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 Women against Sexual Harassment Bill was passed by Rajya Sabha yesterday. Prior to this, no legislation specifically addressed the issue of sexual harassment at the workplace. In 1997, the Supreme Court issued directions in Vishakha vs. State of Rajasthan to deal with the issue. The Supreme Court had also recommended that steps be taken to enact a law on the subject. The Bill was introduced in Parliament in 2010 and was passed by the Lok Sabha on September 3, 2012. In order to protect women from harassment, the Bill establishes a mechanism for redressal of complaints related to harassment. Recently, the Verma Committee in its Report on Amendments to Criminal Laws had made recommendations on the Sexual Harassment Bill. In this blog we discuss some of the key issues raised by the Verma Committee with regard to the issue of sexual harassment at the workplace. Internal Committee: The Bill requires the establishment of a committee within organisations to inquire into complaints of sexual harassment. The Committee shall comprise four members: three would be employees of the organisation; and the fourth, a member of an NGO committed to the cause of women. The Verma Committee was of the opinion that in-house dealing of the complaints would dissuade women from filing complaints. It recommended that a separate Employment Tribunal outside the organisation be established to receive and address complaints of sexual harassment. Requirement for conciliation: Once a complaint is made, the Bill requires the complainant to attempt conciliation and settle the matter. Only in the event a settlement cannot be reached, the internal committee of the organisation would inquire into the matter. The Verma Committee was of the opinion that this is in violation of the Supreme Court’s judgment. It noted that in sexual harassment cases, an attempt to conciliate compromises the dignity of the woman. Action during pendency of the case: As per the Bill, a woman may approach the internal committee to seek a transfer for herself or the respondent or a leave to the complainant. The Verma Committee had recommended that till the disposal of the case, the complainant and the respondent should not be compelled to work together. False complaints: The Bill allows the employer to penalise false or malicious complaints as per their service rules. The Committee was of the opinion that this provision was open to abuse. A PRS analysis of the Bill may be accessed here.
