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:
The Protection of Children against Sexual Offences Act, 2012 was passed by both Houses of Parliament on May 22. The legislation defines various types of sexual offences against children and provides penalties for such acts. According to a report commissioned by the Ministry of Women and Child Development in 2007, about 53% of the children interviewed reported some form of sexual abuse. The law has been viewed as a welcome step by most activists since it is gender neutral (both male and female children are covered), it clearly defines the offences and includes some child friendly procedures for reporting, recording of evidence, investigation and trial of offences. However, the issue of age of consent has generated some controversy. Age of consent refers to the age at which a person is considered to be capable of legally giving informed consent to sexual acts with another person. Before this law was passed, the age of consent was considered to be 16 years (except if the woman was married to the accused, in which case it may be lower). Section 375 of the Indian Penal Code, 1860 states that any sexual intercourse with a woman who is below the age of 16 years is considered to be “rape”. The consent of the person is irrelevant. This post provides a snapshot of the key provisions of the Act, the debate surrounding the controversial provision and a comparison of the related law in other countries. Key provisions of the Act
Debate over the age of consent After introduction, the Bill was referred to the Standing Committee on Human Resource Development. The Committee submitted its report on December 21, 2011 (see here and here for PRS Bill Summary and Standing Committee Summary, respectively). Taking into account the recommendations of the Standing Committee, the Parliament decided to amend certain provisions of the Bill before passing it. The Bill stated that if a person is accused of “sexual assault” or “penetrative sexual assault” of a child between 16 and 18 years of age, it would be considered whether the consent of the child was taken by the accused. This provision was deleted from the Bill that was passed. The Bill (as passed) states that any person below the age of 18 years shall be considered a child. It prohibits a person from engaging in any type of sexual activity with a child. However, the implication of this law is not clear in cases where both parties are below 18 years (see here and here for debate on the Bill in Rajya Sabha and Lok Sabha). The increase in the age of consent to 18 years sparked a debate among experts and activists. Proponents of increasing the age of consent argued that if a victim is between 16 and 18 years of age, the focus of a sexual assault case would be on proving whether he or she consented to the act or not. The entire trial process including cross-examination of the victim would focus on the conduct of the victim rather than that of the accused (see here and here). Opponents of increasing the age of consent pointed out that since this Act criminalises any sexual activity with persons under the age of 18 years (even if consensual), the police may misuse it to harass young couples or parents may use this law to control older children’s sexual behaviour (see here and here). International comparison In most countries, the age of consent varies between 13 and 18 years. The table below lists the age of consent and the corresponding law in some selected countries.
| Countries |
Age of consent |
Law |
| US | Varies from state to state between 16 and 18 years. In some states, the difference in age between the two parties is taken into account. This can vary between 2-4 years. | Different state laws |
| UK | 16 years | Sexual Offences Act, 2003 |
| Germany | 14 years (16 years if the accused is a person responsible for the child’s upbringing, education or care). | German Criminal Code |
| France | 15 years | French Criminal Code |
| Sweden | 15 years (18 years if the child is the accused person’s offspring or he is responsible for upbringing of the child). | Swedish Penal Code |
| Malaysia | 16 years for both males and females. | Malaysian Penal Code; Child Act 2001 |
| China | No information about consent. Sex with a girl below 14 years is considered rape. Sodomy of a child (male or female) below 14 years is an offence. | Criminal Law of China, 1997 |
| Canada | 16 years | Criminal Code of Canada |
| Brazil | 14 years | Brazilian Penal Code 2009 |
| Australia | Varies between 16 and 17 years among different states and territorial jurisdictions. In two states, a person may engage in sexual activity with a minor if he is two years older than the child. In such cases the child has to be at least 10 years old. | Australian Criminal laws |
| India | 18 years. | Protection of Children Against Sexual Offences Act, 2012 |
