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 19, Gujarat reported its first two cases of COVID-19. Since then, the number of cases have risen steadily. As of May 2, Gujarat has 4,721 confirmed cases (second highest in the country, after Maharashtra) of COVID-19. Of this 3,750 are active cases and 236 have died. The state government has responded with various actions to contain the spread and impact of COVID-19.  In this blog, we look at the key measures taken by the Gujarat Government till May 1, 2020.

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Initial phase 

As COVID-19 cases were rising in other parts of the country, the Gujarat government notified the Gujarat Epidemic Diseases, COVID-19 Regulations, 2020 on March 14,. These regulations detail the responsibilities of hospitals and individuals, and the powers of officials with regards to COVID-19. These include: (i) flu corners in all hospitals for screening purposes, (ii) mandatory collection of travel history of people during screenings in all hospitals, (iii) mandating people with travel history to COVID-affected countries to be isolated /quarantined based on symptoms, (iv) forced detention and isolation of suspected patients who refuse voluntary isolation, and (v) containment measures in an area once positive cases are detected.   Some of the other early measures are summarised below:

Health measures

  • The COVID-19 regulations were immediately supplemented with the n-COVID-19 Guidelines. These guidelines cover: (i) case definitions, (ii) basic infection prevention control measures, and (iii) standard precautions to be followed during the care and treatment of suspected patients.

  • On March 15, the government instructed all higher education institutions and other educational institutions including schools, polytechnics, anganwadis, to shut down till March 29. However, examinations of class X, XII, and universities were permitted to continue. Further, spitting in public was made a punishable offence. 

  • On March 19, the government ordered the closure of gyms, amusement parks, wedding halls, till March 31. Additionally, all private doctors, practising modern as well as traditional systems of medicine, were instructed to report suspect cases to the government. 

  • Fever Helpline 104 was launched on March 20 for reporting of suspect cases of COVID-19. Further, guidelines were also issued on the reporting of cases of Severe Acute Respiratory Illnesses (SARI) to the government. These include: (i) preparation of travel history and contact lists of reported suspect cases, (ii) nodal officer to decide on steps and treatment protocol for such cases, (iii) relevant authorities to initiate follow up and contact tracing for the patient for last 14 days, and (iv) initiating cluster management guidelines when new cases emerge. 

Essential goods and services

  • On March 20, a committee was formed by the government for daily monitoring of the availability, supplies, and manufacturing of medicines, masks, and sanitisers. On March 21, a Khas Kharid Committee was set up to ensure procurement of necessary medicines, equipments, and human resources during emergencies, bypassing existing purchase guidelines, if necessary. 

  • Between March 21 and March 22, the government announced a partial lockdown and released a list of essential services and businesses that were allowed to operate till March 25 in the cities of Ahmedabad, Surat, Vadodara,Rajkot, Kutch and Gandhinagar. These include: (i) government and municipal departments, (ii) shops selling essential goods, (iii) various medical facilities such as hospitals, clinics, and pharmacies, (iv) public utilities, (v) railways and transportation facilities, (vi) media, telecom, IT services, and (vii) banks and insurance firms.

  • The government also invited NGOs to collaborate in the fight against COVID-19, by arranging for the supply of masks, sanitisers, and infrared thermometers, and running awareness campaigns.      

Administrative measures

  • On March 18, the government issued guidelines specifying preventive measures to be taken in all government offices and employees. Recommendations inlcude: (i) avoiding face-to-face meetings and non-essential travel, (ii) closure of gyms and yoga centres in the Secretariat, (iii) home quarantine for officials exhibiting any symptoms, and (iv) mandatory leave to be given to such persons going on quarantine.

  • On March 21, the government released the terms of reference of Regional Nodal Officers appointed to work towards preventing the spread of COVID-19.

  • On March 23, the Gujarat Legislative Assembly decided to indefinitely postpone the Rajya Sabha elections that were originally to be held on March 26. 

Other measures

  • An advisory was issued requesting private firms to not lay off workers (even if they fall sick to COVID-19) or reduce their salaries. 

During the lockdown

On March 23, the state government extended and expanded the partial lockdown announced in select cities to the entire state. The lockdown was to be in place from March 23 to March 31. In addition to the exemptions announced in the partial lockdown orders, services such as (i) cattle feeding and veterinary services, (ii) stock broking, (iii) postal and courier services, and (iv) operation of industries where workers are available on site, were permitted.  The state-wide lockdown has been followed by a nation-wide lockdown since March 25 . This has been further extended until May 17.  Some of the key measures undertaken during the lockdown period are: 

Health measures

  • On March 27, all private clinics and hospitals in the state were directed to utilise the Dr. TeCHO mobile app developed by the government. The app can be used for uploading information related to: (i) sample collection and (ii) reporting and surveillance of all SARI cases. Another app was launched to keep track of home quarantined people. 

  • On March 30, COVID-19 was included as a notified disaster under the State Disaster Response Fund (SDRF). Thus, all expenditure related to relief measures for displaced / homeless people, migrant labour or other stranded persons due to the lockdown, will be made out of the SDRF. 

  • On March 31, the government released new guidelines for the clinical management of COVID-19. These cover: (i) triage activities, (ii) case definitions and classification, (iii) infection and prevention control measures, (iii) specimen collection and handling, (iv) management and prevention of medical complications, (v) clinical management for COVID-19, (vi) discharge policy for patients, and (vii) dead body management. 

  • To exclusively cater to COVID-19 cases, four government hospitals and three private hospitals were declared as designated COVID-19 treatment facilities. Further, the government instructed all COVID-19 hospitals to provide treatment to the people free of cost. On May 1, 26 hospitals were additionally designated as COVID-19 facilities.

  • Resource Management: Between March 31 and April 7, the government initiated multiple measures to address the shortage of medical practitioners in government hospitals. These include: (i) extending tenures of retiring medical personnel, (ii) ad-hoc recruitment of teachers in medical colleges, (iii) contract-based appointments of class-1 specialist and class-2 medical officers from private sector, (iv) additional responsibilities to select class-1 doctors from the epidemiologist department, and (v) temporary shifting of Ayurvedic medical officers to various locations.

  • On March 28, the state released guidelines for Human Resource management (HRM) in COVID-19 facilities. These include: (i) creation of district level task forces, (ii) patient flow algorithm, (iii) deployment and rotation of HR, including residents and nursing staff, and (iv) pooling of HR from various institutes and cadres. 

  • The state has also allowed the use of AYUSH remedies and medicines, particularly for persons quarantined through contact tracing and to frontline personnel. Teams of corona warriors have been formed to assist people with preventive care. In addition, local officials have been asked to utilise the services of important stakeholders such as teachers, priests, and others, who can influence the social behaviour of people to deal with COVID-19.

  • A new State Health System Resource Centre has been established as the nodal agency in the state for all COVID-19 related research. Further, a COVID-19 research activity committee has been set up to lead this endeavour.

Welfare measures

  • On March 25, the state government decided to provide ration to 60 lakh poor families who live on daily wages. Further, on March 28,  to minimise the adverse effects of lockdown on casual labour, autorickshaw drivers, and street vendors, the government announced free wheat, rice, pulses, sugar, and iodised salt for the month of April 2020. 

  • Vadil Vandana scheme was launched to provide free of cost meals to the elderly and the aged living alone in various cities of the state.

  • The state also announced that electricity bills from March 1 to April 30, can be paid by May 15.

  • The government announced compensatory packages worth Rs 25 lakh for each frontline worker who may lose life on COVID-19 duty. Such workers include: (i) police personnel and (ii) other government employees under the state government, panchayats, and nagar palikas .

Other measures

  • Industry: Relaxations from the lockdown were announced for factories and IT/ITES firms, from April 20 onwards. For factories, the conditions specified that adult workers shall be allowed to work for not more than 12 hours per day (six hours at a time) or 72 hours per week. Female workers are not allowed to work between 7 pm and 6 am. Wages are to be proportional to the existing wage structure.  IT/ITES firms are allowed operate in non-containment zones at 50% strength and social distancing norms will be required to be followed. 

  • Administrative: On March 30, the government issued an order to continue paying full wages to all fixed-pay government employees who are on leave or working from home during the lockdown. However, the employees are required to report to work whenever required by the government during the lockdown.

  • On April 15, nodal officers were appointed and given additional financial powers to take control of infectious disease control hospitals. 

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