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Legislation

Lapses in the process of drug approval in India

Sakshi - May 29, 2012

The Parliamentary Standing Committee on Health and Family Welfare tabled a Report in Parliament on May 8, 2012, on the functioning of the Central Drugs Standard Control Organization (CDSCO).  CDSCO is the agency mandated with the regulation of drugs and cosmetics in India.  The Report covers various aspects of drug regulation including organizational structure and strength of CDSCO, approval of new drugs, and banning of drugs, among others. Following the Report, the Minister of Health and Family Welfare has constituted a Committee to look into the procedure for drug regulation.  The Committee is expected to make its submissions within a period of two months. This post focuses on irregularities in the approval of new drugs by CDSCO.  It discusses the regulations relating to drug approval and the Standing Committee's observations on the working of CDSCO. Approval of new drugs Drugs are regulated by the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetic Rules, 1945 [Rules].  The CDSCO, under the Ministry of Health and Family Welfare, is the authority that approves new drugs for manufacture and import.  State Drug Authorities are the licensing authorities for marketing drugs. New Drugs are defined as:

  • drugs that have not been used in the country before,
  • drugs that have been approved by a Licensing Authority but are now being marketed for different purposes, and
  • fixed dose combinations of two or more drugs that have been individually approved before but are proposed to be combined in a fixed ratio that has not been approved.

The Rules require an applicant for a new drug to conduct clinical trials in India to determine the drug’s safety and efficacy.  These trials are necessary for both domestically manufactured and imported drugs.  However, the authority can exempt a drug from the requirement of local and clinical trials in the public interest based on data available in other countries. Observations and recommendations of the Committee The Committee found that a total of 31 new drugs were approved between January 2008 and October 2010 without conducting clinical trials on Indian patients.  The Report mentioned that drug manufacturers, CDSCO officials and medical experts colluded to approve drugs in violation of laws.  Following are some of the Report’s findings:

  • Under the Rules, the Drugs Controller General (India) (DCGI), the head of CDSCO, can clear sites of clinical trials after ensuring that major ethnic groups are enrolled in these trials to have a truly representative sample.  This rule was violated by the DCGI when sites for clinical trials were approved without ensuring diversity.  The Committee recommended that the DCGI approve sites for trials only if they cover patients from major ethnic backgrounds.
  •  The Report found that certain actions by experts were in violation of the Code of Ethics of the Medical Council of India.  A review of expert opinions revealed that several medical expert recommendations had been given as personal opinions rather than on the basis of scientific data.  Additionally, many expert opinions were written by what the Report calls ‘the invisible hands’ of drug manufacturers.  The Committee recommended that CDSCO formulate a clear set of written guidelines on the selection process of experts with emphasis on expertise in the area of drugs.
  •  The Rules ban the import and marketing of any drug whose use is prohibited in the country of origin.  CDSCO violated this rule by approving certain Fixed Dose Combination drugs for clinical trials without considering the drugs’ regulatory status in their respective country of origin.  Drugs such as Deanxit and Buclizine, which have been prohibited for sale and use in their countries of origin, Denmark and Belgium, respectively, were approved for clinical trials.  The Committee recommended an inquiry into the unlawful approval of these drugs.
  • The Rules require animal studies to be conducted for approval of a drug for use by women of reproductive age.  CDSCO violated this rule in approving Letrozole for treating female infertility.  Globally the drug has only been used as an anti-cancer drug for use among post-menopausal women.  The drug has not been permitted for use among women of reproductive age because of side effects.  The Committee recommended that responsibility be fixed for unlawfully approving Letrozole.
  •  Rules require Post-marketing Safety Update Reports (PSURs) on drugs to be submitted to CDSCO.  PSURs are used to collect information on adverse effects of drugs on Indian patients as a result of ethnic differences.  When asked by the Committee to furnish PSURs on 42 randomly selected new drugs, the Ministry was able to submit PSURs for only 8 drugs.  The Report contended that this action reflected a poor follow-up of side effects on Indian patients.  The Committee recommended that manufacturers of new drugs be warned about suspension of marketing approval unless they comply with mandatory rules on PSURs.
Parliament

President’s Address 2014 to 2017: Plan vs. Performance

Roopal Suhag - February 6, 2017

Budget Session 2017 commenced with the President, Pranab Mukherjee, addressing a joint sitting of Parliament on January 31, 2017.  This address by the President highlights the legislative and policy activities and achievements of the government in the previous year.  In addition, it gives a broad indication of the government’s agenda for the year ahead.  The address is followed by a motion of thanks that is moved in each House by ruling party MPs.  This is followed by a discussion on the address and concludes with the Prime Minister replying to the points raised during the discussion.

In the lower house, the motion of thanks has begun today.  It began in the upper house on February 2, 2017.  Lok Sabha and Rajya Sabha have allocated two and three days for the discussion, respectively.  In this context, we present an analysis of the salient points of the agenda proposed in the President’s address from 2014 to 2017 and the current status of its implementation.

Policy priority stated in the President’s address (2014 to 2017) Current Status 
Macroeconomy
  • GDP growth has made India the world’s fastest growing economies, among large economies.
  • Foreign exchange reserves have been at an all-time high, and inflation, current account deficit and fiscal deficit have consistently reduced since 2014.
  • The GDP is estimated to grow at 7.1% in 2016-17, compared to its growth of 7.9% in 2015-16.[i]
  • The Economic Survey 2016-17 has stated the GDP growth to be between 6.75% and 7.5% in 2017-18.[ii]
  • The average CPI inflation declined from 5.6% in December 2015 to 3.4% in December 2016.[iii]  In the same period, food inflation also decreased from 6.4% from 1.4%.3
  • Current account deficit decreased from USD 14.7 billion in 2015-16 (April-September) to USD 3.7 billion in the corresponding period in 2016-17.[iv]
  • Foreign exchange reserves presently stand at Rs 24,54,950 crore, an increase of Rs 1,02,130 crore from 2016.[v]
Poverty eradication and financial inclusion
  • The Pradhan Mantri Jan Dhan Yojana was launched to provide universal access to banking facilities.  The coverage under the scheme is close to 100%.
  • The proposed Postal Payment Bank of India will further boost financial inclusion.
  • Presently, around 27 crore accounts have been opened under the scheme.[vi]  However, out of these, 25% of the accounts are zero balance accounts.6
  • The Indian Postal Payments Bank has started.[vii]  The postal network with over 1.5 lakh post offices will also function as postal banks.7
Agriculture and water security
  • Pradhan Mantri Fasal Bima Yojana has expanded risk-coverage, doubled the sum insured, and facilitated low premium for farmers.
  • The government is also committed to implementation of Interlinking of Rivers Project.
  • Pradhan Mantri Fasal Bima Yojana has been implemented by 21 states.[viii]  3.66 crore farmers have been covered under the scheme, out of a total of 11 crore farmers in the country.[ix]
  • In April 2015, a Task Force was constituted on the Interlinking of Rivers Project.[x]  The Task Force is yet to submit its report.  The sub-Committee on restructuring the National Water Development Agency in September 2015 had recommended that a National Interlinking of Rivers Authority should be created through an Act of Parliament.[xi]  So far, further steps have not been taken in this regard.
Energy
  • The Electricity (Amendment) Bill, 2014 has been introduced to bring reforms in the electricity sector.
  • Renewable energy capacity will manifold to 175 GW by 2022.
  • The Electricity (Amendment) Bill, 2014 is pending in the Parliament.  The Standing Committee submitted its report on the Bill in May, 2015.[xii]
  • As of December 2016, 51 GW of renewable energy has been generated in the country.[xiii]  However, in 2016-17, only 26% of the target of the generation of renewable energy could be achieved.13
Governance and legal reforms
  • Close to 1,800 obsolete legislation are at various stages of repeal.
  • My government is committed to providing 33% reservation to women in the Parliament and state Legislative Assemblies.
  • Amendments to the Prevention of Corruption Act are also on the anvil.
  • 758 Appropriation Acts and 295 laws have been repealed.[xiv],[xv]
  • No Bill in relation to providing 33% reservation to women has been introduced yet.
  • The Prevention of Corruption (Amendment) Bill, 2013, is presently pending in Parliament.  The Standing Committee and Rajya Sabha Select Committee have submitted their reports on the Bill.
Defence
  • One Rank One Pension scheme will be implemented.
  • Defence procurement procedure has been streamlined with a focus on indigenously designed, developed and manufactured weapon systems.
  • Recognising the importance of coastal security, the government will set up a National Maritime Authority.
  • The government will also build a National War Memorial to honour the gallantry of our soldiers.
  • The implementation of One Rank One Pension scheme has been initiated.[xvi]  In 2016-17, Rs 12, 456 crore was allocated to the scheme.[xvii]
  • The Defence Procurement Policy 2016 added an additional category “Buy (Indian-Indigenously Designed, Developed and Manufactured) as the most preferred way of capital acquisition.[xviii]
  • The National Maritime Authority and National War Memorial are yet to be established.
Environment
  • Funds will be released to states and union territories for aggressive afforestation.
  • To conserve the Himalayan ecology, a National Mission on Himalayas will be launched.
  • Target for emission standards for motor vehicles has been drastically brought forward to achieve Bharat Stage –VI norm by 2021.
  • Parliament passed the Compensatory Afforestation Fund Bill, 2015 in July 2016.[xix]  The Bill establishes the National Compensatory Afforestation Fund and a State Compensatory Afforestation Fund for each state.  These Funds will be primarily spent on afforestation.
  • The National Mission on Himalayas is yet to be launched.
  • To make Bharat Stage-VI norms applicable by April 1, 2020, a draft notification was released in February 2016.[xx]
Rural and Urban Development
  • To develop 300 rural growth clusters across the country, Shyama Prasad Mukherji Rurban Mission has also been launched.
  • Mission Antyodaya, an intensive participatory planning exercise has been initiated.
  • Annual action plan for 500 cities with an outlay of Rs 50,000 crore has been approved.
  • To implement the Rurban mission, Rs 5,142 crore has been allocated for the period from 2015-16 to 2019-20.[xxi]
  • Under Mission Antyodaya, the release of funds has been lower than the allocated amount in the last three years, from 2014-15 to 2016-17.[xxii]
  • Under the Smart Cities Mission, Rs 4,572 has been released to 98 cities during the years 2015-16 and 2016-17.[xxiii]
Health
  • My government will formulate a New Health Policy and roll out a National Health Assurance Mission.

 

  • Pradhan Mantri Bharatiya Jan Aushadi Pariyojana has been launched to ensure that the poor have access to quality medicines at affordable prices.
  • A group was constituted in July 2014 to prepare a comprehensive background paper for the roll out of the National Health Assurance Mission.[xxiv]  Further progress in this regard has not been made.
  • The draft National Health Policy was released in December 2014 for public comments and suggestions.[xxv]  The Policy has not been finalised yet.
  • Under the Pradhan Mantri Bharatiya Jan Aushadi Pariyojana, Pradhan Mantri Bhartiya Janaushadhi Kendras are proposed to be opened in all 630 districts of the country.[xxvi]
Women and child development
  • A Bill to amend the Juvenile Justice Act has been introduced in Parliament to reform the law relating to juvenile offences.
  • The Juvenile Justice (Care and Protection of Children) Bill, 2014 was passed by Parliament in December 2015.[xxvii]  The Bill permits juveniles between the ages of 16-18 years to be tried as adults for heinous offences.


[Sources: President’s Address to the Parliament from 2014 to 2017; PRS.]

For important highlights from the President’s address in 2017, please see here.  For an analysis of the status of implementation of the announcements made in the 2016 address, please see here.


[i] “Press note on First Revised Estimates of National Income, 2015-16”, Ministry of Statistics and Programme Implementation, January 31, 2017, http://mospi.nic.in/sites/default/files/press_release/nad_PR_31jan17.pdf.

[ii] Economic Survey, 2016-17, http://finmin.nic.in/indiabudget2017-2018/e_survey.asp.

[iii] “Press Release Consumer Price Index Numbers on Base 2012=100 for Rural, Urban and Combined for the Month of December 2016”, Ministry of Statistics and Programme Implementation, January 12, 2017,http://mospi.nic.in/sites/default/files/press_release/CPI_PR12jan17th.pdf

[iv] “Developments in India’s Balance of Payments during the second quarter of 2016-17”, Reserve Bank of India, December 13, 2016, https://www.rbi.org.in/scripts/BS_PressReleaseDisplay.aspx?prid=38884.

[v] “Developments in India’s Balance of Payments during the second quarter of 2016-17”, Reserve Bank of India, December 13, 2016, https://www.rbi.org.in/scripts/BS_PressReleaseDisplay.aspx?prid=38884.

[vi] Progress Report, Pradhan Mantri Jan Dhan Yojana (Last accessed on January 24, 2017),http://www.pmjdy.gov.in/account.

[vii] “Cabinet approves setting up of India Post Payments Bank”, Cabinet, June 1, 2016.

[viii] “Achievements of Ministry of Agriculture and Farmers Welfare”, Ministry of Agriculture, January 2, 2016.

[ix]  “Agricultural Statistics at a Glance 2015”, Department of Agriculture, Cooperation and Farmer’s Welfare, Ministry of Agriculture and Farmer’s Welfare, http://eands.dacnet.nic.in/PDF/Agricultural_Statistics_At_Glance-2015.pdf.

[x] “Task Force on Interlinking Rivers Constituted”, Press Information Bureau, Ministry of Water Resources, April 14, 2015.

[xi] Special Committee for Interlinking of Rivers, National Water Development Agency,http://www.nwda.gov.in/writereaddata/ilr/notification.pdf.

[xii] Report No. 4, Standing Committee on Energy, ‘The Electricity (Amendment) Bill, 2014’, Lok Sabha, May 2015, Standing Committee on Energy, http://www.prsindia.org/uploads/media/Electricity/SC%20report-Electricity.pdf.

[xiii] “Physical Progress (Achievements)”, Ministry of New and Renewable Energy,  March  30, 2015,http://mnre.gov.in/mission-and-vision-2/achievements/.

[xiv] Appropriation Acts (Repeal) Act, 2016, http://lawmin.nic.in/ld/Act22of2016AppropriationActsrepeal.pdf.

[xv] Repealing and Amending Act, 2016, http://lawmin.nic.in/ld/Act23of2016RepealingandAmending.pdf.

[xvi] 12(1)/2014/D (Pen/PoI)- Part II, Government of India, Ministry of Defence, Department of Ex- Servicemen Welfare, November 7, 2015, http://www.desw.gov.in/sites/upload_files/desw/files/pdf/OR OP-DESW-MOD.pdf.

[xvii] Lok Sabha Unstarred Question 1696, Ministry of Defence, November 25, 2016,http://164.100.47.190/loksabhaquestions/annex/10/AU1696.pdf.

[xviii] “Year End Review 2016”, Ministry of Defence, December 31, 2016,http://pib.nic.in/newsite/PrintRelease.aspx?relid=156049.

[xix] The Compensatory Afforestation Fund Act, 2016,http://www.prsindia.org/uploads/media/Compensatory%20Afforestation/CAMPA%20act,%202016.pdf.

[xx] Rajya Sabha Unstarred Question No 82, Ministry of Road Transport and Highways, April 25, 2016.

[xxi] Rajya Sabha Unstarred Question No 914, Department of Rural Development, May 2, 2016 ,http://164.100.47.234/question/annex/239/Au914.pdf.

[xxii] Lok Sabha Unstarred Question No 4443, Ministry of Housing and Urban Poverty Alleviation, December 14, 2016, http://164.100.47.190/loksabhaquestions/annex/10/AU4443.pdf.

[xxiii] Lok Sabha Unstarred Question No 199, Ministry of Urban Development, November 16, 2016,http://164.100.47.190/loksabhaquestions/annex/10/AU199.pdf.

[xxiv] “Rolling out of National Health Assurance Mission”, Press Information Bureau, Ministry of Health and Family Welfare, July 15, 2014.

[xxv] Draft National Health Policy 2015, December 2014, Ministry of Health and Family Welfare,http://www.mohfw.nic.in/showfile.php?lid=3014.

[xxvi] Pradhan Mantri Bharatiya Jan Aushadi Pariyojana guidelines,http://janaushadhi.gov.in/data/Individuals_December_2016.pdf.

[xxvii] The Juvenile Justice (Care and Protection of Children) Act, 2015,http://www.prsindia.org/uploads/media/Juvenile%20Justice/Juvenile%20Justice%20Act,%202015.pdf.

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