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:
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:
As of April 23, Delhi has 2,248 cases of COVID-19. After Maharashtra and Gujarat, Delhi has the highest number of cases in the country. On March 22, when the number of cases rose to 29, the Delhi government announced lockdown in the state until March 31, to contain the spread of COVID-19. This has been followed by a nation-wide lockdown by the central government between March 25 and May 3. In this blog, we summarise some of the key measures taken by the state government in response to COVID-19 so far.
Before the lockdown
On March 8, with three cases of COVID-19 in the state, the Department of Health and Family Welfare decided to carry out an awareness drive at various crowded places during Holi. Along with it, the government also took several other steps for mitigating the spread of COVID-19 in the state. Some of these measures are summarised below.
Health Measures
Disinfecting the vehicles: On March 11 and 12, the government ordered to disinfect minibuses, school buses and school cabs daily.
The Delhi Epidemic Diseases, COVID-19 Regulations, 2020: On March 12, with six cases of COVID-19, the Delhi government notified The Delhi Epidemic Diseases, COVID-19 Regulations, 2020. These regulations are valid for a year. Key provisions include:
(i) All government and private hospitals should have dedicated flu corners.
(ii) home quarantine for people who have travelled through the affected areas, and
(iii) Certain persons authorised under the Regulations, with the approval of the State Task Force, can take necessary measures to contain the spread of COVID-19, such as: (i) sealing a geographical area, (ii) restricting the movement of vehicles and people, and (iii) initiating active and passive surveillance of COVID-19 cases.
Movement Restrictions
Educational institutions: On March 12, the government ordered the closure of all educational institutions up to March 31. The students writing examinations were allowed to attend them along with the staff. However, on March 19, the government ordered the postponement of exams until March 31.
Public gatherings:
Restaurants and private establishments: On March 19, all restaurants were ordered to discontinue sitting arrangements until March 31. Private establishments were ordered to allow their employees to work from home till March 31.
Delhi-Kathmandu bus service: On March 20, the government suspended the Delhi-Kathmandu bus service, officially known as the Maitri Bus Sewa.
During the lockdown
On March 22, when the number of cases rose to 29, the Delhi government announced the lockdown in the state until March 31. The lockdown involved: (i) suspending the public transport services, (ii) sealing borders with Haryana and Uttar Pradesh, (iii) suspending all domestic and international flights arriving in Delhi, and (iv) banning the congregation of more than five persons at any public place. This was followed by a nation-wide lockdown enforced by the central government between March 25 and April 14, now extended till May 3.
Starting from April 20, the central government allowed certain activities in less-affected districts of the country. However, the Delhi government, on April 19, announced that there will not be any relaxation in the lockdown in Delhi, until another comprehensive assessment which will be made on April 27.
Welfare Measures
The Delhi government announced several welfare measures to address the difficulties being faced by people during the lockdown. Key measures include:
Night shelters: The Delhi Urban Shelter Improvement Board is providing free meals to the homeless people staying in the night shelters. On March 25, a hunger helpline was set up which directs the needy people to the nearest night shelter for food.
Hunger Relief Centers: On March 26, the government directed the District Magistrates to set up at least two hunger relief centres in every municipal ward for providing 500 meals twice (lunch and dinner) every day at each centre.
Financial assistance: The government is providing one-time financial assistance of Rs 5,000 to drivers of vehicles such as autos, taxis, and e-rickshaws.
Compensation to family members: The Delhi government will be giving compensation of one crore rupees to the family members of the employees who may die due to COVID-19.
Health Measures
Additional manpower: On March 24, the government ordered the hospitals and institutions under the Department of Health and Family Welfare to engage up to 25% additional manpower in outsourced services such as sanitation, security, and nursing assistants.
Wearing masks made compulsory: On April 8, the government made it compulsory for all people to wear masks in public places, offices, gatherings, meetings, and personal vehicles.
Identification of paid quarantine facilities: On April 13, the government ordered all district magistrates to identify paid quarantine facilities in their respective districts for housing the people who would like to use private facilities on payment basis.
Creation of a multi-sectoral dedicated team: On April 13, the government ordered for the creation of the Corona Foot Warriors and Containment Team at every booth. The government aims to enhance ground level intervention through them.
Setting up Helpline: On April 17, the Department of Health and Family Welfare set up a dedicated 24x7 Whatsapp number for receiving complaints and requests from the people related to COVID-19.
Measures related to Media
The government took the following steps to control the spread of fake news related to COVID-19:
For more information on the spread of COVID-19 and the central and state government response to the pandemic, please see here.
