As of April 22, 2020, Sikkim does not have any confirmed cases of COVID-19.  As of April 21, 2020, 87 samples have been sent for testing from Sikkim.  Of these, 80 have tested negative for COVID-19, and the results of seven samples are awaited.  The state has announced several policy decisions to prevent the spread of the virus and provide relief for those affected by it.  In this blog post, we summarise some of the key measures taken by the Sikkim state government in this regard as of April 22, 2020.  

Response before national lockdown

On March 16, the state government responded to the growing number of suspected cases in India by notifying certain directions to be applicable till April 15, 2020.  These included: (i) banning the entry of all domestic and foreign tourists in to the state, (ii) closing all educational institutes and anganwadis, (iii) prohibiting the use of recreational facilities such as, casinos, gym, and cinemas, (iii) closing three out of five check posts (border opening) for all visitors in to the state and opening the other two only for medical and police teams, and (iv) banning private industries from getting migrant workers from outside the state and avoiding large concentration of workers at one place.

On March 19, assembly of more than five people was prohibited in the state until April 15, 2020.  The government ordered the suspension of all non-essential work on March 19.  The supply of all essential commodities such as food grains, vegetables, sanitisers and masks was allowed.  Further, the formation of a sub-divisional task force to detect suspected cases was ordered.  

On March 22, the government regulated intra-state movement of private vehicles, two-wheelers and taxis on an odd-even basis (allowing plying of vehicles on alternate days as per the number plate) until April 15, 2020.  The government also reduced the budget session of the state to two days on March 23. 

On March 25, the central government announced on a 21-day country-wide lockdown till April 14.  During the lockdown the state government took various steps for physical containment, health, financial and welfare measures.  These are detailed below.

Measures taken during lockdown

Movement Restrictions

Certain movement restrictions were put across the state.   These include:

  • Movement of vehicles: Inter-state movement of vehicles was restricted to vehicles transporting essential goods.  These vehicles need to have a permanent pass for such movement.  On April 5, intra-state movement of vehicles was restricted to government officials, transportation of essential commodities, banks and PSUs, and media and cable networks.   Their passes are valid only from 8am to 5pm.
     
  • Validity of passes:  The state government noted that a large number of vehicle passes were issued due to various reasons.  On April 14, the government ordered that all passes issued by District Magistrates, and other Departmental Authorities (except those issued by the police, health department and forest and environment department) will be invalid from April 14.  New passes will be issued only by Magistrates and Block Development Officers.  
     
  • Securing borders:  In view of the COVID-19 pandemic and to check unauthorised cross-border infiltration from China, Nepal, and Bhutan, the state government secured all porous borders along the Rangpo river and other vulnerable areas.

Essential Goods and Services

On April 5, the state government issued an order requiring establishments such as shops, hotels, private offices, and commercial establishments to remain closed until April 15.  Establishments which were permitted to remain functional include law enforcement agencies, health services, electricity and water services, petrol pumps, and media.  Shops for PDS, groceries, vegetables, milk and, medicines were only allowed remain open from 9 am to 4 pm.

  • Valid prescription and label required:  On March 25, the state prohibited the sale of hand sanitisers without drug manufacturing licence label.  It also prohibited sale of N95 masks to general public without valid prescription. 
     
  • Transit camps:  On April 17, the state government notified that transit camps (temporary accommodation) will be set up for drivers and helpers of vehicles carrying essential goods.

Health Measures

On March 31, the Sikkim government identified and set up dedicated isolation wards and treatment centres in the STNM hospital, Sochakgang as a precautionary measure.  The government also issued directions for citizens to avoid getting infected by coronavirus.  These included social distancing, and maintaining proper hygiene.  

On April 18, the state government made it mandatory for all the public, students, teachers, and government employees, to install the Aarogya Setu application.  The government of India launched a mobile app called ‘Aarogya Setu’ to enable people to assess the risk of catching COVID-19 on April 2, 2020.   The app uses Bluetooth and Global Positioning System (GPS) based device location for contact tracing in order to prevent the spread of COVID-19. 

Welfare Measures

  • Economic relief package:  On March 27, an economic relief package was announced by the state government.   This included free ration in specific quantities (other than the PDS entitlement) to needy families in rural and urban areas, daily wagers, migrant labourers, casual workers, and stranded people.  Further, the government announced an additional incentive wage of Rs 300/day for tea workers at Temi-tea estate. 
     
  • Food distribution:  On April 16, the government announced that Asha workers will be given Rs 5,000 as honorarium for work done during COVID-19.  Further, it ordered the food and civil supply department to compile a list of all the left out beneficiaries for distribution of food relief packages.
     
  • Relief to stranded patients:  On April 16, the government announced that a financial relief of Rs 30,000 will be provided to each patient undergoing treatment and stranded outside Sikkim from the Chief Minister's relief fund.
     
  • Relief for casual workers:  On March 30, the Sikkim government issued directions to all contractors/ employers to pay migrant and casual labourers on the due date without any deductions due to the lockdown.  The state government also provided grants worth Rs 2,000 to the 7,836 registered building and other construction workers in the state.
     
  • Relief for stranded students:  On March 29, the state announced that it will provide Rs 5,000 to each state student stranded outside Sikkim during the nationwide lockdown.

Certain relaxations after 20th April 

On April 14, the nation-wide lockdown was further extended till May 3, 2020.  On April 15, the Ministry of Home Affairs issued guidelines outlining select activities which will be permitted from April 20 onwards.  These activities include health services, agriculture related activities, certain financial sector activities, operation of Anganwadis, MNREGA works, and cargo movement.  Further, subject to certain conditions, commercial and private establishments, industrial establishments, government offices, and construction activities will also be permitted.  The Sikkim government took the following steps in the same line.

  • On April 19, the state government gave directions to all government and PSU offices to work with up to one-third of their actual staff strength from April 20 onwards. 
     
  • On April 19, the state government gave directions and standard operating procedures to be followed at manufacturing establishments, work spaces and public places post April 20.  These include: (i) no overlapping shifts, (ii) staggered lunch breaks, (iii) training on good hygiene practices, (iv) compulsory wearing of face cover, and (v) sanitising workplaces between shifts. 

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.