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.

The budget session of Parliament every year starts with the President’s Address to both Houses.  In this speech, the President highlights the government’s achievements and legislative activities in the last year, and announces its agenda for the upcoming year.   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.

Today, the Budget Session 2019 commenced with the President, Mr. Ram Nath Kovind addressing a joint sitting of Parliament.  In his speech, he highlighted some of the objectives that the government has realised in the past year.  The President also highlighted the progress made by the government under various development schemes such as the Swachh Bharat Abhiyan, the Pradhan Mantri Jan Dhan Yojana, and the Pradhan Mantri Gram Sadak Yojana. 

Given that today’s address comes at the end of this government’s term, we examine the status of some key policy initiatives announced by the current government, that have been highlighted in speeches made in the past five years.  

Policy priority stated in President’s Addresses 2014-2018

                                                                       Current Status

Economy and Finance

Despite a global economic downturn, the Indian economy has remained on a high growth trajectory.

 

  • Growth Rate: The GDP is estimated to grow at 7.2% in 2018-19.[i]  In the last five years, GDP growth rate stayed within 7% and 8% per year, with a dip to 6.7% in 2017-18, the year of demonetisation.[ii],[iii]
  • Inflation: A target of 4% for the Consumer Price Index (CPI) inflation was notified by the Ministry of Finance for the period 2016-2021.[iv] CPI stayed within this band for most of the period between 2014 and 2018.
  • Foreign Exchange Reserves stood at USD 397 billion on January 2019, as compared to USD 313 billion in May, 2014.[v],[vi]

Measures to deal with corruption, black money and counterfeit currency will be introduced

 

  • Demonetisation:  On November 8, 2016, the Government announced the demonetisation of Rs 500 and Rs 1000 notes.[vii]  During the period from November 2016 to October 2017, undisclosed income of over Rs 24,800 crore was detected.[viii]
  • The Fugitive Economic Offenders Bill, 2018 was passed in July, 2018.  The Bill seeks to confiscate properties of economic offenders who have left the country to avoid facing criminal prosecution.[ix]
  • The Prevention of Corruption (Amendment) Bill, 2013 amends the Prevention of Corruption Act, 1988.  Under the 1988 Act, taking of a bribe by a public official was an offence.  The Bill also makes the giving of a bribe an offence.[x] 

To promote the concept of cooperative federalism through One Nation-One Tax and One Nation-One Market, the government introduced the Goods and Services Tax

  • Goods and Services Tax was introduced across the country from July 1, 2017.[xi]  

Agriculture

Agriculture is the main source of livelihood for a majority of people.  For holistic development of the agricultural sector, the Pradhan Mantri Fasal Bima Yojana was launched in 2016

  • Pradhan Mantri Fasal Bima Yojana (PMFBY):  PMFBY was launched with the aim of providing insurance coverage and financial support to farmers in the event of crop failure.  The number of farmers enrolled under the scheme declined from 5.7 crore in 2016-17 to 5.2 crore in 2017-18.[xii]  

Employment and Entrepreneurship

The government has continuously worked for reforms of labour laws.  Minimum wages have increased by more than 40%

 

  • Over the last three years, the Ministry of Labour and Employment has introduced three draft Codes to simplify labour laws.  These are: (i) the draft Labour Code on Industrial Relations, (ii) the draft Code on Social Security and (iii) the draft Code on Occupational Safety, Health and Working Conditions.60  Additionally, in 2017, the Code on Wages Bill, 2017 was introduced in the Lok Sabha.
  • In 2017, the central government increased minimum wages by 40% through a gazette notification.  Minimum wages (per day) for non-agricultural workers increased from Rs 250 to Rs 350 for unskilled workers and Rs 523 for skilled workers.[xiii],[xiv],[xv]

Infrastructure

Cities are the engines of economic growth.  The Smart City programme was initiated to build modern amenities and infrastructure.

 

  • Smart Cities and the Atal Mission for Rejuvenation and Urban Transformation (AMRUT) have an outlay of Rs 48,000 crore and Rs 50,000 crore for the period 2015-2020, respectively.[xvi]
  • As of January 19, 2018, 100 smart cities have been selected.  As of 2018, the total proposed investment in these cities is Rs 2,05,018 crore.[xvii],[xviii]

All rural habitations will be connected with all-weather roads. So far, 73,000 kilometres of roads have been laid in rural areas.

 

  • The Pradhan Mantri Gram Sadak Yojana (PMGSY) aims to connect all eligible unconnected habitations in rural areas with all-weather roads by March 2019.[xix],[xx]  As of January 29, 2019, of the target of 1.52 lakh habitations to be covered since the inception of the scheme, 1.46 lakh (96%) habitations have been connected.[xxi]  

Housing is a fundamental right.  All households shall have a dwelling unit under the Mission Housing for All by 2022.

 

  • Pradhan Mantri Awas Yojana (PMAY) was launched in 2015.  The Yojana has two components: rural and urban. 
  • Under PMAY-Urban, 5,33,000 have been completed in 2018-19.  Under PMAY-Rural, 14,21,850 have been built in 2018-19. [xxii],[xxiii]

Health and Sanitation

Poor sanitation weakens the economic wherewithal of a poor household.  The Swachh Bharat Abhiyan aims to ensure health and sanitation. 

  • Swachh Bharat Mission: Swachh Bharat Mission (SBM) was launched on October 2, 2014 to achieve a clean and open defecation free India.  It has two components: SBM Urban and SBM Rural. [xxiv],[xxv]
  • Under SBM Urban, as of January 29, 2019, 24,130 individual household toilets have been constructed.[xxvi]
  • Under SBM Gramin, as of January 30, 2019, 919 lakh individual household toilets have been constructed (98.81% of target). [xxvii],[xxviii]

The government is committed to providing affordable and accessible healthcare to all its citizens, particularly the vulnerable groups.

  • Ayushmaan Bharat: In the General Budget 2018-19, the Government announced two major initiatives in health sector as a part of the Ayushman Bharat program.  These were: Health and Wellness Centres and the Pradhan Mantri Jan Arogya Yojana (PMJAY).[xxix]
  • Ayushmaan Bharat aims to create 1,50,000 health and wellness centres providing comprehensive primary healthcare. Rs 1200 crore has been allocated for this purpose.[xxx] PMJAY will cover over ten crore poor and vulnerable families. [xxxi]  It will provide coverage of up to five lakh rupees per family per year for secondary and tertiary care hospitalisation.  For the year 2018-19, Rs 3,125 crore has been allocated for this scheme.[xxxii]

Source: President’s Addresses 2014-2018; PRS.

For important highlights from the President’s address in 2019, please see here.  For a deeper analysis of the status of implementation of the announcements made in the President’s addresses from 2014 to 2018, please see here.

 

[i] “Press Note on First Advance Estimates of National Income: 2018-19”, Ministry of Statistics and Program Implementation, Press Information Bureau, http://www.mospi.gov.in/sites/default/files/press_release/Presss%20note%20for%20first%20advance%20estimates%202018-19.pdf.

[ii] “Second Advance Estimates of National Income, 2017-18”, Ministry of Statistics and Program Implementation, Press Information Bureau, http://pib.nic.in/newsite/PrintRelease.aspx?relid=176847

[iii] “Second Advance Estimates of National Income, 2016-17”, Ministry of Statistics and Program Implementation, Press Information Bureau, http://pib.nic.in/newsite/PrintRelease.aspx?relid=158734

[iv] Overview-Monetary Policy, Reserve Bank of India, https://www.rbi.org.in/scripts/FS_Overview.aspx?fn=2752

[v] “Foreign Exchange Reserves,”  Reserve Bank of India, January 25, 2019, https://www.rbi.org.in/Scripts/WSSView.aspx?Id=22729.

[vi] RBI Database, https://dbie.rbi.org.in/DBIE/dbie.rbi?site=home.

[vii] Table No.  160, Handbook of Statistics on the Indian Economy, Reserve Bank of India, https://www.rbi.org.in/Scripts/AnnualPublications.aspx?head =Handbook%20of%20Statistics%20on%20Indian%20Economy

[viii] Lok Sabha Unstarred Question No.  1319, Ministry of Finance, December 22, 2017, http://164.100.47.194/Loksabha/Questions/QResult15.aspx?qref=59329&lsno=16.

[ix] “The Fugitive Economic Offenders Bill, 2018”, PRS Legislative Research, March 16, 2018, http://www.prsindia.org/sites/default/files/bill_files/Fugitive%20Economic%20Offenders%20Bill%20-%20Bill%20Summary.pdf.

[x] “The Prevention of Corruption (Amendment) Bill”, PRS Legislative Research, February 12, 2014, http://www.prsindia.org/sites/default/files/bill_files/Bill_Summary-_Prevention_of_Corruption_1.pdf.

[xi] “GST roll-out – Complete transformation of the Indirect Taxation Landscape; Some minute details of how it happened, Ministry of Finance”, Press Information Bureau, June 30, 2017, http://pib.nic.in/newsite/PrintRelease.aspx?relid=167023.

[xii] Lok Sabha Unstarred Question No. 17, Ministry of Agriculture and Farmers Welfare, December 11, 2018, http://164.100.47.190/loksabhaquestions/annex/16/AS17.pdf.

[xiii] “Year End Review, Ministry of Labour and Employment”, December 18, 2017, http://www.pib.gov.in/PressReleseDetail.aspx?PRID=1512998.

[xiv] Rate of Minimum Wages, Ministry of Labour and Employment, March 1 2017, https://labour.gov.in/sites/default/files/MX-M452N_20170518_132440.pdf.

[xv] Gazette Number 173, Ministry of Labour and Employment, January 19, 2017, Gazette of India, http://egazette.nic.in/WriteReadData/2017/173724.pdf.

[xvi] “Union Cabinet approves Atal Mission for Rejuvenation and Urban Transformation and Smart Cities Mission to drive economic growth and foster inclusive urban development”, Press Information Bureau, April 29, 2015, http://pib.nic.in/newsite/PrintRelease.aspx?relid=119925.

[xvii] “Shillong (Meghalaya) gets selected as the 100th Smart City”, Ministry of Housing and Urban Poverty Alleviation, Press Information Bureau, June 20, 2018, http://pib.nic.in/newsite/PrintRelease.aspx?relid=180063

[xviii] “Year Ender- Ministry of Housing and Urban Affairs-2018”, Ministry of Housing and Urban Affairs, Press Information Bureau, December 31, 2018, http://pib.nic.in/PressReleseDetail.aspx?PRID=1557895.

[xix] PMGSY Guidelines, Ministry of Rural Development, last accessed on October 23, 2018. http://pmgsy.nic.in/.

[xx] “Implementation of PMGSY”, Ministry of Rural Development, Press Information Bureau, December 27, 2018, http://pib.nic.in/newsite/PrintRelease.aspx?relid=186837.

[xxi] Online Management, Monitoring and Accounting System (OMMAS), Pradhan Mantri, Gram Sadak Yojana, last accessed on October 23, 2018, http://omms.nic.in/Home/CitizenPage/#.

[xxii] High Level Physical Progress Report, PMAYG, Ministry of Rural Development, last accessed on January 25, 2019, https://rhreporting.nic.in/netiay/PhysicalProgressReport/physicalprogressreport.aspx

[xxiii] “Year Ender-6-PMAY-Ministry of Housing and Urban Affairs, 2018”, Press Information Bureau, December 27, 2018, http://pib.nic.in/PressReleseDetail.aspx?PRID=1557462.

[xxiv] “Swachh Bharat Mission needs to become a Jan Andolan with participation from every stakeholder: Hardeep Puri, 1,789 Cities have been declared ODF conference on PPP model for waste to energy projects”, Ministry of Housing and Urban Affairs, Press Information Bureau, November 30, 2017, http://pib.nic.in/newsite/PrintRelease.aspx?relid=173995.

[xxv] “PM launches Swachh Bharat Abhiyaan”, Prime Minister’s Office, Press Information Bureau, October 2, 2014, http://pib.nic.in/newsite/PrintRelease.aspx?relid=110247.

[xxvi] “Individual Household Latrine Application”, Ministry of Housing and Urban Affairs, last accessed on January 30, 2019, http://swachhbharaturban.gov.in/ihhl/RPTApplicationSummary.aspx.

[xxvii] “Individual Household Latrine Application”, Ministry of Housing and Urban Affairs, last accessed on January 30, 2019, http://swachhbharaturban.gov.in/ihhl/RPTApplicationSummary.aspx.

[xxviii] Swachh Bharat Mission (Gramin), Ministry of Drinking Water and Sanitation, last accessed on January 30, 2019, https://sbm.gov.in/sbmdashboard/Default.aspx.

[xxix] “Ayushman Bharat for a new India -2022, announced”, Ministry of Finance, Press Information Bureau, February 1, 2018,s http://pib.nic.in/newsite/PrintRelease.aspx?relid=176049

[xxx] About NHA, Ayushmaan Bharat, Ministry of Health and Family Welfare, https://www.pmjay.gov.in/about-nha.

[xxxi] “Ayushman Bharat –Pradhan Mantri Jan AarogyaYojana (AB-PMJAY) to be launched by Prime Minister Shri Narendra Modi in Ranchi, Jharkahnd on September 23, 2018”, Ministry of Health and Family Welfare, Press Information Bureau, September 22, 2018, http://pib.nic.in/newsite/PrintRelease.aspx?relid=183624.

[xxxii] National Health Accounts, estimates for 2014-15 Ministry of Health and Family Welfare, https://mohfw.gov.in/newshighlights/national-health-accounts-estimates-india-2014-15.