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 licenses, States are authorized to grant licenses for sale as well as for manufacturing. There are so many problems in this system. 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 license 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 license number is printed on the label. Actually they do not know whether the company has obtained drug manufacturing license. Even if the company is granted a license, it will be difficult even for the state dugs control, which granted the license, to know whether a particular drug is licensed. From the label it is not even clear under which Form the license is granted.
Another major problem is duplication of trade names of dugs causing spurious drugs in the market. Granting licenses 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 licenses 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, 66,75 mg. All know it is for escape from DPCO and not for benefit of the public. Nowadays it’s a hide and seeks game between state drugs control and NPPA. When NPPA fix ceiling price for a dosage of a drug or its combination, license is taken in slightly modified dosage. But for the manufacturer, who is benefited in granting license for Ibuprofen 333 mg? 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. Granting licenses finishes their duty. No state drugs control people know whether someone 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 gray area. Implementation of product registration is not thorough.
It does not mean that the Drugs Control Administration in India is not good. 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 trillion 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 9000 odd US FDA.
Drugs Control Department is a tiny segment in the Government. The revenue generated is very less. Health 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 Programme, it is Rs 232 crore. The increase in allotment from last year is Rs 0.7 and Rs 27 crore respectively.
The pharmaceutical industry is growing at tremendous speed and India is emerging as world power. It is high time that we should think how to improve the administration.
Solutions
A powerful National Drug Authority (NDA) is the only choice to have a national level uniformity and better drugs control administration. Making it is the problem facing us.
The two broad functions of the drugs control administration are control of sales and control of manufacturing of drugs. Granting of licenses, its renewal, inspections, etc. in this regard can easily be done at local level. In fact, it is 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 license approval of blood bank and IV fluid, practically without any responsibility, has proved this. There is not only non-uniformity among different States, but also within the same State. 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 licenses are issued by CDSCO. In any management system progress can be achieved only through delegation and de-centralisation. On the contrary, we are on the reverse track, which will never yield any development.
To integrate all State drugs control authorities into CDSCO is advisable, but not practically easy. Drugs come under concurrent list and the power enjoyed so far by States will not be easily departed with. There will be strong objections from the States as well as from officers working under it. But, it is definitely possible. The fact that State drugs control authorities are not revenue earning, adds to its possibility. Setting up district level new establishments of CDSCO will be much more expensive than integrating with State drugs control authorities.
Suggestions
I would like to present certain other suggestions, which while meeting the requirements of a strong NDA, will not disturb the existing Centre-State establishments as such. It will be somewhat like the functioning of High Courts and Supreme Courts.
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 Blood Bank licenses to their own bosses. The NDA should be made an independent Department both in the Centre and States. The NPPA should also come under this Department.
Uniform designations, hierarchy and pay structure should be made in all States/Union Territory Drugs Control Administration and CDSCO. For example let all have uniform hierarchy like Drugs Officer, Assistant Drugs Controller, Deputy Drugs Controller, Joint Drugs Controller and Drugs Controller.
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.
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.
The revenue/expenditure of the Departments shall be borne by the State or central government, as at present.
The present CDSCO, New Delhi, will continue as an NDA Headquarters under the central government. All state drugs controllers shall be under the Drugs Controller General of 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. State Drugs Controllers shall be in the cadre of Deputy or Joint Drugs Controller as the case may be (depending on the State) and the senior most Joint Drugs Controller shall be promoted as DCG (I).
The Drugs Inspectors of the CDSCO Zonal offices will continue with the functions of import licensing, port/customs offices, new product approval and as Intelligence Branch. They shall not be connected with licensing. They will collect random sample of drugs, and conduct surprise inspections of manufacturing and sales premises and take prosecutions and corrective measures. Above the level of ADC, they will also merge with the common pool.
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. If one particular inspector is not competent to inspect, there is no meaning in taking him for joint inspections. To get expert opinion from any source, they need not be taken for inspections. 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.
(The author is deputy drugs controller of Kerala)