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.

With the spread of COVID-19, along with the central government, state governments have also announced several policy decisions to contain and prevent the spread of the virus.  In this blog post, we summarise some of the key measures taken by the government of West Bengal in this regard as of April 18, 2020. 

As of April 18, 2020, there have been 287 confirmed cases of COVID-19 in West Bengal. Of these, 55 have been discharged and 10 have died.  To manage patients, there are 66 COVID hospitals, eight testing laboratories, and 582 institutional quarantine centres in the state. 

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Early response: Leading up to lockdown

Between January and February, the state government's efforts were aimed at raising awareness among citizens on COVID-19.  These include advisories on observing precautionary measures, and informing citizens on travel restrictions, home isolation, and screening protocols for foreign returnees.

On March 2, the state government responded to the growing number of suspected cases by issuing guidelines for preparedness by government medical colleges and hospitals.   These covered admission, isolation and management of suspected COVID-19 cases.  These instructions were extended to private medical colleges and hospitals on March 7.  A week later, the government issued protocols for monitoring travellers at various state checkposts by joint teams of state police and paramedical staff, and for reference of symptomatic patients to isolation facilities in the district.  All cases had to be reported on a daily basis to district surveillance teams.  The government also announced the closure of all educational institutions in the state (government and private) till March 31.  

On March 16, the government notified the West Bengal Epidemic Disease COVID-19 Regulations, 2020.  These regulations specify screening and treatment protocol for COVID-19 patients, and empower the district administration to take containment measures to curb the spread of COVID-19.   

The next day, the state reported its first confirmed case of COVID-19.  The government proceeded to issue orders: (i) for segregating isolation wards for suspected and confirmed COVID-19 cases, (ii) specifying treatment protocols for confirmed cases, (iii) establishing medical boards in all COVID-19 hospitals with representation from different medical disciplines, and (iv) establishing fever clinics for suspected patients.  Anganwadi centres and creches were also closed, with provisions to ensure supply of two kilograms of rice and potatoes to each beneficiary.  

On March 21, the government ordered the closure of certain establishments to restrict non-essential social gatherings till March 31, 2020.  This included closure of restaurants, clubs, amusement parks, and museums.  Further, all trains entering the state and inter-state buses were banned till March 31, 2020.

Subsequently, the government announced a lockdown.  In addition to steps for physical containment, the government also undertook various health and welfare measures.  These are detailed below.

Measures taken post-lockdown

On March 22, a lockdown was announced in 23 areas of the state until March 27.  Restrictions during the lockdown included: (i) prohibition on public gatherings of over seven people, (ii) suspension of public transport, and (iii) closure of shops, commercial establishments, offices and factories.  Establishments providing essential goods and services such as health services, print media, banks, groceries, and e-commerce delivery of food and groceries, were excluded from the restrictions.  Over the next few weeks, steps were taken to expand these exemptions, and to regulate the movement of goods and services.

  • List of essential goods and services:  On March 24, the lockdown was extended till March 31 in the entire state, and the exemptions were expanded to include industries producing coal, power, steel, or fertilisers.   After the centre notified a 21-day lockdown, the list of exemptions in the state was gradually expanded to include agricultural operations, fish production, tea garden operations, and operations in krishak bazars for marketing agricultural produce.  At the same time, restrictions were placed on hoarding of masks and hand sanitisers.  

  • Last week, after the central government extended the lockdown till May 3,  orders were passed for resumption of government offices from April 20 onwards at a strength of 25% of workforce.  Similar permission was also granted for restricted operations in jute mills, and IT/IT enabled services.  

  • Regulating movement of goods and services:  A pass system was introduced on March 25 to regulate the movement of persons supplying essential goods and services.  Transportation of non-essential cargo was prohibited till March 31, 2020.  However, as a one-time measure, permission was granted on March 26 to such vehicles to reach their destination.  Two days later, the government ordered for the seamless movement of commodities in all district borders and interstate areas. 

Health Measures

On March 26, a Committee of Experts was constituted to advise on strategies for isolation, quarantine, testing, health infrastructure, and disease prevention.  The Committee has been issuing protocols on clinical management of COVID-19 cases.  The government also established various monitoring committees on setting up isolation hospitals, managing critical care, and to audit the cause of deaths related to COVID-19 patients.  

To respond to the increasing number of patients, the government acquired private healthcare facilities in April.  Further, to expand its testing capacity, the government recommended sample pooling for COVID-19 testing yesterday.

In addition to these measures, the government also issued several guidelines, advisories and orders on containment of the virus, patient handling and protecting healthcare workers.  Some of these are detailed below: 

  • For healthcare facilities:  Advisory for setting up of isolation facilities, orders for establishment of fever clinics to segregate patients with severe symptoms, separation zones for suspected cases to protect healthcare personnel, and use of hydroxychloroquine for asymptomatic healthcare workers.

  • For government:  Guidelines for cluster containment and treatment strategies to contain COVID-19 in hi-risk spots, directions for awareness generation among rural population for containment, and arranging for counselling sessions for quarantined patients.

Welfare/Austerity Measures

  • Creation of relief fund:  The “West Bengal State Emergency Relief Fund” was created on March 23 to mobilise additional resources to cope with the emergency.  On April 2, austerity measures were announced by the government.   These include prohibition on announcement of new schemes, unless required in urgent public interest.

  • Distribution of food:  Free entitlement of wheat and rice was announced on March 26 to beneficiaries under some food subsidy schemes (including the Antyodaya Anna Yojana) until September, 2020.

  • Measures for workers:   Directions were notified in March for provisions on shelter, food, quarantine, wage payment, and continued tenancy for workers.   

  • Free insurance cover was announced on April 1 for treatment of certain categories of persons, including heathcare workers, and police.

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