As of April 22, Uttar Pradesh has seen 1,449 cases of coronavirus disease (COVID-19) and accounts for 6.8% of the total cases in India.  Of the 1,449 persons infected of the disease, 173 have recovered and 21 have died (3.1% of the total deaths in India due to the disease).  These proportions are quite lower as compared to the state’s share in the country’s population (16.5% as per Census 2011).  However, the same holds for the number of persons tested for COVID-19 as well, as of the 4.85 lakh persons tested in India, 37,490 persons (7.7%) have been tested in Uttar Pradesh.

To mitigate the spread of COVID-19 in the state, the state government has taken various measures over the past 2-3 months, spanning across areas such as health, law and order, and social welfare.  This includes imposition of lockdown in 16 districts starting March 23, which was extended to the entire state on March 24, before the nation-wide lockdown came into effect.   This blog post looks at the key measures taken by the state government in response to COVID-19 and the lockdown.

Before the lockdown

One of the earliest steps the state government took in response to COVID-19 was on January 27, when it planned to set up a 10-bed isolation ward in every district hospital and medical college, and increased vigilance on the Indo-Nepal border and airports.  Subsequently, on March 15, it ordered all travellers coming from foreign countries to be kept under surveillance and quarantine for a period of 14 days.  Between March 13 and March 17, the government ordered the closure of educational institutionscinema halls, museums, and tourist spots to prevent public gatherings.   On March 20, this was extended to include malls, and all religious, social, and cultural activities.  Further, to prevent unnecessary crowding, government hospitals were ordered to provide emergency services only.

Welfare measures:  The state government also undertook certain relief measures to provide aid to the persons affected due to COVID-19 and the consequent loss of economic activities.  These include: (i) free treatment for all persons infected with COVID-19, (ii) order to all employers to provide 28-days paid leave to infected or quarantined persons under the Epidemic Diseases Act, 1897, (iii) another order under the Act to all shops and factories to provide paid leave to all workers if the government orders temporary closure of their business, (iv) free one-month ration to 1.65 crore registered construction workers and daily wage labourers for April, and (v) Rs 1,000 per month of direct cash support to 20.4 lakh registered construction workers, and to 15 lakh street vendors and other unregistered workers.

During the lockdown

During the lockdown, the state government’s measures have been aimed towards: (i) strengthening the medical response in the state, (ii) providing relief to various sections of the society from issues being faced during the lockdown, including UP migrants in other states, and (iii) addressing difficulties being faced in the supply of essential goods and services.  For implementation of these measures, the government constituted 11 committees on March 26 for the work related to various departments.  On April 13, similar committees were constituted under the respective Ministers.

Healthcare

Medical facilities:   On March 23, committees were constituted in each district to determine the process for purchase of emergency medical equipment.   On March 25, the government ordered each of the 51 government and private medical colleges in the state to set up isolation wards of 200-300 beds.   It also proposed to conduct training programmes at district-level for AYUSH doctors, nursing staff, retired health workers, and officers of army medical corps.   This was subsequently made more comprehensive by including lab technicians, ward boys, and sweepers.

Testing:  On April 3, the government ordered setting up one testing lab in every medical college, or in a district hospital, in case there is no medical college in the district.   On April 20, the government decided to encourage the use of pool testing within the state to contain the spread of COVID-19.   It also approved consideration of plasma therapy as a treatment option for COVID-19.

Funding:  On April 3, the UP COVID Care Fund was set up for strengthening treatment facilities in medical colleges, and for expenditure on personal protection equipment, test kits, ventilators, isolation and quarantine wards, and telemedicine.  Subsequently, two Ordinances were promulgated on April 8 to deduct the salaries and allowances of Ministers, MLAs, and MLCs for 2020-21 by 30% to donate Rs 20 crore to the UP COVID Care Fund.   Further, Rs 1,509 crore was made available for the Fund by suspending the Local Area Development scheme for legislators for a period of one year.  In addition, the government increased the limit of the Contingency Fund from Rs 600 crore to Rs 1,200 crore through an Ordinance to allow for extra-budgetary expenditure on COVID-19 related measures.

Hotspots:  On April 8, the government sealed the hotspot areas across the state by prohibiting any movement in the area.  Only medical, sanitisation, and doorstep delivery teams are allowed to enter and exit the hotspot areas, and all enterprises are required to be completely closed.  The government has also ordered for door-to-door checking of the residents living in hotspot areas.

Essential goods and services

Other than the distribution of ration, the state government is providing food to persons staying in night shelters, with community kitchens being set up for persons who are unable to cook.  On April 17, the government made access to the Public Distribution System (PDS) universal till June 30, irrespective of the availability of ration card and Aadhaar card.  In case of death of a person, his ration card, maintenance allowance, and other benefits will be provided to his family as per their eligibility.

To prevent profiteering from sale of essential goods, on March 28, the government ordered the shopkeepers to display the price list in their shops.   On March 29, the government decided that the supply of electricity and water will be ensured and these connections will not be cut for one month.  Subsequently, it also ordered that fixed charges for electricity will not be levied for industries during the period of lockdown.  On April 3, the government ordered banks to remain open on holidays so that government relief assistance is available to the beneficiaries.

Migrants

From other states:  On March 26, the state government decided that migrant workers travelling through the state to other states such as Bihar will be provided food and shelter, and sent safely to their destination.  Subsequently, on March 28, the government decided to prepare the list of migrants who came to the state, provide them food, and keep them under surveillance and quarantine.  On April 22, the government allowed migrants from other states to go back to their home state if the respective state government decides to take them back.

From UP:  The state government requested other states to provide food and shelter to the migrants from UP present in their states, and requested the migrants to stay where they are.  To provide further support to migrants, the state government appointed senior administrative and police officials as nodal officers for each state where migrants from UP might be present.  These nodal officers are the main points of contact for migrants living in the respective states.  They are also responsible for coordinating with the respective state government and local administration to ensure the essential needs of migrants such as food and shelter are met, and alleviate their difficulties, if any.

On April 19, the government brought nearly 8,000 students who were studying in Kota back to the state.  The government allowed them to be kept in quarantine in their homes provided they download the Aarogya Setu app.

Economy

The state government is encouraging the purchase of produce by Farmer Producer Organisations directly from farms as an alternate option to mandis.   On April 13, the government formed a committee of officials to prepare a workplan for attracting investment made by countries such as USA and Japan, which is moving out of China, to the state.  In this regard, the government is planning to contact the embassies of various countries.  On April 19, it constituted another committee to work towards providing employment to about 5 lakh migrant workers who have returned to the state in the last 45 days.  On April 20, the government also allowed construction work on expressway projects to begin after preparation of an action plan.  In line with the advisories issued by the central government, the state government decided to provide relaxations from the lockdown in districts with less than 10 cases starting April 20.  The district administrations are preparing action plans for opening up industries in these districts, excluding the ones situated in the hotspot areas.

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.