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.

On January 17, 2020, the Ministry of Health and Family Welfare acknowledged the emergence of COVID-19 that was spreading across China. On January 30, 2020, the country’s first COVID-19 positive case was reported in Kerala.  By March 11, 2020, the World Health Organisation declared COVID-19 as a global pandemic.  This blog summarises the key policy measures taken by government of Kerala to respond to the pandemic.  

As on April 22, Kerala has had 427 confirmed cases of COVID-19, of which 307 have recovered (highest rate of recovery in the country). Only three deaths have been recorded in the state so far.

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Pre-lockdown period: Early measures for containment

Following the first confirmed case involving a returnee from Wuhan, China, the initial responses by the state were aimed at surveilling, identifying, and conducting risk-based categorisation of all passenger arrivals from China and others who had come in close contact with these travellers. As two more cases were confirmed on February 2 and 3, the state government declared a health emergency in the state. 

Subsequently, a health advisory was issued to track, identify, and test all travellers with a travel history to Wuhan since January 15, 2020.  Such passengers and their close contacts were to be kept in isolation for 28 days.  The advisory also directed all lodging establishments to maintain a register of travellers with travel histories to corona-affected countries. A similar advisory was issued for student returnees as well. With no further confirmed cases being reported immediately, on February 12, the state withdrew the health emergency.  However, a high state of response and surveillance continued to be applied.

Second wave of infections

When a second wave of infections began spreading in early March, the government took several multi-pronged measures to address the threat. The following measures were taken in this regard:

  • Health measures: Revised guidelines for the clinical management of COVID19 patients, covering testing, quarantine, hospital admission, and discharge, were issued.  
     
  • Instructions were issued regarding airport safety protocols as well as testing of foreign nationals entering and exiting the state. All foreign arrivals, even if asymptomatic, were to be kept in isolation until their test reports were available. 
     
  • Further guidelines and precautions on social distancing and various hygiene norms, such as, use of sanitsers, were also issued to malls, shopping centres, and salons
     
  • Movement restrictions: All non-medical educational institutions, including anganwadis and madrassas were immediately shut down till March 31 and exams of classes 1-7 were postponed. Exams for classes 8 and above were to be held as scheduled. University exams were also postponed till March 31.
     
  • Government departments were asked to make temporary arrangements regarding working hours of their employees. Officials were also instructed to look into welfare measures for migrant workers.
     
  • Guidelines were also issued to private establishments regarding working time, safety measures, and leave for employees.
     
  • Administrative Measures: On March 17, COVID19 was declared a notified disaster, thus becoming eligible for funds from the State Disaster Response Fund (SDRF). SDRF is the primary fund available with state governments for responses to notified disasters. Notifying a disaster enables states to spend more from the SDRF to fight the said disaster.
     
  • In order to better coordinate the state’s response, the government issued instructions to constitute COVID-19 cells in all departments. Meetings and inspections by government officials were also to be avoided. 
     
  • Local Self Government institutions were assigned various roles and responsibilities. These include: (i) running awareness programs, such as, ‘Break the Chain’ initiative, (ii) conducting sanitation and cleanliness drives, (iii) regular outreach to home isolated/quarantined persons, (iv) activating committee system to manage responsibilities, (v) ensuring availability of essential commodities, (vi) categorising and ensuring available response mechanisms, such as, material resources, volunteers, medical resources etc, and (vii) ensuring special attention to vulnerable populations, such as senior citizens, and persons with co-morbidities or undergoing special treatments. 

The lockdown period

On March 23, Kerala announced a state-wide lockdown till March 31.  A day later, the central government announced a nation-wide 21-day lockdown.  

Restrictions imposed under the state’s order included: (i) stoppage of all forms of passenger transport services, (ii) prohibition of a gathering of more than five persons, and (iii) closure of all commercial establishments, officers, and factories, except those exempted.  Use of taxis, autos or private vehicles was permitted only for procurement of essential commodities or for medical emergencies. Establishments providing essential goods and services such as banks, media, telecom services, petrol bunks, and hospitals were permitted to operate.  

On April 15, the central government extended the lockdown till May 3.  Some of the key measures undertaken during the lockdown period are: 

Administrative Measures

  • A round-the-clock war room, comprising members of different departments, was set up to monitor and supervise all COVID-19 containment activities. 
     
  • Corona media cell was set up to monitor and tackle the threat of fake news surrounding COVID19.  
     
  • With the legislature not in session, the Kerala Epidemic Diseases Ordinance, 2020 was promulgated by the Governor of Kerala on March 26. The Ordinance empowers the state government to undertake necessary measures and specify regulations to counter the threat of an epidemic disease.  It also specifies a penalty for those who violate orders made under this Ordinance. 

Healthcare Measures

Essential Goods and Services

  • On March 25, the state declared a list of essential services under the Kerala Essential Services Maintenance Act, 1994. 
     
  • Various exemptions from lockdown were issued to services that were later deemed essential. These include: (i) shops and bakeries, including departmental stores, (ii) online food deliveries, (iii) parcel services, for delivery of essential goods, (iv) automobile service workshops, (v) shops and service centres for mobile phones, computers etc, only on Sundays, and (vi) plumbers and electricians to undertake maintenance work in houses and flats. 
     
  • On April 3, orders were issued to set up community kitchens under the aegis of Kudumbasree and Local Self Governments (LSGs). Kudumbasree is the poverty eradication and women empowerment programme implemented by the Kerala government. As on April 20, a total of 339 Community Kitchens have been functioning in 249 panchayats across 14 districts of the state. They have served a total of 5,91,687 meals since April 4, 2020. The government has also instructed LSGs to hire volunteers for the kitchen and pay them an honorarium of Rs. 400 (for one-time service) or Rs. 650 (for the whole-day).

Welfare Measures

  • Under SDRF norms, funds were released to the Health Department for relief and response activities for COVID-19. 
     
  • Each District Collector has been allocated Rs. 50 lakh for carrying out various COVID-19 outbreak-related control and prevention activities.
     
  • Financial assistance has been sanctioned to (i) fishermen, (ii) artists, (iii) lottery agents and sellers, and (iii) elephants and other such animals being looked after. 
     
  • A 2000-crore worth Chief Minister’s Helping Hand Loan Scheme was announced for people facing lockdown-related unemployment and hardships. The scheme will be operationalised through neighbourhood groups under the aegis of Kudumbasree. 

Post-lockdown strategies – Strategies easing lockdown relaxations

  • Expert Committee: On April 4, an Expert Committee was constituted by the government and on April 6, the Committee submitted its Report on the guidelines for post-lockdown regulations. It recommended a conditional, three-phase strategy, with districts being the unit of implementation. Relaxations would be progressively eased in each phase depending on criteria, such as, (i) number of new confirmed cases, (ii) percentage increase/decrease in number of persons under home surveillance, and (iii) no emergence of hotspots.. 
     
  • Containment Guidelines: After the lockdown was extended till May 3, the state released revised guidelines for containment, that recommended classification of districts into four zones, based on number of cases and disease threat. The zones – Red, Orange A, Orange B, and Green – would have different, graded restrictions, with Red having stringent restrictions in the form of a lockdown till May 3. The Orange A and B zones would have a lockdown till April 24 and 20 respectively, followed by a partial relaxation thereafter. Green zone would have a lockdown till April 20 and relaxation in restrictions thereafter.
     
  • Based on the above order, the state issued an advisory for industrial units to follow while resuming operations. Some of the Standard Operating Procedures to be followed include: (i) conducting disinfectation of premises, machinery, and vehicles, (ii) arranging exclusive transportation facilities with vehicles operating at 30-40% capacity, (iii) mandatory thermal scanning of people, (iv) following hygiene and social distancing norms, including a cap on elevator capacities and size of meetings (v) mandatory corona-related insurance cover for workers, (vi) mandatory use of CCTVs, and (vii) preparing a list of nearby COVID-19 hospitals .

For more information on the spread of COVID-19 and the central and state government response to the pandemic, please see here.