When we began our research into India’s drug regulatory system last year, one of the first topics that we sought to study was the creation of the Central Drug Standards Control Organisation (CDSCO) and its legal status. From the preliminary research we had conducted, it appeared that the CDSCO had no ability to control or advise the State Licensing Authorities (SLAs) based on the numerous circulars it had issued. The SLAs functioned without any coordination and consistency which I have documented in earlier blog posts; but the question that remained unanswered was why the SLAs simply ignored the directives from the CDSCO. We wanted to know under which law the CDSCO was created so that we could better understand its structural problems and its lack of willingness to enforce the law with errant SLAs. A timely example are the arguments being made in the Delhi High Court in the FDC ban case. The center’s argument seems to be that the SLAs have gone rogue and approved these “harmful FDCs” on their own. How is that even possible if there is accountability in the system? Since we couldn’t find any answers in secondary literature, my attorney filed two RTI applications –first with the Ministry of Health & Family Welfare (MOHFW) since it is the ‘parent’ ministry of the CDSCO and the second with the CDSCO itself. The two pertinent questions that we asked of both the authorities were as follows:

1. Under which legislation/rule/notification has the Central Drug Standard Control Organization (CDSCO) been created by the Central Government?

2. Please provide a copy of the legislation/by-rule/notification under which the CDSCO has been created.”

The responses to the RTIs can be accessed over here and here.

The CDSCO in its reply stated “The CDSCO is the name given to the office of the DCG(I) appointed under Rule 21(b) by the Central Government and the other offices under his control. State licensing authorities was created under the provision of sec. 18 empowered the state government for the purpose.”

The MOHFW in its reply stated “…it is informed that the Central Drugs Standards Control Organisation (CDSCO) headed by the Drugs Controller (India) flows from the various provisions of the Drugs & Cosmetics Act, 1940 and Drugs & Cosmetics Rules, 1945. The said Acts and Rules are in public domain.”

The long and short of both replies is that neither the CDSCO nor the MOHFW are aware of how the CDSCO was created. Rule 21(b) makes no reference to the phrase CDSCO. Similarly, if the CDSCO was a name given the office of the DCGI, there has to be an executive order to that effect from the Central Government stating that the office of the DCGI will henceforth also be referred to as the CDSCO – naming an organisation and creating an organisational structure is usually laid down in a legal instrument. For example, various ministries in the Central Government are created under the Government of India (Allocation of Business) Rules, 1961. Specific organisations like the Central Vigilance Commission (CVC) are created under CVC Act of 2003. Similarly, there must be a law under which the CDSCO was specifically created – neither the CDSCO nor the MOHFW appear to have any clue of the law under which the CDSCO’s existance came into being. Are we therefore surprised when the SLAs routinely ignore the circular’s from the CDSCO? What legal standing does the central drug regulatory authority have in India?

The Katoch Committee’s observations on the functioning of the CDSCO

Post the now famous 59^th Report of Parliamentary Standing Committee on Health & Family Welfare, the MOHFW appointed an Expert Committee headed by Dr. V.M. Katoch to study the recommendations of the Standing Committee. The Katoch committee report can be accessed here. As a part of the exercise, the committee asked the CDSCO to present a self-assessment of its functioning. Some of the disclosures made by the CDSCO in this report are revealing of the rot within the organisation. Sample this excerpt from the report on page 33:

“From early days the CDSCO has been without medical specialists. Therefore, CDSCO was engaging consultation of outside experts for evaluation of safety & efficacy of drugs…..the present cumbersome system of providing TA/DA to the outside experts is a major constraint in getting external expertise. It further requires a well-supported secretarial assistance.”

“Resource in terms of manpower and other infrastructural facilities like working area, archiving, maintaining software based data bank etc. are grossly inadequate for effective functioning in various multi-disciplinary activities of CDSCO.”

“There is a weak administrative infrastructure with respect to handling of administrative activities like service matters, budgets, recruitment, procurement matters etc.”

The remaining “confessions” in the self-assessment report pertain to the lack of training for key personnel, inadequate access to the latest medical literature, inadequate working space, inadequate archiving facilities and non-existence of a data bank of all drug licences issued by various authorities in the country. While some of these issues can be solved by throwing more money at the problem, as the government has announced recently under the 12^th Five year plan, there is a need for radical structural changes in order to make this organization accountable to the people of India. The Katoch committee had recommended a detailed study of the CDSCO. The exact recommendations of the committee are reproduced as follows:

“a) Review of implementation of the Mashelkar Committee report with a view to identify items implemented and those in the pipeline; the likely timeframe of their implementation and decisions on remainder recommendations;

1. b) Study of international role model/s in the field of drug regulation to identify qualitative changes that Indian regulatory system should adopt in its functioning;
2. c) Study of the self-assessment report of the CDSCO extracted under 4.3.5. on pages 33-42 of this report and make critical appraisal of it in context of (i) and (ii) above.
3. d) Carry out in-depth ‘wet’ study of the current structure and functioning of the CDSCO, including newly constituted NDACs, employing work-motion studies, individual and group interviews and other techniques of qualitative research;
4. e) On the basis of the above studies the consultant/consultancy shall prepare a blueprint of structure and functioning of CDSCO, with identification of inputs, implementation programme and outcome of revamping – with clear cut goals and timelines;
5. f) The report so prepared should be critically appraised and accepted by the Government.”

My attorney filed a RTI Application with the MOHFW where we asked them whether such studies were ever commissioned – the answer was in the negative.

So basically, the government is simply throwing more money at the CDSCO without making any attempt to understand the larger problems within the CDSCO despite the CDSCO confessing that it lacked the basic infrastructure to carry out its job of regulation. Not only that, political appointments to head this key regulatory public health function, coupled with undue influence of the pharma lobby over policy making and regulatory enforcement has essentially rendered this institution impotent.

In one of my PILs, I had asked for the Supreme Court to issue directions to the Comptroller & Auditor General (CAG) to carry out a performance audit on the CDSCO, so that we had a better understanding of the problems plaguing the CDSCO. The CAG has experience in carrying out such audits and they do a good job. One such example is an audit of the National Institute of Biologicals (NIB) in 2009 and I was hoping we could replicate the process with the CDSCO.

The lack of statutory basis for the existance of the national drug regulator cannot be an academic exercise. It affects the health of over a billion people who live in India.