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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:
Parliament voted on the Demands for Grants for the Ministry of Home Affairs on May 02, 2012. During the debate, MPs expressed concern over the status of police forces in different States of the country. They emphasised the need to augment the capability of police forces. Though ‘Police’ and ‘Public Order’ are State subjects, the union government provides assistance to States for strengthening their forces. For instance, the Ministry of Home Affairs has been implementing a non-plan scheme for ‘Modernization of Police Forces’ since 1969-70. Under the scheme assistance is provided in the form of grants-in-aid towards construction of secure police stations, outposts, for purchase of vehicles, equipment etc. (To know more about the scheme, see an earlier blog post on the issue.) At the all India level, the sanctioned strength of State Police equals 20.6 lakh personnel. Though there exist wide variations across States, at an average this amounts to 174 police personnel per lakh population. However, the actual ratio is much lower because of high vacancies in the police forces. At the aggregate level, 24% positions are vacant. The table below provides data on the strength of state police forces as in Jan, 2011
State | Sanctioned strength | Sanctioned policemen/ lakh of population | Vacancy |
Andhra Pradesh | 1,31,099 | 155 | 31% |
Arunachal Pradesh | 11,955 | 966 | 42% |
Assam | 62,149 | 200 | 12% |
Bihar | 85,939 | 88 | 27% |
Chhattisgarh | 50,869 | 207 | 18% |
Goa | 6,108 | 348 | 16% |
Gujarat | 87,877 | 151 | 27% |
Haryana | 61,307 | 248 | 28% |
Himachal Pradesh | 17,187 | 256 | 22% |
Jammu & Kashmir | 77,464 | 575 | 6% |
Jharkhand | 73,005 | 235 | 30% |
Karnataka | 91,256 | 155 | 10% |
Kerala | 49,394 | 141 | 7% |
Madhya Pradesh | 83,524 | 115 | 9% |
Maharashtra | 1,53,148 | 139 | 10% |
Manipur | 31,081 | 1,147 | 26% |
Meghalaya | 12,268 | 469 | 17% |
Mizoram | 11,246 | 1,112 | 6% |
Nagaland | 24,226 | 1,073 | 0% |
Orissa | 53,291 | 130 | 18% |
Punjab | 79,565 | 291 | 14% |
Rajasthan | 79,554 | 118 | 11% |
Sikkim | 5,421 | 886 | 27% |
Tamil Nadu | 1,20,441 | 178 | 15% |
Tripura | 44,310 | 1,224 | 17% |
Uttar Pradesh | 3,68,260 | 184 | 59% |
Uttarakhand | 20,775 | 211 | 24% |
West Bengal | 72,998 | 81 | 18% |
A&N Islands | 4,417 | 1,018 | 22% |
Chandigarh | 7,873 | 695 | 22% |
D&N Haveli | 325 | 114 | 13% |
Daman & Diu | 281 | 140 | 6% |
Delhi | 81,467 | 441 | 1% |
Lakshadweep | 349 | 478 | 36% |
Puducherry | 3,941 | 352 | 25% |
All India | 20,64,370 | 174 | 24% |
Source: Lok Sabha Unstarred Question No. 90, 13th March, 2012 and Lok Sabha Unstarred Question No. 1042, March 20, 2012