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 March 22, Bihar registered its first two cases of the new coronavirus disease (COVID-19), one of whom died the same day.  Since then, the number of cases has increased steadily. As of April 19, Bihar has 86 confirmed cases of COVID-19, of which 47 are active cases and 37 have recovered.  33 new cases have been registered since last week. One more death has been registered since March 22.

Given the highly contagious nature of the disease, on March 22, the Government of Bihar announced a state-wide lockdown till March 31.  This was followed by a nation-wide lockdown enforced by the central government between March 25 and April 14, now extended up to May 3.  During the lockdown, severe restrictions have been placed on the movement of individuals. Establishments have remained closed, except those providing essential goods and services.  Restrictions are likely to be relaxed in less-affected districts post-April 20.

In this blog, we look at key measures taken by the state government in response to COVID-19 so far.

Early-stage: screening of travellers, awareness on precautionary measures

The initial responses from the state government were aimed towards: (i) raising awareness about precautionary measures to be taken against the disease, and (ii) screening of international travellers.  In this context, on February 25, the Bihar State Health Society issued advisories for: (i) measures to be taken in schools and colleges, and (ii) reporting of airline passengers and tourists with symptomatic cases to the district health administration.  On March 11, 104 Call Centre was designated as the COVID-19 control room, to address public queries related to the disease.

Prior to lockdown: limiting mass gatherings, mobilisation of the public health system

Limiting mass gatherings

Between March 13 and March 18, the state government issued orders to shut down various premises until March 31. These include Anganwadi centres, educational institutions, and commercial establishments such as cinema halls, parks, and shopping malls. The government staff was directed to come to office on alternate days. Gathering of more than 50 persons at one place was prohibited including any mass family gathering (except marriages).  The transport department was asked to restrict both public and private transport.

Healthcare measures

Welfare measures

  • On March 16, the Chief Minister announced that treatment costs for COVID-19 for residents of Bihar will be sponsored from the Chief Minister Medical Assistance Fund.  Moreover, the state government will provide assistance of four lakh rupees to the family of a person dying due to COVID-19.

  • The government issued directions to provide direct cash transfer in place of the food provided under the Mid-Day Meal scheme in schools, and at Anganwadi centres.

Essential goods and services

On March 21, the Food and Consumer Protection Department directed the district administration to ensure implementation of the Bihar Essential Article (Display of Prices and Stocks) Order, 1977.  The Order requires sellers of specified items to display stock and price for the public’s reference.  The specified items include food items, edible oilseeds, and petroleum products.  The Department also directed the district administration to send proposals for adding any new items to the list of specified items.

During lockdown: strengthening medical response, welfare measures

Upon announcement of the lockdown on March 22, state-level and district-level coordination committees were set up.  During the lockdown, the state government’s measures have been aimed towards: (i) strengthening the medical response in the state, (ii) providing relief to various sections of society from issues being faced during the lockdown, and (iii) addressing difficulties with the supply of essential goods and services.

Healthcare measures

  • On March 25, the Health Department constituted the Bihar COVID-19 Emergency Response Team which is responsible for the control and coordination of all health-related response.

  • Protocols for containment and treatment: Directions have been issued to implement several guidelines related to containment and treatment measures.  These include: (i) set up and operationalization of isolation centres and quarantine centres, (ii) containment plan to address local transmission and community transmission through cluster containment strategy, (iii) surveillance program for Influenza-like Illness (ILI) and Severe Acute Respiratory Illness (SARI), (iv) handling of waste generated during treatment/diagnosis/quarantine, and (v) sanitation of residence and nearby areas of a COVID-19 positive person.

  • Door-to-door screening campaign: On April 14, the Chief Minister issued directions to start door-to-door screening campaign for suspected cases in affected districts including Siwan, Begusarai, and Nalanda.  Such screening campaign will also be run in districts in border-areas, and an area within 3 km radius of the residence of COVID-19 positive patients.

  • Increasing manpower: The government invited medical professionals including doctors, nurses, and paramedics to volunteer.  It also directed the district administration to engage retired doctors, nurses, and paramedics from defence services for volunteer work.  Leaves of all employees of the Health Department were cancelled until April 30.  The Health Department deputed AYUSH practitioners to assist at isolation and quarantine centres.

  • Dedicated infrastructure for COVID-19: On April 5, certain government hospitals were designated as exclusive hospitals for treatment of COVID-19 patients.  The Health Department also directed certain big private hospitals in Patna to stop OPD services.

  • Other health-related measures: On March 23, the state government announced payment of one-month basic salary as an incentive to all doctors and health workers.  On April 13, the Health Department issued an order prohibiting spitting in public places by tobacco, cigarette, and Pan users.  Further, the state government announced that it will procure test kits from the private sector.

Welfare measures

  • Relief package: On March 23, the state government announced a relief package for people affected due to lockdown.  Key features of the relief package are: 

  1. ration of one-month to all ration cardholders for free,

  2. one-time cash transfer of Rs 1,000 per family to ration cardholders,

  3. payment of pensions for three months in advance to all pensioners including pension for old age persons, widows, and physically challenged, and

  4. release of pending scholarships to all students.

  • Help for migrants: On March 26, Rs 100 crore was allocated from the Chief Minister Relief Fund to provide aid to the migrants from Bihar stuck in other parts of the country due to the lockdown.  On April 2, the state government announced that a one-time cash transfer of Rs 1,000 will be provided to the migrants.  On April 13, an additional Rs 50 crore was allocated from the Relief Fund for this purpose.  State-wise nodal officers have been appointed for coordination of relief efforts for migrants.  The state government is running 10 food centres in Delhi to help migrants from Bihar.

  • Relief camps: On March 28, the state government decided to start relief camps along the border (including Nepal border) offering food, shelter, and medical help to persons coming in the state.  Community kitchens and relief camps have been started in government school campuses to provide food and shelter. 

  • Electricity tariff:  On April 8, the State Cabinet approved the proposals for: (i) reducing electricity tariff for domestic and agricultural consumers by 10 paise per unit and (ii) waiving the monthly meter fee.

Measures for businesses and agricultural activities

  • The state government provided certain relaxations to businesses in matters related to taxation.  These include:

  1. extension in the deadline for payment of GST from March 31 to June 30, no interest or penalty charges to be levied for late payment in certain cases,

  2. three-month extension in the deadline for one-time settlement scheme for pre-GST tax disputes, and

  3. cancellation of orders regarding attachment of bank accounts of certain tax defaulters.

  • On April 16, the Chief Minister issued directions to start procurement of wheat through the Primary Agriculture Credit Society (PACS).

Essential goods and services

Other Measures

Education:  On April 8, the cabinet approved the proposal to promote students of Class I to XI (except class X) without annual examination.

Legislature:  Salaries of MLAs and MLCs have been reduced by 15% for one year.  The amount will be donated to the state’s Corona relief fund.

Labour and employment:  On April 16, the Chief Minister issued directions to resume public works under the Saat Nischay Programme, Jal Jeevan Hariyali Yojana, and MNREGA.

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