Lapses in the process of drug approval in India

Sakshi - May 29, 2012

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:

drugs that have not been used in the country before,
drugs that have been approved by a Licensing Authority but are now being marketed for different purposes, and
fixed dose combinations of two or more drugs that have been individually approved before but are proposed to be combined in a fixed ratio that has not been approved.

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:

Under the Rules, the Drugs Controller General (India) (DCGI), the head of CDSCO, can clear sites of clinical trials after ensuring that major ethnic groups are enrolled in these trials to have a truly representative sample. This rule was violated by the DCGI when sites for clinical trials were approved without ensuring diversity. The Committee recommended that the DCGI approve sites for trials only if they cover patients from major ethnic backgrounds.

The Report found that certain actions by experts were in violation of the Code of Ethics of the Medical Council of India. A review of expert opinions revealed that several medical expert recommendations had been given as personal opinions rather than on the basis of scientific data. Additionally, many expert opinions were written by what the Report calls ‘the invisible hands’ of drug manufacturers. The Committee recommended that CDSCO formulate a clear set of written guidelines on the selection process of experts with emphasis on expertise in the area of drugs.

The Rules ban the import and marketing of any drug whose use is prohibited in the country of origin. CDSCO violated this rule by approving certain Fixed Dose Combination drugs for clinical trials without considering the drugs’ regulatory status in their respective country of origin. Drugs such as Deanxit and Buclizine, which have been prohibited for sale and use in their countries of origin, Denmark and Belgium, respectively, were approved for clinical trials. The Committee recommended an inquiry into the unlawful approval of these drugs.

The Rules require animal studies to be conducted for approval of a drug for use by women of reproductive age. CDSCO violated this rule in approving Letrozole for treating female infertility. Globally the drug has only been used as an anti-cancer drug for use among post-menopausal women. The drug has not been permitted for use among women of reproductive age because of side effects. The Committee recommended that responsibility be fixed for unlawfully approving Letrozole.

Rules require Post-marketing Safety Update Reports (PSURs) on drugs to be submitted to CDSCO. PSURs are used to collect information on adverse effects of drugs on Indian patients as a result of ethnic differences. When asked by the Committee to furnish PSURs on 42 randomly selected new drugs, the Ministry was able to submit PSURs for only 8 drugs. The Report contended that this action reflected a poor follow-up of side effects on Indian patients. The Committee recommended that manufacturers of new drugs be warned about suspension of marketing approval unless they comply with mandatory rules on PSURs.

States and State Legislatures

Government of Karnataka’s response to the COVID-19 pandemic (Feb 2020–April 14, 2020)

Prachi Kaur - April 15, 2020

As of April 13, 2020, there have been 260 confirmed cases of COVID-19 in Karnataka. Of these, 70 have been discharged and 10 have died.[1] In order to contain the spread of the disease, both, the Central and State governments have come up with a series of policy responses. In this blog, we take a look at the key measures taken by the Government of Karnataka in this regard as of April 14, 2020.

Movement restrictions

To contain the spread of COVID-19 in the state, the Government of Karnataka took the following measures to restrict the movement of people in the state:

On March 13, the Directorate of Health and Family Welfare ordered the closure of various establishments such as theatres, pubs, gyms, malls, swimming pools, and educational institutions until March 21. The order also directed all international passenger arrivals to be mandatorily home quarantined for 14 days.[2]
On March 20, the above order was revised to extend the closure of said establishments until April 1. The order also banned all religious gatherings.[3]
Further, on March 23, all bus services to and from the nine districts that had reported COVID-19 positive cases were completely stopped until April 1.[4]
The central government later announced a 21-day country-wide lockdown starting March 25.[5] This was followed by the announcement of a pass system by the Bengaluru Commissioner of Police on March 25 to regulate the movement of people in Bengaluru City.[6]
On April 6, District Collectors were empowered to issue inter-district transport passes.[7]
On April 14, the Prime Minister announced the extension of the lockdown till May 3, 2020.[8] On April 15, the Ministry of Home Affairs issued guidelines on the measures to be taken by governments until May 3. As per these guidelines, to mitigate hardship to the public, select activities will be permitted from April 20 onwards. These include health services, agriculture and related activities, financial sector, MNREGA works, cargo movement etc. In addition, subject to conditions, commercial and private establishments, industrial establishments, government offices, construction activities etc, will also be permitted.[9]

Essential Goods and Services

The pass system in Bengaluru City facilitated the movement of personnel involved in manufacturing and providing essential goods and services.
On April 2, the government announced that it will distribute the excess stock of milk to poor people for free.[10]
On April 6, the government declared that rations for the month of April will be supplied to people without the usual OTP authentication process.[11]

Health Measures

Karnataka Epidemic Disease COVID-19 Regulations 2020

On March 11, 2020, the government released the Karnataka Epidemic Disease COVID-19 Regulations 2020 to prevent the spread of COVID19 in the state. These regulations specify the protocol for hospitals to follow for screening and treating COVID-19 patients. These regulations are valid for one year.[12]

Preventive measures

On February 5, 2020, the Department of Health & Family Welfare and AYUSH services issued the Terms of Reference for district-level teams to take preventive measures against the spread of COVID-19.[13] The terms relate to various administrative and complementary aspects related to COVID19 management. These include activities of various teams, human resource management, training and awareness generation etc.

Following this, on April 6, 2020, the Department also issued instructions to all districts to prepare a District Level Crisis Management Plan to prevent large outbreaks of COVID-19.[14]

Setting up of fever clinics, isolation centres etc

On March 4, the state government issued guidelines to the district administration to ensure hospitals maintain a 10-bed isolation ward for COVID-19 patients.[15]

On March 31, the government issued orders to establish fever clinics as the first points of contact for COVID-19 suspect patients. These fever clinics would have COVID-19 Rapid Response team of one doctor, two nurses and a health care worker.[16]

Personnel measures

On March 30, the Department of Health & Family Welfare invited applications from doctors for immediate appointment (on contract basis) in Urban Primary Health Centres in Bengaluru City.[17] Subsequently, on April 2, the state government issued orders to extend the tenure of retiring medical professionals from March 31, 2020 to June 30, 2020.[18]

On March 26, all Registered Medical Practitioners were permitted to provide telemedicine services during the lockdown period. Telemedicine services will be available for minor, non-COVID-19 ailments, and existing patients only.[19]

For more information on the spread of COVID-19 and the central and state government response to the pandemic, please see here.

[1] Novel Coronavirus (COVID19) Media Bulletin, Karnataka, Department of Health and Family Welfare, last accessed on April 15, 2020, https://karunadu.karnataka.gov.in/hfw/kannada/nCovDocs/14-04-2020(English).pdf

[2] GOK order No. DD/SSU/COVID-19/17/19-20, Directorate of Health and Family Welfare, Government of Karnataka, March 13, 2020,

https://karunadu.karnataka.gov.in/hfw/kannada/nCovDocs/Notification(Covid-19)-Dir-HFWS.pdf

[3] Revised GOK order No. DD/SSU/COVID-19/17/19-20, Directorate of Health and Family Welfare, Government of Karnataka, March 20, 2020 https://karunadu.karnataka.gov.in/hfw/kannada/nCovDocs/Revised-Order-COVID-19(20-03-2020).pdf

[4] Order No. STA-6/SCP/PR-20/2019-20, Directorate of Transport, Government of Karnataka, March 23, 2020, https://transport.karnataka.gov.in/storage/pdf-files/restrictions.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] Order No.02 / CP-BLR/Covid-19/2020, Commissioner of Police, Bengaluru City, March 25, 2020, https://karnataka.gov.in/storage/pdf-files/covid_rules/Covid_pass.pdf

[7] Order of Chief Secretary, Government of Karnataka, April 6, 2020, https://ksuwssb.karnataka.gov.in/frontend/opt1/images/covid/Orders/IMG-20200406-WA0005.jpg

[8] “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

[9] 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

[10] Proceedings, Government of Karnataka, April 2, 2020, ,https://ksuwssb.karnataka.gov.in/frontend/opt1/images/covid/Orders/GO%20Free%20Milk%20%20(1).pdf

[11] RD 158 TNR 2020, Government of Karnataka, April 6, 2020, https://ksuwssb.karnataka.gov.in/frontend/opt1/images/covid/Orders/IMG-20200406-WA0015.jpg

[12]Karnataka Epidemic Disease COVID-19 Regulations 2020, Government of Karnataka, March 11, 2020, https://karunadu.karnataka.gov.in/hfw/kannada/nCovDocs/Exercise-of-Powers-COVID-10(11-03-2020).pdf

[13] No. JRO(1A)/148/2019-20, Department of Health & Family Welfare and AYUSH Services Government of Karnataka, February 5, 2020, https://ksuwssb.karnataka.gov.in/frontend/opt1/images/covid/Circulars/%E0%B2%B8%E0%B3%81%E0%B2%A4%E0%B3%8D%E0%B2%A4%E0%B3%8B%E0%B2%B2%E0%B3%86%20%E0%B3%A8%E0%B3%AA.pdf

[14]No. HFW 87 ACS 2020 Department of Health & Family Welfare and Medical Education, April 6, 2020, https://karunadu.karnataka.gov.in/hfw/kannada/nCovDocs/Circular-Preparation%20of%20District%20Level%20Crisis%20Management%20Plan%20for%20COVID-19(06-04-2020).pdf

[15]Circular No. HFW 47 CGM 2020 (P), Government of Karnataka, March 3, 2020, https://karunadu.karnataka.gov.in/hfw/kannada/nCovDocs/Guidelines-Isolation-Ward.pdf

[16]No. HFW 73 ACS 2020, Government of Karnataka, March 31, 2020, https://karunadu.karnataka.gov.in/hfw/kannada/nCovDocs/Circular-Establishment%20of%20Fever%20Clinic%20and%20Movement%20Protocol%20for%20Suspect%20Cases%20of%20COVID-19(31-03-2020).pdf

[17]No. HFW 71 ACS 2020, Department of Health & Family Welfare and Medical Education, March 30, 2020, https://karunadu.karnataka.gov.in/hfw/kannada/nCovDocs/Order%20-%20Immidiate%20Appointment%20of%20Contract%20Doctors%20in%20BBMP%20(30-03-2020).pdf

[18] No. 40 HSH 2020 (B), Government of Karnataka, April 2, 2020, https://ksuwssb.karnataka.gov.in/frontend/opt1/images/covid/Circulars/Extension%20of%20service%20reg_001.pdf

[19]No. HFW 54 CGM 2020, Government of Karnataka, March 26, 2020, https://karunadu.karnataka.gov.in/hfw/kannada/nCovDocs/Order-Registered%20Medical%20Practitioners%20(26-03-2020).pdf