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:
With the spread of COVID-19, along with the central government, the state governments have also announced several policy decisions to contain and prevent the spread of the virus. In this blog post, we summarise some of the key measures taken by the Uttarakhand Government in this regard as of April 16, 2020.
As of April 15, 2020, 2,413 samples have been sent for testing in Uttarakhand. Of these, 37 have been found COVID-19 positive and the results of 354 samples are awaited. Of the 37 confirmed cases, 9 patients have been cured/discharged.[1]
Movement Restrictions
To contain the spread of COVID-19 in the state, the Government of Uttarakhand took the following measures for restricting the movement of people in the state.
On March 20, the Department of Health restricted the entry of all tourists (domestic and foreign) into the state.[2] The Department further issued orders for the closure of all educational institutions, gyms, swimming pools, museums, cultural and social centres, and theatres until March 31.[3]
On March 22, the state announced a complete lockdown till March 31.[4] Restrictions during the lockdown included: (i) prohibiting the gathering of more than five people at any public place, (ii) suspending all public transport including taxis and auto-rickshaws, and (iii) closure of all shops, commercial establishments, offices and factories. Establishments providing essential goods and services were excluded from the lockdown restrictions. These include: police, medical and health, print and electronic media, food, groceries, and their transportation, among others.4
On March 25, the central government announced on a 21-day country-wide lockdown till April 14.[5] On April 14, the lockdown was further extended till May 3, 2020.[6]
On April 15, the Ministry of Home Affairs issued guidelines on the measures to be taken by state governments until May 3.[7] As per these guidelines, select activities will be permitted from April 20 onwards, to mitigate hardship to the public due. These activities include health services, agriculture and related activities, certain financial sector activities, operation of Anganwadis, MNREGA works, and cargo movement, among others. Further, subject to certain conditions, commercial and private establishments, industrial establishments, government offices, and construction activities will also be permitted.7
Health Measures
Uttarakhand Epidemic Disease COVID-19 Regulations 2020
On March 15, 2020, the government notified the Uttarakhand Epidemic Disease COVID-19 Regulations, 2020 for the containment of COVID-19 in the state.[8] Key features of the regulations include the following:
All hospitals (government and private) must have dedicated flu corners for the screening of suspected COVID-19 cases.
The spread of any misinformation must be avoided. No person or organisation can use any print or electronic media for information regarding COVID-19 without prior permission of the state health department.
Guidelines for citizens, healthcare facilities and government departments
The state issued several guidelines and advisories on various subjects related to the containment of the virus.[9] These guidelines have been targeted towards citizens, healthcare facilities, as well as government departments. Some of these guidelines are given below:
For citizens: These include guidelines on the use of masks by the public, guidelines for home quarantine, and advisory to not consume tobacco to prevent the virus.8
For healthcare facilities: Guidelines for health care facilities include: sample collection, packaging and transport guidelines, infection prevention control for suspected cases, clinical management of COVID – 19, and discharge policy for COVID-19 patients, among others.8
For government: Guidelines for government departments include: guidelines for cluster containment, strategy, advisory on the use of hydroxychloroquine for high-risk population, and guidelines for quarantine facilities for COVID-19.8
Administrative Measures
On March 21, the state government cancelled all leaves for employees from the Department of Medical, Health and Family Welfare and ordered all the employees on leave to report back.[10] Further, on March 19, the state government announced that the administrative control of all properties and accommodations under the tourism department and other government enterprises will be given to the respective District Magistrates, temporarily.[11]
Education
On March 21, the state government postponed the correction of all state board examination booklets, which were to be corrected from April 1 to April 15, 2020.[12] The government also postponed exams for the Forest Research Institute, which were supposed to be conducted in March.[13]
For more information on the spread of COVID-19 and the central and state government response to the pandemic, please see here.
[1] Dehradun Health Bulletin on Corona Virus Disease (COVID-19), Status as on April 15, 2020 Time: 05:30 PM, Uttarakhand State Control Room COVID -19, Health and Family Welfare, Uttarakhand, http://health.uk.gov.in/files/Corrected-15-04-2020-Health-Bulletin.pdf.
[2] Order No. 48/PS-Secy(H)/2020, Department of Medical, Health and Family Welfare, March 20, 2020, https://prsindia.org/files/covid19/notifications/427.UK_Advisory_for_Tourists_20_Mar.pdf.
[3] Advisory on social distancing measure in view of spread of COVID-19 disease, Government of Uttarakhand, https://prsindia.org/files/covid19/notifications/1835.UK_Social_Distancing_Advisory_Uttarakhand.pdf.
[4] Order No. UKHFWS/PS-MDNHM/2019-20/217, Department of Medical, Health and Family Welfare and Medical Education, March 22, 2020, https://prsindia.org/files/covid19/notifications/432.UK_Order_Lockdown_Mar_22.pdf.
[5] Order No. 1-29/2020-PP, National Disaster Management Authority, March 24, 2020, https://mha.gov.in/sites/default/files/ndma%20order%20copy.pdf.
[6] “PM addresses the nation for 4th time in 4 Weeks in India’s fight against COVID-19” Press Release, Prime Minister’s office, April 14, 2020, https://pib.gov.in/PressReleseDetail.aspx?PRID=1614255.
[7] Order No.40-3/2020-DM-I(A), Ministry of Home Affairs, April 15, 2020, https://www.mha.gov.in/sites/default/files/MHA%20order%20dt%2015.04.2020%2C%20with%20Revised%20Consolidated%20Guidelines_compressed%20%283%29.pdf.
[8] Notification No. 370/XXVIII(1)/2020-01(06)/2020, Department of Medical Health and Medical Education, March 15, 2020, http://health.uk.gov.in/files/The_Uttarakhand__Epidemic__Disease__COVID-19_Regulation_2020.pdf.
[9] Website of Department of Medical, Health and Family Welfare, Corona (COVID19) updates, Government of Uttarakhand, last visited on March 16, http://health.uk.gov.in/pages/display/140-novel-corona-virus-guidelines-and-advisory-.
[10] Order No. 1P/Ra0pu0/miscellaneous/1/2018, Department of Medical, Health and Family Welfare, March 19, 2020, https://prsindia.org/files/covid19/notifications/430.UK_DG-Order-Cancellalation_of_Leave_Health_Workers_21_Mar.pdf.
[11] Order No. 42/Secy Health/2020, Department of Medical, Health and Family Welfare, March 19, 2020, https://prsindia.org/files/covid19/notifications/1826.UK_Advisory_for_KMVN_and_GMVN_Mar19.pdf
[12] Advisory No. 123/XXIV-B-5/2020/03(01)/2020, Secretary Uttarakhand Government, March 21, 2020, https://prsindia.org/files/covid19/notifications/429.UK_Advisory_for_Board_Student_of_Uttarakhand_21_Mar.pdf.
[13] Advisory No. 122/XXIV-B-5/2020/03(01)/2020, Secretary Uttarakhand Government, March 21, 2020, https://prsindia.org/files/covid19/notifications/1828.UK_Advisory_for_Board_Student_of_FRI_Uttarakhand_Mar21.pdf.
