On January 17, 2020, the Ministry of Health and Family Welfare acknowledged the emergence of COVID-19 pandemic that was spreading across China.  Tamil Nadu reported its first confirmed case of COVID-19 on March 7, 2020.   As of April 28, the state has 1,937 confirmed cases of COVID-19 (seventh highest in the country).  Of these, 1,101 have recovered (third highest rate of recovery in the country among states with 100 or more cases) and 24 have died.  The state government has taken several actions to contain the spread and impact of COVID-19.  In this blog, we look at the key measures taken by the Tamil Nadu government between January 19 and April 28, 2020. 

 image

Initial phase

The Tamil Nadu government came out with a series of responses between January 19 and February 1.  These included: (i) readying Rapid Response Teams (RRTs) at state and district levels, (ii) setting up of a 24/7 control room, (iii) thermal scanning of air travellers from China, (iv) creating isolation wards in the General Hospitals of four major cities, and (v) running appropriate awareness campaigns. 

Some of the other early measures are summarised below:

Health measures

  • On March 13, the Governor declared COVID-19 to be a notified disease in the state of Tamil Nadu, under the Tamil Nadu Public Health Act, 1939.  Notifying a disease allows for incidences of the disease to be mandatorily reported to the government and in turn, helps authorities to respond with appropriate measures to prevent the spread of the disease. 

  • On March 15, the government prescribed the Tamil Nadu COVID-19 Regulations, 2020.  These regulations detail the responsibilities of hospitals and individuals, and the powers of officials in relation to the diagnosis, treatment, and containment of COVID-19. These include (i) creation of isolation wards in hospitals, (ii) containment measures in an area once positive cases are detected, and (iii) mandatory 14-day home isolation for asymptomatic air travellers from COVID-19 affected countries.

  • On March 15, the government also mandated a 14-day institutional isolation for all air travellers to prevent import of infections from other states.  The state also initiated setting up of testing camps and conducting disinfectation drives in the border districts. 

Travel and Movement

  • On March 15, the government notified a series of instructions that restricted the movement of people in the state.  These include (i) shutting down of establishments, such as, educational institutions (up to Class 5), theatres, malls etc, and (ii) banning of inter-state travel for 15 days. 

  • On March 16, the government announced additional restrictions till Mar 31, such as, closure of: (i) anganwadis and making alternate provision of dry ration for children at their homes, (ii) swimming pools, amusement parks, gyms, zoos, museums, bars, clubs etc, and (iii) all educational institutions, except the conduct of practical exams for class 10 and 12, and various entrance exams.  

  • State borders were sealed off for road traffic, except for movement of essential commodities, from March 20 to March 31.  Public transportation services, such as metro rail and inter-state private buses, were also suspended till March 31. 

  • The Prime Minister asked the country to observe a Janta Curfew from 7 am to 9 pm on March 22,. The state government further extended this curfew to 5 am on March 23.  Following this, the government immediately announced a state-wide lockdown from March 24 up to April 1. 

  • On April 5, the government issued an advisory for the quarantine of migrant workers and the conduct of health camps for them. 

Welfare Measures

  • On March 15, the government announced financial assistance of a total of Rs 60 crore to various departments, such as, health, transport etc, to take precautionary measures to combat COVID-19.

  • On March 24, the government announced the distribution of cash support of Rs 1,000 to all entitled family cardholders.  Further, they were also eligible for free supply of essential commodities such as rice, dal, sugar, etc, during the month of April, through the Public Distribution System (PDS). 

During the lockdown

A state-wide lockdown was announced from March 24 to April 1, followed by a nation-wide lockdown between March 25 and April 14.  On April 13, the state-wide lockdown was extended up to April 30. This was followed by the extension of the nation-wide lockdown from April 15 to May 3. Under this, certain activities could be resumed after April 20. 

Some of the key measures undertaken during the lockdown period are: 

Travel and movement

  • Amidst the lockdown, on March 25, the government notified that establishments providing essential goods and services, which were allowed to operate.  These included establishments such as  (i) police forces, (ii) treasury, (iii) public utilities, (iv) banks, (v) media, (vi) telecommunications, and (vii) shops dealing with food, groceries etc.  Further, on March 28, the government permitted a few agriculture-related establishments to operate, such as, Mandis, fertiliser shops, and agencies involved in procurement of agriculture products. 

  • An Expert Committee formed by the state government to formulate guidelines for phased exit from lockdown after April 20, recommended the extension of the lockdown till May 3.  Certain select activities were, however, permitted to resume operations from April 20 onwards. These include (i) MNREGA works related to irrigation and water conservation, (ii) rural construction projects on irrigation, dam safety, hospital buildings, roads and bridges, and (iii) state and central government offices at one-third capacity.  

  • In view of rising number of cases, on April 24, stringent curfew orders were passed in the districts of (i) Chengalpattu, (ii) Kancheepuram, and (iii) Thiruvallur. The curfew will be imposed between April 26 and April 29, from 6 am to 9 pm, and with more stringent restrictions than under the ongoing nation-wide lockdown, such as, (i) petrol bunks to operate only between 8 am and 12 noon, and (ii) supermarkets and shops to remain shut. 

  • Curfew orders were passed in 5 more districts.  In Chennai, Coimbatore and Madurai, curfew is imposed between 6 am and 9 pm from April 26 to April 29.  In Salem and Tiruppur, curfew was imposed from April 26 to April 28. 

Welfare Measures

  • On March 30,   the government announced a cash assistance of Rs 1,500 per month to be credited into the bank accounts of differently-abled persons.  It also announced that transgenders without ration cards, were eligible to receive 12kg of rice, 1kg of dal, and 1 litre of cooking oil, from fair price shops (FPS).

  • On April 2, the government announced a concession package to manufacturers of COVID-19 related medical equipment, who will commence production before July 31, 2020. The package applied to both MSMEs and large manufacturers of equipment, such as, ventilators, Personal Protection Equipment (PPE) kits and medicines.  Some of the concessions include: (i) 30% capital subsidy, upto Rs 20 crore, (ii) 100% stamp duty waiver, (iii) 6% interest subvention for capital loans for two quarters, (iv) commencement of manufacturing without prior approval, and (v) provision of necessary land on priority basis for short-term/long-term leases, etc. 

  • Rs 50 lakh grant was announced to the families of frontline workers in the event of their unfortunate demise.  If infected by COVID-19, they are eligible for Rs 2 lakh assistance towards treatment costs.  In certain cases, if eligible, their kin would also receive a government job offer. 

  • On April 7, the government announced that MLALAD funds could be utilised for COVID-19 prevention and containment activities. A total of Rs 1.25 crore can be utilised towards prevention, containment, treatment, and purchase of medical equipment, PPEs etc.

Health Measures

  • On April 2, the government released a list of designated COVID-19 hospitals in the state. Instructions were issued to refer all COVID-19 positive cases exclusively to these designated hospitals. However, willing citizens were also permitted to approach private hospitals, at their own cost. Private hospitals were further instructed to establish dedicated fever clinics to cope with the increasing load of flu and fever cases.

  • Amidst a rise in the number of cases, on April 4, the government issued instructions to: (i) avoid all kinds of religious gatherings, (ii) hospitals to not show religious bias in treating patients, and (iii) doctors to coordinate with the government and check in on the mental health of quarantined patients via video conferencing facilities such as Skype.

  • On April 5, the government issued cluster containment measures to stop the transmission, morbidity, and mortality associated with the further spread of COVID-19. This was in response to the large number of imported infections from the attendees of the Nizamuddin conference in Delhi. 

  • Resource Management: On March 27, the Chief Minister announced an additional COVID-19 related recruitment of doctors and lab technicians. The recruited members were to join within three days of the notification. On April 25, an additional 1,323 nurses were also recruited.

  • A two-month extension was announced to the tenures of medical professionals retiring on March 31 and April 30.

  • The government also instructed District Authorities to ensure the protection of doctors and other hospital staff who are being forcefully evicted from their houses by landlords. As a measure to develop immunity against COVID-19, the government, on April 25, also recommended providing Zinc and Vitamin tablets, and herbal powder to all personnel on frontline duty in containment areas. 

Other Measures

  • Administrative: Eleven committees have been formed to coordinate implementation of various welfare programmes. In all districts, Crisis Management Committees have been formed under the district collector. 

  • Education: The conduct of semester examinations in universities and colleges is postponed to the beginning of the next academic year, as and when the institutions reopen. Private colleges and schools were also instructed to not compel students/parents to pay pending dues for 2019-20 or advance fees for 2020-21. 

  • Industry: On April 22, the government released a list of industries classified as continuous process industries. These are companies where the production lines are functioning 24/7. The list includes (i) refineries, (ii) large steel plants, (iii) large cement plants, (iv) sugar mills, (v) large paper mills, (vi) tyre manufacturers etc. 

  • Technology: The government launched a Whatsapp Chat Bot for providing latest information and guidance related to COVID-19 in both Tamil & English.

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.