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:
On October 16, the Group of Experts on Privacy, Chaired by Mr. A. P. Shah, submitted its Report to the Planning Commission. The Expert Group was appointed to set out the principles that Indian privacy law should abide by. Even though privacy has been held to be a fundamental right as long back as in 1962, India does not have a law that specifies safeguards to privacy. Moreover, recent government initiatives, such as the UID, involve collection of personal information and storage in electronic form. The absence of a law on privacy increases the risk to infringement of the fundamental right. In this blog we list the recommendations made by the expert group, discuss the status of the right to privacy in India, and why there is a need for an enactment. Recommendations of the Expert Group on Privacy
Present status of the Right to Privacy While the Supreme Court has held privacy to be a fundamental right, it is restricted to certain aspects of a person’s life. These aspects include the privacy of one’s home, family, marriage, motherhood, procreation and child-rearing. Therefore, to claim privacy in any other aspect, individuals have to substantiate these are ‘private’ and should not be subjected to state or private interference. For instance, in 1996 petitioners had to argue before the Court that the right to speak privately over the telephone was a fundamental right. Risks to privacy Government departments collect data under various legislations. For instance, under the Passport Act, 1967 and the Motor Vehicles Act, 1988 persons have to give details of their address, date of birth etc. These enactments do not provide safeguards against access and use of the information by third parties. Similarly, information regarding ownership of property and taxes paid are publicly available on the MCD website. Furthermore, recent government initiatives may increase the risk to infringement of privacy as personal information, previously only available in physical form, will now be available electronically. Initiatives such as the National e-Governance Plan, introduced in 2006 and Aadhaar would require maintenance of information in electronic form. The Aadhaar initiative aims at setting up a system for identifying beneficiaries of government sponsored schemes. Under the initiative, biometric details of the beneficiaries, such as retina scan and fingerprints, are collected and stored by the government. The government has also introduced a Bill in Parliament creating a right to electronic service delivery. As per news reports, a draft DNA Profiling Bill is also in the pipeline.
