As of May 11, 2020, there are 67,152 confirmed cases of COVID-19 in India.   Since May 4, 24,619 new cases have been registered.  Out of the confirmed cases so far, 20,917 patients have been cured/discharged and 2,206 have died.  As the spread of COVID-19 has increased across the country, the central government has continued to announce several policy decisions to contain the spread, and support citizens and businesses who are being affected by the pandemic.  In this blog post, we summarise some of the key measures taken by the central government in this regard between May 4 and May 11, 2020.

Source: Ministry of Health and Family Welfare; PRS.

Industry

Relaxation of labour laws in some states

The GujaratHimachal PradeshRajasthanHaryana, and Uttarakhand governments have passed notifications to increase maximum weekly work hours from 48 hours to 72 hours and daily work hours from 9 hours to 12 hours for certain factories.  This was done to combat the shortage of labour caused by the lockdown.  Further, some state governments stated that longer shifts would ensure a fewer number of workers in factories so as to allow for social distancing.

Madhya Pradesh has promulgated the Madhya Pradesh Labour Laws (Amendment) Ordinance, 2020.  The Ordinance exempts establishments with less than 100 workers from adhering to the Madhya Pradesh Industrial Employment (Standing Orders) Act, 1961, which regulates the conditions of employment of workers.  Further, it allows the state government to exempt any establishment or class of establishments from the Madhya Pradesh Shram Kalyan Nidhi Adhiniyam, 1982, which provides for the constitution of a welfare fund for labour.  

The Uttar Pradesh government has published a draft Ordinance which exempts all factories and establishments engaged in manufacturing processes from all labour laws for a period of three years.  Certain conditions will continue to apply with regard to payment of wages, safety, compensation and work hours, amongst others.  However, labour laws providing for social security, industrial dispute resolution, trade unions, strikes, amongst others, will not apply under the Ordinance. 

Financial aid 

Central government signs an agreement with Asian Infrastructure Investment Bank for COVID-19 support

The central government and Asian Infrastructure Investment Bank (AIIB) signed a 500 million dollar agreement for the COVID-19 Emergency Response and Health Systems Preparedness Project.   The project aims to help India respond to the COVID-19 pandemic and strengthen India’s public health system to manage future disease outbreaks.  The project is being financed by the World Bank and AIIB in the amount of 1.5 billion dollars, of which one billion dollars is being provided by World Bank and 500 million dollars is being provided by AIIB.  This financial support will be available to all states and union territories and will be used to address the needs of at-risk populations, medical personnel, and creating medical and testing facilities, amongst others.   The project will be implemented by the National Health Mission, the National Center for Disease Control, and the Indian Council of Medical Research, under the Ministry of Health and Family Welfare.

Travel 

Restarting of passenger travel by railways

Indian Railways plans to restart passenger trains from May 12 onwards.  It will begin with 15 pairs of trains which will run from New Delhi station connecting Dibrugarh, Agartala, Howrah, Patna, Bilaspur, Ranchi, Bhubaneswar, Secunderabad, Bengaluru, Chennai, Thiruvananthapuram, Madgaon, Mumbai Central, Ahmedabad and Jammu Tawi.  Booking for reservation in these trains will start at 4 pm on May 11.  Thereafter, Indian Railways plans to start more services on new routes.  

Return of Indians stranded abroad

The central government will facilitate the return of Indian nationals stranded abroad in a phased manner beginning on May 7.  The travel will be arranged by aircraft and naval ships.  The stranded Indians utilising the service will be required to pay for it.  Medical screening of the passengers will be done before the flight.  On reaching India, passengers will be required to download the Aarogya Setu app.  Further, they will be quarantined by the concerned state government in either a hospital or a quarantine institution for 14 days on a payment basis.  After quarantine, passengers will be tested for COVID-19 and further action will be taken based on the results.    

For more information on the spread of COVID-19 and the central and state government response to the pandemic, please see here.

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.