The Government of India introduced the the Drugs and Cosmetics (Amendment) Bill, 2013 in Rajya Sabha, (rest of article as drugs Bill). This is a modified version of the same Bill earlier introduced in Lok Sabha during 2007, and examined in detail by the Parliamentary Standing Committee of Ministry of Health & Family Welfare and gave its report in 2008.
The amendments in drugs Bill as proposed have gone off the track. The purpose of this whole exercise was to greatly expand/enlarge the scope of the existing drug control organization [often referred to also as Central Drugs Standard Control Organisation (CDSCO)] to be able to make better and fuller use of the unprecedented scientific and technical advances taking place in the world in the pharmaceutical sectors for healthcare in India, and suitably enlarge the scientific and technical infrastructure of the drug control organization to meet these needs. This has been examined in depth by many committees and especially by the Mashelkar Committee who clearly recommended the large strengthening of the existing Drugs Control Administration. The Mashelkar Committee recommended setting up of a Central Drug Administration.
Mashelkar Committee (2003) summary of recommendations: The Committee concluded that the problems in the regulatory system in the country were primarily due to inadequate or weak drug control infrastructure at the State and Central level, inadequate testing facilities, shortage of drug inspectors, non-uniformity of enforcement, lack of specially trained cadres for specific regulatory areas, non-existence of data bank and non-availability of accurate information.
The Committee concluded that the existing infrastructure at the Centre and States was not adequate to perform the assigned functions efficiently and speedily. The Committee felt that creating another authority will not solve the problem at hand. It was essential to strengthen the existing organisations to enable them to undertake all the functions envisaged for NDA. A strong, well equipped and professionally managed CDSCO, which could be given the status of Central Drug Administration (CDA) was the most appropriate solution. A detailed proposal to create such a structure and strengthen the State level regulatory apparatus with complementary roles of the Centre and the States, while at the same time ensuring uniform and effective implementation, has been considered and recommended by the Committee”.
It is difficult to understand why the recommendations of this report are being ignored and the creation of a new body the - Central Drugs Authority with Drug Control Administration as being a part of it is being created, which will create a total confusion and further weaken the functioning of the Drug Control Authority by the DCGI. This matter has been examined earlier by a Parliamentary Standing Committee of Ministry of Health & Family Welfare on Drugs and Cosmetics (Amendment) 2007. The recommendation of this standing committee did not support setting up of a Central Drug Authority independent of DCGI. The Parliamentary Standing Committee’s 13th report in this context states clearly against this.
From Parliamentary Standing Committee on Health & Family Welfare 13th Report on Drugs ; Cosmetics (Amendment) Bill 2007: The Committee also like to draw attention to the following statement made in the Pharmaceutical Policy, 2002: “The Ministry of Health and Family Welfare would set up a world class Central Drugs Standard Control Organisation (CDSCO) by modernizing, restructuring and reforming the existing system and establish an effective network of drug standards enforcements administrations in the States with the CDSCO a nodal centre, to ensure high standards of quality, safety and efficacy of drugs and pharmaceuticals.”
The Committee fails to understand as to why, instead of, implementing the recommendations of the Mashelkar Committee for strengthening, modernizing, restructuring and reforming the existing CDSCO into a world class system, the Government has entered into rigmarole of setting up a new Authority. Central Drugs Authority, a small body primarily having members with administrative background taking the place of the two Drug Technical Advisory Boards having technical expertise from allopathic and ASU drug sector, is simply not acceptable to the Committee. The Committee, accordingly, recommends the setting up of a 'Central Drug Administration' as an independent body under the Ministry of Health and Family Welfare with its headquarters at Delhi, with its zonal and sub-zonal offices at State level, by strengthening, modernizing and restructuring the CDSCO.
This view has been reiterated in several clauses by the Standing Committee which all together rejected setting up of the proposed Central Drug Authority above the DCGI’s Authority.
There is a need to recognize and review, whether the proposed move as in the drugs Bill is misleading the Parliament. It is now well recognized and accepted that evaluations of drugs and cosmetics is a highly scientific and technical job, relating to evaluations of scientific data related to quality, safety, toxicology, stability, efficacy, and also enforcing the drug regulations effectively. It is important to make provisions that prescribe appointment of scientifically and technically qualified professionals from pharmacy/pharmaceutical sciences/medical qualifications with pharmacology specialisations, and person with impeccable integrity to head the Central and State Drug Control Administration.
Thus what needs to be created without any delay is a strong, well equipped, and professionally managed CDSCO headed by DCGI, which may be called Central Drug Safety and Standards Administration (CDSSA) or by any other suitable name.
The creation of a Central Drug Authority not headed by the DCGI of would not be correct. The drugs Bill may suggest setting up of a small Advisory Committee to the CDSSA consisting of secretaries (or their representatives) of Department of Central Scientific & Industrial Research, Department of Biotechnology, Department of Science & Technology, Department of Health Research, and DG, Indian Council of Medical Research (ICMR), to advise DCGI and CDSSA from time to time. This Advisory body should be in addition to the existing Drug Technical Advisory Board (DTAB) the statutory body under the Drugs & Cosmetics Act, which has served well for over sixty years whose composition need not be changed. There is a strong case to in fact expand Drug Technical Advisory Board with more representatives from scientific and research areas.
The Mashelkar Committee has made very comprehensive recommendations for the restructuring and refurbishing for the National/Central Drugs Administration, which would give adequate coverage for the new responsibilities for the CDSSA. The drugs Bill may make provisions to include any category/item that meets the definition of drugs as per the Act in the regulations under CDSSA, including devices, biotechnology based drugs, vaccines, and separate scientific divisions, supported by Pharmaco-vigilance, GMP inspection team, vigilance team, data management, under DCGI may be created for evaluating them.
The drugs Bill needs to take strong note of the State Licensing Authorities/drug controllers issuing licenses for products that meet the definition of new drugs which rests with DCGI. This includes the controversial fixed dose combinations (FDCs – new combination of two or more drugs already approved which are new drugs and need careful review of its quality, safety and efficacy by the DCGI’s office/expert committee). Current imbroglio with many cases in Courts have emanated from States issuing licences for many fixed dose combinations without Central (DCGI’s review). The drugs Bill should put provisions that clearly stating the authority and evaluation procedures for fixed dose combinations. The issue of allowing drugs for clinical use in the country for those drugs which not been clinically tested in India has often come up for serious consideration. Very clear guidelines need to be drawn up that this shall be restricted only to life saving drugs such as for cancers and for not any other condition. A highly competent Standing Committee should be formed for this purpose, and unless cleared by this committee no drug would be allowed to be clinically tested. Similarly, provisions for 'New Cosmetics' and its clinical trials are seen in the Bill tabled in Rajya Sabha. In the absence of a clear definition of 'New Cosmetics' and also scientifically there is nothing like a new cosmetics, the Parliamentary Standing Committee had recommended to delete all regulations proposed for clinical trials of cosmetics, and the same needs to be considered. If any product wishes to test cosmetics for benefits that are drug like, then the product becomes a drug and ceases to be cosmetic. The dugs Bill should add a clause to hold mandatory review and upgradation of the regulations once in three or four years to take care of social, sociological technological and life style changes affecting the society.
Ten years have elapsed since the time Mashelkar Committee submitted its report in 2003, and the matter of strengthening of the drug regulations and its machinery is already delayed and needs to be resolved at the earliest. The Indian pharmaceutical industry has done remarkably well in the manufacture of quality generic drugs at affordable/competitive prices and is now ready to take up drug discovery and development research, it needs the support of a highly competent drug control administration to regulate effectively its development and growth, so that the products of the Indian pharmaceutical industry are globally accepted.
(The author is an eminent pharmacist, and has served as a member of the Mashelkar Committee).