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:
Earlier today, a Bill to raise maternity benefits was introduced and passed in Rajya Sabha. The Bill amends the Maternity Benefit Act, 1961. The Act regulates the employment of women during the period of child birth, and provides maternity benefits. The Act applies to factory, mines, plantations, shops and other establishments.
Duration of maternity leave: The Act states that every woman will be entitled to maternity benefit of 12 weeks. The Bill increases this to 26 weeks. Further, under the Act, this maternity benefit should not be availed before six weeks from the date of expected delivery. The Bill changes this to eight weeks. In case of a woman who has two or more children, the maternity benefit will continue to be 12 weeks, which cannot be availed before six weeks from the date of the expected delivery.
Maternity leave for adoptive and commissioning mothers: Further, the Bill introduces a provision to grant 12 weeks of maternity leave to: (i) a woman who legally adopts a child below three months of age; and (ii) a commissioning mother. A commissioning mother is defined as a biological mother who uses her egg to create an embryo implanted in another woman. The 12-week period of maternity benefit will be calculated from the date the child is handed over to the adoptive or commissioning mother.
Informing women employees of the right to maternity leave: The Bill introduces a provision which requires every establishment to intimate a woman at the time of her appointment of the maternity benefits available to her. Such communication must be in writing and electronically.
Option to work from home: The Bill introduces a provision that states that an employer may permit a woman to work from home. This would apply if the nature of work assigned to the woman permits her to work from home. This option can be availed of, after the period of maternity leave, for a duration that is mutually decided by the employer and the woman.
Crèche facilities: The Bill introduces a provision which requires every establishment with 50 or more employees to provide crèche facilities within a prescribed distance. The woman will be allowed four visits to the crèche in a day. This will include her interval for rest. Various countries provide maternity leave. However, the duration of leave varies across different countries.[i] We present a comparison of maternity leave available in different countries, as on 2014, below. 
Sources: International Labour Organisation Report (2014); PRS. [i]. “Maternity and Paternity at work: Legislation across countries”, International Labour Organisation Report (2014), http://www.ilo.org/wcmsp5/groups/public/---dgreports/---dcomm/---publ/documents/publication/wcms_242615.pdf.
