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:
Latest in the string of litigations filed after the enactment of the Right of Children to Free and Compulsory Education Act, 2009 (RTE Act), the Delhi High Court ruled that the Act shall not apply to nursery admissions in unaided private schools for the unreserved category of students. The decision, given on February 19, was in response to writ petitions filed by Social Jurist, a civil rights group and the Delhi Commission for the Protection of Child Rights. It contended that the guidelines of the Ministry of Human Resource Development related to schools’ selection procedure should also be applicable to pre-primary and pre-school classes. The right to education is applicable to children between the age of 6 and 14 years. The RTE Act states that schools have to reserve certain proportion of their seats for disadvantaged groups. It adds that where the school admits children at pre-primary level, the reservation for children of weaker sections shall apply. However, it does not mention whether other RTE norms are applicable to pre-schools. It only states that the appropriate government may make necessary arrangements for providing pre-school education to children between the age of 3 and 6 years. Guidelines of the Ministry with regard to selection procedure of students:
The two issues that the court considered were: (a) whether RTE applies to pre-schools including nursery schools and for education of children below six years of age; (b) whether RTE applies to the admission of children in pre-schools in respect of the unreserved seats (25% of seats are reserved for children belonging to disadvantaged groups). According to the verdict, the guidelines issued by the government do not apply to the unreserved category of students i.e. 75% of the admission made in pre-schools in private unaided schools. This implies that private unaided schools may formulate their own policies regarding admission in pre-schools for the unreserved category of students. However, they apply to the reserved category of students i.e. 25% of the admission s made in these schools for disadvantaged groups. The court has however stated that in its view this is the right time for the government to consider the applicability of RTE Act to the nursery classes too. In most schools, students are admitted from nursery and they continue in the same school thereafter. Therefore, the RTE Act’s prohibition of screening at the time of selection is rendered meaningless if it is not applicable at the nursery level.
