As of April 30, Telangana has 1,012 confirmed cases of COVID-19 (9th highest in the country).  Of these, 367 have been cured, and 26 have died.  In this blog, we summarise some of the key decisions taken by the Government of Telangana for containing the spread of COVID-19 in the state and relief measures taken during the lockdown.

Movement Restrictions

For mitigating the spread of COVID-19 in the state, the Government of Telangana took the following measures for restricting the movement of people in the state.

Closure of commercial establishments: On March 14, the government ordered for the closure of cinema halls, amusement parks, swimming pools, gyms and museums until March 21 which was later extended to March 31.

Lockdown:  To further restrict the movement of people, the state and central governments announced lockdown in the state and country.  The lockdown included: (i) closing down state borders, (ii) suspension of public transport services, (iii) prohibiting congregation of more than five people.  The entities providing essential commodities and services were exempted from these restrictions.

 

 

 

 

 

 

 

 

 

 

 

Starting from April 20, the central government allowed certain activities in less-affected districts of the country.  However, on April 19, the state government decided not to allow any relaxation in Telangana until May 7.

Health Measures

Telangana Epidemic Diseases (COVID-19) Regulations, 2020: On March 21, the government issued the Telangana Epidemic Diseases (COVID-19) Regulations, 2020.  The regulations are valid for one year.  Key features of the regulations include:

 (i) All government and private hospitals should have dedicated COVID-19 corners,

 (ii) People who had travelled through the affected areas should be home quarantined for 14 days,

(iii) Procedures to be followed in the containment zones among others.

Private Hospitals: On March 22, for increasing the availability of healthcare facilities in the state, the government issued an order prohibiting private hospitals from performing any elective surgeries.  The hospitals were also instructed to have separate counters for respiratory infections.

Increasing the health workforce in the state: On March 30, the government issued notification for the recruitment of medical professionals on a short term basis.

Prohibition on spitting in public places: On April 6, the Department of Health, Medical and Family Welfare department banned spitting of paan, any chewable tobacco or non-tobacco product, and sputum in public places.

Welfare measures

To mitigate the hardships faced by the people, the government took various welfare measures. Some of them are summarized below:

Relief assistance: On March 23, the government announced the following measures:  

  • 12 kg of rice will be provided for free to all food security cardholders.
  • One-time support of Rs 1,500 will be provided to all food security card holding families for buying essential commodities such as groceries and vegetables.

Factories: On March 24, the government directed the management of factories to pay the wages to all workers during the lockdown period.  

Migrant Workers: On March 30, the government decided to provide 12 kg of rice or atta and one time of support of Rs 500 to all migrant workers residing in the state.

Regulation of school fees: On April 21, the government ordered all private schools not to increase any fees during the academic year of 2020-21.  The schools will charge only tuition fees on a monthly basis. 

Deferment of collection of rent: On April 23, the government notified that house owners should defer the rent collection for three months.  Further, the owners should collect the deferred amount in instalments after three months.

Administrative Measures

Deferment of salaries: The government announced 75% deferment of salaries of all the state legislators,  chairperson of all corporations and elected representatives of all local bodies.  The government employees will have salary deferment from 10% to 60%.  Employees of the  Police Department, Medical and Health Department, and sanitation workers employed in all Municipal Corporations and Municipalities are exempted from deferment of salary.

Chief Minister's Special Incentives: The government granted special incentives to certain categories of employees as follows:

  • Medical and Health Department:  The employees of the Department of Medical and Health were given an additional 10% of their gross salary as an incentive for March and April,
  • Sanitation personnel: The sanitation employees of Greater Hyderabad Municipal Corporation were given 7,500 rupees and the sanitation personnel of other local bodies were provided 5,000 rupees as incentives for March and April,
  • Police: The police personnel were awarded an additional 10% of their gross salary as an incentive for April. 

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.