![](/images/main_logo.png)
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 20, 2020, there are 17,265 confirmed cases of COVID-19 in India. Since April 13, 8,113 new cases have been registered. Out of the confirmed cases so far, 2,547 patients have been cured/discharged and 543 have died. As the spread of COVID-19 has increased across India, the central government has continued to announce several policy decisions to contain the spread, and support citizens and businesses who are being affected by the pandemic. In this blog post, we summarise some of the key measures taken by the central government in this regard between April 13 and April 20, 2020.
Source: Ministry of Health and Family Welfare, PRS.
Lockdown
Lockdown to remain in force until May 3, 2020
The lockdown has been extended until May 3, 2020 with certain relaxations taking force as of April 20, 2020. Activities that continue to remain prohibited after April 20, 2020 include: (i) all international and domestic travel except for healthcare workers and security purposes, (ii) passenger travel in trains, buses and taxis, (iii) industrial activities and hospitality services (other than those permitted), (iv) all educational institutions, and (v) all religious gatherings. Activities that are permitted after April 20, 2020 include: (i) all health services such as hospitals, clinics, and vets, (ii) agricultural operations, fisheries, and plantations, (iii) public utilities including provision of LPG and postal services, (iv) financial establishments such as non-banking financial institutions, banks and ATMs, (v) e-commerce for essential goods only, and (vi) industrial activities such as oil and gas refineries and manufacturing. Persons who do not follow the lockdown may be punishable with imprisonment up to one year and a fine, or both. States and union territories may not dilute these lockdown guidelines specified by the central government. However, they may implement stricter measures.
Certain areas within hotspots demarcated as containment zones
Hotspots refer to areas where there are large COVID-19 outbreaks or clusters with a significant spread of COVID-19. Within hotspots, certain areas may be demarcated as containment zones by the state or district administrations. There will be a strict perimeter control in the containment zones. Inward and outward movement from the containment zones will be restricted except for essential services such as medical emergencies, and law and order related activities.
Movement of stranded migrant labour
The Ministry of Home Affairs has permitted the movement of stranded migrant labour within the state in which they are stranded for work in activities permitted after the relaxation of the lockdown on April 20, 2020. These activities include industrial work, manufacturing, and construction. State governments may undertake skill mapping of migrant labourers and transport them to worksites if they are asymptomatic and willing to work. Movement of migrant labour across state borders continues to be prohibited.
Financial Measures
RBI announced additional measures to combat economic situation due to COVID-19
The International Monetary Fund’s Economic Counsellor has estimated the cumulative loss over 2020 and 2021 to global GDP due to the global economic lockdown to be around 9 trillion dollars. To combat the economic impact of COVID-19 in India, the Reserve Bank of India (RBI) has announced several additional measures. These include: (i) reduction in reverse repo rate from 4% to 3.75%, (ii) targeted long-term repo operations for an aggregate amount of Rs 50,000 crore, (iii) refinancing of financial institutions such as National Bank for Agriculture and Rural Development, Small Industries Development Bank of India, and National Housing Bank for a total amount of Rs 50,000 crore to enable them to meet the financing needs of sectors they cater to.
Dividend payments by banks
In light of the economic impact of COVID-19, the RBI announced that banks shall not make any further dividend payouts from the profits pertaining to the financial year which ended on March 31, 2020. According to RBI, this will allow banks to conserve capital to retain their capacity to support the economy and absorb losses. This restriction will be reassessed based on the financial results of banks for the quarter ending in on September 30, 2020.
Short term credit to states
RBI has announced an increase in the Ways and Means Advances (WMA) limits for states and UTs. WMA limits refer to temporary loans given by the RBI to state governments. The WMA limit has been increased by 60% from the limit as on March 31, 2020, for all states and UTs. The revised limits will be in force between April 1 and September 30, 2020.
Travel and export
Travel restrictions to continue
Since the lockdown has been extended until May 3, 2020, domestic and international travel remains prohibited. All domestic and international flights will not function until May 3, 2020. Further, the Director General of Civil Aviation has specified that airlines should not start allowing ticket bookings from May 4, 2020 onwards as there has been no clearance for such activities to commence. All passenger trains will also remain cancelled until May 3, 2020. There will be a full refund for flight tickets purchased during the lockdown period for travel before May 3, 2020. Further, there will be a full refund for tickets booked for trains that were cancelled during the lockdown and cancellation of advance bookings of tickets for trains not yet cancelled.
Export of paracetamol
The Ministry of Commerce and Industry has specified that formulations made of paracetamol may be freely exported from April 17, 2020 onwards. However, the export of paracetamol active pharmaceutical ingredients (APIs) will continue to be restricted. On March 3, 2020, the export of both formulations made of paracetamol and paracetamol APIs was restricted.
For more information on the spread of COVID-19 and the central and state government response to the pandemic, please see here.