC. See first of all you cannot simply act against all people. Many other constituent associations of IPCA are not only representing pharmacy profession. You have all kinds of people as its members. Even national level leaders of these associations are non-pharmacy people. Remember, only doctors are members of Indian Medical Association. So it does not really matters if IPC does not represent the pharmacy profession in the strictest sense. It is better not to go deep into such subjects. I am very sorry to criticise my people, but let me say we people have not done any constructive work for the betterment of the pharmacy profession. I have said this in IPCA itself that IPC is a criminal wastage of money. In fact in 1995 itself, IPCA had decided in principle to discontinue this IPC. Every organisation will have its own convention. These are all professional organisations. When we are meeting some professional activity should be there and it should be helpful to your members. But that decision was not carried out as money is involved and the charm of the celebrations were too big.
We had planned an exhibition as part of our conference. It was cancelled after the request from IPCA. We lost Rs 30 lakh in the process but we went on with our programmes. If our intention was only to make money would we have cancelled it? Actually we are mobilizing funds for IPC for the past 50 years.
We had the industrial division of IPA as our partners for this conference. From next time onwards, we will conduct it. The conference will take place in every two years.
Your plans for a regional level confederation involving drugs control departments of many countries?
There is a move for a SAARC level confederation of drugs control associations. However it is only in the planning stage and we are yet to chart out the structure and objective of such a grouping.