AIDCOC Opposes CDA - AIDCOC - All India Drugs Control Officers

It is my pleasure and privilege to communicate with you on behalf of the All India Drugs Control Officers' Confederation. We are very proud to inform you that all drugs control officers in this country are affiliated to the AIDCOC through respective State Associations. Officers of Central Drug Control Standard Organizations and officers from smaller states like Assam, Tripura etc. are also affiliated to the AIDCOC as an individual members. The AIDCOC is registered as the society, Public Trust and Charitable Trust.

From the press report, we understand that Government of India in Ministry of Health and Family Welfare is contemplating to establish the Central Drug Authority and also to take over the manufacturing licensing from the State licensing authorities. From the press reports, we also understand that the Government of India is contemplating to take over the manufacturing licensing in selective therapeutic categories. We also understand that the licensing of blood banks will remain with the State licensing authorities.

In fact, we have not received any official communication and we are not aware of the exact scope of Central Drugs Authority to be established. We therefore request you to kindly provide us a copy of the proposal to establish Central Drug Authority and to take over the manufacturing licensing activities. In the meantime, we are submitting our comments on the basis of the information received through press.

We respectfully submit that establishing Central Drug Authority and taking over of manufacturing licensing is not desirable and is also practically not feasible. We have placed on record our opposition to the concept of establishing a National Drug Authority and the concept of centralizing the manufacturing licensing activities before Dr. Mashelkar Committee through our representation dated 08/08/2003 and also during the presentation made by our Secretary General before Dr. Mashelkar Committee on 21/10/2003. We have also placed on record our strong opposition to the proposal of central licensing before your predecessors during our personal meetings and through written representations.

We submit that the proposal is inconsistent with the earlier view taken by the Government of India as is seen from the historical position about the National Drug Authority submitted below.

· Though, the Hathi Committee had recommended to set up the National Drug Authority, the drug policy formulated by the Government of India for the first time in 1978 did not include the concept of National Drug Authority.

· The idea to set up the National Drug Authority was revived by the Government of India in its drug Policy 1986 but was not pursued further.

· The drug policy announced in 1994 once again recommended setting up of an independent body called National Drug Authority by an Act of Parliament. The Ministry of Health and Family Welfare, Government of India prepared a draft National Drug Authority Bill, however, the idea of setting up a National Drug Authority was not pursued further and rightly so as establishing such authority is not desirable and is practically not feasible.

· Dr. Mashelkar Committee also did not favour establishing a Central Drug Authority and observed that "there were several complex, operational, legal and constitutional issues involved in setting up the National Drug Authority". The proposal to take over manufacturing licensing in selected therapeutic categories is also inconsistent with the recommendations of Dr Mashelkar Committee, which has suggested taking over manufacturing licensing in phased manner.

· The Pharmaceutical Policy 2002 also did not have any proposal to establish National Drug Authority but declared its intention to give priority to strength the CDSCO to enable it to effectively act as a nodal center. The policy had emphasized:-

"Set up a word class Central Drug Standard Control Organization (CDSCO) by modernizing, restructuring and reforming the existing system and establish an effective network of Drugs Standard Enforcement Administration in the state with the CDSCO as a Nodal Center to ensure high standards of quality, safety and efficacy of drugs and pharmaceuticals".

· The National Pharmaceutical Policy, 2006 also clearly took cognizance of dual regulatory control over drugs by Central and State Governments and also about the well defined division of responsibility of Central and State Governments. The Policy 2006 has a proposal to establish National Drug Authority but does not have any proposal to take over manufacturing licensing.

i) We would like to draw your attention to the fact that the issue of centralizing the manufacturing licensing was thoroughly deliberated before Dr.Mashelkar Committee. It is pertinent to note that the said proposal was opposed by us and other professional bodies like the Indian Drugs Manufacturers' Association, Small Drugs Manufacturers' Association, FDCA Gujrat Drugs Control Officers' Association. However, Dr. Mashelkar Committee brushed aside the opposition and reservations expressed by the above said professional bodies.

ii) We would also like to draw your attention to the fact that Dr. Mashelkar Committee had asked comments / opinion on Central Licensing from all State Governments and all states except four states have clearly put on record their opposition to the concept of central licensing. Dr. Mashelkar Committee, while recommending central licensing did not record any reason as to why the opposition from majority states was overruled. In fact, the Committee should have given weightage to the views of the majority states and should have also taken in to account the fact that the four states namely Punjab, Arunachal Pradesh, Manipur and Pondicherry which favoured central licensing do not have much manufacturing activities. The Commissioner, FDA, Maharashtra who was member of the Dr. Mashelkar Committee also opposed the Central licensing, however, his objections were overruled without recording the reasons thereof and the Committee has merely recorded his dissent in the report.

We understand that now, the Central Government propose to take over manufacturing licensing in selected therapeutic categories. We do not understand the logic behind such selectivity and how much talked about objective of achieving uniformity will be achieved by such approach. In any case, in our view, uniformity is a big myth and the bogey of uniformity appear to have been raised only for concentrating licensing powers with Central government. In support of our contentions, we submit below following points:-

Even in exclusively Central Government Departments like Income-Tax, Central Excise etc. much disparity in terms of interpretation and implementation is noticed. It is also established fact that these departments are more effective in the state where the state machinery is well organized and effective. CDSCO is also effective in the States where the Drugs Control Organizations are well organized and strong.

It should be noted that the Government of India (as it was in pre-independence period ) could enact Drugs and Cosmetics Act, 1940 only after obtaining resolution from the provincial Governments empowering the Central Government to legislate. Therefore, any move to amend Drugs and Cosmetics Act, 1940 and Rules, 1945 to provide for Central Licensing is likely to create many legal hurdles.

Couple of years back the Government of India took decision to take powers as Central License Approving Authority for the purpose of regulating activities of Blood Banking and Large Volume parentrals. However, this experiment has not yielded the desired results and has in fact, resulted in delay in grant or renewal of licenses, presumably because of the inadequate manpower in CDSCO and dilution of the responsibility.

If we take review of another area of joint responsibility of CDSCO and State Drugs Control Organizations as regards, certification of the manufacturers on the basis of WHO guidelines for Good Manufacturing Practices, it can be clearly seen that this experiment could not bring the desired objective of achieving uniformity vis-a-vis, quality assurance level.. Though, it would not be fair to comment and quote the examples, the gap in the quality assurance level in WHO GMP certificate holders in various states can be ascertained by carrying out random inspections by the audit team specially constituted for the purpose.

We submit that the existing Legislative scheme is adequate to ensure uniformity in implementation. The lawmakers, in their legislative wisdom, have already provided for a system to achieve uniformity in implementation. The lawmakers have taken in to consideration the federal structure and the legislative powers of the Central Government and State Government in respect of subjects on the concurrent list. Therefore, the statutory provisions as regards, Drugs Consultative Committee for securing uniformity and Drugs Technical Advisory Board for tendering proper advise to the authorities have been incorporated in the Drugs and Cosmetics Act, 1940. The specific Section 33(p) empowering Central Government to issue directives for proper implementation has also been incorporated under the Act. If these provisions and the legislative scheme is not utilized properly, the blame should go to the implementing authorities and not to the system. We believe that the uniformity in implementation can be achieved by proper utilization of the existing system and legislative mechanism coupled with administrative measures suggested by us before Dr. Mashelkar Committee.

We once again reiterate that the proposal to take over manufacturing is not desirable and practically not feasible if we take in to consideration the logistic and legal issues involved in the entire process of implementation of the Drugs and Cosmetics Act, 1940 and Rules, 1945

i) Legal: The subject of drug is on the concurrent list and therefore both Central Government and State Government can legislate on the subject. The Government of India (as it was in pre-independence period) could enact the Drugs and Cosmetics Act, 1940 only after obtaining resolution from the provincial Governments empowering the Central Government to legislate on the subject which was exclusively the subject of provincial list. Precisely, for this reason, the Drugs and Cosmetics Act has a specific provision that section 18 of the Act, which is a prohibitory section, can come into the operation only from the such date as may be notified by the State Government. This clearly indicates that the legislative scheme envisages that the State Government shall be responsible for the implementation of the Act, and therefore also for licensing which is accepted as one of the effective tool for quality monitoring.

Therefore, any move to amend the Drugs and Cosmetics Act, 1940 and Rules, 1945 to take over the entire manufacturing licensing will create legal hurdles. In fact, the existing provision incorporated under Rule 68 A and other relevant rules as regards the CLAA can be considered as contrary to the legislative scheme and the constitutional validity of the said rules can be questioned.

ii) Logistic: Manufacture, sale and distribution is a composite activity and for the purpose of effective implementation it should be viewed as such and only single agency should be responsible for implementation of the Act. If the manufacturing activity is controlled or regulated by one agency and the sale and distribution is regulated by another agency it would create many logistic problems such as jurisdiction and co-ordination between State Government and Central Government. It would also adversely affect speed and effective investigation involving both traders and manufacturers.

iii) Inadequate Manpower: The comparison between the manpower deployed by the CDSCO and the State Drug Control Organizations clearly indicate the disparity and the inadequate number of Drugs Inspector and supervisory officers available with CDSCO. For example, in the State of Maharashtra, 14 Assistant Commissioners and 25 Drugs Inspectors are exclusively assigned the job of monitoring activities of the license of manufacturers. As against this, CDSCO (West Zone) has only 4 Drugs Inspectors and 1 Dy. Drugs Controller responsible for monitoring this activity. The inadequacy is further highlighted if we take into consideration the fact that these officers are responsible for 5 states. Similar situation exists in other states and the manpower in various zones of CDSCO is too inadequate. It is not known as to how the Government of India can provide the manpower on the scale provided by the State Governments. The track record of CDSCO on this issue indicates that it is not feasible. From Dr. Mashelkar Committee's report itself it is observed that the posts created in 1992 could not be filled because of administrative complexities. The inference is very clear the Government of India could not handle the administrative complexities and therefore there is a question mark on the feasibility of providing necessary manpower. This is also clear from the fact that the Government of India could not provide any additional manpower during last three years and could not even fill the post of the Drugs Controller General India. Even if the option of taking officers from state drugs control organisations is considered, its feasibility is a big question mark. It will create many chronic disputes about inter-se-seniority and the promotions.

iv) Span of Control: In Maharashtra, FDA has presence at all district places with Assistant Commissioner as head of the office and the divisions are headed by the Joint Commissioners. The licensing powers for the purpose of grant or renewal of manufacturing licenses have been delegated at the divisional level. Similar set up exists in States like Gujarat, Karnataka, Andhra Pradesh etc. (Except delegation of licensing powers). As against this, the CDSCO (west zone) is responsible for Maharashtra, Gujarat, Goa, Div-Daman and Madhya Pradesh. As stated above, it would be impossible for the Central Government to establish zonal and district offices in all states.

The scheme of the Act under the Prevention of Food Adulteration Act, 1954 is similar to that of scheme and provisions under the Drugs and Cosmetics Act, 1940. Faced with the problem of lack of uniformity in implementation, emphasis on sampling based implementation and punitive action and multiplicity of legislation and implementing agency, the Central Government has enacted the Food Safety and Standards Act, 2006 [Act 34 of 2006, Ministry of Law and Justice (legislative department)]. Under the said Act, the Central Government has established an autonomous Food Safety and Standard Authority of India. Section 16 of the Act specifies the duties of food authority which includes regulating and monitoring the manufacture, processing, distribution, sale and import of food so as to ensure safe and wholesome food. The food authority is also responsible for providing scientific advice on technical support to Central Government and State Governments and is also empowered to issue directions for the Commissioner Food and Safety appointed by the state Government. The Food Safety and Standards Act, 2006 has however maintained the concept of well defined division of responsibilities between the Central and State Government with Central Government responsible for legislation, policy review and monitoring and the State Government responsible for implementation of the Act including the licensing.

We submit that the scheme under the Food Safety and Standards Act, 2006 is ideal in the context of our federal structure and in the context of division of legislative powers of the Central and State Government. We request you to kindly examine the various provisions under the Food Safety and Standards Act, 2006 and consider following the same scheme for the purpose of achieving uniformity in implementation.

a) The legislative scheme and the division of responsibilities between the Central Government and State Governments should not be tinkered with. The proposal to establish Central Drug Authority and to take over manufacturing licensing should be dropped.

b) The priority should be given to strengthening of the Drugs Control Organization at Central and State Level instead of creating a separate National Drug Authority.

c) The Central Government should pursue the agenda of strengthening the Central Drug Standard Control Organization as declared in Pharmaceutical Policy 2002 to enable it to effectively act as a nodal center

d) The Central Government should take immediate steps to implement recommendations of Dr. Mashelkar Committee on strengthening of drug control organizations at state level instead of diverting its attention, resources and energy on establishing a Central Drug Authority and Centralizing manufacturing licensing.

e) The Central Government should devote its energy and resources in legislation, policy making, monitoring of implementation at state level, continuous review of the products approved at state level, import and approval of new drugs including clinical trials.

Notwithstanding above, if the Central Government considers it absolutely necessary to establish Central Drug Authority it should be substitute to the Central Drugs Standard Control Organization and should not be in addition to the CDSCO. Such Central Drug Authority should be like National Food and Standard Authority established under the Food Safety and Standards Act, 2006. Simultaneously, independent Drugs Control Organization headed by the Commissioner of Drugs Safety should be established at state level with necessary infrastructure, budget and manpower. The proposed Central Drug Authority should perform the functions of the CDSCO and the implementation of the Drugs and Cosmetics Act, 1940 and Rules, 1945 should remain with the State Governments.

We also submit that the proposal should be discussed with all stakeholders before it is finalized. We also request you to kindly give us an appointment for personal hearing so as to enable us to present our case before you in person.

1) Smt. P. Lakshmi, Hon. Union State Minister for Health and Family Welfare, Government of India, New Delhi.

2) Shri. Naresh Dayal _(I.A.S.), Secretary, Health and Family Welfare, Ministry of Health and Family Welfare, Government of India, New Delhi.

3) Dr. M. Venkateswarlu, Drugs Controller General India, Directorate of Health Services, Ministry of Health and Family Welfare, Government of India, New Delhi.