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.

In April 2020, the International Labour Organisation (ILO) estimated that nearly 2.5 crore jobs could be lost worldwide due to the COVID-19 pandemic in 2020.  Further, it observed that more than 40 crore informal workers in India may get pushed into deeper poverty due to the pandemic.  In this blog post, we discuss the effect of COVID-19 on unemployment in urban areas as per the quarterly Periodic Labour Force Survey (PLFS) report released last week, and highlight some of the measures taken by the central government with regard to unemployment.

Methodology for estimating unemployment in PLFS reports

The National Statistics Office (NSO) released its latest quarterly PLFS report for the October-December 2020 quarter.  The PLFS reports give estimates of labour force indicators including Labour Force Participation Rate (LFPR), Unemployment Rate, and distribution of workers across industries.  The reports are released on a quarterly as well as annual basis.  The quarterly reports cover only urban areas whereas the annual report covers both urban and rural areas.  The latest annual report is available for the July 2019-June 2020 period.

The quarterly PLFS reports provide estimates based on the Current Weekly Activity Status (CWS).  The CWS of a person is the activity status obtained during a reference period of seven days preceding the date of the survey.  As per CWS status, a person is considered as unemployed in a week if he did not work even for at least one hour on any day during the reference week but sought or was available for work.  In contrast, the headline numbers on employment-unemployment in the annual PLFS reports are reported based on the usual activity status.  Usual activity status relates to the activity status of a person during the reference period of the last 365 days preceding the date of the survey.

Unemployment rate remains notably higher than the pre-COVID period 

To contain the spread of COVID-19, a nationwide lockdown was imposed from late March till May 2020.   During the lockdown, severe restrictions were placed on the movement of individuals and economic activities were significantly halted barring the activities related to essential goods and services.  Unemployment rate in urban areas rose to 20.9% during the April-June quarter of 2020, more than double the unemployment rate in the same quarter the previous year (8.9%).  Unemployment rate refers to the percentage of unemployed persons in the labour force.  Labour force includes persons who are either employed or unemployed but seeking work.  The lockdown restrictions were gradually relaxed during the subsequent months.   Unemployment rate also saw a decrease as compared to the levels seen in the April-June quarter of 2020.  During the October-December quarter of 2020 (latest data available), unemployment rate had reduced to 10.3%.  However, it was notably higher than the unemployment rate in the same quarter last year (7.9%).

Figure 1: Unemployment rate in urban areas across all age groups as per current weekly activity status (Figures in %)

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Note: PLFS includes data for transgenders among males.
Sources: Quarterly Periodic Labour Force Survey Reports, Ministry of Statistics and Program Implementation; PRS.

Recovery post-national lockdown uneven in case of females

Pre-COVID-19 trends suggest that the female unemployment rate has generally been higher than the male unemployment rate in the country (7.3% vs 9.8% during the October-December quarter of 2019, respectively).  Since the onset of the COVID-19 pandemic, this gap seems to have widened.   During the October-December quarter of 2020, the unemployment rate for females was 13.1%, as compared to 9.5% for males.

The Standing Committee on Labour (April 2021) also noted that the pandemic led to large-scale unemployment for female workers, in both organised and unorganised sectors.  It recommended: (i) increasing government procurement from women-led enterprises, (ii) training women in new technologies, (iii) providing women with access to capital, and (iv) investing in childcare and linked infrastructure.

Labour force participation

Persons dropping in and out of the labour force may also influence the unemployment rate.  At a given point of time, there may be persons who are below the legal working age or may drop out of the labour force due to various socio-economic reasons, for instance, to pursue education.  At the same time, there may also be discouraged workers who, while willing and able to be employed, have ceased to seek work.  Labour Force Participation Rate (LFPR) is the indicator that denotes the percentage of the population which is part of the labour force.  The LFPR saw only marginal changes throughout 2019 and 2020.  During the April-June quarter (where COVID-19 restrictions were the most stringent), the LFPR was 35.9%, which was lower than same in the corresponding quarter in 2019 (36.2%).  Note that female LFPR in India is significantly lower than male LFPR (16.6% and 56.7%, respectively, in the October-December quarter of 2019).

Figure 2: LFPR in urban areas across all groups as per current weekly activity status (Figures in %)

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Note: PLFS includes data for transgenders among males.
Sources: Quarterly Periodic Labour Force Survey Reports, Ministry of Statistics and Program Implementation; PRS.

Measures taken by the government for workers

The Standing Committee on Labour in its report released in August 2021 noted that 90% of workers in India are from the informal sector.  These workers include: (i) migrant workers, (ii) contract labourers, (iii) construction workers, and (iv) street vendors.  The Committee observed that these workers were worst impacted by the pandemic due to seasonality of employment and lack of employer-employee relationship in unorganised sectors.  The Committee recommended central and state governments to: (i) encourage entrepreneurial opportunities, (ii) attract investment in traditional manufacturing sectors and developing industrial clusters, (iii) strengthen social security measures, (iv) maintain a database of workers in the informal sector, and (v) promote vocational training.  It took note of the various steps taken by the central government to support workers and address the challenges and threats posed by the COVID-19 pandemic (applicable to urban areas): 

  • Under the Pradhan Mantri Garib Kalyan Yojana (PMGKY), the central government contributed both 12% employer’s share and 12% employee’s share under Employees Provident Fund (EPF).  Between March and August 2020, a total of Rs 2,567 crore was credited in EPF accounts of 38.85 lakhs eligible employees through 2.63 lakh establishments.
     
  • The Aatmanirbhar Bharat Rozgar Yojna (ABRY) Scheme was launched with effect from October 2020 to incentivise employers for the creation of new employment along with social security benefits and restoration of loss of employment during the COVID-19 pandemic.  Further, statutory provident fund contribution of both employers and employees was reduced to 10% each from the existing 12% for all establishments covered by EPF Organisation for three months.  As of June 30, 2021, an amount of Rs 950 crore has been disbursed under ABRY to around 22 lakh beneficiaries.
     
  • The unemployment benefit under the Atal Beemit Vyakti Kalyan Yojana (launched in July 2018) was enhanced from 25% to 50% of the average earning for insured workers who have lost employment due to COVID-19.
     
  • Under the Prime Minister’s Street Vendor’s Aatma Nirbhar Nidhi (PM SVANidhi) scheme, the central government provided an initial working capital of up to Rs 10,000 to street vendors.  As of June 28, 2021, 25 lakh loan applications have been sanctioned and Rs 2,130 crore disbursed to 21.57 lakh beneficiaries.

The central and state governments have also taken various other measures, such as increasing spending on infrastructure creation and enabling access to cheaper lending for businesses, to sustain economic activity and boost employment generation.