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 30, Telangana has 1,012 confirmed cases of COVID-19 (9th highest in the country). Of these, 367 have been cured, and 26 have died. In this blog, we summarise some of the key decisions taken by the Government of Telangana for containing the spread of COVID-19 in the state and relief measures taken during the lockdown.
Movement Restrictions
For mitigating the spread of COVID-19 in the state, the Government of Telangana took the following measures for restricting the movement of people in the state.
Closure of commercial establishments: On March 14, the government ordered for the closure of cinema halls, amusement parks, swimming pools, gyms and museums until March 21 which was later extended to March 31.
Lockdown: To further restrict the movement of people, the state and central governments announced lockdown in the state and country. The lockdown included: (i) closing down state borders, (ii) suspension of public transport services, (iii) prohibiting congregation of more than five people. The entities providing essential commodities and services were exempted from these restrictions.
Starting from April 20, the central government allowed certain activities in less-affected districts of the country. However, on April 19, the state government decided not to allow any relaxation in Telangana until May 7.
Health Measures
Telangana Epidemic Diseases (COVID-19) Regulations, 2020: On March 21, the government issued the Telangana Epidemic Diseases (COVID-19) Regulations, 2020. The regulations are valid for one year. Key features of the regulations include:
(i) All government and private hospitals should have dedicated COVID-19 corners,
(ii) People who had travelled through the affected areas should be home quarantined for 14 days,
(iii) Procedures to be followed in the containment zones among others.
Private Hospitals: On March 22, for increasing the availability of healthcare facilities in the state, the government issued an order prohibiting private hospitals from performing any elective surgeries. The hospitals were also instructed to have separate counters for respiratory infections.
Increasing the health workforce in the state: On March 30, the government issued notification for the recruitment of medical professionals on a short term basis.
Prohibition on spitting in public places: On April 6, the Department of Health, Medical and Family Welfare department banned spitting of paan, any chewable tobacco or non-tobacco product, and sputum in public places.
Welfare measures
To mitigate the hardships faced by the people, the government took various welfare measures. Some of them are summarized below:
Relief assistance: On March 23, the government announced the following measures:
Factories: On March 24, the government directed the management of factories to pay the wages to all workers during the lockdown period.
Migrant Workers: On March 30, the government decided to provide 12 kg of rice or atta and one time of support of Rs 500 to all migrant workers residing in the state.
Regulation of school fees: On April 21, the government ordered all private schools not to increase any fees during the academic year of 2020-21. The schools will charge only tuition fees on a monthly basis.
Deferment of collection of rent: On April 23, the government notified that house owners should defer the rent collection for three months. Further, the owners should collect the deferred amount in instalments after three months.
Administrative Measures
Deferment of salaries: The government announced 75% deferment of salaries of all the state legislators, chairperson of all corporations and elected representatives of all local bodies. The government employees will have salary deferment from 10% to 60%. Employees of the Police Department, Medical and Health Department, and sanitation workers employed in all Municipal Corporations and Municipalities are exempted from deferment of salary.
Chief Minister's Special Incentives: The government granted special incentives to certain categories of employees as follows:
For more information on the spread of COVID-19 and the central and state government response to the pandemic, please see here.
