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:
In the last few years, several states have enacted laws to curb cheating in examinations, especially those for recruitment in public service commissions. According to news reports, incidents of cheating and paper leaks have occurred on several occasions in Uttarakhand, including during the panchayat development officer exams in 2016, and the Uttarakhand Subordinate Services Selection Commission exams in 2021. The Uttarakhand Public Service Commission papers were also leaked in January 2023. The most recent cheating incidents led to protests and unrest in Uttarakhand. Following this, on February 11, 2023, the state promulgated an Ordinance to bar and penalise the use of unfair means in public examinations. The Uttarakhand Assembly passed the Bill replacing the Ordinance in March 2023. There have been multiple reports of candidates being arrested and debarred for cheating in public examinations for posts such as forest guard and secretariat guard after the ordinance’s introduction. Similar instances of cheating have also been noted in other states. As per news reports, since 2015, Gujarat has not been able to hold a single recruitment exam without reported paper leaks. In February 2023, the Gujarat Assembly also passed a law to penalise cheating in public examinations. Other states such as Rajasthan (Act passed in 2022), Uttar Pradesh (Act passed in 1998) and Andhra Pradesh (Act passed in 1997) also have similar laws. In this blog, we compare anti-cheating laws across some states (see Table 1), and discuss some issues to consider.
Typical provisions of anti-cheating laws
Anti-cheating laws across states generally contain provisions that penalise the use of unfair means by examinees and other groups in public examinations such as those conducted by state public sector commission examinations and higher secondary education boards. Broadly, unfair means is defined to include the use of unauthorised help and the unauthorised use of written material by candidates. These laws also prohibit individuals responsible for conducting examinations from disclosing any information they acquire in this role. The more recent laws, such as the Gujarat, Uttarakhand, and Rajasthan ones, also include the impersonation of candidates and the leaking of exam papers within the definition of unfair means. Uttarakhand, Gujarat, Rajasthan, Uttar Pradesh, Chhattisgarh, and Andhra Pradesh prohibit the use of electronic aids. Maximum prison sentences for using such unfair means range from three months in Uttar Pradesh, to seven years in Andhra Pradesh.
Issues to consider
The Gujarat and Uttarakhand anti-cheating Acts have relatively stringent provisions for cheating. The Uttarakhand Act has a fixed 3-year prison sentence for examinees caught cheating or using unfair means (for the first offence). Since the Act does not distinguish between the different types of unfair means used, an examinee could serve a sentence disproportionate to the offence committed. In most other states, the maximum imprisonment term for such offences is three years. Andhra Pradesh has a minimum imprisonment term of three years. However, all these states allow for a range with respect to the penalty, that is, the judge can decide on the imprisonment term (within the specified limits) depending on the manner of cheating and the implications of such cheating. Table 1 below compares the penalties for certain offences across eight states.
The Uttarakhand Act has a provision that debars the examinee from state competitive examinations for two to five years upon the filing of the chargesheet, rather than upon conviction. Thus, an examinee could be deprived of giving the examination even if they were innocent but being prosecuted under the law. This could compromise the presumption of innocence for accused candidates. The Gujarat and Rajasthan laws also debar candidates from sitting in specified examinations for two years, but only upon conviction.
These laws also vary in scope across states. In Uttarakhand and Rajasthan, the laws only apply to competitive examinations for recruitment in a state department (such as a Public Commission). In the other six states examined, these laws also apply to examinations held by educational institutions for granting educational qualifications such as diplomas and degrees. For example, in Gujarat, exams conducted by the Gujarat Secondary and Higher Secondary Education Board are also covered under the Gujarat Public Examination (Prevention of Unfair Means) Act, 2023. The question is whether it is appropriate to have similar punishments for exams in educational institutions and exams for recruitment in government jobs, given the difference in stakes between them.
Sources: The Rajasthan Public Examination (Measures for Prevention of Unfair Means in Recruitment) Act, 2022; the Uttar Pradesh Public Examinations (Prevention of Unfair Means) Act, 1998; the Chhattisgarh Public Examinations (Prevention of Unfair Means) Act, 2008; the Orissa Conduct of Examinations Act, 1988; the Andhra Pradesh Public Examinations (Prevention of Malpractices and Unfair means) Act, 1997; the Jharkhand Conduct of Examinations Act, 2001, the Uttarakhand Competitive Examination (Measures for Prevention and Prevention of Unfair Means in Recruitment) Act, 2023, the Gujarat Public Examination (Prevention of Unfair Methods) Act, 2023; PRS.