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:
This post is pursuant to the discussion on population stabilization being held in Parliament currently. India is the second most populous country in the world, sustaining 16.7% of the world's population on 2.4% of the world's surface area. The population of the country has increased from 238 million in 1901 to 1,029 million in 2001. Even now, India continues to add about 26 million people per year. This is because more than 50% of the population is in the reproductive age group. India launched a family planning programme in 1952. Though the birth rate started decreasing, it was accompanied by a sharp decrease in death rate, leading to an overall increase in population. In 1976, the first National Population Policy was formulated and tabled in Parliament. However, the statement was neither discussed nor adopted. The National Health Policy was then designed in 1983. It stressed the need for ‘securing the small family norm, through voluntary efforts and moving towards the goal of population stabilization’. While adopting the Health Policy, Parliament emphasized the need for a separate National Population Policy. This was followed by the National Population Policy in 2000. The immediate objective of the policy was to address the unmet needs for contraception, health care infrastructure and personnel, and to provide integrated service delivery for basic reproductive and child health care. The medium-term objective was to bring TFR (Total Fertility Rate - the average number of children a woman bears over her lifetime) to replacement levels by 2010. In the long term, it targeted a stable population by 2045, ‘at a level consistent with the requirements of sustainable economic growth, social development, and environmental protection.’ (See http://populationcommission.nic.in/npp.htm) Total Fertility Rate India’s TFR was around 6.1 in 1961. This meant that an average woman bore over 6 children during her lifetime. Over the years, there has been a noticeable decrease in this figure. The latest National Family Health Survey (NFHS III, 2005-06) puts it at 2.7. TFR is almost one child higher in rural areas (3.0) than in urban areas (2.1). TFR also varies widely across states. The states of Andhra Pradesh, Goa, Himachal Pradesh, Karnataka, Kerala, Maharashtra, Punjab, Sikkim and Tamil Nadu have reached a TFR of 2.1 or less. However, several other states like UP, Bihar, MP, Rajasthan, Orissa, Uttaranchal, Jharkhand and Chhattisgarh, where over 40% of the population lives, TFR is still high. (See http://www.jsk.gov.in/total_fertility_rate.asp) Factors that affect population growth The overarching factor that affects population growth is low socio-economic development. For example, Uttar Pradesh has a literacy rate of 56%; only 14% of the women receive complete antenatal care. Uttar Pradesh records an average of four children per couple. In contrast, in Kerala almost every person is literate and almost every woman receives antenatal care. Kerala records an average of two children per couple. Infant mortality In 1961, the Infant Mortality Rate (IMR), deaths of infants per 1000 live births, was 115. The current all India average is much lower at 57. However, in most developed countries this figure is less than 5. IMR is the lowest at 15 in Kerala and the highest at 73 in Uttar Pradesh. Empirical correlations suggest that high IMR leads to greater desire for children. Early marriage Nationwide almost 43% of married women aged 20-24 were married before the age of 18. This figure is as high as 68% in Bihar. Not only does early marriage increase the likelihood of more children, it also puts the woman's health at risk. Level of education Fertility usually declines with increase in education levels of women. Use of contraceptives According to NFHS III (2005-06), only 56% of currently married women use some method of family planning in India. A majority of them (37%) have adopted permanent methods like sterilization. Other socio-economic factors The desire for larger families particularly preference for a male child also leads to higher birth rates. It is estimated that preference for a male child and high infant mortality together account for 20% of the total births in the country. Government initiatives The National Population Policy 2000 gave a focused approach to the problem of population stabilization. Following the policy, the government also enacted the Constitution (84th Amendment) Act, 2002. This Amendment extended the freeze on the state-wise allocation of seats in the Lok Sabha and the Rajya Sabha to 2026. It was expected that this would serve ‘as a motivational measure, in order to enable state governments to fearlessly and effectively pursue the agenda for population stabilization contained in the National Population Policy, 2000’. The National Commission on Population was formed in the year 2000. The Commission, chaired by the Prime Minister, has the mandate to review, monitor and give directions for implementation of the National Population Policy. The Jansankhya Sthirata Kosh (National Population Stabilization Fund) was setup as an autonomous society of the Ministry of Health and Family Welfare in 2005. Its broad mandate is to undertake activities aimed at achieving population stabilization. Programmes like the National Rural Health Mission, Janani Suraksha Yojana, ICDS (Integrated Child Development Services) etc. have also been launched by the government to tackle the healthcare needs of people. This is also expected to contribute to population stabilization. Free contraceptives are also being provided. In addition, monetary incentives are given to couples undertaking permanent family planning methods like vasectomy and tubectomy. Nutritional and educational problems are being targeted through programs like the mid-day meal scheme and the recently enacted Right to Education. ---------------- For more details on the issue, see the website of the National Population Stabilization Fund (http://www.jsk.gov.in/) Sources: Registrar General, India National Population Stabilization Fund National Commission on Population National Family Health Survey III (2005-06)
