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:
By Rohit and Aakanksha In February this year, Bihar made it mandatory for its employees to declare their assets. The new guidelines prescribe that departmental proceedings would be initiated against those who fail to submit these details. Information filed by employees is now being displayed online. For instance, click here to see information put out by the Department of Agriculture. Some other states have also followed suit. Rajasthan became the second state to do so. Asset details of employees have been posted on the Department of Personnel website. MP and Meghalaya have announced their intention to implement similar changes. The central government too has decided to put the asset details of All India Service and other Group A officers in the public domain. Employees of the central government are governed by the Central Civil Services (Conduct) Rules, 1964. Under these rules, civil servants are required to file details of their assets on a periodic basis. However, until now the information provided by employees was held in a fiduciary capacity and kept confidential. With the new order coming in, this information will now be available to the public. To ensure compliance, the government has decided that defaulters should be denied vigilance clearance and should not be considered for promotion and empanelment for senior level positions. It is interesting that the Central Information Commission, in an earlier decision dated July 23rd 2009, had held that 'disclosure of information such as assets of a Public servant, which is routinely collected by the Public authority and routinely provided by the Public servants, cannot be construed as an invasion on the privacy of an individual. There will only be a few exceptions to this rule which might relate to information which is obtained by a Public authority while using extraordinary powers such as in the case of a raid or phone-tapping. Any other exceptions would have to be specifically justified. Besides the Supreme Court has clearly ruled that even people who aspire to be public servants by getting elected have to declare their property details. If people who aspire to be public servants must declare their property details it is only logical that the details of assets of those who are public servants must be considered to be disclosable. Hence the exemption under Section 8(1) (j) of RTI cannot be applied in the instant case.' For the Supreme Court judgement referred to in the above decision, click here. These are interesting developments, especially given the recent debate on corruption. Let's wait and see if other states follow Bihar's lead.
