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 May 5, Assam has 43 confirmed cases of COVID-19. Of these, 32 have been cured, and 1 person has died. In this blog, we summarise some key decisions taken by the Government of Assam until May 5 for containing the spread of the pandemic in the state.
Movement Restrictions
For containing the spread of COVID-19 in the state, the Government of Assam took the following measures for restricting the movement of people in the state. On March 19, the Department of Health and Family Welfare issued an order for closure of all museums, libraries, coaching centers among others until March 31.
Lockdown: To further restrict the movement of individuals, in order to contain the spread of the disease, the state government enforced a state-wide lockdown from March 24 to March 31. The lockdown involved: (i) sealing the state borders, (ii) suspension of public transport services, (iii) closure of all commercial establishments, offices, and factories, and (iv) banning the congregation of more than five people at any public place. Establishments providing essential goods and services were excluded from the lockdown restrictions. Limited rituals were allowed in places of worship without any community participation.
This was followed by a nation-wide lockdown enforced by the central government between March 25 and April 14, now extended till May 18. Starting from May 4, based on the Ministry of Home Affairs guidelines, the state government has allowed certain activities with restrictions in green zones of the state. Activities such as e-commerce for all commodities, construction activities in urban areas, functioning of government and private offices among others are being allowed in green zones.
Health Measures
The Assam COVID-19 regulations, 2020: On March 18, the government issued the Assam COVID-19 regulations, 2020. These regulations are valid for one year. Key features of the regulations are as follows:
All government and private hospitals should have separate corners for the screening of COVID patients. Further, they should record the travel history of such persons during screening,
No hospital can refuse the treatment of suspected/ confirmed COVID-19 cases,
People travelled through affected areas must voluntarily report to the authorities, and
District administration 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.
The Assam COVID-19 Containment Regulations, 2020: On March 21, the government issued the Assam COVID-19 Containment Regulations, 2020. These regulations detail the measures to be taken in case of community transmission within a geographical area. These include enhanced active surveillance, testing of all suspected cases, isolation of cases and home quarantine of contacts, among others.
Guidelines to Airports: On March 18, the government issued instructions regarding procedures to be followed at the airports for the screening of passengers. The guidelines allocate responsibilities such as thermal screening of passengers, counselling, transportation of passengers among others to various teams at the airports.
Medical colleges and Hospitals: On March 23, the Department of Health and Family Welfare directed all medical colleges and district hospitals to set up isolation wards. On March 27, the Department of Health and Family Welfare released measures to be followed in medical colleges and hospitals. These include: (i) seven days of training on critical care to all doctors, nurses, final year students of bachelor programs and Postgraduate students, (ii) Principals should set up a core team in every college for managing COVID-19 patients, among others.
Welfare measures
Food distribution: On March 28, the government decided to provide gratuitous relief such as rice, pulses among others to all wage earners, slum dwellers, rickshaw pullers, homeless, and migrant labourers living in municipal towns for seven days.
Minor Forest Produce (MFP): For enhancing the income of tribal farmers, the government revised rates of 10 MFPs such as honey, hill broom and added 26 new MFPs for Minimum support price in the state.
One-time financial assistance for persons stranded outside India: On March 22, the government announced one-time financial assistance of $2,000 to residents of Assam stranded in foreign countries. People who went abroad 30 days before the stoppage of international flights (on March 22) and are unable to return will receive this financial assistance.
Administrative measures
On March 21, the government constituted the task force at the State level and District level for implementation of various measures for containment of COVID-19 in the state.
On April 2, the government constituted a committee for monitoring and checking of fake news across all forms of media.
On April 29, the Department of Finance announced certain austerity measures in the context of the fiscal situation that arose due to COVID-19. These include suspension of MLA area development funds from April to July 2020, reduction in establishment expenditure, and a ban on the purchase of vehicles by the government (except ambulances and for policy duty).
For more information on the spread of COVID-19, and the central and state government response to the pandemic, please see here.
