India may be the only country where there is no central licensing for drugs. Drugs come under the concurrent list of the constitution. While the central government holds power to issue import licences, states are authorized to grant licences for sale as well as for manufacturing. This system is riddled with problems. There is absolutely no mechanism to know whether a drug marketed in one state is really licensed in another state. One has just to believe the licence number as shown in the label. The Drugs Control Department of Kerala presumes that all drugs marketed in Kerala are under valid drug manufacturing license, because a licence number is printed on the label. Actually they do not know whether the company has obtained a drug manufacturing licence. Even if the company is granted a licence, it will be difficult even for the state dugs control, which granted the licence, to know whether a particular drug is licensed. From the label it is not even clear under which Form the licence is granted.
Another major problem is duplication of trade names of dugs causing spurious drugs in the market. Granting licences for irrational combinations causes the most serious problem. Most of the ban under Section 26A comes under irrational combinations. Unless a ban on combinations is made, it is impossible to fix guidelines in granting licences for combination drugs. Each state and each authority vary in their outlook.
Another problem is the case with over and under dose formulations. We can see Aspirin tablets with strengths of 33, 35, 62.5, 65, 66,75mg. Everybody knows it is done purposefully to escape DPCO and not for the benefit of the public.
Nowadays it is a hide and seek game between state drugs control and NPPA. When NPPA fixes ceiling price for a dosage of a drug or its combination, companies go for licences for slightly modified dosages. But for the manufacturer, who is benefited in granting licence for Ibuprofen 333mg? Instead of fixing the ceiling price for Pharmacopoeia dosage forms and allowing prorate increase or decrease, the NPPA also help the manufacturer by fixing ceiling price for individual dosage.
In the case of imports of drugs, the situation is worse. Import licence is granted by the CDSCO. Their duty ends with the granting of licenccs. No state drugs control person knows whether a manufacturer is actually licensed. We can see many drugs, which are not granted permission as new drugs, are available in the market either as drug itself or as dietary supplements. Import of drugs is a grey area. And implementation of product registration is not thorough.
It does not mean that the Drugs Control Administration in India is not effective. Actually it is one of the best. We do not have the problems of hoarding and black marketing in drugs. All drugs are available to the public at all times. The prices of drugs are also the cheapest in the world. The publicity of duplicate or counterfeit drugs is mostly exaggerated. In fact, the efficiency of the drugs control administration in India can be understood only if you know that the 6 billion dollar pharmaceutical industry is regulated by just less than 900 field staff. We can compare it with the number in police, motor vehicle and other departments in India as well as with the US FDA which has a 9000- odd staff strength.
Drugs control department is a tiny segment in the government. The revenue generated is very less. Health care is usually associated with doctors and health services department by the government.
The budget allocation for 2004-05 of the central government for CDSCO is just Rs 27.10 crore, while for a single project, National Aids Control Program, it is Rs 232 crore. The increase in allotment from last year is Rs 0.7 and Rs 27 crores respectively.
As the pharmaceutical industry is growing at tremendous speed and India is emerging as a world power, it is high time that we thought how to improve the administration.
SOLUTIONS
A powerful NDA is the only choice to have a national level uniformity and better drugs control administration. However, making it is a real big problem facing us.
The two broad functions of the drugs control administration is control of sales and control of manufacturing of drugs. Granting of licences, its renewal, inspections, etc. in this regard can easily be done at local level. In fact, it is rather better due to linguistic and other reasons.
To convert the present CDSCO as licensing authority for manufacturing licenses is neither advisable nor practical. The CDSCO do not have the infrastructure and expertise to grant licenses. An experiment with four offices and 30 field staff will only be a child's play. The example of approving licences for blood banks and I V fluids, practically without any responsibility, has proved this.
The lack of uniformity is not only among different states, but also within the same state itself. Different drug inspectors of the CDSCO have different standards while inspecting blood banks and manufacturing units. There is inordinate delay in just approving the licenses. It takes six months to one year to get back a license approved by the CDSCO. What will be the case when all manufacturing licences are issued by CDSCO. In any management system progress can be achieved only through delegation and de-centralization. On the contrary, we are on the reverse track, which will never yield any productive development.
SUGGESTIONS
Here are some suggestions which could possibly meet the requirements of a strong NDA, while not disturbing the existing centre-state establishments as such.
1 Drugs Control Administration in many States, Union Territories as well as CDSCO is at present not independent departments and they are working under Health Services Department. They grant licences to blood bank. The NDA should be made an independent Department both in the centre and in the states. The NPPA should also come under this Department.
2. Uniform designations, hierarchy and pay structure should be made in all states/union territory drugs control administration and CDSCO. For example, let all of them have uniform hierarchic structure like Drugs Officer, Assistant Drugs Controller, Deputy Drugs Controller, Joint Drugs Controller and Drugs Controller.
3. The state level appointments and promotions shall be only up to assistant drugs controller, for the control of sale of drugs. State and UT shall keep seniority list of drugs officers.
4. Any promotion above assistant drugs controller will only be at national level. If an ADC doesn't want promotion, he can continue in his own state service. Once he accepts promotion he will have to serve in any state where vacancy arises. At the time of promotion to assistant drugs controller, he has to opt whether to continue in the state service or accept promotion and enter central service. It will be better if we can form Indian Pharmacy Service comprising all with 50% direct recruitment.
5. The revenue/expenditure of the departments shall be borne by the state or central government, as at present.
6. The current CDSCO office, New Delhi will continue as an NDA headquarters under the central government. All state drugs controllers shall be under the Drugs Controller General India. The seniority list of assistant drugs controller (opting for IPS), deputy drugs controller and joint drugs controller working in the states, UT and CDSCO shall be prepared and all further promotions made by the central government. There is no necessity of creating new offices, instead the present offices can be effectively utilized. As the heads of offices are from common pool, there will be uniformity of administration also. If there are funds, the number of field force can be increased.
The system of joint licensing shall be abolished, as it serves no purpose. One authority can issue license. It is not proper to take any outside person to inspect licensed premises. It is worse when one licensee is taken as an expert and inspects other licensed premises.
A powerful intelligence wing, not connected with licensing, will be able to wipe off all spurious and duplicate drugs from India.
There are several issues connected with this proposal that needs to be studied in depth for effective solutions. While some State DCA deals with food also, the idea of Food and Drugs Administration is also to be considered. The food administration in India is namesake.
- (The author is deputy drugs controller, Thiruvananthapuram, Kerala)