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.

Parliament

How votes are counted in Indian elections?

Manish Kanadje - May 22, 2019

The counting of votes for General Election 2019, which concluded on Sunday, will begin tomorrow, i.e., 23^rd May at 8 AM. The election was conducted in 7 phases for 543 constituencies of Lok Sabha. The Election Commission of India (ECI) uses Electronic Voting Machines (EVM) to conduct elections. Since 2000, ECI has conducted 113 assembly elections and three general elections using EVMs.[1] Voter Verified Paper Audit Trail (VVPAT) system was added to EVMs in 2013 to increase transparency and improve voter confidence in the system. The VVPAT system generates a printed paper slip bearing the name and election symbol of the candidate. On April 8, 2019, Supreme Court instructed the ECI that printed VVPAT slips from randomly selected five polling stations in each assembly segment of a parliamentary constituency should be matched with EVMs.[2] In this blog, we explain the election counting process in India.

Who is responsible for counting the votes?

The Returning Officer (RO) is responsible for conducting elections in a constituency, which also includes counting of votes.[3] The RO is an officer of the government or a local authority nominated by the ECI for each constituency in consultation with the state government.[4]

Where does the counting take place?

The RO decides the place where the votes will be counted for the parliamentary constituency. The date and time of counting is fixed by the ECI. Ideally counting of votes for a constituency should be done at one place, preferably at the Headquarter of the RO in that constituency. It should be performed under the direct supervision of the RO.However, each Parliamentary Constituency has multiple assembly segments. In this situation, counting can take place at different locations for various assembly segments under the direct supervision of an Assistant Returning Officer (ARO).

Layout of the Counting Hall

Page 431, Handbook for Returning Officer Document 23 Edition 1, Election Commission of India

Counting of votes for each assembly segment of a parliamentary constituency is performed in a single hall. In each round of counting, votes from 14 EVMs are counted. In case of simultaneous parliamentary and assembly elections, such as Odisha, the first seven tables are used for counting votes for assembly elections, and the rest for parliamentary elections.

In constituencies with a large number of candidates, it may not be possible to count votes for all candidates in a single hall without overcrowding it. In such a situation, the number of counting halls or tables can be increased with the prior permission of the ECI. A hall can also be used for counting votes of another assembly segment after the results of the first segment are declared. However, counting may be done for only one assembly segment in a hall at any point of time.

What is the counting process?

Counting is performed by counting supervisors appointed by the RO. Counting staff is appointed through a three stage randomisation process to ensure impartiality. Candidates along with their counting agents and election agents are also present in the counting hall.

Counting of votes begins with Electronically Transmitted Postal Ballots (ETPB) and Postal Ballots (PB). These votes are counted under the direct supervision of the RO. Counting of EVMs can start 30 minutes after the commencement of PB counting, even if all PBs have not been counted. At the end of each round of counting, the results from 14 EVMs are declared.

What is the process for counting VVPAT slips?

The ECI prescribes the process for randomly selecting one EVM for each assembly segment of a parliamentary constituency for VVPAT matching.The verification of VVPAT paper slips is conducted inside a secured VVPAT Counting Booth in the counting hall with access to authorised personnel only. Any counting table in the hall can be converted into VVPAT Counting Booth after completing EVM vote counting. Parliamentary constituencies generally have between five and ten assembly segments.

The Supreme Court has decided that VVPAT slips of five randomly selected polling stations for each assembly segment shall be matched with the result shown in the respective EVMs. This implies that VVPAT paper slips need to be matched for about 25-50 machines for each parliamentary constituency. This process requires personal supervision of RO/ARO. The ECI has decided that the counting of five VVPATs will be done sequentially.[5] The RO can declare the final result for the constituency after the VVPAT matching process has been completed.

What happens if there is a discrepancy between the VVPAT count and the EVM results?

In such a case, the printed paper slips count is taken as final. The ECI has not clarified whether there would be any further action (such as counting of all VVPATs in a constituency or assembly segment) if there is a discrepancy in the counts of one of the five VVPATs.

[1] https://www.eci.gov.in/files/file/8756-status-paper-on-evm-edition-3/.

[2] N Chandrababu Naidu and Ors. v. Union of India and Anr WP(C). 273/2019 decided on April 8, 2019.

[3] https://www.eci.gov.in/files/file/9400-hand-book-for-returning-officer-february-2019/.

[4] https://www.eci.gov.in/faqs/elections/election-machinery/faqs-election-machinery-r1/.

[5] https://www.eci.gov.in/files/file/10197-mandatory-verification-of-vvpat-paper-slips-regarding/.