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As of April 27, 2020, there are 27,892 confirmed cases of COVID-19 in India.  Since April 20, 10,627 new cases have been registered.  Out of the confirmed cases so far, 6,185 patients have been cured/discharged and 872 have died.  As the spread of COVID-19 has increased across India, 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 April 20 and April 27, 2020.

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Source: Ministry of Health and Family Welfare; PRS.

Lockdown

Relaxation of lockdown for shops in specific areas

On April 25, the Ministry of Home Affairs passed an order allowing the opening of: (i) all shops in rural areas, except those in shopping malls, and (ii) all standalone shops, neighbourhood shops, and shops in residential complexes in urban areas.  Shops in markets, market complexes, or shopping malls in urban areas are not allowed to function.  Only shops registered under the Shops and Establishments Act of the respective state or union territory will be allowed to open.  Further, no shops can open in rural or urban areas that have been declared as containment zones.  The order also specifies that the sale of liquor continues to be prohibited. 

Functioning of Central Administrative Tribunals to remain suspended

The functioning of Central Administrative Tribunals will remain suspended until May 3, 2020.  Once functioning begins, certain days already declared as holidays may be reassigned as working days.  This decision was made keeping in mind that most of the Central Administrative Tribunals are located in COVID-19 hotspots. 

Financial measures

RBI announces Rs 50,000 crore special liquidity facility for Mutual Funds

The Reserve Bank of India (RBI) has decided to open a special liquidity facility for mutual funds (SLF-MF) worth Rs 50,000 crore.  This will ease liquidity pressures on mutual funds.  Under the SLF-MF, RBI will conduct repo operations of 90 days tenor at the fixed repo rate.  The SLF-MF will be available for immediate use, and banks can submit their bids to avail funding.  The scheme is available from April 27 to May 11, 2020, or until the allocated amount is utilised, whichever is earlier.  RBI will review the timeline and amount of the scheme, depending upon market conditions.  Funds availed under the SLF-MF can be used by banks exclusively for meeting the liquidity requirements of mutual funds.  This can be done through: (i) extending loans, and (ii) undertaking outright purchase of and/or repos against collateral of investment grade corporate bonds, commercial papers, debentures, and certificates of deposits held by mutual funds.

RBI extends benefits of Interest Subvention and Prompt Repayment Incentive schemes for short term crop loans

The Reserve Bank of India has advised banks to extend the benefits of Interest Subvention of 2% and Prompt Repayment Incentive of 3% for short term crop loans up to three lakh rupees.  Farmers whose accounts have become due or will become due between March 1, 2020 and May 1, 2020 will be eligible. 

Protection of healthcare workers

The Epidemic Diseases (Amendment) Ordinance, 2020 was promulgated 

The Epidemic Diseases (Amendment) Ordinance, 2020 was promulgated on April 22, 2020.  The Ordinance amends the Epidemic Diseases Act, 1897.  The Act provides for the prevention of the spread of dangerous epidemic diseases.  The Ordinance amends the Act to include protections for healthcare personnel combatting epidemic diseases and expands the powers of the central government to prevent the spread of such diseases.  Key features of the Ordinance include:

  • Definitions:  The Ordinance defines healthcare service personnel as a person who is at risk of contracting the epidemic disease while carrying out duties related to the epidemic.  They include: (i) public and clinical healthcare providers such as doctors and nurses, (ii) any person empowered under the Act to take measures to prevent the outbreak of the disease, and (iii) other persons designated as such by the state government.  

  • An ‘act of violence’ includes any of the following acts committed against a healthcare service personnel: (i) harassment impacting living or working conditions, (ii) harm, injury, hurt, or danger to life, (iii) obstruction in discharge of his duties, and (iv) loss or damage to the property or documents of the healthcare service personnel.  Property is defined to include a: (i) clinical establishment, (ii) quarantine facility, (iii) mobile medical unit, and (iv) other property in which a healthcare service personnel has direct interest, in relation to the epidemic. 

  • Protection for healthcare personnel and damage to property:  The Ordinance specifies that no person can: (i) commit or abet the commission of an act of violence against a healthcare service personnel, or (ii) abet or cause damage or loss to any property during an epidemic.  Contravention of this provision is punishable with imprisonment between three months and five years, and a fine between Rs 50,000 and two lakh rupees.  This offence may be compounded by the victim with the permission of the Court.  If an act of violence against a healthcare service personnel causes grievous harm, the person committing the offence will be punishable with imprisonment between six months and seven years, and a fine between one lakh rupees and five lakh rupees.  These offences are cognizable and non-bailable.

For more details on the Ordinance, please see here

Financial aid

Progress under the Pradhan Mantri Garib Kalyan Package 

According to the Ministry of Finance, between March 26 and April 22, 2020, approximately 33 crore poor people have been given financial assistance worth Rs 31,235 crore through bank transfers to assist them during the lockdown.  Beneficiaries of the bank transfers include widows, women account holders under Pradhan Mantri Jan Dhan Yojana, senior citizens, and farmers.  In addition to direct bank transfers, other forms of assistance have also been initiated. These include

  • 40 lakh metric tonnes of food grains have been provided to 36 states and union territories. 

  • 2.7 crore free gas cylinders have been delivered to beneficiaries.

  • Rs 3,497 crore has been disbursed to 2.2 crore building and construction workers from the Building and Construction Workers’ Funds managed by state governments. 

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.