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.

As of May 4, 2020, there are 42,533 confirmed cases of COVID-19 in India.   Since April 27, 14,641 new cases have been registered.  Out of the confirmed cases so far, 11,707 patients have been cured/discharged and 1,373 have died.   As the spread of COVID-19 has increased across India, the central government has continued to announce several policy decisions to contain the spread, and support citizens and businesses who are being affected by the pandemic.  In this blog post, we summarise some of the key measures taken by the central government in this regard between April 27 and May 4, 2020.

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Source: Ministry of Health and Family Welfare; PRS.

Lockdown

Extension of lockdown until May 18, 2020

The Ministry of Home Affairs passed an order extending the lockdown for two weeks from May 4, 2020 (until May 18, 2020).  Activities that remain prohibited in the extended lockdown include: 

  • Travel and movement: Passenger movement by: (i) air (except for medical and security purposes), (ii) trains (except for security purposes), (iii) inter-state buses (unless permitted by central government), and (iv) metro, remains prohibited.  Inter-state movement of individuals is also prohibited except for medical reasons or if permitted by the central government.  Intra-state movement of persons for all non-essential activities will remain prohibited between 7pm and 7am. 

  • Education:  All educational institutions such as schools and colleges will remain closed except for online learning. 

  • Hospitality services and recreational activities:  All hospitality services such as hotels will remain closed except those being used as quarantine facilities, or those housing persons such as healthcare workers, police, or stranded persons.  Further, recreational facilities such as cinemas, malls, gyms, and bars will remain closed. 

  • Religious gatherings:  All religious spaces will remain closed and congregation for religious purposes will remain prohibited. 

The revised guidelines for the lockdown include risk-profiling of districts into red, green and orange zones.  Zone classifications will be decided by the Ministry of Health and Family Welfare and shared with states on a weekly basis.  States may include additional districts as red or orange zones.   However, they may not lower the classification of any district.  For a district to move from a red zone to an orange zone, or from an orange zone to a green zone, it must have no new cases for 21 days.  Classification of and activities permitted in the zones include: 

  • Red zones or hotspots: These districts will be identified based on the total number of active cases, doubling rate of confirmed cases, and testing and surveillance feedback.  Additional activities prohibited in red zones include: (i) cycle and auto rickshaws, (ii) taxis, (iii) buses, and (iv) barber shops, spas and salons.  Activities that are permitted include: (i) movement of individuals (maximum two persons in four wheelers, and one person in two wheelers), (ii) all industrial establishments in rural areas and certain industrial establishments in urban areas such as manufacturing of essential goods, and (iii) all standalone and neighbourhood shops. 

  • Green zones: These zones include districts with no confirmed cases till date or no confirmed cases in the last 21 days.  No additional activities are prohibited in these zones.  In addition to activities permitted in red zones, buses can operate with up to 50% seating capacity. 

  • Orange zones: These zones include all districts that do not fall in either red or green zones.  Inter and intra-state plying of buses is prohibited in these zones.  Activities that are permitted (in addition to those permitted in red zones) include: (i) taxis with a maximum of one driver and two passengers, (ii) inter-district movement of individuals and vehicles for permitted activities, and (iii) four wheeler vehicles with a maximum of one driver and two passengers.

Certain areas within red and orange zones will be identified as containment zones by the district administration. Containment zones may include areas such as residential colonies, towns, or municipal wards. In containment zones, local authorities must ensure 100% coverage of Aarogya Setu App, contract tracing, quarantine of individuals based on risk, and house to house surveillance.  Further, movement of persons in or out will be prohibited except for medical emergencies and essential goods, amongst other measures. 

Movement of stranded persons

The Ministry of Home Affairs has permitted the movement of migrant workers, pilgrims, tourists, students, and other stranded persons, by special trains.  To facilitate this, all states and union territories will designate nodal authorities for sending, receiving, and registering stranded persons.  The state sending persons and the state receiving persons both need to agree to the exchange.  Each train can carry up to 1,200 persons and no train may run at less than 90% capacity.  Passengers approved for travel by the state governments may be required to pay some part of the ticket fare. 

Education

UGC issues guidelines on examinations and the academic calendar for universities

The University Grants Commission (UGC) issued guidelines on examinations and the academic calendar for universities in view of the COVID-19 pandemic.  

  • Academic Calendar: Classes for the even semester in universities were suspended from March 16, 2020 onwards. The guidelines prescribe that online teaching must continue till May 31 through social media (WhatsApp / YouTube), emails, or video conferencing. The examinations for the current academic year should be held in July, 2020 and the results for the same should be declared by July 31 (for terminal year students) and by August 14 (for intermediate year students)

  • The Academic Session 2020-21 may commence from August 2020 for old students and from September 2020 for fresh students. The admission process for the fresh students can be done in August. Consequently, the commencement of even semester for 2020-21 can be from January 27, 2021. The commencement of academic session 2021-22 may be from August 2021. The universities may follow a 6-day week pattern to compensate the loss of teaching for the remaining session of 2019- 20 and the 2020-21 academic session.

  • Examination: The universities may conduct semester or yearly examinations in offline or online mode. This has to be done while observing the guidelines of “social distancing” and ensuring fair opportunity for all students. They may adopt alternative, simplified methods of examinations such as multiple choice questions based examinations or open book examination. If examinations cannot be conducted in view of the prevailing situation at the time, grading may be done on the basis of internal assessments and performance in previous semester. The universities may conduct the Ph.D viva examinations through video conferencing.

  • Other guidelines: Every University should establish a COVID-19 cell for handling student grievances related to examinations and academic activities during the pandemic and notify effectively to the students. Further, a COVID-19 cell will be created in the UGC for faster decision making.

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