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.

In response to the COVID-19 pandemic, the central and state governments have implemented several measures to reduce the spread of the disease and provide relief for those affected by the it.  In this blog, we look at some of the key measures taken by the Government of Chhattisgarh with regard to public health, ensuring supply of essential commodities and providing relief to affected persons.  

COVID-19 cases in the State

As of April 21, 2020, Chhattisgarh has 36 confirmed cases of COVID-19.  Of these, 11 are active cases, and 25 patients have been cured or discharged.   This is illustrated below in Figure 1. 

Figure 1: Day wise COVID-19 Cases in Chhattisgarh

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Sources: Ministry of Health and Family Welfare, Government of India; PRS.

Key measures taken by the State Government

On March 13, 2020, the Department of Health and Family Welfare notified the Chhattisgarh Epidemic Disease, COVID-19 Regulations, 2020.   Key provisions of the regulations include: 

  • The district collector can take necessary actions such as sealing geographical area of the district and ban vehicular movement, in order to prevent the spread of the epidemic.  Further, the district administration may take measures such as closure of schools, offices and banning public gatherings. 
     
  • In order to avoid rumours and unauthenticated information, no person or institution can use any print or electronic media for information regarding COVID-I9 without prior permission of Health Department.
     
  • All health facilities (including private) should have COVID-19 corners for screening of suspected cases.  Further, they should record travel history of a person if he has travelled to an area affected by COVID-19.  

Movement restrictions:  Following these regulations, the government announced several additional measures to restrict movement of people to contain the spread of COVID-19.

  • On March 19, the Transport department stopped running of all inter-state buses in the state to restrict movement to and from the state.  On March 21, all city bus services in urban areas of the state were suspended. This was followed by stoppage of all transport including auto, taxi and e-rickshaws.
     
  • On March 22, the government announced a lockdown in all urban areas of the state till March 31 during which all offices, institutions and other activities were to remain closed.   Essential services such as medical shops, vegetable shops, petrol pumps, electricity and water supply services were open.    
         
  • On March 25, the central government announced on a 21-day country-wide lockdown till April 14.  On April 14, the lockdown was further extended till May 3, 2020. 

Essential Goods and Services: Following the lockdown, the government notified certain additional essential goods and services that will remain unaffected by the lockdown.   These are noted below:  

  • On March 13, 2020, the central government notified hand sanitisers, surgical masks and N-95 masks as Essential Commodities.  This implies that the government can regulate the product, supply and pricing of these items.   Following this, the state government notified that the district administration should monitor the price of surgical masks, N-95 masks and hand sanitisers in each district of the state.
     
  • On March 24, the state department of Food and Public Distribution notified certain additional essential goods and services under the Essential Commodities Act, 1955.  These include: (i) wheat and rice mills, (ii) operations of items used in acquirement or storage of items under the Public Distribution System, such as fertilisers, (iii) supply of Petrol, Diesel, CNG and LPG, among others.
     
  • On April 15, the Ministry of Home Affairs issued guidelines on the measures to be taken by state governments until May 3.  As per these guidelines, select activities will be permitted in less-affected districts from April 20 onwards to reduce the hardships faced by people.  Permitted activities include: (i) health services such as hospitals, clinics, and vets, (ii) agriculture and related activities such as fisheries and plantations, (iii) MNERGA work, (iv) construction activities, and (v) industrial establishments.

Relief measures:  During the lockdown, the state government announced several measures to provide relief to the affected individuals.  Key measures include: 

  • Rice for two months will be provided in April to all beneficiaries under the Public Distribution System.  Antyodaya & Annapurna ration card holders will also get sugar and salt for two months in April.  Two quintal of rice is allocated to every gram panchayat, which can be utilised for distribution to individuals without ration cards, subject to a maximum of 5 kg for an individual. 
     
  • 4 kg of rice at primary level and 6 kg at upper primary level will be provided to school children under the Mid-day Meal Scheme, on account of closure of schools.  Further, arrangements will be made to provide ready to eat take home rations for undernourished children between the age of 3 to 6 at Aanganwadi centres.  
  • The government approved sanction of MLA funds for corona virus prevention and other necessary arrangements and support.  The Chief Minister announced that there will be no mandatory deduction from salaries of state government officials and employees for pandemic relief. 
     
  • The state’s Labour Department sanctioned Rs 3.8 crore to aid labourers affected due to lockdown. 
     
  • Pending taxes, interest and penalties of bus and truck operators of nearly Rs 331 crore to be waived off.  

Health Measures:  Over the last few weeks, the government issued several guidelines and orders on containment of the virus, patient handling and protection of healthcare workers.  Some of these are noted below:

  • On March 23, the government of Chhattisgarh declared Corona Virus as a "Notified Infectious Disease" under the Chhattisgarh Public Health Act, 1949.  Further, it notified measures to be taken for prevention of spread of COVID-19 at industries and workplaces.  These included restricting the number of employees at workplaces, and ensuring sanitisation at workplace.  
     
  • Guidelines regarding bio-medical waste in quarantine homes and camps were notified.  These guidelines provide that all workers involved in waste collection should be provided with personal protective equipment.  Further, vehicles carrying such waste should be sanitised with 1% hypochlorite after every trip. 
     
  • On April 11, the Department of Health and Family Welfare made it mandatory to wear a mask for all persons while stepping out of their house for any public place. 
     
  • The department also released guidelines for patients cured of COVID-19.  These guidelines provide that such persons should be escorted to their home district from the hospital and regular monitoring and supervision of their health should be ensured by the district administration.   
     
  • Further, the department released guidelines for continuation of other hospital services during COVID-19 outbreak.  The guidelines provide that the patients should be advised on phone as far as possible, and should be given separate timings for in-person appointments to avoid congestion at hospitals.  On April 18, the Chief Minister announced an online health consultation website for patients, through which patients can seek free of cost advice from doctors.   

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