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 India, children between the age group of 6 and 14 years have the fundamental right to free and compulsory education. This right is implemented through the Right of Children to Free and Compulsory Education Act, 2009 (RTE Act). The Act is applicable to all categories of schools (government and private). According to recent media reports (see here and here), many schools (including government schools) are flouting norms laid down in the RTE Act. Unaided schools have criticised state government over norms related to religious and linguistic status of minority schools (see here and here). The government has also faced flak over unclear norms on neighbourhood schools and reimbursement of money to private schools (see here, here and here). Most Acts ‘delegate’ the power to make rules and regulations for operationalising the law to the executive (Ministry). We provide an overview of the Rules notified by the state governments. The central government notified the RTE Rules 2010 on April 9, 2010, which are applicable to all schools under the central government, and in the five Union Territories without legislatures. Most of the states have notified similar Rules with a few variations. The Rules define the limits of a neighbourhood and make it mandatory for the local authority to maintain list of children within its jurisdiction. They also prescribe the composition of the School Management Committee to be formed in government schools. Private schools shall reserve 25% of the seats for disadvantaged children. These schools shall be reimbursed for either their tuition charge or the per-student expenditure in government schools, whichever is lower. All private schools have to be recognised before they can start operation. Recognition is contingent upon meeting the minimum standard laid down in the Act Existing private schools have to meet the norms within three years of commencement of the Act. If they are not compliant after three years, they shall cease to function. Government schools under the central government have to meet only two conditions: the minimum qualification for teachers and the student-teacher ratio. For all state government schools and un-adided schools, the power to make rules is delegated to the state government. The central government circulated Model Rules for the RTE Act to the states. All state governments, except Goa, have notified the state RTE Rules. Delhi and Puducherry have also notified them. Most of the states have notified similar Rules with a few variations. We list some of the variations. Andhra Pradesh: The break-up of the 25% quota among the various disadvantaged groups have been included in the Rules. Scheduled Castes: 10%; Scheduled Tribes: 4%; Orphans, disabled and HIV affected: 5% and children with parents whose annual income is lower than Rs 60,000: 6%. Rajasthan: Private schools either have to be affiliated with a university or recognised by any officer authorised by the state government. Karnataka: In addition to the minimum norms under RTE Act, private schools have to comply with the Karnataka Education Act, 1983. Gujarat: If an existing recognised school is unable to meet the infrastructure norms it may be given the option of demonstrating that it achieved certain learning outcomes, both in terms of absolute levels and as improvement from previous years. Uttar Pradesh: The government shall pay per child reimbursement to the school after it gives a list of children with their Unique Identity Number and other details. Kerala: The local authority has to maintain a record of all the children (0-14 years) within its jurisdiction. It shall also maintain the Unique Identity Number of every child, as and when issued by the competent authority, to monitor his enrolment, attendance and learning achievements. Haryana: Defines textbooks, uniform and writing material. It states that Hindi is to be the preferred medium of instruction in all schools. For using other language, permission of Director, Elementary Education Dept is required (to be given within 45 days or deemed to be granted). West Bengal: The Rules give detailed definition of the appropriate age for each class. They require schools to be set up in a relatively noise-free and pollution-free area with adequate supply of drinking water and electricity. Existing schools (which are already recognised or affiliated with a Board) may get the local municipal authorities to provide infrastructural support including relaxation of building rules to comply with the requirements of the Act. Additional sources
