PARLIAMENT OF INDIA
`RAJYA SABHA
`
`59
`
`DEPARTMENT-RELATED PARLIAMENTARY STANDING
`COMMITTEE ON HEALTH AND FAMILY WELFARE
`
`FIFTY-NINTH REPORT
`ON
`THE FUNCTIONING OF THE CENTRAL DRUGS
`STANDARD CONTROL ORGANISATION (CDSCO)
`
`(PRESENTED TO THE RAJYA SABHA ON 8 MAY, 2012)
`(PRESENTED TO THE RAJYA SABHA ON 8 MAY, 2012)
`TH
`TH
`(LAID ON THE TABLE OF THE LOK SABHA ON 8 MAY, 2012)
`(LAID ON THE TABLE OF THE LOK SABHA ON 8 MAY, 2012)
`TH
`TH
`
`
`RAJYA SABHA SECRETARIATRAJYA SABHA SECRETARIAT
`
`NEW DELHINEW DELHI
`
`MAY, 2012/VAISHAKHA, 1934 (SAKA)MAY, 2012/VAISHAKHA, 1934 (SAKA)
`
`Exhibit 1118
`IPR2017-00807
`ARGENTUM
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`000001
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`Website : http://rajyasabha.nic.in
`E-mail
`: rs-chfw@sansad.nic.in
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`PARLIAMENT OF INDIA
`PARLIAMENT OF INDIA
`RAJYA SABHA
`RAJYA SABHA
`
`DEPARTMENT-RELATED PARLIAMENTARY STANDING
`DEPARTMENT—RELATED PARLIAMENTARY STANDING
`COMMITTEE ON HEALTH AND FAMILY WELFARE
`COMMITTEE ON HEALTH AND FAMILY WELFARE
`
`FIFTY-NINTH REPORT
`FIFTY—NINTH REPORT
`ON
`ON
`
`THE FUNCTIONING OF THE CENTRAL DRUGS
`THE FUNCTIONING OF THE CENTRAL DRUGS
`STANDARD CONTROL ORGANISATION (CDSCO)
`STANDARD CONTROL ORGANISATION (CDSCO)
`
`(PRESENTED TO THE RAJYA SABHA ON 8TH MAY, 2012)
`(PRESENTED TO THE RAJYA SABHA ON 8TH MAY, 2012)
`(LAID ON THE TABLE OF THE LOK SABHA ON 8TH MAY, 2012)
`(LAID ON THE TABLE OF THE LOK SABHA ON 8TH MAY, 2012)
`
`
`
`RAJYA SABHA SECRETARIAT
`RAJYA SABHA SECRETARIAT
`NEW DELHI
`NEW DELHI
`
`APRIL, 2012/VAISHAKHA, 1934 (SAKA)
`APRIL, 2012/VAISHAKHA, 1934 (SAKA)
`
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`CONTENTS
`
`1. COMPOSITION OF THE COMMITTEE .........................................................................................
`
`(i) Main Committee ..........................................................................................................
`
`(ii) Sub-Committee – III on Draft Reports ...................................................................
`
`2. PREFACE
`
`............................................................................................................................
`
`PAGES
`
`(i)-(ii)
`
`(i)
`
`(ii)
`
`(iii)
`
`3. REPORT ..................................................................................................................................
`
`1—32
`
`4. STUDY NOTE ...........................................................................................................................
`
`33—35
`
`5. OBSERVATIONS/RECOMMENDATIONS — AT A GLANCE ............................................................
`
`36—46
`
`6. MINUTES ................................................................................................................................
`
`47—58
`
`(i) Main Committee ..........................................................................................................
`(ii) Sub-Committee – III on Draft Reports ...................................................................
`
`49—54
`55—58
`
`7. ANNEXURES .............................................................................................................................
`
`59—103
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`COMPOSITION OF THE COMMITTEE
`(MAIN COMMITTEE)
`
`RAJYA SABHA
`1. Shri Brajesh Pathak — Chairman
`#2. Shri Janardhan Dwivedi
`*3. Shrimati Viplove Thakur
`4. Dr. Vijaylaxmi Sadho
`5. Shri Balbir Punj
`6. Dr. Prabhakar Kore
`7. Shrimati Vasanthi Stanley
`@8. Shri Rasheed Masood
`9. Shrimati B. Jayashree
`10. Shri Derek O’Brien
`
`LOK SABHA
`11. Shri Ashok Argal
`12. Shrimati Harsimrat Kaur Badal
`13. Shri Vijay Bahuguna
`14. Shrimati Raj Kumari Chauhan
`15. Shrimati Bhavana Gawali
`16. Dr. Sucharu Ranjan Haldar
`17. Dr. Monazir Hassan
`18. Dr. Sanjay Jaiswal
`19. Shri S. R. Jeyadurai
`20. Shri P. Lingam
`21. Shri Datta Meghe
`22. Dr. Jyoti Mirdha
`23. Dr. Chinta Mohan
`24. Shri Sidhant Mohapatra
`25. Shrimati Jayshreeben Kanubhai Patel
`26. Shri M. K. Raghavan
`27. Shri J. M. Aaron Rashid
`28. Dr. Arvind Kumar Sharma
`29. Shri Radhe Mohan Singh
`30. Shri Ratan Singh
`31. Dr. Kirit Premjibhai Solanki
`
`SECRETARIAT
`Shri P.P.K. Ramacharyulu, Joint Secretary
`Shri R.B. Gupta, Director
`Shrimati Arpana Mendiratta, Joint Director
`Shri Dinesh Singh, Deputy Director
`# Ceased to be a Member w.e.f. 27th January, 2012 and re-nominated to the Committee on 2nd February, 2012.
`* Ceased to be a Member w.e.f. 2nd April, 2012.
`@ Ceased to be a Member w.e.f. 9th March, 2012.
`
`(i)
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`SUB-COMMITTEE III ON DRAFT REPORTS –
`
`1. Dr. Jyoti Mirdha — Convenor
`
`RAJYA SABHA
`
`2. Shri Balbir Punj
`
`LOK SABHA
`
`3. Dr. Sanjay Jaiswal
`
`SECRETARIAT
`Shri P.P.K. Ramacharyulu, Joint Secretary
`Shri R.B. Gupta, Director
`Shrimati Arpana Mendiratta, Joint Director
`Shri Dinesh Singh, Deputy Director
`
`(ii)
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`PREFACE
`
`I, the Chairman of the Department-related Parliamentary Standing Committee on Health and
`Family Welfare, having been authorized by the Committee hereby present this Fifty-Ninth Report
`of the Committee on the functioning of the Central Drugs Standard Control Organisation.
`
`During the course of examination of the subject mentioned above, the Committee heard the
`2.
`views of Secretary, Department of Health and Family Welfare along with the representatives of the
`Central Drugs Standard Control Organisation (CDSCO) on the 5th January, 12th October, 2011 and
`04th May, 2012.
`
`During the course of the finalization of its Report, the Committee relied upon the following
`3.
`documents/papers received from the Department of Health and Family Welfare:–
`
`(i)
`
`(ii)
`
`Status Note;
`
`Questionnaire Part I and II on the functioning of CDSCO; and
`
`(iii) Questionnaire Set I and II on the functioning of CDSCO.
`
`Study Note on the visit of the Committee to Tamil Nadu and Karnataka from 1st to 5th
`4.
`November, 2011 on functioning of CDSCO is also attached with Report of the Committee.
`
`The Committee at its meeting held on 4th May, 2012, considered and adopted the Draft
`
`5.
`Report.
`
`The Sub-Committee-III on Draft Reports considered and adopted the Report at its meeting
`6.
`held on 11th April, 2012.
`
`For facility of reference and convenience, observations and recommendations of the
`7.
`Committee have been printed in bold letters in the body of the Report.
`
`NEW DELHI;
`4rd May, 2012
`Vaishakha 14, 1934 (Saka)
`
`BRAJESH PATHAK
`Chairman,
`Department-related Parliamentary
`Standing Committee on Health and Family Welfare.
`
`(iii)
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`1
`
`REPORT
`
`INTRODUCTION
`
`1.
`
`Drug Regulation
`
`Drugs are an integral and inseparable part of medical care. As per the directory of
`1.1
`pharmaceutical manufacturing units in India brought out by the National Pharmaceutical Pricing
`Authority in 2007, more than 10,500 drug manufacturers are operating in the country with
`estimated turnover of just over Rs. 50,000 crore for domestic sale alone.
`
`Medicines apart from their critical role in alleviating human suffering and saving lives have
`1.2
`very sensitive and typical dimensions for a variety of reasons. They are the only commodity for
`which the consumers have neither a role to play nor are they able to make any informed chokes
`except to buy and consume whatever is prescribed or dispensed to them because of the following
`reasons:
`•
`•
`•
`•
`
`Doctors decide which drugs and brands to prescribe;
`
`Consumers are totally dependent on and at the mercy of external entities to protect
`their interests.
`
`Drug regulators decide which medicines can be marketed;
`
`Pharmaceutical companies either produce or import drugs that they can profitably sell;
`
`It is because of these typical dimensions that the state’s responsibility to regulate the
`1.3
`import, manufacture and sale of medicines so as to ensure that they are both safe, effective and
`of standard quality acquire almost sacrosanct dimensions. Under the circumstances, effective,
`transparent drug regulation free from commercial influences is essential to ensure the safety,
`efficacy and quality of drugs with just one objective, i.e., welfare of patients.
`
`Taking into account the immense importance and impact of drug regulation on humanity,
`1.4
`the Committee examined the functioning of The Central Drugs Standards Control Organisation
`(CDSCO), the agency mandated with the task of drug regulation in India to determine if rules and
`laws were being implemented efficiently and honestly in the interest of patients. It did not go into
`the scientific Issues such as merits of medicines being sold in the country. As the successive
`narrative would unravel, the drug regulatory system in the counhy suffers from several deficiencies
`and shortcomings, some systemic and severa] manmade.
`
`15.
`
`Licensing and monitoring of manufacturing facilities and distribution channels,
`
`Post-marketing adverse drug reaction (ADR) monitoring,
`
`Drug regulation covers many functions, namely:
`• Marketing approval of new medicines based on safety and efficacy studies,
`•
`•
`•
`•
`•
`•
`
`Quality control (QC),
`
`Periodic review and re-evaluation of approved drugs,
`
`Conhol of drug promotion
`
`Regulation of drug trials.
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`1.6 While most functions pertaining to drug regulation come under the jurisdiction of Central
`Government and are carried out by the Central Drug Standards Conhol Organization (CDSCO),
`others viz. licensing and monitoring of manufacturing units and distribution channels; quality
`control etc. are carried on by state level drugs authorities under the administrative control of State
`Governments.
`
`Drugs and Cosmetics Act, 1940 and Rules 1945, Drugs & Magic Remedies (Objectionable
`17.
`Advertisements) Act, 1954 as amended from time to time are the principal legislations that govern
`the functioning of CDSCO and state drug authorities.
`
`Drugs belonging to various systems of medicine (Allopathy, Homoeopathy, Ayurveda, Siddha
`1.8
`and Unani) as well as cosmetics are regulated by CDSCO. However the present Report is confined
`to the aspect of regulation by the CDSCO and related agencies of drugs used in modem medicine
`only.
`
`2.
`
`Mandate and Structure of CDSCO
`
`In its Status Report on CDSCO, the Ministry of Health and Family Welfare stated that the
`2.1
`mission of CDSCO was to “meet the aspirations.... demands and requirements of the
`pharmaceutical industry.” As against this, the stated missions of Drug Regulatory Authorities of
`developed countries are as follows:
`
`United States: The Food and Drugs Administration (USFDA) mission is, “protecting the
`public health by assuring the safety, efficacy, and security of human and veterinary drugs.”
`
`United Kingdom: The Medicine and Healthcare Regulatory Authority’s (MHRA) mission is
`“to enhance and safeguard the health of the public by ensuring that medicines and medical
`devices work, and are acceptably safe.”
`
`Australia: The mission statement of Therapeutic Coods Administration (TGA) states:
`“Safeguarding public health & safety in Australia by regulating medicines....”
`
`The Committee is of the firm opinion that most of the ills besetting the system of
`2.2
`drugs regulation in India are mainly due to the skewed priorities and perceptions of
`CDSCO. For decades together it has been according primacy to the propagation and
`facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest
`stakeholder i.e. the consumer has never been ensured. Taking strong exception to this
`continued neglect of the poor and hapless patient, the Committee recommends that the
`Mission Statement of CDSCO be formulated forthwith to convey in very unambiguous terms
`that the organization is solely meant for public health.
`
`The Ministry, in the status note, has stated that CDSCO, headed by the Drugs Controller
`2.3
`General (India) [DCGI] in the Directorate General of Health Services under the Ministry of Health
`and Family Welfare is responsible for performing regulatory functions under the Drugs and
`Cosmetics Act, 1940 and Rules.
`
`The Committee has noted that the CDSCO with its Headquarters at New Delhi has six zonal
`2.4
`offices situated at Mumbai, Chennai, Kolkata, Ghaziabad, Hyderabad, Ahmedabad and three sub-
`zonal offices at Bangalore, Jammu and Chandigarh for performing certain activities in coordination
`with the State Drug Authorities. It has offices at 11 seaports/airports at Mumbai (sea and airport),
`Nhava Sheva (sea port), Kolkata (sea and airport), Chennai (sea and airport), Hyderabad (Airport),
`Delhi (Airport), Kochi (seaport) and Ahmedabad (airport), to regulate the import and export of
`drugs and cosmetics. It has six drug-testing laboratories situated at Kolkata, Mumbai, Chennai,
`Guwahab, Chandigarh and Hyderabad.
`
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`The Ministry has further informed the Committee that CDSCO performs the following
`2.5
`functions at its Headquarters:
`
`(i)
`
`Grant of approval to manufacture and/or import of new drugs including vaccines and
`bio-therapeutic products after examining their safety and efficacy.
`
`(ii)
`
`Grant of permission to conduct clinical trials.
`
`(iii) Approval of the licenses to manufacture certain categories of drugs as Central
`License Approving Authority (CLAA), i.e., blood banks, large volume parenterals,
`vaccines/sera, r-DNA derived products, in-vitro diagnostic kits for detection of HIVl
`& 2, HCV & HBsAg and notified medical devices.
`
`(iv) Registration of foreign manufacturers whose products are to be imported into the
`country, in respect of drug formulations/Bulk drugs, Medical Devices, Blood
`products.
`
`(v) Grant of licenses to import drugs in the country.
`
`(vi) Grant of Test Licenses for import of drugs for the purpose of examination, test and
`analysis.
`
`(vii) Grant of licenses to import drugs by Government hospitals or Medical Institutes for
`the use of their patients.
`
`(viii) Grant of permissions for manufacture of drugs for the purpose of exports which are
`otherwise not permitted to be manufactured in the country.
`
`(ix) Convening the meetings of Drugs Technical Advisory Board (DTAB) to discuss
`matters arising out of the administration of the D&C Act and the Rules and
`recommend amendments, if required.
`
`(x)
`
`Convening the meetings of the Drugs Consultative Committee (DCC) to secure
`uniformity throughout India in the administration of this Act and Rules.
`
`(xi) Coordinating the activities of the State Drug Authorities and advising them on matters
`relating to uniform administration of the Act and Rules in the country.
`
`(xii) Monitoring of adverse drug reactions as a part of Pharmaco-vigilance programme.
`
`(xiii) Recommend banning of drugs considered harmful or sub-therapeutic under Section
`26A of the Drugs and Cosmetics Act.
`
`(xiv) Clinical trial site inspections.
`
`(xv) Conducting workshops and training programs in respect of various issues related to
`quality control of drugs.
`
`The Committee noted from the background note that the zonal/sub-zonal offices perform
`2.6
`the following functions:
`•
`
`Inspection of manufacturing premises jointly with State Drug Authorities for drugs
`covered under the CLAA Scheme, i.e., IV Fluids, large volume parenterals, vaccine
`& sera, blood & blood products, r-DNA products (biotech products), etc., for the
`purpose of grant/renewal of licenses.
`
`•
`
`Inspection of private testing laboratories in coordination with the State Drug
`Inspectors for approval of these laboratories for carrying out tests on drugs/
`cosmetics on behalf of the licensees.
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`•
`
`•
`
`•
`•
`
`•
`
`Inspection of manufacturing facilities of the firms for grant of WHO GMP
`Certification Scheme.
`
`Inspection of firms for capacity assessment and other provisions at the request of the
`Central Government.
`
`Inspections to investigate complaints received from various forums.
`
`Coordination with the State Drug Authorities to sort out problems involved in the
`investigations of drugs manufactured in one State and declared “Not of Standard
`Quality” in another State and other such matters.
`
`Launching of prosecutions in cases detected by the zonal offices of CDSCO.
`
`According to the Ministry, the Airport and Seaport Offices monitor and regulate import and
`2.7
`export of drugs and cosmetics and also draw samples for verifying the quality.
`
`2.8
`
`The Central Drug Testing Laboratories perform the following functions:
`
`(i)
`
`(ii)
`
`To undertake the testing/analysis of drugs and cosmetics;
`
`Act as an Appellate Authority for the class of drugs notified under the Act; and
`
`(iii) Central Drug Laboratory, Kolkata maintains reference standards as per Indian
`Pharmacopoeia for testing of drugs.
`
`The Ministry also stated that the activities of zonal/sub-zonal and port offices have been
`2.9
`harmonized in a manner so as to strengthen CDSCO during the last two years. Comprehensive
`guidelines for harmonization of activities of zonal/sub zonal/port offices of CDSCO have been
`prepared and came into effect on 1.6.2011. These are available on CDSCO website.
`
`The Committee was also informed that the following functions have been delegated to the
`2.10
`zonal offices of CDSCO w.e.f. 1.6.2011.
`
`(i)
`
`(ii)
`
`(iii)
`
`Grant of NOC for obtaining licence from State Drug Authority to manufacture drugs
`for examination, test and analysis purpose.
`
`Grant of NOC for manufacture of unapproved/ approved new drugs and banned
`drugs for the purpose of exports.
`
`To grant permission for import of small quantities of drugs for personal use as per
`Drugs and Cosmetics Rules.
`
`(iv) NOC for import of dual use items not for medicinal use.
`
`On a query as to how far CDSCO has been successful in carrying out its wide-ranging
`2.11
`regulatory functions, the Ministry stated that CDSCO with limited manpower and infrastructure is
`carrying out functions assigned to it to the best of its capabilities. The Ministry, however, felt that
`to meet the aspirations of industry and other stakeholders and bringing it at the lever of developed
`countries, a strong, well-equipped, independent and professionally managed CDSCO is the need of
`the day. The pharmaceutical industry is growing at the rate of approximately 10% per year. The
`Ministry stated that the workload of CDSCO is increasing at the rate of approximately 20% per
`year while there is no corresponding rise in the manpower and infrastructure to meet the demand
`of the industry and discharge mandatory functions.
`
`The Ministry, explaining about the initiatives taken to strengthen the CDSCO stated that it
`2.12
`is being expanded to meet the requirements of the pharmaceutical industry. Two sub-zonal offices
`at Hyderabad and Ahmedabad have been converted into zonal offices. Three new sub-zonal offices
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`at Bangalore, Jammu and Chandigarh have been set up to cater to the need of the pharmaceutical
`industry.
`
`It was also stated that in order to maintain quality of drugs stored at the Air Ports for
`2.13
`import or export, pharmaceutical zones at Delhi, Hyderabad and Mumbai Air Ports are being set
`up for proper storage of drugs.
`
`2.14 On being asked to comment as to whether CDSCO (Hqrs) has the requisite infrastructure,
`the Committee was informed that there were four Deputy Drugs Controllers and five Assistant
`Drugs Controllers in Headquaters. These nine officers have to handle each year the work load of
`approximately 20,000 applications, over 200 meetings, attending to 11,000 public/industry
`representatives, responding to 700 parliament questions, around 150 court cases etc. Further, these
`nine officers also attend the meetings of DTAB and its sub-committees, Drugs Consultative
`Committee, National List of Essential Medicines (NELM), prepare the guidance documents on
`various subjects, provide inputs for amendments of Drugs and Cosmetics Act and Rules, build up
`pharmacovigilance programme, train the newly recruited staff and attend any other tasks assigned
`by Director-General of Health Services or Ministry of Health and Family Welfare, from time to
`time. Each officer, thus, handles multiple responsibilities and is in charge of various sections of
`different technical requirements leading to their being overburdened and overstretched.
`
`The Ministry is of the opinion that there is very poor infrastructure to handle matters like
`2.15
`budget, recruitment, administration, and procurement. On a question as to whether there exists any
`effective mechanism by which the CDSCO Headquarters is in a position to co-ordinate and monitor
`the functioning of its zonal offices, sub-zonal offices, sea ports & airports offices and drug testing
`laboratories, the Ministry stated that CDSCO, at present, does not have a separate division for
`coordinating activities of all these offices. It is, however, proposed to have a separate division to
`coordinate such activities as and when the manpower is available. It was also brought to the notice
`of the Committee that there is a need for computer management system and video conferencing
`facilities for quick availability of information, creation of database and better co-ordination between
`the offices by linking through the networking managed by a professional agency.
`
`Explaining about the steps taken to strengthen the manpower at CDSCO, the status of
`2.16
`various posts sanctioned/ created/proposed has been given as under:
`
`No. of permanent posts as
`on 2008
`
`No. of new posts created
`in 2008 and 2009
`
`111
`
`216
`
`No. of additional
`proposed posts
`
`1045
`
`The Committee noted that the permanent staff, in position, as on October, 2011 is 124 out
`2.17
`of 327 sanctioned posts. Besides, 140 contractual staff are working at the Headquarters of the
`CDSCO. It was also stated that filling up of 203 vacant posts in CDSCO through UPSC, in
`consultation with the Ministry, was bein8 done and filling up of following posts was in process
`including:
`•
`
`2 posts of Joint Drugs Controller (India) UDC(I)] being filled up by deputation
`through UPSc.
`
`•
`
`•
`
`•
`
`5 posts of Deputy Drugs Controller (India) [DDC(I)] being filled up by direct
`recruitment through UPSc.
`
`16 posts of Assistant Drugs Controller (India) [ADC(I)] being filled up by deputation
`through UPSc.
`
`100 posts of Drug Inspectors being filed up by direct recruitment through UPSc.
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`•
`
`31 posts of Assistant Drugs Inspectors being filled up by direct recruitment through
`Staff Selection Commission.
`
`In regard to appointment of medical doctors in CDSCO, the Health Secretary informed the
`2.18
`Committee that the doctors do not wish to join CDSCO. It was further stated that though
`recruitment rules provide for appointing people with MBBS Degree or/with pharmacology,
`microbiology, but usually, there was no response from the persons from these fields.
`
`The Committee notes with serious concern that CDSCO is substantially under-
`2.19
`staffed. Of the 327 sanctioned posts, only 124 are occupied. At this rate, what would be the
`fate of 1,045 additional posts that have been proposed is a moot point. If the manpower
`requirement of the CDSCO does not correspond with their volume of work, naturally, such
`shortage of staff strains the ability of the CDSCO to discharge its assigned functions
`efficiently. This shortcoming needs to be addressed quickly. Consideration can also be given
`to employ medically qualified persons as Consultants/Advisers (on the pattern of Planning
`Commission) at suitable rank.
`
`The Committee also gathers that the average time taken for the completion of
`2.20
`recruitment process is approximately 12 to 15 months. The Committee, therefore,
`recommends that to overcome the staff shortage, the Ministry should engage professionally
`qualified persons on short-term contract or on deputation basis until the vacancies are filled
`up. Due to the very sensitive nature of regulatory work, great care will need to be taken
`to ensure that persons employed for short periods did not and will not have Conflict of
`Interest for a specified period.
`
`2.21 At the same time, the optimal utilization of the current staff in the best interest of
`public is the responsibility of those who run the CDSCO. In a resource-constrained country
`like India, it is extremely difficult to meet the demands, however, genuine, of all the State
`entities in full. Hence, prioritization is the key. For example, work relating to an application
`for Marketing Approval of a New Drug that will be used by millions and thus have an
`impact on the well being of public at large in India for years to come, is far more important
`and urgent than giving permission to a foreign company to conduct clinical trials on an
`untested new patented, monopoly drug.
`
`The Committee also observes that the strengthening of drugs regulatory mechanisms
`2.22
`cannot be achieved by manpower augmentation alone. A host of issues involving capacity-
`building of CDSCO like upgradation of existing offices, setting up of new offices, creation
`of new central drugs testing laboratories and equipping them with the state-of-the-art
`technology to enable them to carry out sophisticated analysis of drugs, upgradation of the
`existing 6 Central Drugs Testing Laboratories, skill development of the regulatory officials,
`implementation of an effective result-oriented pharmacovigilance programme drawing on
`global experience, increased transparency in decision-making of CDSCO etc. will have to be
`addressed before the desired objectives are realized.
`
`In the absence of any reasons for unwillingness on the part of medically qualified
`2.23
`persons to join CDSCO, the Committee is of the opinion that emoluments and perquisites
`may not be the main or only reason. It is noticed that minimum prescribed academic
`qualifications for the post of DCGI is barely B.Pharm. On the other hand for Deputy Drugs
`Controller (DDC), the prescribed minimum qualification is post-graduation for medically
`qualified persons. The stumbling block is the requirement that DCGI should have
`experience in the “manufacture or testing of drugs or enforcement of the provisions of the
`Drugs and Cosmetic Act for a minimum period of five years.” This requirement virtually
`excludes even highly qualified medical doctors from occupying the post of DCGI. Moreover
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`7
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`the rule stipulates that doctors with post-graduation should be either in pharmacology or
`microbiology only, thus excluding post-graduates, even doctorates (like DM) in a clinical
`subject. Besides, highly qualified medical doctors may be reluctant to work under and report
`to a higher officer with lesser qualifications in a technology driven regulatory authority set-
`up. Unless these concerns are addressed, it would be difficult to get the desperately required
`medically qualified professionals on the rolls of CDSCO.
`
`3.
`
`Qualification and Powers of DCGI
`
`The drug sector has two distinct manifestations nowadays. On one hand, drugs
`3.1
`development and manufacturing is a very capital intensive and long term affair, on the other, the
`end product is to be made available to a multitude of very differently placed people so as to ensure
`their health and well being. In such a peculiar situation, the role of the drugs regulator has
`undoubtedly assumed critical significance. S/he has to be an outstanding professional of proven
`merit and standing who ensures that the massive investment compulsions of the drugs industry
`never outweigh the public health interests. With this aim in mind, the Committee went into details
`of qualifications and experience of Heads of National Drugs Regulatory Authorities of United States
`and United Kingdom.
`
`The Commissioner of United States Food and Drugs Administration (USFDA) is an
`3.2
`experienced medical doctor, scientist, and public health specialist. After doing medical course at
`Harvard Medical School, she conducted research on neuroscience at Rockefeller University, studied
`neuron pharmacology at the National Institute of Mental Health, and later focused on AIDS research
`as an Assistant Director of the National Institute of Allergy and Infectious Diseases. In 1994, she
`became one of the youngest persons ever elected to the Institute of Medicine. In 1997, at the
`request of the then President of USA, she accepted the position of Assistant Secretary for Policy
`and Evaluation in the U.S. Department of Health and Human Services (HHS) before taking over as
`chief of USFDA.
`
`The Committee also noted that the current Chief Executive of the British Medicine and
`3.3
`Healthcare Regulatory Authority (MHRA) is a professor qualified in medicine from Cambridge,
`followed by post-graduation and epidemiological training at Harvard School of Public Health in the
`United States. He then taught as Senior Lecturer in Clinical Pharmacology at Leicester University.
`His clinical and research interests have been in coronary heart disease. He was the Regional
`Director of Research and Development, National Health Service Executive, Trent. Before taking up
`the current position in MHRA, he was the Director, NHS Health Technology Assessment Program.
`
`Compared to the above, the academic qualifications of the Licensing Authority (i.e. Drugs
`3.4
`Controller General, India) are specified in Rule 49A and 50A of the Drugs and Cosmetic Rules. As
`per these Rules, the Licensing Authority (DCGI) should be (a) a graduate in pharmacy or
`pharmaceutical chemistry (B.Pharm) or (b) a graduate in medicine with specialization (post-
`graduation) in clinical pharmacology or microbiology (MD) with five years’ experience.
`
`The Ministry informed the Committee that the Mashelkar Committee, 2003, had
`3.5
`recommended for providing financial power to the DCGI at par with heads of CSIR and ICMR.
`The specific observation of the Mashelkar Committee is that the functions of CDSCO involve
`considerable sourcing of expertise from external experts and institutions. It is necessary that such
`consultations are managed speedily, since drug regulatory activities are very time-sensitive. This
`would require provision of sufficient funds at the disposal of DCGI to mitke payments of
`honorarium and travel expenses without delay, as per the systems available with CSIR and ICMR
`
`The Committee fails to understand as to how a graduate in pharmacy or
`3.6
`pharmaceutical chemistry (B.Pharm) is being equated with a medical graduate with MD in
`
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`8
`
`Pharmacology or Microbiology. Apart from the obvious anomaly, with rapid progress in
`pharmaceutical and biopharmaceutical fields, there is urgent need to revise the
`qualifications and experience as minimum eligibility criteria for appointment as DCGI. The
`Committee is of the view that it is not very rational to give powers to a graduate in
`pharmacy, who does not have any clinical or research experience to decide the kinds of
`drugs that can be prescribed by super specialists in clinical medicine such as those holding
`DM and PhD qualifications and vast experience in the practice of medicine and even
`research.
`
`On a larger plane, the Committee is disillusioned with the qualifications provided in
`3.7
`the age old Rules for the head of a crucial authority like CDSCO. The extant Indian system
`is nowhere in so far as sheer competence and professional qualifications are concerned when
`compared with countries like USA and UK. There is, therefore, an urgent need to review
`the qualifications, procedure of selection and appointment, tenure, emoluments, allowances
`and powers, both administrative and financial of the DCGI. While doing so, the Government
`may not only rely on the Mashelkar Committee Report which recommended augmented
`financial powers to DCGI but also take cue from similar mechanisms functioning in some
`of the developed countries like USA, UK, Canada, etc. in order to ensure that only the best
`professional occupies this onerous responsibility. The Committee should be kept informed of
`the steps taken to address this issue.
`
`In the considered opinion of the Committee, there can never be a more opportune
`3.8
`time than now, to usher in these changes recommended by it. The post of DCGI is vacant
`as of now, with an official holding temporary charge. They, therefore, desire that the
`Government should take immediate measures in terms of their instant recommendations to
`ensure that CDSCO is headed by an eminent and professionally qualified person.
`
`4.
`
`Role of the State Drug Regulatory Authorities
`
`In reply to a query, the Ministry has informed the Committee that the condition of state
`4.1
`drugs regulatory systems is a matter of serious concern. The Committee was informed that in
`order to make the State Governments appreciate their responsibilities and obligations and for
`strengthening their licensing and enforcement apparatus, the issue was discussed in the 39th
`meeting of the Drugs Consultative Committee held on 10 December, 2008 and in the Conference
`of the State Health Ministers and Health Secretaries held at Hyderabad from 11 to 13 January, 2011.
`One of the key resolutions adopted in the aforesaid Conference was that the Centre and State
`Governments should draw up a time-bound action plan for creation of new posts and filling up of
`vacant posts mainly of Drugs Inspectors and upgradation of Drugs Testing Laboratories.
`
`The Ministry also informed the Committee that the Mashelkar Committee in 2003 had
`4.2
`recommended one drugs inspector